chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 28-Apr-2015) concerns a 73 year-old male patient who had a past medical history of lymphoma and prostate cancer. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, one month after the vaccination, the patient was brought to the Emergency Department, and subsequently hospitalised, with a change in mental status and fall. He reported having a fever, muscle ache, sore throat and fatigue for the 1 day. His temperature was 99.5 F and the rest of the physical examination was unremarkable. The laboratory data demonstrated normal BMP (basic metabolic panel), mild elevation in WBC (white blood count), elevation of liver enzymes (AST 300, ALT 100). Creatinine kinase was 3000 and continued to rise to as high as 12000 which was thought to be out of proportion to the duration of fall (30 minutes), Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive, and PCR (Polymerase Chain Reaction) was negative. His EEG (electroechocardiogram), chest radiograph were unremarkable. He had aggressive intravenous fluids and was treated with azithromycin and oseltamivir. His renal function remained stable and patient improved remarkably within 3 days. His creatinine kinase did trend down. The outcome was not reported (recovered for fever, muscle aches, sore throat and fatigue). Reporter comments: 48% of the influenza A (H3N2) viruses collected and analyzed from October 1 through November 22, 2014 were antigenically 'like' the 2014-2015 influenza A (H3N2) vaccine component, but that 52% were antigenically different (drifted) from the H3N2 vaccine virus. Decreased vaccine effectiveness has been observed with antigenic drift in past seasons. Vaccine effectiveness in patients over 65 years of age is with time, in preventing laboratory-confirmed influenza infection was 61 percent (95% CI 5 to 84 percent) during the first 100 days after vaccination. Influenza vaccine prevents the severity of illness in patients over 65 years of age.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Approximately 3 hours after getting his shots (on 4/28/15), the patient started to have an unusual inconsolable cry and irritability.  The mother checked his legs and both injection sites (R and L thighs) were minimally erythematous, but she noted unremarkable overall. The finding that surprised the mother the most was the L pretibial area (knee to ankle) that was very red, swollen, mildly tensed, appeared tender, hot to touch (celullitis-like picture), with multiple petechiae. In the L leg received 2 shots: Hib and PCV. The mother applied cool compresses, gave him Tylenol, which helped with redness/ swelling/ warmth, but more petechiae appeared later that evening. He stopped crying, fed well and then fell asleep. On 4/29 his leg looked improved but not completely resolved with same petechiae, only mild swelling, no erythema/ warmth. And he seemed happy. He has been a healthy baby so far, except for one episode of AOM requring Amoxicillin x 10 days, at approx 74 DOL.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site warmth, Irritability, Petechiae
Clinical narrative: Approximately 3 hours after getting his shots (on 4/28/15), the patient started to have an unusual inconsolable cry and irritability.  The mother checked his legs and both injection sites (R and L thighs) were minimally erythematous, but she noted unremarkable overall. The finding that surprised the mother the most was the L pretibial area (knee to ankle) that was very red, swollen, mildly tensed, appeared tender, hot to touch (celullitis-like picture), with multiple petechiae. In the L leg received 2 shots: Hib and PCV. The mother applied cool compresses, gave him Tylenol, which helped with redness/ swelling/ warmth, but more petechiae appeared later that evening. He stopped crying, fed well and then fell asleep. On 4/29 his leg looked improved but not completely resolved with same petechiae, only mild swelling, no erythema/ warmth. And he seemed happy. He has been a healthy baby so far, except for one episode of AOM requring Amoxicillin x 10 days, at approx 74 DOL.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Arthralgia, myalgia, stiffness.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Severe Lt arm pain and numbness for > 1 day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain, Pyrexia
Clinical narrative: Local swelling, achy, feverish.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cough, Dizziness, Headache, Oropharyngeal pain
Clinical narrative: Dizziness, chills, T 100.5, headache, sore throat, cough. Seen in urgent care clinic, given after breathing treatment and antibiotics. Coughing still after 3 weeks.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Vaccine given 4/22/15. Patient at clinic. 4/24/15: Left arm swollen - red - Patient states that she applied VICKS VAPOR RUB to site. MD order cold compress and ADVIL BID with food PRN.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Localized reaction to PREVNAR 13 (R) upper thigh 4 x 5 cm pinkness/warmth at inj site non tender, no induration, swelling or fever.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Follow up information has been received on 07-APR-2015, it was reported that the freezer in which the vaccines were stored went through "an auto defrost". There were no adverse events. On the same day 07-APR-2015, follow-up information has been received from Healthcare worker who provided patients' identifiers. This report refers to a 16 year old patient, who on 05-MAR-2015, was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml (route was not reported), lot number as K011801, exp. date: 21-AUG-2016. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.38
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to approximately 4 month old male patient. No concurrent or medical history was reported. On 15-APR-2015 the patient was vaccinated with ROTATEQ, (2 ml, oral). Concomitant therapies included PENTACEL and PREVNAR. On 15-APR-2015, the patient vomited immediately after the vaccine was administered. The child was crying at the time of administration. The outcome of vomiting was unknown. The reporter did not provide the causality between the event and the suspect drug. No product quality issue was involved. This is one of the 2 reports from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Pruritus, Rash, Skin warm
Clinical narrative: This spontaneous report was received from a 56 year old female patient with drug hypersensitivity to AUGMENTIN and diabetes mellitus. The patient's medical history included 2 myocardial infaction (May 2006 and January 2014). On 14-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX in the left arm to prevent Shingles (administration route, lot number and expiration date were not provided). Concomitant therapies included EFFIENT, LIPITOR, ZESTRIL, SYNTHROID, omeprazole and clonazepam. On 15-APR-2015, the patient experienced rash, Injection site induration and skin warm. On 16-APR-2015 the patient experienced pruritus (reported as: "it was itching like crazy"). The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaenous report as received from a healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored PNEUMOVAX 23 (lot # K019386 and expiry date: 09-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 13-MAR-2015, the patient was administered improperly stored PNEUMOVAX 23 (lot # K022886 and expiry date: 06-JUN-2016). No adverse effects were reported. The vaccine was stored as 48F for 130 hours. No product quality complaint (PQC) was reported PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose and frequency not provided). No concomitant therapy was reported. Healthcare worker stated that since March improperly stored (Oka/Merck) were administered to unspecified patients. No adverse events were reported. The outcome of the events was unknown. The events were considered to be not related to (Oka/Merck). No product quality issue was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 23 year old female patient. On 27-APR-2015, the patient was vaccinated with the first dose of GARDASIL that had expired on 19-MAR-2015 (0.5 ml, intramuscular in the left deltoid, lot # H013977). No adverse effect was reported. Additional information is not expected as the reporter did not want any follow up correspondence.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2105, the unspecified number of patient were administered unspecified doses of improperly stored RECOMBIVAX HB (lot # K014697 and expiry date: 04-FEB-2016). No adverse effects were reported. No product quality complaint (PQC) was reported RECOMBIVAX HB. This is one of the several reports form 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 medical assistant refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history and concomitant medications was not reported. In April 2015 (reported for all products as since 01-APR-2015), the patients were administered improperly stored VAQTA (route, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 27-APR-2015 the patient was vaccinated with an expired dose of PROQUAD (lot number reported as J004173, expiration date 08-OCT-2014, 0.5 ml, subcutaneous). No adverse effects were reported. 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 medical assistant refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history and concomitant medication was not reported. In April 2015 (reported for all products as since 01-APR-2015), the patients were administered improperly stored GARDASIL (route, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored PNUEMOVAX23 (lot # K022886 and expiry date: 09-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported PNEUMOVAX23. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Seizure
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 72 year old female patient. The patient had a history of seizures. On 21-APR-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency not provided). No concomitant therapy was reported. On 23-APR-2015, the patient developed a headache. On 26-APR-2015, the patient went to the emergency room because she was having a seizure (medically significant). Patient sought medical attention-she called the pharmacist. She was not admitted to the hospital. The outcome of the events was reported as recovered, as of 27-APR-2015. Causality assessment was not provided. No product quality issue was involved. Upon internal review, event seizure was considered to be medically significant. Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: RV5
Symptoms: Crying, Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to approximately 4 month old female patient. No concurrent or medical history was reported. On 15-APR-2015, the patient was vaccinated with ROTATEQ, (2 ml, oral). Concomitant therapies included PENTACEL and PREVNAR. On 15-APR-2015, the patient vomited immediately after the vaccine was administered. The child was crying at the time of administration. The outcome of vomiting was unknown. The reporter did not provide the causality between the event and the suspect drug. No product quality issue was involved. This is one of the 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist via center, concerns to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2015, the patient was vaccinated with an expired dose of VARIVAX, (expiration date: 24-MAR-2015), (dose, route, lot number and indication were not reported). Conocomitant therapies and relevant laboratories test of the patient were not reported. Additional information is not expected since the pharmacist declined to provide further information of the report.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored GARDASIL (lot # H020901 and expiry date: 05-JUL-2015). No adverse effects were reported. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was vaccinated with PROQUAD (Merck) (lot no. J013436, exp date: 24-APR-2015)(injection, dose and frequency not provided). No concomitant therapy was reported. Healthcare worker stated that since March improperly stored PROQUAD (Merck) were administered to unspecified patients. No adverse events were reported. The outcome of the events was unknown. The events were considered to be not related to PROQUAD (Merck). No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of VAQTA (route, strength, lot# and does were unknown), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Lethargy
Clinical narrative: Information has been received from a consumer referring to a male patient of unknown age who was one of his friend's sons. The patient had 5 siblings. The patient was one of the first 4 boy patients out of 6 children. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date the patient was vaccinated with MMR II (dose, frequency, route and lot# were not reported). The reporter reported that on unspecified date, following MMR II vaccinations, the patient had some minor changes in his behaviors (type of behavior changes unspecified) and within a week of vaccinations with MMR II, his behavior changes were very clear and drastic and they all became less interactive and lethargic. On an unknown date the patient was diagnosed with autism. The reporter stated that his friend decided not to vaccinate his two other children with MMR II after experienced with his 4 boys and these two children did not have autism. The outcome of autism was not reported. This case was linked with other 3 cases as they are siblings. And the cases were from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Gait disturbance, Neurological symptom, Peripheral swelling
Clinical narrative: This is an initial spontaneous report from a contactable nurse, from an office, reporting on a patient. A 73-year-old male patient, who was a pharmacist, received PREVNAR 13 (Lot# L35183, expiration date 30Sep2016, and NDC# 0005197101) intramuscular at 0.5ml, single in his left deltoid on 15Apr2015. He did not receive any other vaccines or medications that day to their knowledge. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient reported that his left hand swelled up, he had a neurological type reaction, his leg wouldn't move to walk, he had no balance on his left side and it was almost a stroke like reaction. He did not state how long the symptoms lasted, or when they first appeared and he declined an appointment, when offered, to see the physician when they called and spoke to him on 20Apr2015. He told the office employee he was fine and just wanted his side effects reported to the manufacturer. The patient recovered from all the events.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX 19400 Plaque forming units (PFU) (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Vaginal haemorrhage
Clinical narrative: This spontaneous report as received from a father reporting on his 11 years old daughter. She had no pertinent medical history and no drug reactions or allergies. The patient was prepubescent. On 16-APR-2015 the patient was vaccinated with the first dose of GARDASIL or GARDASIL 9 (dose, route, lot # not provided). The reporter was not sure which vaccine it was and stated that his daughter was vaccinated "because MERCK pushed the doctor into telling that his daughter need it". On 19-APR-2015 the patient experienced vaginal bleeding and was tired after vaccination. The patient did not seek medical attention and there was no treatment given and no lab diagnostic studies were performed. By the time of the report the patient did not recovered from the events. Relatedness between the events and suspect vaccines was not specified. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Follow up information has been received from 07-APR-2015, it was reported that the freezer in which the vaccines were stored went through "an auto defrost". There were no adverse events. On the same day 07-APR-2015, follow-up information has been received from Healthcare worker who provided patients' identifiers. This report refers to a 4 year old patient, who on 27-FEB-2015, was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml (route was not reported), lot number as K011801, exp. date: 21-AUG-2016. This is one of several reports received from the same source. Additional informatiton has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Hypersensitivity, Pallor, Petechiae, Rash erythematous, Rash generalised
Clinical narrative: Information has been received via Pfizer (MFR #US-WYE-H02045408) on 27-APR-2015, from an investigator concerning a 4 month old male subject enrolled in a study. The subject's concurrent conditions and medical history were not reported. There were no known allergies. On 02-JAN-2008, the subject received the second dose of ROTATEQ, 1 dose form (DF) per day orally. Other suspect therapies included the second dose of pneumococcal 13-valent conjugate vaccine, 1 DF per day intramuscularly, the second dose of PEDIARIX 1 DF per day intramuscularly and the second dose of ACTHIB 1 DF per day intramuscularly, all on 02-JAN-2008. Concomitant therapies were not reported. On the night of 02-JAN-2008, the subject's mother noticed a rash/allergic reaction, which proceeded to spread over the entire body. Treatment for the event included BENADRYL (0.4 cc) on 05-JAN-2008, which was administered by the subject's mom. The subject presented to the clinic on 06-JAN-2008 (also reported as 2007) and rash was characterized by red, blanchable petechiae on entire body, excluding the face. On that day, body temperature was 36.7 centigrade. Further treatment included topical hydrocortisone (0.5%). The subject recovered on 09-JAN-2008 and was withdrawn from the study. Action taken with ROTATEQ, PEDIARIX and ACTHIB was not reported. Action taken with pneumococcal 13-valent conjugate vaccine was withdrawn. The investigator and medical monitor considered hypersensitivity possibly related to ROTATEQ as well as other suspect therapies. The event hypersensitivity was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Speech disorder
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a patient of unknown age and gender. Patient's pertinent medical history and previous drug reactions and allergies were unspecified by the reporter. On an unknown date, in October 2014, approximately (six months ago), the patient was vaccinated with ZOSTAVAX. Concomitant medications were unspecified by the reporter. On an unknown date, the patient experienced impaired speaking ability. The patient sought medical attention. The outcome of impaired speaking ability was unknown. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored GARDASIL (lot # K006191 and expiry date: 02-FEB-2017). No adverse effects were reported. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter.  Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Follow up information has been received on 07-APR-2015, it was reported that the freezer in which the vaccines were stored went through "an auto defrost". There were no adverse events. On the same day 07-APR-2015, follow-up information has been received from Healthcare worker who provided patients' identifiers. This report refers to a 4 year old patient, who on 04-MAR-2015, was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml (route was not reported), lot number as K011801, exp. date: 21-AUG-2016. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swollen injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Red spot that is about 3" x 4", large (2 different spots) effuse. Recommending patient call MD to make sure not infected.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This report has been received from a pharmacist via Pfizer (MCN 2015091157) and refers to a 70-year-old patient of unknown gender. The information on concurrent conditions and concomitant medication was not provided. On 08-MAR-2015, the patient was erroneously vaccinated with PNEUMOVAX 23 instead of PREVENAR 13 (dose, route of administration and lot # not reported). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored GARDASIL (lot # K006124 and expiry date: 02-FEB-2017). No adverse effects were reported. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. The patient was reported to be allergic to penicillin, mycins and sulfa. On an unknown date, the patient received ZOSTAVAX. Other suspect therapies included PREVNAR 13. It was reported that the patient developed reaction to ZOSTAVAX that lasted a year. Reporting pharmacist enquired regarding PREVNAR 13 if it was made from any source of penicillin, neomycin, streptomycin or sulfa. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored GARDASIL (lot # J009788 and expiry date: 17-MAR-2016). No adverse effects were reported. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a physician referring to a 15 month old male patient. The patient's medical history included exposure to herpes zoster. The patient didn't have drug reactions/allergies. On 17-APR-2015, the patient was administered MMR II, (lot number was reported as K012473, exp. was unknown), 0.5ml, subcutaneously in the left arm and (Merck) VARIVAX, (lot number was reported as K020761, exp. was unknown), 0.5 ml, subcutaneously in the right arm. The patient didn't have any concomitant medications. On 20-APR-2015, the patient developed a widespread vesicular rash. The patient sought medical attention by office visiting. On 23-APR-2015, the physician evaluated the patient in the office and noted the widespread rash, with a new vesicle on the patient's leg that erupted on that day. The physician diagnosed the patient with a varicella rash due to his exposure to herpes zoster. There was no treatment given to the event and no lab diagnostics studies performed. The outcome of the event was reported as not covered. The causality of the event was (Merck) VARIVAX or MMR II was reported as not related. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Drug hypersensitivity, Electroencephalogram abnormal, Pyrexia, Rash
Clinical narrative: After hours call cyanotic episode 04/08/2014 at 9:52 pm. Admitted to hospital 4/11/2015 to 4/14/2015 DX seizures then admitted to hospital on 4/24/2015 to 4/27/2015 fever T105 and rash, hyper sensitivity reaction to phenobarbital.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Seizure
Clinical narrative: After hours call cyanotic episode 04/08/2014 at 9:52 pm. Admitted to hospital 4/11/2015 to 4/14/2015 DX seizures then admitted to hospital on 4/24/2015 to 4/27/2015 fever T105 and rash, hyper sensitivity reaction to phenobarbital.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came back to clinic 2 days after receiving vaccine complaining of "reaction" no resolving. There was a red circle approximately 1-2 inches in diameter around the injection site. The injection site was swollen, warm, and painful.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Injection site erythema, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Redness, density, warm to touch at injection site. Shoulder weakness, and pain radiating down arm and to axilla.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male patient with medical history of diabetes and hypertension and without drug reactions/allergies. On 21-APR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K023624, expiration as 19-FEB-2016, dose, route were unspecified). Concomitant medication included unspecified diabetic and blood pressure medications. The patient came back to the pharmacy on 23-APR-2015, because there was red, raised, itchy, quarter sized area around the vaccine injection site (start date April 2015). The pharmacist reported that there was no rash present. No lab diagnostic studies were performed and no treatment was given for the events. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis, Tendonitis
Clinical narrative: Progressively sore shoulder following vaccination impaired range of motion reaching overhead, behind back in following weeks. Saw GP, who suspected tenonitis went to orthopedist on 2/2-diagnosed with frozen shoulder. Injected and oral steroids and PT.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Progressively sore shoulder following vaccination impaired range of motion reaching overhead, behind back in following weeks. Saw GP, who suspected tenonitis went to orthopedist on 2/2-diagnosed with frozen shoulder. Injected and oral steroids and PT.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Fatigue, Herpes virus infection, Lip swelling, Malaise
Clinical narrative: Chills, felt sick, fatigue-started evening of vaccine, continued x 2 days. 1 week later, lips swollen and tingling, has persisted since then.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia oral
Clinical narrative: Chills, felt sick, fatigue-started evening of vaccine, continued x 2 days. 1 week later, lips swollen and tingling, has persisted since then.
Age: 82.0
Sex: U
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Influenza virus test, Laboratory test, Urticaria
Clinical narrative: Next day, broke out in hives - lasted 7 months.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 13-MAR-2015, the patient was administered improperly stored GARDASIL (lot # K00691 and expiry date: 02-FEB-2017). No adverse effects were reported. The vaccine was stored as 48F for 58 hours. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered doses of improperly stored PNEUMOVAX 23 (lot # L001322 and expiry date: 06-JUL-2016). No adverse effects were reported. No product quality complaint (PQC) was reported PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Noted soreness/redness (1" diameter) next AM (approximately 4-28-15 9:00 AM) states "it felt bruised at first" with pruritus or drug. No other sx. Very slightly elevated approximately equal to 1 mm raised. Required varicella series for higher education (1st dose). Hx of chickenpox in 2000.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report was received from an office manager via a company representative concerning a daughter of a co-worker. The patient's age was unknown. The patient's pertinent medical history and concurrent conditions were not provided. In January 2015 the patient was vaccinated with an unspecified dose of GARDASIL (lot# and route not provided). The office manager reported that her co-worker stated that her daughter experienced amenorrhoea reported as "had not had her period" since receiving GARDASIL in January 2015. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.35
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Crying
Clinical narrative: 105 degree temp, non-stop crying 4 hrs, TYLENOL was given.
Age: 1.15
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Mother states pt hospitalized due to seizures that mother states she was told by ER doctor were due to MMR vaccine. Mother states pt hospitalized 4-27-15, MMR given 3-5-15. Pt got other vaccinations on 4-20-15. Mother called today stating fever still not controlled.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, chills, pain and redness at site.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Bumps on left side of face, itchy.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at site of injection about 3" long and 2" wide.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site cellulitis
Clinical narrative: Pt had PCV vaccine placed 4/27/15 and developed cellulitis at site of vaccine placement.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Gait disturbance, Pain in extremity, X-ray of pelvis and hip
Clinical narrative: Patient given immunization on 01-29-2015. As per patient she started having (R) leg pain approximately 2 weeks later, has difficulty walking due to pain. Vaccination given in the arm seen orthopedics and had multiple ER visits. Now (R) side better c/o pain (L) leg.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on 29-APR-2015 was vaccinated with a dose of MMR II, subcutaneous, lot # J003004 and expiration date on 14-MAR-2015. No temperature excursion was associated with MMR II. No adverse effect reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site paraesthesia, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old female patient. The patient's medical history included 2 prior episodes of shingles (unspecified dates and lengths of time). On an unknown date the patient was vaccinated with her first dose of ZOSTAVAX (lot#, dose, route and duration were unspecified). Unspecified concomitant medication was taken. The patient experienced swelling, redness, tingling, and itching at the injection site immediately after receiving the ZOSTAVAX vaccine while already in the physician's office. The patient did not seek medical attention, as she was already in the physician's office when her reactions occurred. No lab diagnostics studies were performed and no treatment was given for the events. Since that unspecified date, the patient had called the physician's office to let them know she was still experiencing the itching and tingling. It was unspecified how long the swelling and redness lasted. The itching and tingling still remained with the patient as of 27-APR-2015. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy, lightheaded, nausea. Blood pressure checked sitting, laying down, standing. Juice given. Temp taken. Patient laid down for 1 hour after injection given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 who on 08-APR-2015 was vaccinated with an expired dose of VARIVAX (Merck) subcutaneous, 0.5ml dose, lot # J002618 which expired on 01-MAR-2015. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner of unknown age and gender referring to her/himself. On an unspecified date, "over 1 year ago", in approximately 2014, the patient was inadvertently administered with ZOSTAVAX (strength, dose, route and lot # not reported) which had been improperly stored. No adverse effects were reported. Additional information is not expected because the reporter was not consent to contact her physician.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bedridden, Decreased appetite, Extra dose administered, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a adult female patient who received BOOSTRIX for wound. Co-suspect products included DTaP vaccine. In 2014, the patient received BOOSTRIX and DTAP vaccine. In 2014, an unknown time after receiving BOOSTRIX and DTAP vaccine, the patient experienced extra dose administered. On an unknown date, the patient experienced bedridden, appetite lost, generalised joint pain and fever. On an unknown date, the outcome of the extra dose administered, bedridden, appetite lost, generalised joint pain and fever were unknown. The reporter considered the extra dose administered, bedridden, appetite lost, generalised joint pain and fever to be almost certainly related to BOOSTRIX and DTAP vaccine. Additional information received: In 2014, the patient received a dose of Tdap (unknown name). Then, 6 months later, the patient received a BOOSTRIX dose for a wound she had, that led to an extra dose administered. She also experienced adverse events: bedridden, appetite lost, generalised joint pain and fever. The nurse which is the patient reported to the sales representative that she was almost certain the issues were from the BOOSTRIX, but was unsure if it was from the combination of both products.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood immunoglobulin M increased, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of immunoglobulin M increased in a 33-year-old male patient who received TWINRIX (batch number 3EX72, expiry date 22nd March 2016). On 4th February 2015, the patient received the 1st dose of TWINRIX. In February 2015, less than a month after receiving TWINRIX, the patient experienced feeling unwell. On 25th February 2015, the patient experienced immunoglobulin M increased. On an unknown date, the outcome of the immunoglobulin M increased and feeling unwell were unknown. It was unknown if the reporter considered the immunoglobulin M increased and feeling unwell to be related to TWINRIX. Additional information received: Serologic testing reported that IgM was borderline elevated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient presented to hospital ER the evening she received vaccines. Patient had 3 seizures witnessed by her mother. The seizures started around 10:00 pm and lasted about 1 minute in duration. Mom reported that patient had fever before seizures. Patient was given IV KEPPRA and admitted to the hospital for further evaluation. Patient was discharged on 4/29/15.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: Child had diarrhea for eight days.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Epstein-Barr virus test, Fatigue, Full blood count, Lipids, Metabolic function test
Clinical narrative: Fatigue, increase sleeping, otherwise remainder ROS wnl, benign exam.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Somnolence, Vitamin D
Clinical narrative: Fatigue, increase sleeping, otherwise remainder ROS wnl, benign exam.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Severe swelling and discomfort at injection site that lasted several days.
Age: 54.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Burning sensation, Carpal tunnel decompression, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling, numbness and a bad burning sensation that wouldn't go away.  Started to go up hand to lower arm, but then prescribed STEROIDS to calm down.  Burning sensation subsided, but not numbness in fingers.  Carpal Tunnel surgery required. Fingers still numb.