chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood test, Hyperaesthesia, Hypersensitivity, Imaging procedure
Clinical narrative: Stomach 'pain' and hypersensitivity to area under both breasts.  Gradually the hypersensitivity went to the waist area.  Many pain killers and nerve drugs used which didn't help.  I used Ibuprofen with some relief.  Pain level ~2-3 usually and would lead to nausea if irritant didn't stop.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Scan
Clinical narrative: Stomach 'pain' and hypersensitivity to area under both breasts.  Gradually the hypersensitivity went to the waist area.  Many pain killers and nerve drugs used which didn't help.  I used Ibuprofen with some relief.  Pain level ~2-3 usually and would lead to nausea if irritant didn't stop.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Medical history and concurrent condition were not reported. On 11-DEC-2013, the patient was vaccinated with ROTATEQ (lot number not provided), expiration date 09-DEC-2013. Secondary therapies and concomitant therapies were not reported. On 11-DEC-2013, the primary reporter reported that the patient was vaccinated with ROTATEQ today and it was expired. No adverse effects were reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia, Pharyngeal oedema
Clinical narrative: Redness, swelling at injection site w/ yellow fever vaccine "throat feels swollen; tingling hands, feet" w/ oral thyroid vaccine.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever of 102.6 reported by parent about 2 hours after administration of vaccine. TYLENOL was given by parent and fever went down to 101.7 within an hour. By 9:00 PM temperature returned to normal.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Pyrexia
Clinical narrative: The patient experienced swelling of arm, developed fever on Sunday 12/15/13. His PCP prescribed Prednisone and I spoke with patient 12/18/13 -> pt feeling much better.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Rash erythematous, Tenderness
Clinical narrative: Erythema, swelling, tenderness, pain of upper left extremity; 15 x 10 cm area with overlying erythematous plaque like rash in annular pattern. Began 12 hrs post vaccination. Still resolving 5 days later. No treatment aside from cold compress.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: 8 cm oval area of erythema (L) anterior forearm lower half. This may not be related to immunization which was given in the deltoid muscle.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Rash
Clinical narrative: This spontaneous report as received from a 68 year old female consumer refers to herself. The patient also had unspecified allergies to CELEBREX (unspecified manufacturer/dose/frequency) and BENADRYL (unspecified manufacturer/dose/frequency). In November 2005 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date not specified), injection, one dose for prevention of shingles. Concomitant medication included unspecified thyroid medicine and unspecified eye drop. The patient stated they received ZOSTAVAX and then developed a "breakout" on her back in the 2009, and then the patient developed a second "breakout" on her back in the year 2011. The patient treated herself with VALTREX (unspecified manufacturer/dose/frequency). The patient reported she became "violently ill" after taking VALTREX (unspecified manufacturer/dose/frequency). None lab diagnostics studies was performed. On unknown dates, the patient was recovered from "breakout". The patient didn't seek medical attention. The outcome of "violently ill" was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Hallucination, Hypoaesthesia, Muscular weakness, Swollen tongue
Clinical narrative: Within 5-6 hours after vaccine, he was having tongue swelling, legs went weak and numb. Patient started having hallucinations. Took to ER, given IV fluids and ZOFRAN, and DILAUDID. About 24 hrs. after vaccine he also developed vomiting and diarrhea.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Within 5-6 hours after vaccine, he was having tongue swelling, legs went weak and numb. Patient started having hallucinations. Took to ER, given IV fluids and ZOFRAN, and DILAUDID. About 24 hrs. after vaccine he also developed vomiting and diarrhea.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). On an unspecified date in December 2013 the patient experienced injection site pain and swelling that continued one week after receiving ZOSTAVAX. No PQC was reported. It was also reported that therapy of ZOSTAVAX was not discontinued. At the time of reporting, the outcome of injection site pain and swelling was unknown. The patient sought medical attention by calling her pharmacy. Additional information is not available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Laboratory test normal, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 18 year old female patient. The patient had no pertinent medical history and no drug reactions or drug allergies. On 14-MAY-2012 the patient received her third dose of GARDASIL (lot number, dose, frequency, route and site of administration were not reported). There was no concomitant medication. The physician reported that she received the results of the pregnancy test on 16-MAY-2012. The patient took positive blood test for pregnancy and unspecified other lab work with "results within normal limits" (dates unknown). On 14-MAY-2012 the patient was 4-6 weeks pregnant, with last menstrual period (LMP) of 02-APR-2012 and estimate date of delivery (EDD) of 07-JAN-2013. The pregnancy outcome was outcome pending. No adverse effect was reported. None treatment was given for adverse events. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain in extremity, Tendonitis
Clinical narrative: This spontaneous report as received from a pharmacist  refers to a 45 year old female patient. Medical history and drug allergies were reported as none. On 30-JUL-2013, patient was vaccinated with VARIVAX (0.5 ml, subcutaneous). On 01-SEP-2013, the patient received her second dose of VARIVAX 9dose, concentration and lot number not provided). No concomitant therapy was reported. On 04-SEP-2013 (reported as 3 days after), the patient experienced redness and pain at the injection site. The patient was given AUGMENTIN and TORADOL. On an unknown date, the patient experienced an arm pain that radiated up to the patient's neck in the injection arm. On 16-DEC-2013, the patient was seen by an unspecified physician that diagnosed her with tendonitis. No lab diagnostic studies were performed. The pharmacist reported that redness and pain at the injection site improved on an unspecified date. The outcome of tendonitis was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a male consumer of unknown age referring on himself. Medical history and concurrent conditions were not reported. On 02-DEC-2013, 4 days ago, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). NO co-suspect therapies were reported. ON 02-DEC-2013, the patient had a slight headache after receiving ZOSTAVAX. The patient explained that the headache began following his vaccination and went away later in that evening. The causality was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 66 year old female patient. The patient's medical history included mild hypertension. Four years ago (estimated as December 2009) the patient was vaccinated with ZOSTAVX, administered via injection. In the first week of December 2013 (reported by the physician as last week), the patient presented at the physician office with shingles on the right side of the neck and chest wall. The onset date of shingles on the right side of the neck and chest wall was reported as four years ago (estimated as December 2009). It was also noted that the patient had been in general good health. As treatment for the adverse event, the patient received unspecified antiviral and pain medication. The action taken with ZOSTAVAX was not applicable. ZOSTAVAX was not reintroduced. The outcome of the adverse event was unknown and the causality assessment was not provided. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a 23 year old female patient. On 01-SEP-2009, the patient was vaccinated with her first dose of GARDASIL (concentration, dose and lot number not reported). On 01-FEB-2010, the patient received her second dose of GARDASIL (concentration, dose and lot number not reported). It was reported that the patient had not yet received her third dose of GARDASIL. The reporter stated that no adverse effects have been observed or reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Blindness, Eye inflammation, Eye pain, Intracranial pressure increased, Lumbar puncture
Clinical narrative: Optic Neuritis.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging abnormal, Optic neuritis, Pain, Visual field tests abnormal
Clinical narrative: Optic Neuritis.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Optic neuritis
Clinical narrative: Optic Neuritis.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Respiratory disorder
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 72 year old male patient. On 30-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for vaccination. On unspecified date, before ZOSTAVAX the patient was administered AFLURIA (dose, route indication and lot number were not reported). on 25-NOV-2013, the patient was admitted to the hospital with Guillain-Barre Syndrome. The exact date that the Guillain-Barre Symptoms began was unspecified. The patient sought medical attention, he went to the hospital. The outcome of Guillain-Barre Syndrome was unknown. Upon internal review Guillain-Barré Syndrome was considered as medically significant. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 72 year old male patient. On 30-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for vaccination. On unspecified date, before ZOSTAVAX the patient was administered AFLURIA (dose, route indication and lot number were not reported). on 25-NOV-2013, the patient was admitted to the hospital with Guillain-Barre Syndrome. The exact date that the Guillain-Barre Symptoms began was unspecified. The patient sought medical attention, he went to the hospital. The outcome of Guillain-Barre Syndrome was unknown. Upon internal review Guillain-Barré Syndrome was considered as medically significant. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Blood pressure increased, Dyspnoea, Electrocardiogram abnormal, Nausea
Clinical narrative: This spontaneous report (initial receipt 06-Dec-2013) concerns a 70-years-old male patient who had a medical history of chronic obstructive pulmonary disease (COPD) and was a past smoker. The patient's concomitant medication included salbutamol. On 05-Dec-2013, the patient received the flu vaccine (manufacturer and batch number not provided) in the right arm. On 05-Dec-2013, the patient also received intramuscular PNEUMOVAX 23 (batch number J009833) at 0.5 ml, in the same right arm. On 06-Dec-2013, the patient presented to the doctor's office. The patient was able to walk into the office. However, he was nauseous, short of breath and his 'blood pressure was through the roof' (unspecified what the blood pressure reading was). An EKG (electrocardiogram) was performed and some abnormality was found. The physician did not feel comfortable letting the patient return home and the patient was rushed to a local hospital by ambulance. It was unknown if the patient was hospitalised as an inpatient. Outcome was reported as not recovered.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Influenza A virus test negative, Influenza virus test negative
Clinical narrative: 85 y/o male h/o poorly controlled COPD administered ZOSTAVAX in morning then by mid afternoon body aches, SOB, COPD exacerbation.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 85 y/o male h/o poorly controlled COPD administered ZOSTAVAX in morning then by mid afternoon body aches, SOB, COPD exacerbation.
Sex: F
Vaccine: HPV4
Symptoms: Papillary thyroid cancer
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 2. Batch number, lot number and expiry date were not reported. Patient had received first two doses of the GARDASIL vaccination series. No concomitant medications were reported. On an unknown date the patient was diagnosed with papillary thyroid cancer (medically significant). The outcome of papillary thyroid cancer was reported as not recovered. The causality of the event to suspect product was unknown. Upon internal review the event of papillary thyroid cancer was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008945 (Same reporter link). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a registered nurse via a representative refers to a male patient of unknown age. At unspecified time, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose, route not reported) at unspecified unidentified private physician's in the recent past. On an unknown date, the patient received the second dose of GARDASIL (lot #, expiration date, dose, route not reported) at unspecified time. After receiving the second dose of GARDASIL, the patient "started to have seizures". The cause for seizures was being evaluated and that the patient was due to have third dose of GARDASIL in January 2014. It was unknown how the patient was doing presently. The outcome of the event was unknown. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to approximately 15 year old patient of unknown gender. On 09-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008840, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to approximately 15 year old patient of unknown gender. On 09-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 24-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008944 (Same reporter link). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Tonic convulsion
Clinical narrative: Generalized tonic seizure < 1 min in duration.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14-NOV-2013 the patient was vaccinated with a dose of unknown age and gender. On 14-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot number H017698, 02-JUL-2013) 0.5 ml, (dosing regimen and frequency unknown) intramuscularly that was exposed to 31 degree Fahrenheit for 10 hours. No adverse event was reported. No product quality issue was reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to approximately 16 week old patient. On an unknown date the patient was vaccinated with ROTATEQ suspension 2 (lot# and expiry date not provided). The nurse reported that the patient received dose 1 of vaccinated with ROTATEQ at 16 weeks of age. No symptoms reported. No other details reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date in September 2013, the patient was vaccinated with first dose of GARDASIL. On 16-DEC-2013 the patient was vaccinated with third dose GARDASIL. On 16-DEC-2013 the patient was given the third dose of GARDASIL too early. The patient did not experience any adverse effect. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date approximately in May 2013 (also reported as approximately 7 months ago) the patient was vaccinated with GARDASIL dose 1. On an unknown date approximately in 2013 (also reported as approximately 5 and one half month later than the first dose) the patient was vaccinated with GARDASIL dose 2 and on an unknown date approximately in 2013 (also reported as approximately 5 weeks after the second dose). No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a patient of unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL lot #, dose and route not reported). The primary reporter reports that an unspecified patient received the first dose of GARDASIL (lot #, dose and route not reported) series on an unspecified date, the second dose in the series was administered "2 months later" and the third dose in the GARDASIL (lot #, dose and route not reported) series was administered 2 months after the second dose. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to approximately 16 year old patient of unknown gender. On 10-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008942, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 70 year old female patient refers to herself. On 04-DEC-2013 the patient was vaccinated with her one time dose of ZOSTAVAX, subcutaneous in the left arm. The patient stated that on 05-DEC-2013 she was dizzy and had itchiness at the injection site on her left arm after receiving the ZOSTAVAX vaccine. The patient did not sought medical attention. The patient was given no treatment for AE. The outcome of dizzy and had itchiness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, firmness 10 cm diameter left deltoid area. Appeared day following vaccines and persisted.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Local swelling, Skin reaction, Skin warm
Clinical narrative: Noticed (R) leg red, swollen, warm to touch took to ER, put on Cephalexin.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: ZOSTAVAX Immunization given 12/5/13 and pt in to Primary Care provider for visit for a rash on 12/7/13 which was diagnosed as Shingles. Pt reported at time of visit that rash had started 2 days prior. Rash and blisters were not associated with the vaccine admin site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt complains of itchiness and occurring shortly after flu shot on 12-2-13 and its spread mostly on her chest area.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site swelling, Urticaria
Clinical narrative: Had large swelling at site of PNEUMOVAX injection immediately - followed by urticaria/generalized for 2 weeks until receiving Prednisone.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously. Dose number, lot number, dose, route and frequency were not reported. The pharmacist reported that another unspecified pharmacist (at another pharmacy) had administered an expired dose of ZOSTAVAX (date unspecified). No adverse event was reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event, Transfusion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) while on long term therapy with prednisone 20 mg. On an unknown date in 2013 the patient received blood transfusion (details unspecified) and started therapy with Cellcept (manufacturer unknown). It was also reported that the patient experienced no adverse events. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old patient (gender unspecified). The healthcare worker reported that on 14-NOV-2013, a 13 year old patient was inadvertently administered ZOSTAVAX, 0.5 milliliter (ml) subcutaneously. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase, Aspartate aminotransferase normal, Blood albumin, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Blood calcium, Blood chloride decreased, Blood creatinine increased, Blood glucose normal, Blood potassium normal
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Blood sodium decreased, Blood urea increased, Blood urine absent, Carbon dioxide normal, Glucose urine absent
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Injection site pain, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Mean cell volume normal, Mean platelet volume increased, Nitrite urine absent, Pain, Platelet count normal
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Protein total, Protein urine present, Pyrexia, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Specific gravity urine normal, Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, White blood cell count increased
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: pH urine normal
Clinical narrative: Patient developed a fever and c/o body aches and pain at the injection site after receiving pneumococcal vaccine.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a 82 year old female consumer refers to herself. On 09-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported) in the back of her upper right arm. The patient reported that she believed that ZOSTAVAX was administered in the wrong area and improperly, not subcutaneous. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Blood test abnormal, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 20 year old female patient (also reported as in her twenties). On an unknown date the patient was vaccinated with M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown). On an unknown date the patient underwent a blood test that revealed that she is not immune to M-M-R II. The outcome of the events was unknown. The relatedness of the events to M-M-R II was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Skin sensitisation
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 57 year old female patient. The patient was on unspecified blood pressure medication. On an unknown date approximately in May 2013 (reported as 7 months ago) the patient was vaccinated with ZOSTAVAX, single dose injection. On an unknown date approximately in December 2013 (reported as recently) the patient experienced tingling, itching, sensitivity and pain in varying spots on her body, including the bottoms of her feet. The patient had not presented with any rash, blisters or lesions. It was also reported that the injection site was also not involved. The patient did not seek medical attention. The outcome of the events was reported as not recovered (also reported the patient present status unspecified by the reporter). Reporter's causality was not provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 14 year old female patient with no known pertinent medical history or drug allergies/ reactions. On 15-OCT-2013, the patient was vaccinated with her first and only dose of GARDASIL (lot # J008423; exp. Date: 21-JAN-2013) (dose not provided) intramuscular. There was no concomitant medication. On an unspecified date, on approximately October 2013, the patient broke out in a rash. The patient sought medical attention, the patient's mother called the office. No laboratory tests were performed. The patient was treated with Benadryl. On an unknown date, in 2013, the patient recovered, "the rash cleared up fine". Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 17-DEC-2013 the patient was vaccinated with 2 ml (overdose) PNEUMOVAX23, via an unknown route. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On approximately 13-DEC-2013 (also reported as today) the patient was vaccinated with ROTATEQ (lot number H011456, expiry date 21-NOV-2013) (dosing regimen and frequency unknown). No adverse event was reported. No product quality issue was reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from an approximately 29 year old female physician regarding herself. The patients medical history included gastroesophageal reflux disease. On an unknown date in September 2013, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly. Concomitant therapies included ZOLOFT. On 12-DEC-2013 the patient developed a rash on her arms, legs, hands and torso after receiving her second dose of GARDASIL on 11-DEC-2013. It was reported that the patient had sought medical attention however no intervention to prevent serious criteria was done. The patient did not experience any significant disability or incapacity and was not hospitalized. The patient was evaluated and treated with Intra Venous SOLUMEDROL and an epinephrine injection on an unknown date in December 2013 in the Emergency room and was discharged to home from the emergency room. The physician reported that prior to going to the emergency room, she tried using BENADRYL, ALLEGRA, prednisone and ZYRTEC with no relief of the rash. The outcome rash on her arms, legs, hands and torso was reported as recovering. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality issue was reported. Upon internal review the event rash on her arms, legs, hands and torso was considered as medically significant. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 92 year old female patient. Patients current condition included allergy to ACE inhibitors and fish. On 09-DEC-2013, in a nursing home, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and dose were not reported) dose 1, subcutaneously after having shingles the previous week (December 2013). No concomitant medications were reported). On 16-DEC-2013, 8 days after onset of therapy the patient experienced swelling of tongue (medically significant). The patient was treated with BENADRYL and epinephrine in separate arms (It is unspecified if the BENADRYL and epinephrine have been administered). The outcome of swelling of tongue was reported as not recovered/not resolved. The causality of the event in relation to ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #, expiry not reported). No concomitant medication was reported. On an unknown date the patient developed shingles and was hospitalized. Length of hospitalization was not reported. The patient eventually died. It was unknown what treatment the patient received for shingles. The outcome of shingles was reported as fatal. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Injection site reaction, Rash, Rash erythematous
Clinical narrative: 12/19/2013 Mild Other. Parents noticed a rash with red (Mom said wasn't an "angry red") and clear raised dots on patient's left arm (at the injection site) and on both legs. They also said he was breathing heavy the evening of the same day he had the shot, but said it may have just been some congestion. Parents are encouraged to keep an eye on the rash and see a doctor if it gets worse.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Swollen tongue
Clinical narrative: Pt noticed itchiness that started on her head and migrated to her whole body - patient took BENADRYL when her tongue started to swell. BENADRYL helped relieve symptoms.
Age: 1.06
Sex: M
Vaccine: HEPA, MMRV, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt administered both VARIVAX and PROQUAD injections instead of VARIVAX and MMR injections.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Malaise
Clinical narrative: Approximately 3 hrs after vaccine pnt felt ill - was admitted to hospital with cardiac arrhythmia. Cardiologist stated he has seen a number of similar cases and felt the vaccine is a factor. Pnt put on XARELTO 20mg and DILTIAZEM XT 120mg.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: Chest pain subsequently diagnosed with myocarditis.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram abnormal, Cough, Guillain-Barre syndrome, Lung infection
Clinical narrative: Begin with a sore throat the next day with onset of coughing that I still have today.  1st doctor gave antibiotic steroid pak, steroid shot and antibiotic.  I have not taken antibiotic, since 2006.  That did not work.  Coughing became worse.  To the point of vomiting.  I went to a different doctor and he preformed a lung x-ray and CT scan and gave me 750 mg. of Levaquin for 5 days.  This still did not work.  I returned to doctor on 12/17/2013.  Given an inhaler, nasal spray and more Levaquin 750 mg.  On last two days and still not working.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Begin with a sore throat the next day with onset of coughing that I still have today.  1st doctor gave antibiotic steroid pak, steroid shot and antibiotic.  I have not taken antibiotic, since 2006.  That did not work.  Coughing became worse.  To the point of vomiting.  I went to a different doctor and he preformed a lung x-ray and CT scan and gave me 750 mg. of Levaquin for 5 days.  This still did not work.  I returned to doctor on 12/17/2013.  Given an inhaler, nasal spray and more Levaquin 750 mg.  On last two days and still not working.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HEPA, HPV4
Symptoms: Suicidal ideation
Clinical narrative: Mother reports sudden onset of suicidal tendencies in child 4 weeks after having received HPV vaccine.  Per Mother, no signs of depression prior to receiving HPV vaccine.  Mother is requesting this be reported as an adverse reaction to vaccine.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HEPA, HPV4
Symptoms: Depression, Suicidal ideation
Clinical narrative: Mother reports sudden onset of suicidal tendencies in child 4 weeks after having received HPV vaccine.  Per Mother, no signs of depression prior to receiving HPV vaccine.  Mother is requesting this be reported as an adverse reaction to vaccine.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt c/o itchiness and hives over whole body started this morning. pt denied fever, difficulty breathing, SOB, headache, dizziness, angioedema, chest discomfort, tachypnea and allergies to food.  Treatment: HYDROXYZINE HCL 25 MG TABS (HYDROXYZINE HCL) one to two tabs po every 6hrs as needed for itching, rash or allergy. PREDNISONE 20 MG TABS (PREDNISONE) two tabs po every morning with food, until asthma or allergy resolves.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Wrong technique in drug usage process
Clinical narrative: Severe pain in upper shoulder, went to doctor they x-rayed and no noticeable problems. Problem still persists. They gave patient the high dose vaccine and used a long needle. Patient is certain that the needle penetrated her bone. Patient only weighs 97 pounds.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT ARM RED AND SWOLLEN (VACCINE ADMINISTERED IN LEFT DELTOID).
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Barium swallow, Blood test, Computerised tomogram, Dizziness, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome, no feeling both hands, feet. Urinary retention, motor and sensory deficit, dizziness, blurred vision, loss of facial feeling. Received IVIgG, taking gabapentin, PERCOCET. OT and physical therapy.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypokinesia, Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Guillain-Barre syndrome, no feeling both hands, feet. Urinary retention, motor and sensory deficit, dizziness, blurred vision, loss of facial feeling. Received IVIgG, taking gabapentin, PERCOCET. OT and physical therapy.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss, Urinary retention, Vision blurred
Clinical narrative: Guillain-Barre syndrome, no feeling both hands, feet. Urinary retention, motor and sensory deficit, dizziness, blurred vision, loss of facial feeling. Received IVIgG, taking gabapentin, PERCOCET. OT and physical therapy.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Eye discharge, Heart rate increased, Pharyngeal oedema, Pyrexia
Clinical narrative: Flu shot at 11 a.m., on Dec. 4th. At 2:30 my throat started swelling, rapid heart beat, fever, face swelling and white thick fluid in eyes. Went to ER. I took BENADRYL thinking this would help before we called 911. Given methylprednisolone to take for 6 days.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Flu shot at 11 a.m., on Dec. 4th. At 2:30 my throat started swelling, rapid heart beat, fever, face swelling and white thick fluid in eyes. Went to ER. I took BENADRYL thinking this would help before we called 911. Given methylprednisolone to take for 6 days.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site rash, Lymphadenopathy, Pruritus
Clinical narrative: Bullseye rash around injection site swollen armpit/lymph nodes red, itchy.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain, Rash, Rash erythematous, Skin plaque
Clinical narrative: Sx (x3 days) soreness after receiving injections then the day after shots given. Patient noticed (2) red spots that have now grown into one large plaque very painful, no drainage, no chest pains, no dyspnea, no nausea or vomiting or diarrhea, no fever. These red spots are medial upper arm. Not at shot injection site. Treated with doxycycline hyclate 100 mg bid x 14 days.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Laboratory test, Pallor, Peripheral coldness
Clinical narrative: Patient noted approximately 1 1/2 day after event cold, pale hands. Patient noted physician conducted testing for thoracic outlets syndrome. Patient stated she did take Naproxen after vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Malaise, Pain, Pyrexia
Clinical narrative: Fever x 1 week. Achy, unwell feeling. Site reaction - softball sized red area egg sized lump.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Spoke with Dad - area was red/warm about size of quarter on (L) arm - after BENADRYL/Ibuprofen given - great improvement. Spoke with Dad on 12-13-13 area completely back to normal - per Dad wouldn't even known he had a vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Approx 8 hr after receiving vaccine in (L) deltoid. Pt reports having (L) arm numbness and c/o pins and needles in fingers. Lasted 3 full days and completely resolved on 4th day.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever and lethargy. Reported 102 degrees fever per mom. No fever at 12/16/13 visit.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Blood immunoglobulin E normal, Injection site erythema, Injection site pruritus, Injection site rash, Local reaction
Clinical narrative: Localized reaction at influenza vaccine administration site (R) deltoid - no pain - pruritus and erythema with pinpoint bumps - Rx with Hydrocortisone cream.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included Hib (non-gsk); Merck; unknown; unknown given on 15 May 2013; pneumococcal vaccines (non-gsk); Pfizer; unknown; unknown given on 15 May 2013. On 15 May 2013 at 11:30 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 15 May 2013, approximately 2.5 to 3 hours after vaccination with PEDIARIX, the subject experienced injection site redness (described as "leg is red from hip to toe") and injection site hot to touch (described as "leg is hot to touch"). The nurse reported that the subject did not have fever. The nurse also stated that "only the PEDIARIX was administered in that leg [left thigh]. The other vaccinations were administered in the other leg." At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with PEDIARIX.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Feeling abnormal, Incorrect dose administered, Somnolence
Clinical narrative: This case was reported by a consumer (grandmother of subject) and described the occurrence of fuzzy in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined; GlaxoSmithKline; unknown; unknown thigh given on 24 October 2012 at 10:00; unspecified vaccine; manufacturer unspecified; oral given on 24 October 2012. On 24 October 2012 at 10:00 the subject received the 1st and 2nd dose of PEDIARIX (unknown route, unknown leg) and experienced overdose. The subject "received two doses of PEDIARIX instead of one dose of PEDIARIX and one dose of HIB vaccine." On 24 October 2012, less than one day after vaccination with PEDIARIX, the subject experienced a "little fuzzy" and sleepy. The reporter consulted with the physician and the physician said that her grandson was going to be okay. At the time of reporting the outcome of the events were unspecified. No further details were available for reporting.