chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient called within 24 hours of admin and complained of inj site being 'slightly irritated.' Discussed some first aid measures if needed. Told him to call back later that day to check in. He didn't feel it had gotten worse but told him to call back tomorrow if it had.  Another pharmacist on duty (imz pharmacist) took the call on Sunday (48 hours post inj) and didn't realizie the severity of the reaction.  He called his health ins nurse line with concerns of it becoming raised and redness spreading with the skin feeling coarse. He complained of lines of inflammation spreading up toward his neck and down his arm. He did take ibuprofen but didn't feel it was helping.  He appeared at the pharmacy today 2/23 5pm to show a pharmacist his reaction site and it was clearly inflamed and elevated, but he felt it had improved the last 24 hours. The patient was informed we would report the ADR and followed by more discussion about medical attention needed if it didn't improve.  Following up with him tomorrow.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: At injection site patient has quarter sized hard lump under skin and a quarter size red spot that is hot to touch on skin. Redness spread over the next few days.
Age: 1.25
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: Gait disturbance, Injection site swelling, Weight bearing difficulty
Clinical narrative: Swollen R thigh at site of injection and refusal to bear weight x2 days, limp x2 days until time of presentation for limp. No erythema, induration, fevers.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Patient complained of itching within 5 minutes of administration.  Patient was offered Benadryl but declined.  Injection site was examined and showed erythema underneath the bandaid so bandaid was removed.  No other redness was noticed.  Patient was repeatedly checked, denied any dizziness, difficulty breathing, etc., only slight itching at injection site.  Patient again refused Benadryl but was advised to have some on hand if needed.  The following day the patient phoned the pharmacy stating she had a large are of redness (approximately 3"x7" at the injection site) with itching and some bumps.  Patient was advised to seek medical attention if reaction was immediately bothersome or continued to increase or if bumps became blisters with discharge.  Patient sought medical attention 02/24/2015 (48 hours following admistration of immunization) with ordering physician.  Patient was given prescription for Valtrex 500mg 2 tid #42 and Bactrim ds 1 bid #20.  Patient was told she had shingles (contracted from the vaccine).
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Autism
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of Autism in a male patient who received PEDIARIX. On an unknown date, the patient received the 2nd dose of PEDIARIX (unknown). On an unknown date, unknown after receiving PEDIARIX, the patient experienced Autism (serious criteria GSK medically significant). On an unknown date, the outcome of the Autism was unknown. It was unknown if the reporter considered the Autism to be related to PEDIARIX.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Pathology test, Unresponsive to stimuli
Clinical narrative: Patient passed away 2 days after a healthy well baby check up at the office, was found unresponsive, taken to ER where he was declared deceased. Results of pathology still pending.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Gastroenteritis viral, Guillain-Barre syndrome, Paralysis, Syncope, Walking aid user
Clinical narrative: Pt states she had stomach flu in early October and shortly after (10/4/14) she collapsed and was taken to hospital. By the time she arrived at hospital she was experiencing near full paralysis which was later diagnosed as being consistent with Guillain Barre. She spent a total of 5 months in the hospital and rehabilitation facility. She is now home and walking with assistance of walker.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with a dose of ROTATEQ (2 ml, orally, lot# and expiration date were not provided), that underwent a temperature excursion. No adverse effect reported. This case is linked to MARRS# 1502USA009813 (same patient link). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Paraesthesia, Pruritus
Clinical narrative: Itchy, tingly and burning. Redness in the area. Give BENADRYL.
Age: 1.37
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Viral test negative
Clinical narrative: Rash and fever.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site atrophy
Clinical narrative: Atrophy of (L) deltoid.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Left arm red, erythematous and painful.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram normal, Tic
Clinical narrative: Child started having body tics on 12-25-14. Takn to ER.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Eye movement disorder, Febrile convulsion, Irritability, Malaise
Clinical narrative: Patient came to office on 2/22/15 for fever and follow up of a seizure. She has been ill for 5 days with fevers reaching 103 on the first day of the illness. She had some shaking with eyes rolling back on the day following her 6 month vaccines which included PENTACEL, Hep B, PCV13 and ROTATEQ. She was taken to the ER on 2/11/15 where diagnosed with febrile seizure. No work up for the fever was done as the fever was attributed to the vaccines received the day prior. Her mother has been giving her ibuprofen and TYLENOL "around the clock" but she has continued to run fever without any further seizures. Her mother feels she is irritable, not sleeping well and not eating well. She is taking fluids ok without emesis and does better when she has taken a dose of ibuprofen.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Poor quality sleep, Pyrexia, Seizure, Tremor
Clinical narrative: Patient came to office on 2/22/15 for fever and follow up of a seizure. She has been ill for 5 days with fevers reaching 103 on the first day of the illness. She had some shaking with eyes rolling back on the day following her 6 month vaccines which included PENTACEL, Hep B, PCV13 and ROTATEQ. She was taken to the ER on 2/11/15 where diagnosed with febrile seizure. No work up for the fever was done as the fever was attributed to the vaccines received the day prior. Her mother has been giving her ibuprofen and TYLENOL "around the clock" but she has continued to run fever without any further seizures. Her mother feels she is irritable, not sleeping well and not eating well. She is taking fluids ok without emesis and does better when she has taken a dose of ibuprofen.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Listless, Pallor
Clinical narrative: The night after receiving vaccinations, he was noted to have circumoral pallor and listlessness. Taken to ER but didn't go in because he recovered.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Seizure with fever to 102. C. Counted < 5 min, generalized seizures.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patient (age and gender not reported). Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date unspecified number of unspecified patients were all administered PROQUAD (Merck) (dose, route of administration, anatomical location, lot#, expiration date were not reported) that underwent post supported excursion. Concomitant therapies were not reported. No adverse effects were reported by any patients. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.87
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, Full blood count, Rash maculo-papular
Clinical narrative: Hives entire body. Onset - 3 hrs after MMR vaccine. 2/23/15 - playful child and exam: skin - hives maculopap urticar lesion.
Age: 1.87
Sex: M
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate, Urticaria
Clinical narrative: Hives entire body. Onset - 3 hrs after MMR vaccine. 2/23/15 - playful child and exam: skin - hives maculopap urticar lesion.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: 6 x 6 cm lesion, slightly raised, dull erythema, nontender anterior thigh.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Bronchitis, Chest discomfort, Pyrexia
Clinical narrative: Donor came to center to report that after immunization on 1/30/15, donor got a fever on 1/31/15 which continues until 2/1/15 together with "chest heaviness". Donor went to doctor, dx with bronchitis and tx with oral amoxicillin.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling, Rash erythematous
Clinical narrative: 12 hours after receiving the ZOSTAVAX, noted a swelling in her fingers and ankles and a red, bumpy rash on face and chest. After 24 hours, the symptoms and signs resolved. (Was not seen by physician for these).
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Developed welts/hives on side and back 2 days after MMR vaccine, advised BENADRYL, quh pm, cool compresses to area, and avoid heat to rash.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, an unspecified number of patients were administered with improperly stored doses of PROQUAD (Merck) (doses, routes of administration, lot numbers and expiration dates were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to an unspecified number od patients of unknown age and gender. Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date, unspecified number of patients received improperly stored RECOMBIVAX HB (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved, This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: Severe headache, chills, body aches, sore joints, extreme fatigue, weakness symptoms lasted 4 days-unable to go to work, also arm pain.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Severe headache, chills, body aches, sore joints, extreme fatigue, weakness symptoms lasted 4 days-unable to go to work, also arm pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, Cardiac monitoring, Chest X-ray, Differential white blood cell count, Full blood count
Clinical narrative: 12 minute tonic-clonic seizure and 104 fever on 2/10/15. Given nasal VERSED by Medic and taken to ED.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Generalised tonic-clonic seizure, Metabolic function test, Pyrexia, Respiratory viral panel, Urine analysis
Clinical narrative: 12 minute tonic-clonic seizure and 104 fever on 2/10/15. Given nasal VERSED by Medic and taken to ED.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Pt had PNEUMOVAX immunization earlier today and presents now for swelling and pain in his L arm radiating down past his elbow. There is no redness, F/S/C. And pain and numbness at site injection.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Received phone call yesterday from patient (2/11/15) reported her (L) arm really red and swollen-told her she could try ice packs (cold compresses) if worse to to see MD-Let me know if went-APN notified us she had seen patient in clinic office.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Gait disturbance, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: MENACTRA vaccine administered (L) deltoid at doctors office 02/10/15-witih 1/2 hour of vaccine patient felt nauseous and dizzy. One hour post vaccine she developed whole body twitching-worse in the neck. Difficulty in walking due to shaking and spasms. She was taken to local emergency room. (At 10:30 today, pt was at pediatricians office, receiving meningitis vaccine. At 11am she felt nauseous and dizzy, and by 11:30am she developed twitching to her whole body, worse in her neck. No numbness or tingling, but she was having trouble walking due to the shaking and spasms. By 11:45 her neck began twitching to the left uncontrollably which mom called peds office who told her to come to ER. No recent illness. was feeling fine this morning. Denies constitutional symptoms prior to vaccine. No SOB or difficulty swallowing. No rash.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: MENACTRA vaccine administered (L) deltoid at doctors office 02/10/15-witih 1/2 hour of vaccine patient felt nauseous and dizzy. One hour post vaccine she developed whole body twitching-worse in the neck. Difficulty in walking due to shaking and spasms. She was taken to local emergency room. (At 10:30 today, pt was at pediatricians office, receiving meningitis vaccine. At 11am she felt nauseous and dizzy, and by 11:30am she developed twitching to her whole body, worse in her neck. No numbness or tingling, but she was having trouble walking due to the shaking and spasms. By 11:45 her neck began twitching to the left uncontrollably which mom called peds office who told her to come to ER. No recent illness. was feeling fine this morning. Denies constitutional symptoms prior to vaccine. No SOB or difficulty swallowing. No rash.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Dizziness, Electroencephalogram normal, Electromyogram normal, Hypersensitivity
Clinical narrative: MENACTRA vaccine administered (L) deltoid at doctors office 02/10/15-witih 1/2 hour of vaccine patient felt nauseous and dizzy. One hour post vaccine she developed whole body twitching-worse in the neck. Difficulty in walking due to shaking and spasms. She was taken to local emergency room. (At 10:30 today, pt was at pediatricians office, receiving meningitis vaccine. At 11am she felt nauseous and dizzy, and by 11:30am she developed twitching to her whole body, worse in her neck. No numbness or tingling, but she was having trouble walking due to the shaking and spasms. By 11:45 her neck began twitching to the left uncontrollably which mom called peds office who told her to come to ER. No recent illness. was feeling fine this morning. Denies constitutional symptoms prior to vaccine. No SOB or difficulty swallowing. No rash.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Movement disorder, Muscle twitching, Muscular weakness, Nuclear magnetic resonance imaging normal, Postural orthostatic tachycardia syndrome
Clinical narrative: MENACTRA vaccine administered (L) deltoid at doctors office 02/10/15-witih 1/2 hour of vaccine patient felt nauseous and dizzy. One hour post vaccine she developed whole body twitching-worse in the neck. Difficulty in walking due to shaking and spasms. She was taken to local emergency room. (At 10:30 today, pt was at pediatricians office, receiving meningitis vaccine. At 11am she felt nauseous and dizzy, and by 11:30am she developed twitching to her whole body, worse in her neck. No numbness or tingling, but she was having trouble walking due to the shaking and spasms. By 11:45 her neck began twitching to the left uncontrollably which mom called peds office who told her to come to ER. No recent illness. was feeling fine this morning. Denies constitutional symptoms prior to vaccine. No SOB or difficulty swallowing. No rash.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Psychogenic seizure, Seizure, Wheelchair user
Clinical narrative: MENACTRA vaccine administered (L) deltoid at doctors office 02/10/15-witih 1/2 hour of vaccine patient felt nauseous and dizzy. One hour post vaccine she developed whole body twitching-worse in the neck. Difficulty in walking due to shaking and spasms. She was taken to local emergency room. (At 10:30 today, pt was at pediatricians office, receiving meningitis vaccine. At 11am she felt nauseous and dizzy, and by 11:30am she developed twitching to her whole body, worse in her neck. No numbness or tingling, but she was having trouble walking due to the shaking and spasms. By 11:45 her neck began twitching to the left uncontrollably which mom called peds office who told her to come to ER. No recent illness. was feeling fine this morning. Denies constitutional symptoms prior to vaccine. No SOB or difficulty swallowing. No rash.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself, with no know drug reactions or allergies. On 12-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. On the same date, the patient's injection-site arm had been painful and difficult to move. It was reported that the patient sought medical attention by calling the county health clinic. There has been no product quality complaint involved. The outcome of the events was unknown. The causal relationship between PNEUMOVAX 23 and the events was not rated by the reporter. Additional information is not expected as there is no contact information.
Age: 16.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Upper left arm swelling and redness.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients who since 27-JAN-2015 have been administered unknown doses of RECOMBIVAX HB intramuscular (dose, lot number and expiration date were not reported); that underwent through a supported temperature excursion nevertheless no adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response, Viral titre
Clinical narrative: This spontaneous report was received from the patient's mother who is also a dentist, refers to a female patient of an unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient received complete series of RECOMBIVAX HB injection (strength, dosage route and lot# were not reported). Concomitant therapy was not reported. The patient's mother informed that on an unknown date the patient did not seroconvert. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to an unspecified number of patients of unknown age and gender. Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date, unspecified number of patients received improperly stored GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Viral titre decreased
Clinical narrative: This spontaneous report as received from the patient's mother who is also a dentist, refers to a 21 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient received complete series of RECOMBIVAX HB injection (strength, dosage route and lot# were not reported). Concomitant therapy was not reported. The patient's mother informed that on an unknown date the patient had low titer levels (below 5), subsequently the patient received a booster of RECOMBIVAX HB injection (strength, dosage route and lot# were not reported), and again did not seroconvert. In 2014 the patient began RECOMBIVAX HB injection (strength, dosage route and lot# were not reported) series again, the patient's mother reported that the second dose was administered 10 weeks and 2 days later. The outcome of the low titer level was unknown. The is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash near groin, itchy, occurred 2 days after vaccination-patient things it is shingles.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: She is due for PREVNAR 13 and we gave that today and then she had some itching following that on her arms. There is no swelling of her mouth or throat her lips and gave her some IM BENADRYL with resolution of her symptoms. She can take some oral BENADRYL at home as needed.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On unspecified times in 2011, the patient received the first and second dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 20-FEB-2015, the patient was vaccinated with the third dose of GARDASIL intramuscular, 0.5 ml, (lot number and expiry date were not provided). No adverse effects reported. There was not concomitant medication provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Malaise
Clinical narrative: This spontaneous rport as received from a physician who is also the patient's sister refers to a 26 year old female patient. In 2008 the patient was vaccinated wiht a first dose of GRADASIL (dose, lot # and expiration date were not reported). In 2008, after vaccination of GARDASIL, the patient experienced malkaise as she did not feel well and fatigue as she was very tired. The physician stated that "she is a difficult patient who did not want to pursue further doses". Therapy  with GARDASIL was discontinueed. At the time of the report the outcome of malaise and fatigue was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients. Sometime in the month of February 2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot #, dose and route were not reported). No symptoms reported. This is one of reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to an unspecified number of patients of unknown age and gender. Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date, unspecified number of patients received improperly stored vaccinated with VAQTA (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients. Sometime in the month of February 2015, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot #, dose and route were not reported). No symptoms reported. This is one of reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a healthcare worker (certificated medical assistant) referring to a 13 year old child patient. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot # and dose were not reported). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patient (age and gender not reported). Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date unspecified number of unspecified patients were all administered ZOSTAVAX, (0.65 ml, subcutaneous, anatomical location, lot#, expiration date were not reported) that underwent post supported excursion. Concomitant therapies were not reported. No adverse effects were reported by any patients. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reproter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to two children of unknown age and gender. On 10-FEB-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, dose and route unknown). No adverse effects reported. The outcome of the events was unknown. No PQC (Production Quality Control) involved. Causality and action taken were not provided. Additional information is not expected since reporter did not allow to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patient (age and gender not reported). Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date unspecified number of unspecified patients were all administered VARIVAX (Merck) (dose, route of administration, anatomical location, lot#, expiration date were not reported) that underwent post supported excursion. Concomitant therapies were not reported. No adverse effects were reported by any patients. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-FEB-2015 the patient was vaccinated with an expired RECOMBIVAX HB (lot # H014132, expiration date 08-FEB-2015, 0.5 ml dose, intramuscularly, frequency not reported). No adverse effects noted. Potency supported. No other information provided. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash started in legs on 2/18/15 after 2nd dose. Rash has spread to arms and chest.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a non-pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with a first dose GARDASIL (route of administration, lot number, expiry date were not reported) and after vaccination she fainted while still in physician's office. The therapy with GARDASIL was continued. The outcome of the event was reported as recovered/resolved. The relationship between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have been vaccinated with improperly stored PROQUAD (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to several patients of unknown age, gender and demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, indication, route of administration, lot number and expiry date were not reported). On an unknown date, after receiving ZOSTAVAX, the patients experienced mild cases of shingles. The outcomes of the event were unknown. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients may had been vaccinated with improperly stored VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse events were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient requested MMR vaccine, but received GARDASIL instead.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness on upper arm (left).
Age: 1.45
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test normal, Febrile convulsion
Clinical narrative: Pt had increase in temp days after MMR had febrile seizure was seen in ER.
Age: 1.45
Sex: M
Vaccine: MMR, MMR
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Pt had increase in temp days after MMR had febrile seizure was seen in ER.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia
Clinical narrative: Fever, 101.3 degrees Fahrenheit (taken rectally).
Age: 0.77
Sex: M
Vaccine: FLU4, HEP
Symptoms: Crying, Dyskinesia, Infantile spasms, Malaise, Muscle spasms
Clinical narrative: Whole body spams/jerk, not unlike what an infantile spasm looks like, followed by crying.  Five, single, independent episodes of one full body spasm/jerk over the course of 15 hours after the vaccine was administered.  They did not appear in a close cluster, but were spaced by variable time, even hours in between.  Two were observed by my husband while I was at work and he told me about them when I arrive home around 6:30pm.  Three more occurred through the evening and night, with the last at maybe 2am.  He also developed a high fever, with the highest recorded temp of 103.5 with an Exergen temporal thermometer.  Not sure when exactly the fever spiked, but I do not believe he had the highest fever reading until sometime after he had the first two episodes.  After the third episode, the first that I observed, I thought it might be a very short febrile seizure and called the on call doctor to ask whether to use an anti-pyretic.  Only later did I investigate further (I am a physician, but do not see peds) and realized that febrile seizures are generally ONE episode and not multiple (though looking back, the on-call doctor did imply that by saying if he had more we should go to the ER).  After more investigating and observing video of infantile seizures, the episodes appeared most like an infantile seizure, but not in close clusters.  He appeared ill consistent with the fever of a viral infection, possible flu, but no worse between the spasms.  Prior to the vaccination, his doctor and I had discussed whether or not to administer the vaccine, given the fever the few days before, but he was comfortable with doing it because patient's fever was below 100.0 and I agreed with his assessment.  In general, patient has been fine since.  He does appear a little "twitchy" at times, particularly when he is sleepy, but I cannot be sure whether that is new or something that we notice now because of being more attentive.  My husband has observed the twitching, as well.  I can honestly say that we never observed any "twitching" prior.  We probably should have gone to the ER, and the on call doctor did advise that if they continued, but since they were not getting longer or more frequent, we decided to wait and see and he stopped having them by morning.
Age: 0.77
Sex: M
Vaccine: FLU4, HEP
Symptoms: Muscle twitching, Pyrexia, Viral infection
Clinical narrative: Whole body spams/jerk, not unlike what an infantile spasm looks like, followed by crying.  Five, single, independent episodes of one full body spasm/jerk over the course of 15 hours after the vaccine was administered.  They did not appear in a close cluster, but were spaced by variable time, even hours in between.  Two were observed by my husband while I was at work and he told me about them when I arrive home around 6:30pm.  Three more occurred through the evening and night, with the last at maybe 2am.  He also developed a high fever, with the highest recorded temp of 103.5 with an Exergen temporal thermometer.  Not sure when exactly the fever spiked, but I do not believe he had the highest fever reading until sometime after he had the first two episodes.  After the third episode, the first that I observed, I thought it might be a very short febrile seizure and called the on call doctor to ask whether to use an anti-pyretic.  Only later did I investigate further (I am a physician, but do not see peds) and realized that febrile seizures are generally ONE episode and not multiple (though looking back, the on-call doctor did imply that by saying if he had more we should go to the ER).  After more investigating and observing video of infantile seizures, the episodes appeared most like an infantile seizure, but not in close clusters.  He appeared ill consistent with the fever of a viral infection, possible flu, but no worse between the spasms.  Prior to the vaccination, his doctor and I had discussed whether or not to administer the vaccine, given the fever the few days before, but he was comfortable with doing it because patient's fever was below 100.0 and I agreed with his assessment.  In general, patient has been fine since.  He does appear a little "twitchy" at times, particularly when he is sleepy, but I cannot be sure whether that is new or something that we notice now because of being more attentive.  My husband has observed the twitching, as well.  I can honestly say that we never observed any "twitching" prior.  We probably should have gone to the ER, and the on call doctor did advise that if they continued, but since they were not getting longer or more frequent, we decided to wait and see and he stopped having them by morning.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on back and arms. Benadryl taken.  Hives continue at this time 02/23/2015 at 11:23 PM.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Myalgia, Pyrexia
Clinical narrative: Muscle pain; back hip and knee pain; fever.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient had fever and developed a rash.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm, shoulder pain that radiates to left back.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: None at this time - reporting due to patient being pregnant.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to a 44 years old female patient. The patient's medical history included cough caused by unspecified ACE inhibitor. On 13-FEB-2015, the patient was vaccinated with dose of PNEUMOVAX 23 lot # K010466, expiration date: 23-MAR-2016, (dose, route and anatomical location were not reported). Concomitant therapies included CYMBALTA, BYDUREON, LIPITOR, metoprolol, hydrochlorothiazide (manufacturer unknown), losartan potassium (manufacturer unknown), metformin, diazepam (manufacturer unknown) and omeprazole (manufacturer unknown). In February 2015, the patient experienced redness all down her left arm associated with a fever of 104.5 grades Fahrenheit (F). In February 2015, the patient was admitted to the hospital and was given unspecified intravenous antibiotics. The fever and redness down her arm subsided in February 2015, but after that, the patient was experiencing significant pain down her arm and a large "knot" under the arm. At the time of this report, the patient was still in the hospital. The outcome of the events of "redness all down her left arm associated with a fever of 104.5 F" was reported as recovered/resolved. The outcome of the events of "the patient was experiencing significant pain down her arm" and "a large "knot" under the arm" was unknown. The relatedness between the events and the vaccination with PNEUMOVAX 23 was not provided. Upon internal review the event of "the patient was experiencing significant pain down her arm" was considered medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC13
Symptoms: Flushing, Rash generalised, Skin warm
Clinical narrative: Skin warm and flush, body rash covering torso area and legs and parts of neck and face. Mother treated with Motrin, Benadryl, Zantac and Tylenol.
Age: 1.1
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Abasia, Computerised tomogram, Encephalitis, Febrile convulsion, Nuclear magnetic resonance imaging
Clinical narrative: High temp (104) three febrile seizures, localized the left side of body. Diagnosed with post infectious cerebellitis. Was not able to walk for 6 days.
Age: 1.1
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: High temp (104) three febrile seizures, localized the left side of body. Diagnosed with post infectious cerebellitis. Was not able to walk for 6 days.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient was given Pediarix, ActHIb, PCV13, Rotateq. Approximately 3 minutes after she developed hives on abdomen. No facial swelling or respiratory distress. Benadryl was given and she was dischaged after 30 minutes per Dr.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Local reaction to left thigh, swollen and reddened area measured 2in X 2in. Seen by MD new measurements on Sat 02/21/2015 as per mom 5in X 3in. MD aware and evaluated.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: EMESIS AND DIARRHEA.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Initial unsolicited case received from a consumer, who is also the patient's wife, on 16 February 2015. Another case for the patient's wife, with a similar event, is captured in case number 2015SA020526. A 58-year-old male patient received an intramuscular left deltoid injection of FLUZONE QIV (lot number not reported) on 27 September 2014. On 12 February 2015, i.e. 4.5 months post-vaccination, the patient was seen in the emergency room and tested positive for influenza type A. The event was treated with TAMIFLU and TYLENOL, and remained ongoing. Documents held by sender: None.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Animal bite, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Decreased appetite
Clinical narrative: 10-22-2014 PREVNAR 13 - Rt deltoid. 25 headache - fatigue. 11-6 saw PCP - increased headache, increased fatigue - loss of appetite, wt loss, nauseated - prescribed depression meds. 11-9 feeling a lot worse, stop meds - (not depressed). 11-11 saw PCP - questioned PREVNAR 13 - possible cause of symptoms - (treated dog bite). 11-24 symptoms worse - Rx prescribed - levofloxacin 750 mg - (? no fever, cough or any new symptoms). 12-03 feeling worse - saw PCP - chest x-ray done because of Rt chest pain with deep breathing, S.O.B., - Dx pneumonia, sent to E.R. Admitted to hosp. Received 2 or 3 IV antibiotics. 12-6 dc'ed - being followed by pulmonary spec. 2-18 filing report to CDC - still not back to normal.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Painful respiration
Clinical narrative: 10-22-2014 PREVNAR 13 - Rt deltoid. 25 headache - fatigue. 11-6 saw PCP - increased headache, increased fatigue - loss of appetite, wt loss, nauseated - prescribed depression meds. 11-9 feeling a lot worse, stop meds - (not depressed). 11-11 saw PCP - questioned PREVNAR 13 - possible cause of symptoms - (treated dog bite). 11-24 symptoms worse - Rx prescribed - levofloxacin 750 mg - (? no fever, cough or any new symptoms). 12-03 feeling worse - saw PCP - chest x-ray done because of Rt chest pain with deep breathing, S.O.B., - Dx pneumonia, sent to E.R. Admitted to hosp. Received 2 or 3 IV antibiotics. 12-6 dc'ed - being followed by pulmonary spec. 2-18 filing report to CDC - still not back to normal.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Weight decreased
Clinical narrative: 10-22-2014 PREVNAR 13 - Rt deltoid. 25 headache - fatigue. 11-6 saw PCP - increased headache, increased fatigue - loss of appetite, wt loss, nauseated - prescribed depression meds. 11-9 feeling a lot worse, stop meds - (not depressed). 11-11 saw PCP - questioned PREVNAR 13 - possible cause of symptoms - (treated dog bite). 11-24 symptoms worse - Rx prescribed - levofloxacin 750 mg - (? no fever, cough or any new symptoms). 12-03 feeling worse - saw PCP - chest x-ray done because of Rt chest pain with deep breathing, S.O.B., - Dx pneumonia, sent to E.R. Admitted to hosp. Received 2 or 3 IV antibiotics. 12-6 dc'ed - being followed by pulmonary spec. 2-18 filing report to CDC - still not back to normal.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Disability, Hypoaesthesia, Liver function test abnormal, Muscular weakness
Clinical narrative: Patient developed acute myositis and transverse myelitis within a few days of flu shot, involving elevated transaminases and CPK; lower extremity weakness and numbness, responsive to IV steroids and acute rehab, still with residual disability.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse, Myositis, Nuclear magnetic resonance imaging abnormal, Transaminases increased
Clinical narrative: Patient developed acute myositis and transverse myelitis within a few days of flu shot, involving elevated transaminases and CPK; lower extremity weakness and numbness, responsive to IV steroids and acute rehab, still with residual disability.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Intussusception, Laparoscopic surgery, Ultrasound scan
Clinical narrative: Intussusception, reduced by Laparoscopic surgery. Symptoms: crying episodes of every 10 minutes.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Overdose
Clinical narrative: Double dose of HIB administered. One dose of HIB, and an additional dose in Pentacel.
Age: 31.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Hypoaesthesia, Paraesthesia, Small fibre neuropathy
Clinical narrative: Numbness began on the left side of my foot.  Then spread to right foot.  Now numbness/tingling in both hands and spreading up the legs.
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, IPV, UNK
Symptoms: Agitation, Asthenia, Body temperature increased, Confusional state, Crying
Clinical narrative: No noticeable leg soreness/pain at injection site. Shaky, trembling hands, slight weakness, irritability, more frequent cries. Eating habits changed. Exclusively breastfed baby turned head to and away from breast, over and over (seemed confused/unusual/not seen before). Didn't eat well first night/couldn't/confused? Duration of 02/12/2015, after 4 injections. 02/13/2015: 100.3 temp set in, lasted whole day. Baby cried with more intensity and agitation, eating habits still unusual, didn't/couldn't eat well. Baby always loved looking at herself in the mirror, instant smile at the sight every time from 2 months of age: no longer smiled/blank stare or unnoticed. Getting baby to laugh or smile over the course of the next 7 days following after injections no longer an easy task. Response to stimulation seemed dampened. Sleep pattern changed. Baby seemed mostly back to her old self on 02/21/2015.
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, IPV, UNK
Symptoms: Diet refusal, Eating disorder, Irritability, Nervousness, Sleep disorder
Clinical narrative: No noticeable leg soreness/pain at injection site. Shaky, trembling hands, slight weakness, irritability, more frequent cries. Eating habits changed. Exclusively breastfed baby turned head to and away from breast, over and over (seemed confused/unusual/not seen before). Didn't eat well first night/couldn't/confused? Duration of 02/12/2015, after 4 injections. 02/13/2015: 100.3 temp set in, lasted whole day. Baby cried with more intensity and agitation, eating habits still unusual, didn't/couldn't eat well. Baby always loved looking at herself in the mirror, instant smile at the sight every time from 2 months of age: no longer smiled/blank stare or unnoticed. Getting baby to laugh or smile over the course of the next 7 days following after injections no longer an easy task. Response to stimulation seemed dampened. Sleep pattern changed. Baby seemed mostly back to her old self on 02/21/2015.