chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Extreme shoulder pain, could not move arm, still run a temperature (low grade) every night. Have some more movement now - still need help getting dressed. Still extreme pain. ER gave Hydrocodone/Acetaminophen, Ondansetron. Dr. visit three days later, take TYLENOL, another visit - got TRAMADOL. Exhausted, loss of appetite, lost weight, nights are terrible - even with pain pills - no sleep because of pain.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Activities of daily living impaired, Body temperature increased, Decreased appetite, Fatigue, Insomnia
Clinical narrative: Extreme shoulder pain, could not move arm, still run a temperature (low grade) every night. Have some more movement now - still need help getting dressed. Still extreme pain. ER gave Hydrocodone/Acetaminophen, Ondansetron. Dr. visit three days later, take TYLENOL, another visit - got TRAMADOL. Exhausted, loss of appetite, lost weight, nights are terrible - even with pain pills - no sleep because of pain.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Weight decreased
Clinical narrative: Extreme shoulder pain, could not move arm, still run a temperature (low grade) every night. Have some more movement now - still need help getting dressed. Still extreme pain. ER gave Hydrocodone/Acetaminophen, Ondansetron. Dr. visit three days later, take TYLENOL, another visit - got TRAMADOL. Exhausted, loss of appetite, lost weight, nights are terrible - even with pain pills - no sleep because of pain.
Age: 76.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Injection site pain, Nausea, X-ray
Clinical narrative: Extreme shoulder joint pain, could not move arm without occasionally pain. ER visit - prescribed Hydrocodone, took x-rays because of existing fibrosis. Dr. visit 1 week later - still pain in shoulder and arm. Prescribed TRAMADOL. Still has dull ache in joint and arm, pain is bad at night.
Age: 76.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Arthralgia, Chest X-ray, Pain, Pain in extremity
Clinical narrative: Extreme shoulder joint pain, could not move arm without occasionally pain. ER visit - prescribed Hydrocodone, took x-rays because of existing fibrosis. Dr. visit 1 week later - still pain in shoulder and arm. Prescribed TRAMADOL. Still has dull ache in joint and arm, pain is bad at night.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Headache, fever, nausea.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Headache, Lumbar puncture normal, Pruritus, Pyrexia, Somnolence
Clinical narrative: Headache, fever, nausea.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Headache, fever, nausea.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, nausea.
Age: 0.18
Sex: F
Vaccine: DTAPH
Symptoms: Crying, Eating disorder, Hypotonia, Pyrexia, Respiration abnormal
Clinical narrative: Fever, 90+ hours of crying, cessation of eating, voiding, going limp, sporadic breathing.
Age: 0.18
Sex: F
Vaccine: DTAPH
Symptoms: Urinary retention
Clinical narrative: Fever, 90+ hours of crying, cessation of eating, voiding, going limp, sporadic breathing.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Atrophy, Blood pressure increased, Computerised tomogram, Electronystagmogram, Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no medical history and drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 lot # 1947AA expiry date-20-OCT-2013, in the right arm. On 01-OCT-2013 the patient experienced injection felt like an electric shock and with in hours site became red, swollen and warm. The injection site became hard and size of a lemon. The patient iced her arm and took ADVIL which did not do anything. The patient stated that pain is worse at night and causes difficulty sleeping. The patient had seen an unspecified neurologist, who prescribed her Gabapentin. The patient had decreased mobility of injection arm and despite pain subsiding activity causes flare-ups. In addition blood pressure is increased, causing an unspecified physician to increase her treatment of Atenolol, amlodipine, Losartan. On 03-APR-2014 the patient had limb and muscle weakness and significant loss of use of her arm (disability). The reporter stated that the patient might have some atrophy. Investigations included CAT scan (unknown date): unknown results and ENG (unknown date): unknown results. The outcome of significant loss of use of her arm, she may have some atrophy, activity causes flare-ups, decreased mobility of injection arm, difficulty sleeping, pain is worse at night, injection site became hard and size of a lemon, site became red, swollen and warm, injection felt like an electric shock, she had limb and muscle weakness and blood pressure is increased is unknown. The causality assessment was not provided. No product quality compliant was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no medical history and drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 lot # 1947AA expiry date-20-OCT-2013, in the right arm. On 01-OCT-2013 the patient experienced injection felt like an electric shock and with in hours site became red, swollen and warm. The injection site became hard and size of a lemon. The patient iced her arm and took ADVIL which did not do anything. The patient stated that pain is worse at night and causes difficulty sleeping. The patient had seen an unspecified neurologist, who prescribed her Gabapentin. The patient had decreased mobility of injection arm and despite pain subsiding activity causes flare-ups. In addition blood pressure is increased, causing an unspecified physician to increase her treatment of Atenolol, amlodipine, Losartan. On 03-APR-2014 the patient had limb and muscle weakness and significant loss of use of her arm (disability). The reporter stated that the patient might have some atrophy. Investigations included CAT scan (unknown date): unknown results and ENG (unknown date): unknown results. The outcome of significant loss of use of her arm, she may have some atrophy, activity causes flare-ups, decreased mobility of injection arm, difficulty sleeping, pain is worse at night, injection site became hard and size of a lemon, site became red, swollen and warm, injection felt like an electric shock, she had limb and muscle weakness and blood pressure is increased is unknown. The causality assessment was not provided. No product quality compliant was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Muscular weakness, Musculoskeletal disorder, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no medical history and drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 lot # 1947AA expiry date-20-OCT-2013, in the right arm. On 01-OCT-2013 the patient experienced injection felt like an electric shock and with in hours site became red, swollen and warm. The injection site became hard and size of a lemon. The patient iced her arm and took ADVIL which did not do anything. The patient stated that pain is worse at night and causes difficulty sleeping. The patient had seen an unspecified neurologist, who prescribed her Gabapentin. The patient had decreased mobility of injection arm and despite pain subsiding activity causes flare-ups. In addition blood pressure is increased, causing an unspecified physician to increase her treatment of Atenolol, amlodipine, Losartan. On 03-APR-2014 the patient had limb and muscle weakness and significant loss of use of her arm (disability). The reporter stated that the patient might have some atrophy. Investigations included CAT scan (unknown date): unknown results and ENG (unknown date): unknown results. The outcome of significant loss of use of her arm, she may have some atrophy, activity causes flare-ups, decreased mobility of injection arm, difficulty sleeping, pain is worse at night, injection site became hard and size of a lemon, site became red, swollen and warm, injection felt like an electric shock, she had limb and muscle weakness and blood pressure is increased is unknown. The causality assessment was not provided. No product quality compliant was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Disability, Herpes zoster, Musculoskeletal disorder, Neuralgia
Clinical narrative: This spontaneous report was received from a female patient of approximately 74 years of age. The patient's current condition included allergy to sulfa. Approximately on an unknown date in 2006 (reported as seven and a half years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration dates were not reported) (dose number, strength, dose and route of administration were not reported). No concomitant medications were reported. On an unknown date in February 2013 the patient developed shingles. The patient stated that it was the worst pain imaginable. The patient was referred to an unspecified neurologist for the treatment. The patient was treated with VALTREX, Prednisone, Gabapentin, oxycodone and another unspecified medication. At the time of the report the patient still had affected nerves in the right arm and she could not use her right arm like she could in the past (disability). There were no lab diagnostic studies performed. The patient was not hospitalized. There was no product quality complaint involved. The patient also reported that the doctor stated to her that 5 patients had developed shingles after receiving ZOSTAVAX 7 years ago (approximately in 2007) (MARRS ID 1404USA005449). The patient and the physician wanted to know if there should be a booster dose of ZOSTAVAX given to the patients after a certain period of time. The outcome of the events was reported as recovering. The causality of the events was unknown. This case is linked to case # 1404USA005449 via the same reporter link. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pain in extremity
Clinical narrative: My arm started to hurt about 5 min after vaccine. Got a little better after 10 min. Last night the pain to progressed to severe and still very painful.
Sex: U
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report as received from health department Alert of 01-APR-2014, refers to 4 adult patients. On an unknown date the patients experienced measles. The patients were previously vaccinated with measles, mumps, and rubella virus vaccine, (manufacturer unknown) (lot#, dose and route not reported). The outcome of measles was unknown. Total 25 measles cases were reported in the Alert. Six cases had been hospitalized. Five cases (including this case, the other case was captured in MARRS 1404USA005179) were confirmed as vaccinated with MMR vaccine before. It was not reported which cases among the 25 cases the hospitalized cases refer to. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report as received from health department Alert of 01-APR-2014, refers to a 2 year old patient. On an unknown date the patient experienced measles. The patient was vaccinate with the first dose of measles, mumps, and rubella virus vaccine, (manufacturer unknown) (lot #, dose and route not reported) before exposure. The outcome of measles was unknown. Total 25 measles cases were reported in the Alert. Six cases had been hospitalized. Five cases (including this case, other four cases was captured in MARRS 1404USA006359) were confirmed as vaccinated with MMR vaccine before. It was not reported which cases among the 25 cases the 6 cases hospitalized cases refer to. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. Th reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005559, 1404USA005561, 1404USA005562 and 1404USA005563) from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (Merck) (lot#: J014328, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005559, 1404USA005560, 1404USA005562 and 1404USA005563) from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Neck pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. On an unknown date after receiving the vaccination the patient developed neck pain and has a possible diagnosis of torticollis. The patient sought medical attention by visiting the physician's office. The outcome of patient developed neck pain and has a possible diagnosis of torticollis is unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient has drug reactions/allergies with penicillin. There was no pertinent medical history reported. On 25-MAR-2014, some where around 10:15am-10:30am, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot# J008435, expired date 11-OCT-2014. No concomitant medications reported. It was reported that after vaccination on 25-MAR-2014 the patient experienced baseball size raised area that was bright red at the injection site and it was warm to touch and also had headache at the same day night (25-MAR-2014). The over the counter unspecified cortisone cream was given as treatment for the adverse events. The patient sought medical attention (patient called pharmacist). Lab diagnostics were reported as none. The outcome of the events warm to touch, baseball size raised area that was bright red at the injection site and headache was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to a patient of unknown age and gender. No medical history or current conditions were reported.On 01-APR-2014 the patient was inadvertently vaccinated with MMR II (lot # 0233AE, expiration date 26-JAN-2014) 0.5 ml, subcutaneously for unknown indication. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dehydration, Influenza like illness, Influenza virus test positive
Clinical narrative: No adverse effects reported from immz, however child was admitted to hospital 4/10/14 w/ flu like sym and tested positive for flu. Treated for dehydration etc...unsure if child is still in hospital or discharged.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005560, 1404USA005561, 1404USA005562 and 1404USA005563) from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via company representative refers to four patients of unspecified demographics. Patients medical history, drug allergies and reactions were unspecified. On an unknown date in 2008 (reported as sometimes in 2008), the patients were vaccinated with VARIVAX injection (dose, frequency, lot number and expiry date were unspecified) for prevention of chicken pox. It was reported that age of all four patients was appropriate to receive VARIVAX vaccine. Concomitant therapy was unspecified. On an unknown ate, all four patients developed mild chickenpox. All four patients sought medical attention, they visited physicians office. No product quality complaint was involved. The outcome of event milk chickenpox was reported as recovered (on an unspecified date). The reporters causality assessment for the event mild chickenpox with the therapy of VARIVAX was not reported. Additional information is not expected.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Balance disorder, Decreased appetite, Irritability, Poor quality sleep
Clinical narrative: Fussiness, loss of balance when walks. Not sleeping well, poor appetite, no fever, no rash, no local reaction - was admitted to hosp next day. Symptoms got worse.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Balance disorder, Blepharospasm, Central nervous system inflammation, Decreased appetite, Hemiparesis
Clinical narrative: Fussiness, loss of balance when walks. Not sleeping well, poor appetite, no fever, no rash, no local reaction - was admitted to hosp next day. Symptoms got worse.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Insomnia, Irritability, Pain
Clinical narrative: Fussiness, loss of balance when walks. Not sleeping well, poor appetite, no fever, no rash, no local reaction - was admitted to hosp next day. Symptoms got worse.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, (lot number unknown) subcutaneous at 12 months of age. Approximately one year later, she developed shingles on an unspecified date. The outcome of shingles is unknown. Unspecified medical attention was sought via office visit. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (Merck) (lot#: J005177, expiration date: 03-NOV-2014) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005558, 1404USA0055589, 1404USA005560, 1404USA005561, 1404USA005562 and 1404USA005563) from the same source. Additional information has ben requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions and drug reactions/allergies were reported. On 04-APR-2014 the patient was vaccinated with VARIVAX lot # 0414AE expire date 27-FEB-2014 dose 2, 0.5 ml, subcutaneous. No concomitant medications were reported. It was reported that the patient was administered with an expired dose (expire date 27-FEB-2014) of VARIVAX on 04-APR-2014. The reporter also noted that the patients first dose was given a long time ago on an unspecified date and this expired dose would have been the patients second dose of VARIVAX given. No adverse effect reported. The patients sought medical attention was not reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 5 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1403USA005558, 1404USA005559, 1404USA005560, 1404USA005561 and 1404USA005562) from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 were exposed to unspecified temperature excursion not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005559, 1404USA005560, 1404USA005561 and 1404USA005563) from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 5 year old patient unknown of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J005177, expiration date: 03-NOV-2014) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005559, 1404USA005560, 1404USA005561, 1404USA005562, and 1404USA005563) from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Lot# not reported)(dose, frequency and route unspecified by the reported). No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient received a dose of improperly stored VARIVAX on 07-APR-2014. No adverse event reported. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Aches, fever, weakness.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Exposure during pregnancy, Insomnia, Pain, Pain in extremity
Clinical narrative: Left arm intolerable pain. Inability to lift arm without significant  strain/pain. Inability to sleep on left slide due to excruciating pain. Inability to sleep due to inability to sleep on left side (33 weeks pregnant).
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Uncontrollable crying for 2 hours starting at 6:00 pm. Mother reports child cried for 3 hours uncontrollably after 1st dose of DTaP. Reports father was changing diaper, touched child's leg, and crying started. Crying stopped 30 minutes after parents gave child ibuprofen. Mother reports she gave child ibuprofen 1 hour before vaccinations were given this time, and child cried anyways for 2 hours uncontrollably starting at 6:00pm. Encouraged mother to contact child's provider to report both reactions. Mother reports infant is well after crying stopped with no other problems. Mother reports no redness, swelling, heat, or pain at injection sites, and reports child has no fever. Reports there was no redness, swelling, heat, or fever with 1st injections either.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash outbreak on tailbone, much worse than previous outbreaks which were considered minor per patient.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Secretion discharge, Swelling
Clinical narrative: Redness, swelling, drainage, reported blisters, itching. Worse 04/11/2014.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Agitation, Blood electrolytes, Blood gases, Blood glucose, Chest X-ray
Clinical narrative: Gray color, diaphoretic, 80% O2 SAT, agitated, coughing, yelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Hyperhidrosis, Screaming, Skin discolouration
Clinical narrative: Gray color, diaphoretic, 80% O2 SAT, agitated, coughing, yelling.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema abnormal, Intussusception
Clinical narrative: Patient had routine 2-mo immunizations on 3/24/14 -> admitted to hospital for intussusception on 3/29/14 and treated successfully via barium enema.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Received Tdap, Varicella and MENVEO on 4/8/14. On 4-10-14 Right arm was swollen, red hard and warm to touch. Took ADVIL and BENADRYL. 4-11-14 AM symptoms had improved.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Disturbance in attention, Dizziness, Dyspnoea, Erythema
Clinical narrative: Swelling, redness to (L) arm, itching all over, rash on back, dizziness/lightheaded, difficulty concentrating, chills, shortness of breath. Treatment: MEDROL dose pack, Triamcinolone cream.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Pruritus generalised, Rash
Clinical narrative: Swelling, redness to (L) arm, itching all over, rash on back, dizziness/lightheaded, difficulty concentrating, chills, shortness of breath. Treatment: MEDROL dose pack, Triamcinolone cream.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with PEDVAX HB (lot # and expiration date not reported) (dosing regimen and frequency unknown) which was exposed to temperatures outside the prescribing information. No concomitant medications were reported. No adverse events were reported. This case is linked to case number 1403USA007008 and 1403USA005427. Follow up information as received for PEDVAX HB, lot # H015034, expiration date 19-DEC-2014. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain upper, Pyrexia, Vomiting
Clinical narrative: Stomach ache on 4-7, vomiting x3 on 4-9, fever of 99 to 100 from 4-9 to 4-11.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mom brought patient in 48 hours after vaccination complaining of swelling and redness in the childs right leg. Swelling was around the site as well as redness surround about 10 inches away from vaccine site. Child state the area had been itchy and it hurt.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy test positive, Decreased appetite, Dizziness, Dyspnoea, Food allergy
Clinical narrative: THE DAY AFTER I STARTED WITH HEAT FLASHES I WAS NOT HUNGRY AND FELT LIKE FAINTING. ON FRIDAY THE 29 MY HEAT FLASHES STOP AROUND 10 AM. I DECIDED TO EAT BUT WASNT REALLY HUNGRY AT AROUND 3-4 I WENT TO GET ORANGE CHICKEN AND A FEW MINUTES LATER I GOT AN ALLERGIC REACTION ON MY LIPS TWO DAYS LATER I GOT HIVE ALL OVER MY LEGS TO A TRADITIONAL MEAL I HAVE ALWAYS HAD IN THE PAST AND AFTER THE FLU SHOT I HAVE BEEN GETTING ALLERGIC REACTIONS TO EVERYTHING I EAT WHICH THEY HAVE BECOME SEVERE NOW AND ITS AFFECTING MY BREATHING.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Hot flush, Hypersensitivity, Urticaria
Clinical narrative: THE DAY AFTER I STARTED WITH HEAT FLASHES I WAS NOT HUNGRY AND FELT LIKE FAINTING. ON FRIDAY THE 29 MY HEAT FLASHES STOP AROUND 10 AM. I DECIDED TO EAT BUT WASNT REALLY HUNGRY AT AROUND 3-4 I WENT TO GET ORANGE CHICKEN AND A FEW MINUTES LATER I GOT AN ALLERGIC REACTION ON MY LIPS TWO DAYS LATER I GOT HIVE ALL OVER MY LEGS TO A TRADITIONAL MEAL I HAVE ALWAYS HAD IN THE PAST AND AFTER THE FLU SHOT I HAVE BEEN GETTING ALLERGIC REACTIONS TO EVERYTHING I EAT WHICH THEY HAVE BECOME SEVERE NOW AND ITS AFFECTING MY BREATHING.
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received on 08 April 2014 from a non health care professional. A female patient (now 23 years of age and date of birth not reported) had received as a child DTaP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an anaphylactic reaction to pertussis of the DTaP vaccine and was hospitalized for several days. According to the reporter, the individual was not a patient of their practice and they had no further information to provide regarding the situation and asked for no further contact regarding the situation. The patient's outcome was recovered. Documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: Influenza like illness, Occupational exposure to product
Clinical narrative: Initial case received on 01 April 2014 from a health care professional. A patient (date of birth, age and gender not reported), with no reported medical history and no reported concomitant medication, experienced severe flu like symptoms following the administration of IMOVAX rabies (lot number J1391, expiry date: 26 July 2015) in the context of a professional exposure on an unspecified date. Time to onset, site and route of administration were not reported. The outcome of the event was not reported. Further information will be requested from the reporter. Documents held by sender: none.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an immunocompromised male patient in his 60s. In approximately 2012, reported as two years ago, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. The physician reported that on approximately 30-MAR-2014 (10 days ago), the patient was diagnosed at an unspecified urgent care facility with shingles of the shoulder. The patient was prescribed an unspecified antiviral medication and was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a female patient of unknown age. On 04-MAR-2014 the patient was vaccinated intramuscularly with the first unspecified dose of GARDASIL (lot number and expiration date not reported). On 04-APR-2014 the nurse practitioner called the patient to remind her that her next dose of GARDASIL was due. The patient told the nurse that she was 2 months pregnant. The method used for determining that the patient was pregnant was unspecified. No known adverse effects. The patient became pregnant with Last Menstrual Period (LMP) in February 2014. Initial exposure to GARDASL was at 3 weeks. The pregnancy outcome was pending. Additional information has ben requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 2 month old patient (gender unspecified). On 01-APR-2014, the patient was vaccinated with first dose of ROTATEQ vial, oral, (dose and frequency unspecified) (lot number J001815 expiry date 06-JUN-2014) which had been exposed to 0 Celsius (C) for 102.25 hours. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint involved. The outcome of received first dose of ROTATEQ which had been exposed to 0 Celsius (C) for 102 hours was unknown. No further information reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Local swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Right arm swelling, redness, itching, painful at vaccine site. Bicep swollen. Notes fingers were swollen in the A.M.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Approximately 3 weeks ago developed rash on face, no itching - stopped using acne medication cream from dermatologist. Has been applying baby powder to face. No fever and no rash, exception face and chin. Took to Dr to see rash, told to apply hydrocortisone 1% ointment and call dermatologist. 4/3/2014 Td to client, states she used ointment for few days and rash disappeared.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt states arm still hurts 45 days after vaccine.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed 4 x 6 cm area of swelling and redness on (L) thigh.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Skin discolouration
Clinical narrative: 3 hours after vaccination "everything went black" which lasted a couple seconds. Then patient states her face was purple, which lasted 5-6 hours. After this time no other symptoms occurred.
Age: 48.0
Sex: F
Vaccine: YF
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site, numbness in (R) arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin normal, Blister, Blood test normal, Chapped lips, Cheilitis
Clinical narrative: Case number PHEH2014US007035, is an initial spontaneous report from a consumer received on 08 Apr 2014. This report refers to a 70-year-old female patient. Past medical history included allergic to dust, dust mites, weeds, grass, mold and cats. She was not allergic to any foods. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date at the end of Jan 2014. One to two days after vaccination she experienced sneezing, runny nose and her eyes were weeping. Later her eyes on the rim began to itch badly. Approximately four days after vaccination, lips became very swollen (three times of normal size), chapped, and peeled. Also her lips are burned, raw, itching, stung with blisters and continue to ooze lymphatic fluid. It was reported that couple of days her symptoms diminish but the symptoms continue to recur. She met her primary health care profession three times. She was on a six day regimen of prednisone. She had a relief for three days and in the evening of the fifth day on prednisone symptoms returned. She saw a dermatologist and had skin biopsy; result was negative. Also had a blood work done which was negative. The outcome of the events sneezing, runny nose, eyes weeping and eyes itching was recovered. The outcome of the rest of the events was unknown. The seriousness and causality was not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Eyelids pruritus, Lip exfoliation, Lip pruritus, Lip swelling
Clinical narrative: Case number PHEH2014US007035, is an initial spontaneous report from a consumer received on 08 Apr 2014. This report refers to a 70-year-old female patient. Past medical history included allergic to dust, dust mites, weeds, grass, mold and cats. She was not allergic to any foods. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date at the end of Jan 2014. One to two days after vaccination she experienced sneezing, runny nose and her eyes were weeping. Later her eyes on the rim began to itch badly. Approximately four days after vaccination, lips became very swollen (three times of normal size), chapped, and peeled. Also her lips are burned, raw, itching, stung with blisters and continue to ooze lymphatic fluid. It was reported that couple of days her symptoms diminish but the symptoms continue to recur. She met her primary health care profession three times. She was on a six day regimen of prednisone. She had a relief for three days and in the evening of the fifth day on prednisone symptoms returned. She saw a dermatologist and had skin biopsy; result was negative. Also had a blood work done which was negative. The outcome of the events sneezing, runny nose, eyes weeping and eyes itching was recovered. The outcome of the rest of the events was unknown. The seriousness and causality was not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort, Rhinorrhoea, Secretion discharge, Sneezing
Clinical narrative: Case number PHEH2014US007035, is an initial spontaneous report from a consumer received on 08 Apr 2014. This report refers to a 70-year-old female patient. Past medical history included allergic to dust, dust mites, weeds, grass, mold and cats. She was not allergic to any foods. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date at the end of Jan 2014. One to two days after vaccination she experienced sneezing, runny nose and her eyes were weeping. Later her eyes on the rim began to itch badly. Approximately four days after vaccination, lips became very swollen (three times of normal size), chapped, and peeled. Also her lips are burned, raw, itching, stung with blisters and continue to ooze lymphatic fluid. It was reported that couple of days her symptoms diminish but the symptoms continue to recur. She met her primary health care profession three times. She was on a six day regimen of prednisone. She had a relief for three days and in the evening of the fifth day on prednisone symptoms returned. She saw a dermatologist and had skin biopsy; result was negative. Also had a blood work done which was negative. The outcome of the events sneezing, runny nose, eyes weeping and eyes itching was recovered. The outcome of the rest of the events was unknown. The seriousness and causality was not reported.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Decreased appetite, Exposure during pregnancy, Fatigue, Injection site pain
Clinical narrative: Sore muscles, whole body Tenderness at injection site Fatigue, general weakness Lack of appetite Slight nausea
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea
Clinical narrative: Sore muscles, whole body Tenderness at injection site Fatigue, general weakness Lack of appetite Slight nausea
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Rash macular
Clinical narrative: raised erythematous macular rash with burning and itching measuring 14 by 10 cm with 10 cm clear fluid filled vesicle in center
Age: 1.01
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient presented to Hospital ER via EMS with concern for febrile seizure that occured earlier that day.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Temperature 100.8 and Slightly Fussy. Mom gave Tylenol 2.5 ML every 4 hrs as needed.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reports developing intermittant pain in shoulder and arm of injection arm
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports developing intermittant pain in shoulder and arm of injection arm
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Pt experienced fever up to 100.1 degrees, unconsolable crying and vomiting. Pt was treated with TYLENOL for the fever.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Aphasia, Headache, Laboratory test, Nuclear magnetic resonance imaging, Pain
Clinical narrative: 04/04/14 client reports that by evening of vaccination day she was feeling achy with a mild, continual headache. She did not have a fever and did report taking ADVIL helped. Encouraged client to continue taking ADVIL if she was able to, drink fluids and get some rest. If symptoms continued enc. client to seek medical care. 04/07/14 follow up call to client. Reports not a lot of change. Low grade fever of 99 degrees F. Has appt to see her primary care provider. 04/11/14 follow up call client reports provider thought it was a prolonged reaction to vaccination. Cont. with ADVIL. Reports though that 04/09/14 evening she developed aphasia x2 nights (Wed and Thurs) and was taken to ED. Stayed the night and had various tests performed: MRI, USounds, etc. to r/o stroke. All tests came up inconclusive. She was told that it was possibly TIA. Is following up with ophthalmologist today. No longer has body aches and has less of a headache today.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: 04/04/14 client reports that by evening of vaccination day she was feeling achy with a mild, continual headache. She did not have a fever and did report taking ADVIL helped. Encouraged client to continue taking ADVIL if she was able to, drink fluids and get some rest. If symptoms continued enc. client to seek medical care. 04/07/14 follow up call to client. Reports not a lot of change. Low grade fever of 99 degrees F. Has appt to see her primary care provider. 04/11/14 follow up call client reports provider thought it was a prolonged reaction to vaccination. Cont. with ADVIL. Reports though that 04/09/14 evening she developed aphasia x2 nights (Wed and Thurs) and was taken to ED. Stayed the night and had various tests performed: MRI, USounds, etc. to r/o stroke. All tests came up inconclusive. She was told that it was possibly TIA. Is following up with ophthalmologist today. No longer has body aches and has less of a headache today.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swollen upper left thigh. Rx for KEFLEX 250 mg/5mL 1 tsp p.o. tid for 7 days.
Age: 17.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, IPV, TD
Symptoms: Incorrect storage of drug
Clinical narrative: Temp in the refrigerator was 19 degrees C for approx. 2 hrs. Action recalled client.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Incorrect storage of drug
Clinical narrative: Temp in the refrigerator was 19 for approx 2hrs. Action recalled client.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning two patients of unknown age and gender who on 28-MAR-2014 were vaccinated with MMR II lot # 0649AE, 0.5 ml, subcutaneous that had expired on 27-MAR-2014. No adverse events were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEP, HEPA, HPV4, IPV, MMRV, MNQ, TDAP
Symptoms: Incorrect storage of drug
Clinical narrative: Temp in the refigerator below 1.9 for apprx. 2 hrs. Action recalled client.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warmth to left arm 3 1/2 inch x 3 inch. Given KEFLEX (250/g) 8ml PO TID x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Back pain, Pyrexia
Clinical narrative: Fever and Back Pain after vaccines. Dad gave Tylenol.
Sex: M
Vaccine: HEP
Symptoms: Full blood count, Premature baby, Rash generalised, White blood cell count decreased
Clinical narrative: Rash all over the body. No fever. Delivered at 37 weeks gestation. WBC showed few WBC. Given NEUPOGEN. Dr did not document that this was a vaccine reaction at the time. Mom call me on 4/07/2014 the Director of the unit now to ask me to report this as an adverse reaction as she feels that is what it was at that time. I do not believe the hospital would have report at that time since the provider did not state it as a reaction. The provider stated to the mother that he felt this was an in utero occurrence. The baby was early so it is difficult to speak to if the baby required longer hospitalization or not. No disabilities stated by mom when she recently called.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea, lack of energy, severe arm soreness.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Influenza like illness, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Over a period of week, painful swollen lymph nodes in right armpit, right jaw and left back of head. Treated with ibuprofen. Over a period of several days, sore ankle, knee, hip joints. Treated with ibuprofen. Mild flu like symptoms and low-grade fever.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Conjunctivitis infective, Cough, Headache, Myalgia
Clinical narrative: Muscle ache and pains. Slight fever, nausea, vomiting. Headache weakness. Pink eye. Runny nose, severe coughing.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Rhinorrhoea, Streptococcus test negative, Vomiting
Clinical narrative: Muscle ache and pains. Slight fever, nausea, vomiting. Headache weakness. Pink eye. Runny nose, severe coughing.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth, Local swelling
Clinical narrative: Pain at injection site. Swelling of upper arm. Red welt at injection site with redness spreading away from injection site over the course of the following 2 days. Warmth at injection site and surrounding areas.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymphadenopathy, Oropharyngeal pain, Rash
Clinical narrative: 12 days after vaccine administered, bumps present on forehead, neck, shoulders and chest. Swollen lymph nodes behind ears and neck. Sore throat and fatigue also.