chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received from a nurse who reported that an unspecified number of patients were administered improperly stored doses of MMR II and GARDASIL on unspecified dates. No adverse events were reported. No further information was provided. Additional information had been requested.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Hepatitis B surface antibody negative, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old male patient without drug reactions or allergies. No pertinent medical history and concomitant medication were reported. The patient was administered doses of RECOMBIVAX HB (lot number not reported) on 25-OCT-2001, 03-DEC-2001 and 10-JUN-2002 (dose unknown). The result of a "hepatitis B titer" drawn on 31-JUL-2014 was "less than 5". As treatment for the "negative titer of less than 5" the patient was administered doses of RECOMBIVAX HB (Lot Number reported as 1572AA, Expiration Date 26-MAY-2014) on 19-AUG-2014 and 07-OCT-2014 which had expired (dose unknown). On an unspecified date in 2014 the patient was diagnosed with Bell's Palsy. No treatment for Bell's Palsy was reported. The outcome of the events was unknown. The relationship between RECOMBIVAX HB and the events was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Rash pruritic, Rash pustular, Viral titre
Clinical narrative: This spontaneous report as received from a nurse refers to a 38 year old female patient with thyroid disease, Gastroesophageal reflux disease (GERD) and allergy to MACRODANTIN. Medical history was not reported. On 12-NOV-2014 varicella titers were performed and the result was 0.46 (units not provided). On 26-NOV-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) injection, 0.5 ml, subcutaneous, lot # K005178, expiration date 10-APR-2016, as a school requirement. Concomitant therapies included SYNTHROID and omeprazole. The nurse informed that 17-DEC-2014 the patient developed an itching and burning rash on an unspecified location on her body, also informed that on an unknown date in December 2014 (also reported as a couple days later) the patient developed pustules from head to toe on her body, the nurse stated that the patient was seen by a dermatologist on an unspecified date and also stated that on 17-JAN-2015 the patient had a titer level drawn for the varicella and the result on the titer was 1.05 (units not provided). The outcome of the events was recovered on an unspecified date. 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 registered nurse and refers to unspecified number of patients of unknown age and gender. The patient's medical history, current conditions, drug reactions and allergies were unknown. On 09-JAN-2015, the patients were vaccinated with doses of VARIVAX (Merck) (dose, route of administration, anatomical location and exp. date were not reported) that have been exposed to a supported temperature excursion (also reported as supported defrost cycling). No adverse effects have been observed or reported. The outcome of the event was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.48
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. Unspecified number of patients were vaccinated with VARIVAX (Merck) (dose, route of administration and anatomical location was unknown) on an unspecified dates since 07-JAN-2015 that had been exposed to a supported temperature excursion. Concomitant medications were unspecified by reporter. The reporter was not aware of any adverse experiences. The outcome of the events was unknown. The causality was unknown. No additional information was provided. 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 licensed practical nurse (also reported as registered nurse) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of VAQTA (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is the one of several reports from the same reporter source. 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 registered nurse and refers to unspecified number of patients of unknown age and gender. The patient's medical history, current conditions, drug reactions and allergies were unknown. On 09-JAN-2015, the patients were vaccinated with doses of PROQUAD (Merck) (route of administration, anatomical location and exp. date were not reported) that have been exposed to a supported temperature excursion (also reported as supported defrost cycling). No adverse effects have been observed or reported. The outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a Registered Nurse who stated that the refrigerator temperature rose to 16C time of excursion 67 hours (worse case), affecting PNEUMOVAX (dose, duration and site not reported) "(not supported)". The reporter stated that vaccines had experienced a previous temperature excursion of 14C for 12 hours. Temperature ranged and time frame: 16C for 67 hours and 14C for 12 hours. This is one of several reports received from the same reporter. Additional information is not expected because the registered nurse stated she did not want to receive any further follow up letters.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a 31 year old female patient. It was reported that the patient had no pertinent medical history. On 13-JAN-2015, the patient was mistakenly vaccinated with a dose of GARDASIL (dose, dose number, lot/batch number and expiration date were not reported) instead of unknown other vaccine, possible TDAP. It was reported that the patient was not on any concomitant medications. It was reported that at that time, the patient was 27 weeks gestation. The patient became pregnant with LMP of 08-JUL-2014 (estimated based on 27 weeks gestation on 13-JAN-2015) and EDD of 14-APR-2015 (estimated based on 27 weeks gestation on 13-JAN-2015). No adverse effects were noted. It was reported that the medication error was not related to packaging. The patient sought medical attention by visiting the physician's office on 13-JAN-2015. At the time of the report the pregnancy outcome was pending. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Caesarean section, Exposure during pregnancy, No adverse event, Rhesus antibodies negative
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a 31 year old female patient. It was reported that the patient had no pertinent medical history. On 13-JAN-2015, the patient was mistakenly vaccinated with a dose of GARDASIL (dose, dose number, lot/batch number and expiration date were not reported) instead of unknown other vaccine, possible TDAP. It was reported that the patient was not on any concomitant medications. It was reported that at that time, the patient was 27 weeks gestation. The patient became pregnant with LMP of 08-JUL-2014 (estimated based on 27 weeks gestation on 13-JAN-2015) and EDD of 14-APR-2015 (estimated based on 27 weeks gestation on 13-JAN-2015). No adverse effects were noted. It was reported that the medication error was not related to packaging. The patient sought medical attention by visiting the physician's office on 13-JAN-2015. At the time of the report the pregnancy outcome was pending. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound antenatal screen normal, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a 31 year old female patient. It was reported that the patient had no pertinent medical history. On 13-JAN-2015, the patient was mistakenly vaccinated with a dose of GARDASIL (dose, dose number, lot/batch number and expiration date were not reported) instead of unknown other vaccine, possible TDAP. It was reported that the patient was not on any concomitant medications. It was reported that at that time, the patient was 27 weeks gestation. The patient became pregnant with LMP of 08-JUL-2014 (estimated based on 27 weeks gestation on 13-JAN-2015) and EDD of 14-APR-2015 (estimated based on 27 weeks gestation on 13-JAN-2015). No adverse effects were noted. It was reported that the medication error was not related to packaging. The patient sought medical attention by visiting the physician's office on 13-JAN-2015. At the time of the report the pregnancy outcome was pending. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 59 year old male patient with no drug reactions/allergies and no pertinent medical history. On 29-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, site of administration, lot# and expiration date were not provided). There was no concomitant medication. On 06-DEC-2014, the patient experienced soreness at the injection, that spread to his shoulder and elbow, across the back to the other arm, accompanied by severe joint pain. No lab diagnostic studies were performed. The patient had an office visit on an unspecified date and was treated with ibuprofen. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a Registered Nurse who stated that the refrigerator temperature rose to 16C time of excursion 67 hours (wore case), affecting MMR "(not supported)". The reporter stated that vaccines had experienced a previous temperature excursion of 14C for 12 hours. Temperature ranged and time frame: 16C for 67 hours and 14C for 12 hours. This is one of several reports received from the same reporter. Additional information is not expected because the registered nurse stated she did not want to receive any further follow up letters.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 24 year old male patient with no relevant medical history nor current conditions. On 11-OCT-2014 the patient was vaccinated with the first dose of GARDASIL (route, lot number and expiration date were not reported). On 20-DEC-2014, the patient received a second dose of GARDASIL lot # 0324AE, expiration date: 20-OCT-2014 (dose and route were not reported). After vaccination the pharmacist noticed the vaccine was expired. Patient had none concomitant medication. It was unknown if the patient could continue to get the third GARDASIL injection. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Injection site hypoaesthesia, Injection site pain, Pruritus, Rash erythematous
Clinical narrative: Red bumps, itching alot, burning. Felt numb and then a stabbing pain in left arm where shot was.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: Pt received MMRV vaccine alone last week and developed some redness, swelling and feeling firmness. Pt was given BENADRYL and the reaction improved the following day. Dr advised pt it sounded like a mild local reaction, perhaps mild allergy. This is pt's last booster.
Age: 1.44
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray normal, Eye discharge, Influenza virus test negative, Irritability, Pyrexia
Clinical narrative: High fever starting 1/11/15 to 105.5 nasal and eye discharge. Fussiness.
Age: 1.44
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: High fever starting 1/11/15 to 105.5 nasal and eye discharge. Fussiness.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, heat, swelling, pain at the injection site, approximately 9 x 4 inches in diameter. Treatment: AUGMENTIN 875-125 mg 1 tab twice a day with meals.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Swelling face
Clinical narrative: 29 year old male had possible high risk rabies exposure received RABIVERT in deltoid. Fifteen minutes later generalized facial swelling, no airway obstruction resolved with BENADRYL.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to a 37 year old female patient. On 20-OCT-2014 the patient was vaccinated with GARDASIL, subdermal. The outcome of the patient currently 37 years old and received her first dose of GARDASIL which was given subdermal is unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Rash erythematous, Rhinorrhoea
Clinical narrative: Information was received from a pharmacist regarding a 55 year old female patient with hypertension, allergies (unspecified), and no drug reactions/allergies, who on 01-DEC-2014, was vaccinated with a single dose of ZOSTAVAX (lot # K012785, expiration date 28-NOV-2015), subcutaneously in the left upper arm. Concomitant therapies included FLONASE and SINGULAIR. On 03-DEC-2014, the patient called the pharmacy stating she had developed hard, red, painful bumps on her left arm and her face. She also developed a runny nose on 03-DEC-2014. No treatment was given. The outcome of the runny nose and the hard, red, painful bumps on her left arm and her face was reported as not recovered. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown age and gender. On an unknown date the patients were vaccinated with second dose of RECOMBIVAX HB (Strength: 10MCG/1.0 ml 10 standard packages syringe of 1) (Lot # not reported). Nurse reported that unspecified number of patients had received second dose of RECOMBIVAX HB outside of recommended interval and some patients received second dose of RECOMBIVAX HB at month 2 or 3 after the first dose. No adverse effects reported. No product quality complaint was involved. Additional information is not expected. Because the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients received second doses of GARDASIL (dose, lot#, route and site of administration were not reported) late. No symptoms were reported. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 38-year-old male patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Office was sent a recall notification from their distributor regarding ENGERIX B and storage temperatures. The office has already administered the vaccine to 5 adults. Reporter is not certain what type of excursion took place (high or low temps). At this time, no reports to the office have been received from the patients following vaccination. Vaccines were given this week. Three female: 37, 62 and 52-year-old. Two male: 38 and 65-year-old. Follow-up received on 8 December 2014: Patient got ENGERIX B which was not stable. No adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date about 50 doses of VARIVAX (Merck) (route, dosage, lot# and expiration date were not reported), were administered to unspecified patients since VARIVAX (Merck) underwent a temperature excursion. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date about 68 doses of PROQUAD (Merck) 0.5 ml, subcutaneous (dosage, lot# and expiration date were not reported), were administered to unspecified patients since PROQUAD underwent a temperature excursion. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Product quality issue
Clinical narrative: This case was reported by a physician and described the occurrence of expired vaccine used in a adult male patient who received HAVRIX (bath number AHAVB515AA, expiry date 3rd November 2013). This case was associated with a product complaint. Previously administered products included HAVRIX adult with an associated reaction of no adverse event. On 6th December 2014, the patient received the 2nd dose of HAVRIX adult (injection). On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced expired vaccine used and product complaint. On an unknown date, the outcome of the expired vaccine used and product complaint were unknown. Additional information received on 08 December 2014; This case was reported by a other health professional and described the occurrence of expired vaccine used in a adult female patient who received HAVRIX (expiry date 3rd November 2013). This case was associated with a product complaint. This is one of the 2 cases reported by the same reporter for the same vaccine and concerning members of a same family (husband and wife). Follow-up information received on 12 December 2014: This case was reported by a other health professional and described the occurrence of expired vaccine used in a adult female patient who received HAVRIX adult (batch number AHAVB515AA, expiry date 3rd November 2013). This case was associated with a product complaint. Per the GSK lot locater system, the last shipment from this particular lot occurred on 14 May 2013, so GSK was not implicated in the recent supply of a carton of expired product received in October 2014. Follow-up information received on 22 December 2014: The entire box of expired lot vaccines came from the wholesaler and not from GSK.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX .5 ml on an unknown date. On unknown date, an unknown time after receiving BOOSTRIX the subject developed drug exposure during pregnancy (Non-serious). The outcome of drug exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Gestational age was unknown. Estimated date of delivery is unknown. No other adverse events were reported.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site cyst
Clinical narrative: Small cyst on selective area on (L) thigh no swelling, no redness no tenderness.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a male patient who received BOOSTRIX (batch number 54MX9, expiry date 21st October 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage o drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: One dose of BOOSTRIX and one dose of PEDIARIX were given to different pts. after the vaccine was exposed to 31F, HCP had info on the BOOSTRIX dose, but did not have the info. available for the PEDIARIX dose.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Redness and irritation on injection site on right leg, patient prescribed: Sulfamethoxazole-Trimethoprim 200-40mg/5mL take 5 mL po BID x 10 days.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 45-year-old male patient who received ENGERIX B (batch number AHBVC034AA, expiry date 6th January 2014). On an unknown date, the patient received ENGERIX B 1 ml. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 45 years old male received expired ENGERIX B.
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to his currently 20 year old male son with no pertinent medical history and no known drug reactions or allergies. On 01-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not provided). On 21-SEP-2013, the patient was vaccinated with the second dose of GARDASIL (route, lot # and expiration date were not provided). On 23-JAN-2014, the patient was vaccinated with the third dose of GARDASIL (route, lot # and expiration date were not provided). On an unknown date, the patient had a patient visit with his physician and the nurse gave him a fourth dose of GARDASIL (route, lot # and expiration date were not provided). Consumer said his son had already complete the three dose series of GARDASIL. The patient did not experience any side effects. There were no laboratory diagnostics studies performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adolescent male patient who received INFANRIX (batch number UNKNOWN, expiry date unknown). In August 2014, the patient received INFANRIX. On an unknown date, the dose was an unknown dose. In August 2014, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to INFANRIX. Additional information: Nurse reported to GSK Account Manager that a 10 to 11 year old  male inadvertently received INFANRIX instead of BOOSTRIX. The nurse noted to the account manager that the color coding on the syringes is very close shades of green. The mother of the child was contacted and no reactions were reported. Product was administered via injection at a dose of 0.5ml but the specific arm for site was unknown.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 32-year-old male patient who received TWINRIX adult (batch number 3J3R4, expiry date 19th February 2016). Concomitant products included TWINRIX adult. On 30th October 2014, the patient received the 2nd dose of TWINRIX adult. On 30th October 2014, an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information: Per the nurse the patient received the first dose of TWINRIX on 23 October 2014 and inadvertently received the second dose on 30 October 2014.
Age: 1.26
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received KINRIX. The patient's past medical history included RSV (respiratory syncytial virus). On 20th June 2014 14:30, the patient received KINRIX (intramuscular). On 20th June 2014 14:30, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional information: The mother of the patient planned to follow-up with her son's physician on 10/31/14.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection was inadvertently given in the subacromial bursa. Patient had resultant severe shoulder pain and decreased range of motion. Initially given prednisone.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 27 August 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 11 February 2014. The subject was exposed to the vaccine at 28 weeks and 1 day gestation. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014: VAERS details were provided.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling (2 cm radius) on left thigh. No discharge. Normal leg movement.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients (ages and genders not specified) who reported that one dose of VARIVAX (Merck) and 10 doses of PROQUAD (Merck) that were improperly stored were administerd to an unspecified number of patients. No adverse effects were reported. 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 certified medical assistant concerning seven patients (ages and genders not specified). On an unspecified date, doses of VARIVAX (Merck) 0.5 mL that underwent a temperature excursion were administered to seven unspecified patients. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: T\\\]his spontaneous report as received from a licensed practical nurse (also reported as registered nurse) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of PNEUMOVAX 23 (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is the one of several reports from the same reporter source. 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 licensed practical nurse (also reported as registered nurse (R.N.)) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of GARDASIL (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of RECOMBIVAX HB (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is the one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JAN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J000493, expiration date 14-APR-2014, 0.65 ml/ once, subcutaneous). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report had been received from a registered nurse via company representative refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route and lot number not provided). On unknown dates, the patients fainted after receiving a dose of GARDASIL. These patients recovered on unspecified dates. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter via another company refers to several female patients of unknown ages. On 02-DEC-2014 these patients were vaccinated with RECOMBIVAX HB (strength, dose, route and expiration date not reported, lot# reported as K012933). The reporter reported this product had been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fine rash started 1/07/15 at 6pm, on face 1st, spread to entire body 1/8/15. 1/9/15 to ER, and ER Dr thought was the vaccines. Low grade fever started 1/7/15, highest fever was 101 degrees. Gave BENADRYL on 1/9/15.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pruritus, Vomiting
Clinical narrative: Case number PHHY2013US127853 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 500427) web site on 11 Nov 2013. This report refers to a 25-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in the left arm on 22 Aug 2013 at 1:00 pm. On 22 Aug 2013, at 5:00 pm, she experienced nausea, vomiting, headache and itching. The outcome of the events was reported as complete recovery.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Case number PHHY2013US127860 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 500430) web site on 11 Nov 2013. This refers to an 18-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in the arm on 22 Aug 2013. On 22 Aug 2013, he experienced vomiting thrice, headache and dizziness. The outcome of the events was reported as complete recovery.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US127890 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501232) website on 11 Nov 2013: This report refers to a 66-year-old female patient. her medical history included Meniere's disease and her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in to the left arm on 29 Aug 2013. On the same day within 20 minutes after vaccination, she became lightheaded and dizzy after receiving vaccine. her legs were propped. Meclizine was administered. Breathing continued steady and ambulance was called. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 59.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Case number PHHY2013US127896 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501356) web site on 11 Nov 2013. This refers to a 59-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in to the right arm along with ZOSTAVAX (other manufacturer, batch number: J003F16) subcutaneously in to the left arm on 29 Aug 2013. On 02 Sep 2013, he experienced a blister about three inches at injection site. He case to the pharmacy and was recommended to visit emergency room (ER) care for redness about two inches and a blister at the site. There was no trouble breathing; he was going to follow up with urgent care. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2013US127906 is an initial spontaneous report received from Vaccine Event Reporting System (VAERS reference number: 501723) website on 11 Nov 2013: This report refers to a 68-year-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of flu shots which were well tolerated. He was vaccinated with FLUVIRIN (batch number: unknown) on 05 Sep 2013. On the same day after vaccination he experienced red rash in crotch area and underneath the armpit, near the rear. The rash itched and was red; it had spread further. Apart from the rash, there was no other reaction so far. Final outcome of the events was reported as condition unchanged as on 07 Sep 2013. No further information about seriousness and causality was reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2013US127910 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501736) web site on 11 Nov 2013. This report refers to a 62-year-old female patient. Her concomitant medications included unspecified medicines for blood pressure, diabetes and pain. She was vaccinated with FLUVIRIN (batch number: 1300771) along with PNEUMOVAX (other manufacturer, batch number: J004747) on 03 Sep 2013. Both the vaccines were administered intramuscularly in to the left arm. Starting from the same day, she complained of painful swollen arm persisting for days after vaccine was administered. Final outcome of the events was reported as condition unchanged as on 08 Sep 2013. No further information about seriousness and causality was reported.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: Case number PHHY2013US127912 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501750) web site on 11 Nov 2013. This report refers to an 82-year-old female patient. She had a medical history of eye problems which included glaucoma and concomitant medications included Timolol, Gabapentin, TRAVATAN Z and aspirin. On 02 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly on her left arm. On 03 Sep 2013, she experienced bruise-like marking on her left arm at the injection site with bluish/purple/reddish coloration. She did not complaint of any pain, soreness or swelling. She was taken to the emergency room on an unspecified date. She was informed by the treating physician that it was a bruise from vaccination and was not associated with any infection. She had not recovered from the events as of 09 Sep 2013. No seriousness and causality was reported.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3
Symptoms: Headache, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2013US127917 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501864) web site on 11 Nov 2013. This report refers to a 70-years-old male patient. His medical history and concomitant medications were not reported. On 06 Sep 2013, he was vaccinated with FLUVIRIN (batch number: 1307701) and PNEUMOVAX (other manufacturer, batch number: H018608) intramuscularly on his left arm. On 07 Sep 2013, he experienced slight fever, headache, and redness at or below injection sites along with pain in arm. On 09 Sep 2013, he returned to pharmacy at 10 am to show his arm. He reported that, he had recovered from headache, but pain in arm was still persisting. Outcome of the other events was reported as condition unchanged as on 09 Sep 2013. The seriousness and causality of the events were not reported.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Case number PHHY2013US127917 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501864) web site on 11 Nov 2013. This report refers to a 70-years-old male patient. His medical history and concomitant medications were not reported. On 06 Sep 2013, he was vaccinated with FLUVIRIN (batch number: 1307701) and PNEUMOVAX (other manufacturer, batch number: H018608) intramuscularly on his left arm. On 07 Sep 2013, he experienced slight fever, headache, and redness at or below injection sites along with pain in arm. On 09 Sep 2013, he returned to pharmacy at 10 am to show his arm. He reported that, he had recovered from headache, but pain in arm was still persisting. Outcome of the other events was reported as condition unchanged as on 09 Sep 2013. The seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Headache, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2013US127923 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501864) web site on 11 Nov 2013. This report refers to a 51-year-old female patient. Her medical history included hypertension, migraines and diabetes mellitus. Her concomitant medications were not reported. On 06 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308401) intramuscularly on her left arm. On the same day after vaccination she experienced temperature of 103 degree Celsius, diarrhea and vomiting. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Case number PHHY2013US127923 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501864) web site on 11 Nov 2013. This report refers to a 51-year-old female patient. Her medical history included hypertension, migraines and diabetes mellitus. Her concomitant medications were not reported. On 06 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308401) intramuscularly on her left arm. On the same day after vaccination she experienced temperature of 103 degree Celsius, diarrhea and vomiting. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Headache, Injection site induration, Myalgia, Nausea
Clinical narrative: Case number PHHY2013US127926 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500430) web site on 11 Nov 2013. This report refers to a 31-year-old female patient. Her medical history and concomitant medications were not reported. On 06 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1307601) and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly on her left arm. On 07 Sep 2013, she experienced muscle tenderness, hardness from shoulder to elbow in vaccinated arm, followed by onset of nausea, vomiting, dizziness, and headache at 4:45 pm day after vaccination. Nausea and vomiting resolved after a few hours. Tender, firm arm soreness (not at injection site) with rash continued 48 hours after vaccination. Final outcome of the other events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash, Tenderness, Vomiting
Clinical narrative: Case number PHHY2013US127926 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500430) web site on 11 Nov 2013. This report refers to a 31-year-old female patient. Her medical history and concomitant medications were not reported. On 06 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1307601) and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly on her left arm. On 07 Sep 2013, she experienced muscle tenderness, hardness from shoulder to elbow in vaccinated arm, followed by onset of nausea, vomiting, dizziness, and headache at 4:45 pm day after vaccination. Nausea and vomiting resolved after a few hours. Tender, firm arm soreness (not at injection site) with rash continued 48 hours after vaccination. Final outcome of the other events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site swelling
Clinical narrative: Case number PHHY2013US127693 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502157) web site on 11 Nov 2013. This report refers to a 71-year-old female patient. Her medical history included allergy to Sulfa, Penicillin, food and unspecified respiratory allergies. This poly medicated patient was vaccinated with FLUVIRIN (batch number: 1305101) intramuscularly into left arm on 10 Sep 2013. On the same day, immediately upon giving the vaccination, her arm began to swell in the area of injection and around it which also turned in to purple/red in color. The reaction area was measured 2 x 2 inches. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US127715 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502266) web site on 11 Nov 2013. This report refers to a 63-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307801) intramuscularly in to the left arm on undetermined date. On an unspecified date after vaccination, she experienced redness, swelling and warmth at the injection site. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2013US127718 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502270) website on 11 Nov 2013. This report refers to a 55-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly into left arm on 03 Sep 2013. Since 04 Sep 2013, she had been experiencing sore arm and inability to raise the arm. She visited the emergency room due to these events. She was advised to seek medical treatment if she was in severe pain and unable to lift arm. Outcome of the events were reported as not recovered as of 12 Sep 2013. No seriousness and causality was reported for the events.