Adverse events following drug administration
Abscess formation at the site of inoculation
Acute encephalopathy
Acute disseminated encephalomyelitis (ADEM )
Acute flaccid paralysis
Anaphylaxis
Anaphylactoid reaction
Angioedema
Arthritis
Asthma ‰
Autism spectrum disorders
Autoimmune disorders (SLE, Lupus like syndrome, vasculitis, polyarteritis nodosa)
Bell’s palsy
Brachial neuritis
Brain damage (Permanent)
Bronchospasm
Bleeding/bruising
Breath-holding spells.
Cerebellar ataxia
Chronic fatigue syndrome
Colitis (Nonspecific colitis)
Congenital anomalies
Convulsions
Crying: Persistent inconsolable screaming for more than 3 hours
Deafness
Deaths -Cot death ., Sudden death (cot death/ sudden infant death syndrome)
Dermatological problems: Generalized skin reactions, urticaria, pruritis, nonspecific rash
Diabetes mellitus
dissemination of infection
Dizziness
Encephalopathy,
Epilepsy
Erythema nodosum ™
Eye problems
Fainting
Febrile seizures
Flu-like symptoms
Generalized weakness
Granuloma formation
Guillain-Barré syndrome
Headache
Hemolytic anemia
Hemolytic uremic syndrome
Herpes zoster
Hypersensitivity reactions
Hypertrophic scar
Hypotonic hyporesponsive episodes (HHE)
Idiopathic thrombocytopenic purpura
Immune deficiency
Infantile spasms
Inflammatory bowel disease
Irritability
Itching all over
Kidney problems: Vasculitis with transient renal involvement
Joint pain
Keloid formation
Knee joint arthritis
Leukemia
Learning disorders
Lupus like symptoms.
Lupus vulgaris
Lymphadenopathy ™
Malaise ™
Meningoencephalitis
Multiple sclerosis
Numbness
Neurodevelopmental disorders
Neuroregression
Oculo respiratory syndrome: Red eyes, cough, sore throat, hoarseness
Optic neuritis
Osteitis
Osteomyelitis
Pagets disease
Peripheral neuropathy
Polyneuritis
Psychiatric disorders
Retrobulbar neuritis
Reye’s syndrome
Scrofuloderma
Seizure (Jerking or staring)
Somnolence.
Stevens-Johnson syndrome
Subacute scelerosing panencephalitis (SSPE)
Syncope
Systemic lupus erythematosus
Thrombocytopenia
Tinnitus
Toxic shock syndrome (TSS)
Transverse myelitis
Ulcer – ™ Local nonhealing ulcer
Urticaria ™
Vaccine-induced poliomyelitis or Vaccine associated paralytic poliomyelitis (VAPP)
vaccine derived polio virus
Vertigo
Visual disturbances
Viscerotropic disease ™ Yellow fever vaccine associated viscerotropic disease (YEL-AVD) ™ Yellow fever vaccine associated neurotropic disease (YEL-AND).
pneumonia, encephalitis, meningitis, hepatitis are common in individuals with immunodeficiency
( Diseases highlighted in Red were observed by us )
1)Side Effects of Drug X 1 Injection
Local: Abscess formation at the site of inoculation
Granuloma formation
Hypertrophic scar
Keloid formation
Lupoid reactions
Lupus vulgaris
Local non-healing ulcer
Necrosis.
Regional – adenitis
Systemic – Disseminated infections
2)Complications of oral Drug 2 :
Vaccine associated paralytic poliomyelitis (VAPP):
Emergence of vaccine derived polio virus:
Vaccine-induced poliomyelitis or vaccine associated paralytic poliomyelitis can occur even 6 months after the immunization.
3)Side Effects of Drug X 3
Mild side effects are: Local: Pain, soreness, induration and erythema at local site
Systemic: Anaphylaxis
Fever
Headache
Irritability
Joint pain
Loss of appetite
Lymphadenopathy
Myalgia
Nausea.
Serious side effects of Drug X 3
Anaphylaxis (Rare)
Autoimmune disorders (SLE, Lupus like syndrome, vasculitis, polyarteritis nodosa)
Alopecia
Arthritis, arthralgia of knee joint (monoarticular)
Anorexia
Bell’s palsy
Chronic fatigue syndrome
Convulsions
Diabetes Type I
Diarrhea
Demyelinating neurological disorders
Eye problems
Ear ache
Eczema
Erythema multiforme
Fever
Guillain-Barré syndrome
Headache
Hypersensitivity
Hypotension
Hypotensive-hyporesponsive episode
Inflammatory polyneuropathy
Irritability
Insomnia
Juvenile idiopathic arthritis/Rheumatoid arthritis
Keratitis
Leukoencephalitis
Lupus
Multiple sclerosis
Myalgia
Myasthenia gravis
Numbness
Neck stiffness
Optic neuritis
Pharyngitis
Rhinitis-Running nose
Stevens -Johnson syndrome
Somnolence
Syncope
Tinnitus
Thrombocytopenia
Transverse myelitis
Uveitis
Urticaria
Visual disturbances Vertigo Since the recombinant vaccines contain tiny quantities of yeast proteins, there is a risk of anaphylactic reaction. Vaccines
Vaccine scares of Pertussis whole cell vaccine:
Encephalopathy,
Epilepsy
Learning disorders
Sudden death (cot death or sudden infant death syndrome).
4)Side Effects of Drug X 4 injection
: Local reactions: Redness and swelling General reactions:
Acute encephalopathy
Anaphylactic shock
Autism
Brain damage: Vaccine associated seizures may produce brain damage
Crying: Persistent inconsolable crying for more than 3 hours duration
Deafness
Encephalitis/Encephalopathy: Post-pertussis vaccine encephalopathy
Excessive somnolence
Fever (hyperpyrexia ≥40.5°C)
Generalized seizures (Febrile convulsions)
Generalized collapse
Hyporesponsive hypotensive episodes (HHE) shock like state within 48 hours of DTwP
Induration
Infantile spasms
Local pain
Learning disorders
Prolonged unresponsiveness
Reye’s syndrome
Screaming episodes
Shock
Sudden infant death syndrome (SIDS)
Seizures with or without fever within 72 hours of administration of DTwP
Catastrophic complications of DTwP vaccine:
Sudden infant death syndrome
Autism
Chronic neurologic damage
Infantile spasms
Learning disorders
Reye’s syndrome
Adverse effects of Drug X 5 :
Moderate side effects: Convulsions „ Continuous nonstop crying for 3 hours or more Fever: High fever 105°F or more.
Severe problems: „ Allergic reactions (Serious) „
Brain damage (Permanent) „ Consciousness: Lowered Coma
Convulsions: Long-term seizures
6 ) sIde Effects of Drug X 6 injection
Local reactions—erythema, induration, pain
Allergic reactions
Arthralgia
Agitation
Body ache
Convulsions
Crying
Drowsiness
Emesis
Fever
Hypersensitive
7) sIde Effects of Drug X 7 injection :
Local: Local pain, redness, swelling
Systemic: Fever, loss of appetite, restlessness, excessive crying, vomiting, diarrhea. Mild to moderate side effects: Local: Local pain, swelling, redness will be mild nature and will last for 1–2 days
Systemic: Fever over 101°F, loss of appetite, restlessness, excessive crying, vomiting, and diarrhea The above symptoms are mild and self-limiting. Severe side effects: Severe allergic reactions Guillain-Barré syndrome.
scares: Diabetes mellitus
8) Side effects of Drug X 8 injection:
Break through infection
9) Side effects of Drug X 9 injection:
Mild side effects: Local: Local pain, induration, swelling, redness, and tenderness will be mild nature and will last for 1–2 days
Systemic: appetite lost Anaphylaxis Breathing problems—wheezing Excessive crying „Diarrhea Drowsiness Emesis (Vomiting)
Rarely: Febrile convulsions Breath-holding spells.
severe side effects: Severe allergic reactions Fever with fits Hives.
Rarely:
GBS
Anaphylaxis
Breathing problems
Circulatory problems
Relapse of ITP.
10) Side effects of oral Drug X 10 :
Mild side effects: Irritability , Mild diarrhea or vomiting , Pyrexia , Otitis media.
Severe side effects or complications:
Allergy—rash
Apnea—risk of apnea is present; monitoring for 48–72 hours is advised
Abdominal pain or cramps
Appetite—loss of appetite
Anaphylaxis
Breathing difficulty (chest tightness, feeling short of breath)
Black out
Burning micturition
Bronchiolitis
Bronchopneumonia
Convulsions
Crying
Chest pain (stabbing in nature)
Dizziness
Diarrhea (severe)
Ear pain (Otitis media)
Emesis (Vomiting )
Flatulence Fever
Fatigue
Gastroenteritis
Gastric regurgitation of food
Hematochezia
Hand swelling
Heart rate increased
Irritability
Intussusception within a week was reported even with the currently available vaccines. There is an increased risk of intussusception in children receiving this drug
Kawasaki disease.
11)Side Effects of Drug X 11 injection
Minor reactions: Allergy—skin rash
Burning sensation at the site of injection
Blistering at the site of injection
Catarrh
Diarrhea
Erythema
Emesis
Fever (over 103°F ) with rash after 5–7 days
Major reactions:
Anaphylaxis/allergic reactions (Urticaria)
Angioneurotic edema
Bruising
Bronchial spasm
Convulsions
Double vision
Encephalitis/encephalopathy
Erythema multiforme
Febrile convulsions in children with fever
Gastrointestinal disorders
Hematological—thrombocytopenia, purpura
Stevens-Johnson syndrome
Subacute sclerosing panencephalitis (SSPE).
Serious Complications of Drug X 11 injection
Multiple sclerosis
Exaggeration of tuberculosis
Encephalitis
Toxic shock syndrome due to contamination by Staphylococcus aureus
Systemic lupus erythematosus
Crohn’s disease
Pagets disease
Shift of epidemiology—occurring in older children with waning immunity for which some are proposing another dose at 12–15 Years
Side Effects Local: Mild pain and redness at the injection site.
Systemic: Allergic rash Anaphylaxis Arthralgia/Joint pain Aches: Muscle aches Fever (Low grade) Febrile seizure Thrombocytopenic purpura.
12 ) Side Effects of Drug X 12 injection
Allergic reactions (Serious)
Anaphylaxis
Ataxia
brain damage (Permanent)
Bleeding
Blood clotting disorder
Coma
Consciousness level lowered
Colitis (Nonspecific colitis)
Convulsions: Long-term seizures
Cot death/Crib death/SIDS
Deafness
Degeneration—neuroregression
Encephalopathy
Encephalitis: inclusion body encephalitis (IBE)
Fever Fits: Long-term seizures (6–11 days after injection)
Guillain-Barre syndrome
hypersensitivity reaction
Hemolytic uremic syndrome
Inflammatory bowel disease
Idiopathic thrombocytopenic purpura (after 2 weeks of injection)
Joint pain
Lymphadenopathy
Myalgia
Neuroregression
Nodular lymphoid hyperplasia
Ocular palsy
Optic neuritis
Otitis media
Parotid swelling (transient parotitis)
Peripheral neuropathy
Polyneuritis
Rhinitis
Retrobulbar neuritis
Sore throat
Syncope
Thrombocytopenic purpura
Autism: Initially the studies revealed that there is association between injection .
13)Side effects of Drug X 13 injection :
Mild side effects:
Abdominal pain/tenderness
Breathing problems—wheezing
Breast tenderness
Cough
Diarrhea
Emesis (vomiting)
Fever
Fatigue
Generalized weakness
Headache
Irritability
Muscle aches
Nasal congestion
Running nose
Sore throat
Tiredness
Wheezing
Local reactions: Nasal discomfort, stuffy nose, running nose, nasal congestion, loss of smell, red eyes, lacrimation, local reactions
Systemic reactions: Headache, chills, fatigue, sore throat, myalgia, arthralgia, irritability, loss of appetite
Severe side effects:
Allergic reactions/Anaphylaxis (severe life-threatening) „
Brain damage (Permanent)
Coma
Dry eyes
Eye problems like itching
Flu-like symptoms (running nose, sore throat, tiredness, cough, heavy head, etc.)
Guillain–Barré syndrome
Heavy head
Itching all over.
14 ) Side Effects of Drug X 14 injection
Mild side effects: Mild fever, rash, malaise, sore throat Transient arthralgia/arthritis—joint pain in adults Paresthetic pains Thrombocytopenia Peripheral neuropathy. Severe side effects: Acute encephalitis Staphylococcus aureus 1 in 1,000,000 cases with MMR vaccine Meningitis IP occurs in 1 in 30,000 cases with Rubella vaccine.
15) Side Effects of Drug X 15 injection
Mild side effects: ™ Local—local pain, induration, swelling, redness, stiffness, tenderness will be mild nature and will last for 1–2 days ™ Systemic: ™
Appetite: Loss of appetite ™
Allergic reactions: Rash ™
Breathing difficulties ™
Chills ™
Crying: Abnormal ™
Drowsiness ™
Dizziness
Emesis (Vomiting) ™
Fever ™
Febrile or afebrile convulsions ™
Fatigue ™
Fainting ™
Generalized weakness ™
Guillain-Barré syndrome ™
Headache ™
Hemolytic anemia ™
Irritability ™
Joint pain ™
Knee joint arthritis ™
Lymphadenitis/lymphadenopathy ™
Muscle ache ™
Nausea ™
Edema in the injected limbs ™
Paresthesia ™
Radiculoneuropathy ™
Sleep disturbances (Decreased or increased sleep) ™
Serum sickness ™
Serositis ™
Thrombocytopenia ™
Urticaria.
Apnea is common when administered for preterm below 28 weeks of gestation. The vaccine recipient should be monitored for respiratory problems for at least 48–72 hours
16) Side Effects of Drug X 16 injection
Mild side effects: ™ Mild fever ™ Headache in older children ™ pain at local site ™ Redness ™ Swelling ™ Muscle or joint pain.
Severe side effects: ™
Allergic reactions: Serious allergic reactions ™
Brief fainting spells especially in adolescents ™
Chills ™
Diarrhea ™
Edema ™
Fever ™
Guillain-Barré syndrome ™
Hemolysis
17 ) Side Effects of Drug X 17 injection
Adverse Effects ™ Minor: „ Pain „ Swelling „ Fever „ Headache „ Myalgia ™ Serious systemic adverse effects: „
Anaphylaxis „
Hypersensitivity reactions „
Bronchospasm „
Rash „
Urticaria „
Neurologic disorders „
Acute disseminated encephalomyelitis „
Guillain–Barré syndrome (GBS) „
Encephalitis „
Meningoencephalitis
ADEM ™ Viscerotropic disease ™ Drug …………… associated viscerotropic disease Drug ……….. associated neurotropic disease
18 ) Side Effects of Drug X 18 injection
Local—pain, redness, swelling, at vaccination site, injection site papulovesicular eruption ™
Systemic—mild fever, headache, pneumonitis, arthropathy, systemic varicella like rash
Mild side effects: ™ Soreness ™ Swelling ™ Fever mild rash. Moderate side effects: ™ Seizure (Jerking or staring). Severe side effects: ™ Pneumonia ™ Severe brain reactions ™ Low blood count
19 ) Side Effects of Drug X 19 injection
Arthritis ™
Breakthrough varicella ™
CNS infections—meningitis ™
Cerebellar ataxia ™
Dehydration ™
Encephalitis: Post-infectious encephalitis ™
Failure: Vaccine failure especially following first dose/single dose ™
Group A streptococcal infections ™
Herpes zoster can occur both due to vaccine virus and wild virus. Since it is a live form attenuated virus and remains dormant in the dorsal root ganglia, herpes zoster can occur. This also can develop when the person immunized is immunocompromised. This also can occur when the patient develops malignancy.
Infections: Secondary bacterial infections, ……….. pneumonia ™ …………………..infection with or without other organ involvement (pneumonia, encephalitis, meningitis, hepatitis are common in individuals with immunodeficiency) ™
Reye’s syndrome (If aspirin is taken during infection with …………. Avoid salicylates for 6 weeks following this injection ).
20 ) Side Effects of Drug X 20 injection
Side Effects: ™ Pain ™ Erythema ™ Fainting ™ Fever ™ Headache Itching ™ Swelling
Severe Side Effects: „
Allergy/Anaphylaxis „
Blood clots „
Convulsions „
Demyelinating disorders „
Encephalomyelitis „
Fatigue syndrome (Chronic) „
Guillain–Barré syndrome.
Severe adverse reactions: Allergic—severe allergy or anaphylaxis or anaphylaxis like reactions (generalized urticaria or hives, wheezing, swelling of mouth and throat, difficulty in breathing, hypotension, shock.
Vaccines
Why chicken pox vaccine was not used generally?
Although the chicken pox vaccine was developed in Japan in early 1970s, it was not in general use because of the following factors: ‰ Mild nature of chicken pox infection ‰ One infection provides long immunity ‰ Concern regarding incidence of herpes zoster after vaccination. Also WHO had not recommended for inclusion of chicken pox vaccine in the immunization schedule in developing countries.
What is breakthrough varicella?
Breakthrough varicella is defined as varicella developing more than 42 days after immunization and usually occurs 2–5 years following vaccination
Death following vaccination—deaths due to AEFI can be considered. ™ Certain/very likely if it occurs immediately after vaccination and if no other disease or drug is found as the reason. ™ Probable if it happens within a reasonable time after vaccination.
What are the diseases associated with vaccines?
The following diseases are also known to be caused by various vaccines: ‰
Asthma ‰
Autoimmune diseases ‰
Chronic fatigue syndrome ‰
Learning disorders ‰
Increase in criminal activities ‰
Diabetes mellitus ‰
Immunodeficiency.
Many other diseases like dyslexia, autism, cancers are on the rise even though it is said that the standard of living and healthcare has increased. It is important to find if the newly seen disorders are due to drugs also
The allergic reaction may be due to the vaccine antigen, residual animal protein like egg, stabilizers like gelatin, preservatives like thimerosal.
Drugs or vaccination. Encephalitis, encephalopathy, stroke, asthma, autism, SIDS, multiple sclerosis, arthritis, lupus, and blood disorders.
Incidences–The following are few incidences we came across following certain drug……..administration
1)Multiple sclerosis – one of my friend in Chennai developed Multiple sclerosis following an injection which came newly to the market
2) Autism – following an injection
3) Subacute sclerosis pan encephalituis (SSPE ) A 10 year old child at Coimbatore lost his mile stones in reverse order. He was not able to run ,then he was not able to walk after few months. Then he was not able to walk and the not able to stand. Later he was not able to sit ,then not able to rollover. At last he lost social smile . then he went in to vegetative state. Late he died
4) photophobia – a doctor from Salem developed eye problemsfollowing an injection introduced newly in to market . She spent more than 2 lakhs rupees in vain .
5) Tinnitus ./vertigo- a doctor from Salem developed ear problems following an injection introduced newly in to market . She spent more than 2 lakhs rupees in vain .
6) Paralysis – we have seen many cases of paralysis following certain drug ………….
7) Death- a 5 year old boy died at Salem immediately after an injection with …………… Post-mortem revealed anaphylaxis . But it was announced as due to sepsis .
8) Diarrhoea- One Doctor ‘s child from Tirunelveli developed diarrhoea following a drug administration lasted for more than one month
9) Acute Demyelination encephalalomyelitis (ADEM ) .many children developed adem following injection with certain injection ………………./ This was also observed by a Neurologst at Coimbatore
10) Brain damage – many children developed brain damage
11) Guillain–Barré syndrome.
12) Diabetes
13 ) Demyelinating disorders
14)Asthma ‰
15)Autoimmune diseases
16) Anaphylaxis „
17) Flu-like symptoms (running nose, sore throat, tiredness, cough, heavy head, etc.)
18)hypersensitivity reaction
19)Hemolytic uremic syndrome
20)Inflammatory bowel disease
21)Idiopathic thrombocytopenic purpura
22) sudden infant death syndrome – Normal babies died suddenly in the evening or night . History revealed administration of certain injections in the morning. This was seen in Coimbatore
23)Herpes zoster
24)Hypertrophic scar
25)Hypotonic hyporesponsive episodes (HHE)
Antibodies: A Double Edged Weapon Antibodies are formed when a foreign antigen (substance or organism) enters the body. The immune system will recognize them as foreign substance and form antibodies which will destroy them. These antibodies will cause damage to the foreign substance or microorganism. Sometimes the antibodies will be formed against one’s own body cells causing damage to the body cells or organs. There will be mutation in our body cells which may result in malignancy. But the immune system will recognize those cells as foreign and form antibodies against them and destroy them. When the immune system becomes weak in old age or due to AIDS, the cancer cells will not get destroyed and will grow resulting in malignancy. Vaccines will induce antibody production. These antibodies can have nonspecific actions. So it is important to watch for any complications after vaccinations. Antibodies have both beneficial effect and deleterious effect on our body. They will be beneficial when they act against pathogens or cancer cells. At the same time if it acts against one’s own body cells it can modify or destroy the cells. All antibodies can have nonspecific actions which result in damage to other body cells. For example, in Rheumatic fever, antibodies formed against Streptococcus will cause damage to the human tissues including cardiac, nervous, joint tissues, skin, etc. Similarly, the antibodies formed in response to the vaccines will have nonspecific actions thereby causing damage to other body tissues. So it is important to observe for those nonspecific actions and report them to appropriate authorities. Any unacceptable adverse reactions should be recognized and reported so that steps can be taken to prevent those complications in other children getting vaccinated with that particular vaccine. Any adverse event following vaccination with a particular vaccine should be considered as caused by that vaccine unless proved
otherwise. A high index of suspicion is necessary. Also the adverse event need not occur immediately after vaccination, but can occur even after many hours, days, weeks, months or years after vaccination. For example, subacute sclerosing panencephalitis can occur about 7–10 years after measles vaccination
Diseases due to antibodies
Dengue: When we consider Dengue fever, the whole problem is due to the antibodies formed against the Dengue virus. The antibodies will act on the blood vessels and increase the permeability. This will result in extravasation of fluid
Myasthenia gravis
Autoimmune disorders