chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On 12-AUG-2014, the patient was vaccinated with (Oka-Merck) PROQUAD (Lot#J000141, Expiration date 04-JUL-2014) (dose and route were not reported). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
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. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on 16-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 INJ (lot # J006242, expiration date 03-AUG-2014), 0.5 ml, intramuscular. No adverse effects were reported. This case is linked to case MARRS # 1408USA015389 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, route and lot were not provided). No adverse effects reported. This is one of several reports received from the same reporter.  Additional information is not expected, because is not possible contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored M-M-R II (dose, route and lot were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because it not possible contact the physician.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's relevant medical history and past drug history were unknown. On 16-AUG-2014, the patient received one injection of PNEUMOVAX23 (lot number reported as J006246, expiration date reported as 03-AUG-2014 (dose and route not provided). There were no co-suspect therapies. Concomitant therapies included NORVASC, hydrochlorothiazide (manufacturer unknown) and LOPRESSOR. The pharmacist reported that on 16-AUG-2014, the patient accidentally received an expired dose of PNEUMOVAX23. The patient's relevant tests or laboratory data were unknown. As of 25-AUG-2014, it was unknown if the patient would received PNEUMOVAX23 again and the outcome of receiving an expired dose was unknown. The pharmacist reported that the patient had not called to report any adverse events. Lot number J006246 is not valid for PNEUMOVAX23. This case is linked to cases MARRS# 1408USA015182 and MARRS#1408USA015409 (same reporter link). Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 80 year old patient of unknown gender. In August 2011, three years ago, the patient was vaccinated with ZOSTAVAX lot# and strength unknown, one injection, subcutaneous for prevention of shingles. On unspecified date in August 2013, one year ago, the patient experienced shingles and was experiencing chronic pain from nerve damage and complications with Postherpetic Neuralgia (PHN). The outcome of shingles, complications with (phn) postherpetic neuralgia and nerve damage was unknown. The patient sought medical attention ("out patient setting") and received unknown treatment for the events. The outcome of chronic pain from nerve damage and complications with (phn) postherpetic neuralgia was not recovered as she was still experiencing at the time of the report. Additional information is not expected since we cannot contact physician.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient of unknown gender. On 18-AUG-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (lot# K002930, expiration date 26-FEB-2016, 0.5 ml, subcutaneous), which had been improperly stored at -12.2 for 3 hours cumulatively. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 24 year old female patient. The patient was allergic to penicillin. The patient's medical history included pregnant. Concomitant therapies included prenatal vitamins. On 12-AUG-2014 the patient was vaccinated with GARDASIL lot # J010668, expiration date: 29-APR-2016, 1 single dose/ as directed, intramuscular by the medical assistant and meant to give a Tetanus shot. The event happened in the medical office. No adverse effect reported. No treatment was given. No labs was performed. It was reported that the patient was pregnant with LMP of 20-FEB-2014 (pregnant gestation was reported as at 26 weeks at the time of reporting) and EDD of 27-NOV-2014. Initial exposure to GARDASIL was at 24 week(s). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. On 25-AUG-2014 the patient accidentally received an expired dose of PNEUMOVAX 23 (frequency unknown, dose, route reported as injection, lot # J006921, expiration date 09-AUG-2014) (reported as for an unknown indication). Concomitant therapies included XANAX, diazepam (manufacturer unknown), gabapentin, REGLAN and VALTREX. The patient's relevant tests or laboratory data was unknown. As of 25-AUG-2014, it was unknown if the patient would receive PNEUMOVAX 23 again. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
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. Information about concurrent conditions, concomitant medication and medical history was not provided. On 27-AUG-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot# J006242, expiration date 03-AUG-2014, 0.5 ml) intramuscularly. No adverse effect was reported. Additional information is not expected because no consent to contact.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route and lot number were not reported) and (Oka-Merck) PROQUAD (dose, route and lot number were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient of unknown age. On 27-AUG-2014 the patient was  vaccinated with (Oka/Merck) VARIVAX (dose, route and lot number were not reported) and (Oka/Merck) PROQUAD (dose, route and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient of unknown age. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route and lot number were not reported) and (Oka-Merck) PROQUAD (dose, route and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown gender 6 month old patient. On 27-AUG-2014 at the age of 6 months the patient was vaccinated with a dose of VARIVAX (Merck) (dose number, route and dose unknown). No adverse effect reported. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 21-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 64 year old female patient. No pertinent medical history reported. On an unknown date (a couple of years ago) the patient was vaccinated with ZOSTAVAX (dose and frequency unknown), (lot number not reported) through an unspecified route for prevention of shingles. No concomitant therapies reported. On an unknown date in August 2014 (reported as last week) the patient presented to office with a rash. The patient sought medical attention. The physician prescribed unspecified steroid to rule out poison ivy. The redness resolved yet rash remained. The physician diagnosed it as shingles and the physician ordered unspecified antiviral therapy as treatment. The outcome of shingles was unknown. Causality for the event was unknown. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 3 year old patient. On 05-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reprots received from the same source. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 13 month old patient. On 07-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 2 year old patient. On 29-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administration error, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 26-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number# and frequency not provided) for "patient request for shingles prevention". Pharmacist used a 5/8 inch needle for subcutaneous injection. Pharmacist described the patient's skin as taut and stated she could barely push the ZOSTAVAX into the patient's skin. Fluid filled under the patient's skin at the injection site of administration. Pharmacist removed the needle from the initial site and administered the ZOSTAVAX remaining in the syringe into at least two more sites in the same activity. The patient ended up with three, small fluid bubbles in the same area also described as a subcutaneous bubble under the patient's skin. Pharmacist additionally stated there was no problem with the syringe used. The action taken and outcome were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 23-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.97
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 23 month old patient. On 11-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient. On 09-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 13 month old patient. On 15-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 01-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old patient. On 31-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 2 year old patient. On 14-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. No information about medical history, concurrent conditions was reported. The patient had an unknown reaction to sulfonamides. On 26-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot# K007548, dose not reported), single dose subcutaneous in the left arm. No concomitant medications were reported. On 27-AUG-2014, 1 day after onset of therapy the patient developed redness, tenderness, and induration at the injection site. The patient self-treated with ibuprofen. The patient came to the pharmacy on 28-AUG-2014, because the reaction is getting worse. The patient has been referred to her provider for evaluation. No lab diagnostics studies were performed. The patient sought medical attention at the pharmacy. There was no product quality complaint. The outcome was reported as not recovered/not resolved. The causality of the event was not specified. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, 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. On an unknown date those patients were vaccinated with an improperly stored in June 2014 ZOSTAVAX (dose, units, route of administration, anatomical location, lot numbers were not reported). The reporter stated that the vaccine was evaluated by the Company and found to be viable and since then they were administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter refused to contact physician.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 2 year old patient. On 07-AUG-2014 the patient was vaccinated with M-M-R II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Hypoaesthesia oral
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 60 year old female patient with allergic to monosodium glutamate (MSG). On 27-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The physician reported to the representative that "the patient experienced numbness of the tongue and high blood pressure, after receiving ZOSTAVAX" on 27-AUG-2014. Patient sought medical attention by office visit on an unspecified date. The outcome of numbness of the tongue and high blood pressure was reported as recovered/resolved. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 24-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. Activity date reported as 28-JUL-2014. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old female patient. On 15-AUG-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU, (with lot number J016257 and expiry date 20-FEB-2015) (dosing regimen unspecified) for prevention of shingles. No concomitant medication was reported. On 15-AUG-2014, the patient experienced inflammation and soreness in the middle of her rash and itchiness. The patient did not receive treatment for the events but sought medical attention. VZV packet was offered to the patient (details unspecified) and she was not pregnant while vaccination. The outcome of all the events was not resolved. The causality of the events was unknown for ZOSTAVAX. A product quality complaint (PQC) was not involved. This is one of several reports from same reporter. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
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 20-AUG-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose and route were not reported, lot # J009827, expiration date 10-AUG-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored in June 2014 (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location, lot numbers were not reported). The reporter stated that the vaccine was evaluated by the Company and found to be viable and since then they were administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter refused to contact physician.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 30-JUL-2014 the patient was vaccinated with M-M-R II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. 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 regarding an unspecified number of patients. No information regarding medical history and drug reactions or allergy was provided. The reporter stated that on an unknown date an unspecified number of patients were vaccinated with doses of GARDASIL (Dose, frequency, product lot/expiry date not reported) that were improperly stored. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 21 years old female patient. It was reported that the patient was not pregnant. Sometime in 2007 the patient was vaccinated with first dose of GARDASIL (dose, frequency, lot# and expiration date were not reported). Subsequently, on unknown dates, the patient was vaccinated with the second and third dose of GARDASIL three-dose series at 15 years of age and on unknown date the patient tested positive for HPV. It was reported that smear cervix (pap test) was performed (unknown date). The patient sought medical attention. The outcome of HPV infection was not reported. The relatedness between GARDASIL and HPV infection was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients. No information regarding medical history and drug reactions or allergy was provided. The reporter stated that on an unknown date an unspecified number of patients were vaccinated with doses of PEDVAXHIB (Dose, frequency, route, product lot/expiry date not reported) that were improperly stored. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 29-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J006242, intramuscular, once in the left deltoid. The consumer's medical history, concomitant medications, and past drug history are unknown. It was later noticed that this vaccine had expired on 03-AUG-2014. At the time of the call the pharmacist reported that the patient had not called to report any adverse events. There was no laboratory data reported. As of 29-AUG-2014 it is unknown if the patient will receive another injection of PNEUMOVAX 23 and the outcome of receiving expired vaccine is unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site streaking, Injection site ulcer
Clinical narrative: This spontaneous report was received from a 66 year old male physician with no medical history and with no drug reactions or allergies reporting on himself. On 22-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, intradermally in the outer axillary area of unspecified arm, lot#, expiration date not reported). Concomitant medications were not reported. The physician/patient reported that he received a dose of ZOSTAVAX and he thought it might have been administered intradermally in the outer axillary area of an unspecified arm. He stated that after he received the ZOSTAVAX, a bandaid was applied and he left the bandaid on for a "couple days" and when he took the bandaid off it was "immediately" painful at the injection site (in approximately August 2014, exact date not specified). He reported that prior to taking the bandaid off, it was a "little achy" at the injection since an unspecified date (in approximately August 2014). He also stated that he noted a "linear" ulcer located at the injection site after the bandaid was removed (in approximately August 2014, exact date not specified). He also described the skin at the injection site as looking like a "needle track" which he noted after removal of the bandaid (in approximately August 2014, exact date not specified). He reported that it hurt to have anything touch the injection site since an unspecified date (in approximately August 2014). There were no laboratory tests performed. There was no treatment given for the reported events. The outcome of linear ulcer located at the injection site after the bandaid was removed, the skin at the injection site looking like a needle track and painful at the injection site/a little achy at the injection/it hurts to have anything touch the injection site was reported as not recovered/not resolved. The patient did not seek medical attention. The relatedness between the therapy with ZOSTAVAX and the events of linear ulcer located at the injection site after the bandaid was removed, the skin at the injection site looking like a needle track and painful at the injection site/a little achy at the injection/it hurts to have anything touch the injection site was not reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 14 year old patient of unknown gender. On 14-JUL-2014 the patient was vaccinated with (Oka-Merck) PROQUAD injection. No concomitant medication was reported. On 14-JUL-2014 it was reported that a 14 year old patient received (Oka-Merck) PROQUAD and no adverse symptoms reported. The outcome of 14 year old patient received (Oka-Merck) PROQUAD and no adverse symptoms reported is unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 18 year old patient. On 22-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 68 year old female patient. On 21-AUG-2014 the patient was vaccinated with ZOSTAVAX lot no. K003601 (expiry 19-MAR-2014) 1 single shot injection. No concomitant medication was reported. In approximately August 2014 the patient experienced redness and swelling the size of a dollar bill down the back of her arm. On 22-AUG-2014, the patient called the pharmacy and then on 23-AUG-2014, visited pharmacy to show redness and swelling the size of a dollar bill down back of her arm. No itchiness was indicated. Lab diagnostics were not performed. The patient seeked medical attention in the pharmacy. Product quality complaint was not filed. The outcome of event was unknown. The causality of events with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients. No information regarding medical history and drug reactions or allergy was provided. The reporter stated that on an unknown date an unspecified number of patients were vaccinated with doses of ROTATEQ (dose, frequency, product lot/expiry date not reported) taken orally that were improperly stored. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 14 year old female patient. On 28-AUG-2014 the patient was vaccinated with GARDASIL (dose, lot no. not reported) intramuscular. On 28-AUG-2014, therapy the patient experienced nausea right after GARDASIL injection. Nausea lasted for 30 minutes. The outcome of nausea was reported as recovered on 28-AUG-2014. There was no intervention to prevent serious criteria. The patient did not receive any treatment for the event. Product quality complaint was not involved. The causality of nausea with GARDASIL was unknown. Additional information is not expected because physician cannot be contacted.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 03-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. Activity date was reported as 22-AUG-2014. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician (friend of the unspecified patient) refers to a 70 years old patient of unknown gender. In approximately 2006 (also reported as on an unspecified date approximately 8 years ago), the patient was vaccinated with ZOSTAVAX vial, (dose, frequency, route of administration and indication were not provided). Concomitant medications were not reported. The ZOSTAVAX was transported from an unspecified pharmacy to an unspecified physician's office packed in dry ice. The ZOSTAVAX may have been exposed to colder than prescribed temperatures. No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was available. Additional information has been requested.
Age: 1.26
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 month old patient. On 08-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to her son of unknown age. On 24-FEB-2014, the patient was vaccinated with the first dose of VAQTA, 0.5 ml, intramuscular (lot number not reported). On 19-AUG-2014, 5 days earlier than recommended minimum interval of 6 months, the patient was vaccinated with the second dose of VAQTA 0.5 ml, intramuscular (lot number not reported). No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old patient. On 09-AUG-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a nurse practitioner via Company Representative refers to a female patient in her early 20's. On an unknown dates the patient was vaccinated with series of three doses of GARDASIL (doses, Lot# numbers and routes of administration were not reported). On an unknown date, after receiving all three doses of GARDASIL the patient developed genital warts. On an unknown date the patient recovered from genital warts and on an unknown date the genital warts returned again. The patient was treated in unspecified way. The patient sought medical attention by visiting the office. The patient's present status was unknown. Relatedness between genital warts and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (route, dose and lot were not reported) that was improperly stored. No adverse symptoms reported. The outcome of patient received improperly stored VARIVAX (Merck) was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 84 year old male patient. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patient was vaccinated with ZOSTAVAX refrigerated vial (dose, route and lot number not provided). No co-suspect or concomitant therapies were provided. The physician reported that the patient developed shingles on 2 separate unspecified occasions after receiving ZOSTAVAX vaccine (dates not provided). At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Influenza like illness, Poor quality sleep
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient with none drug reactions or allergies. On 04-AUG-2014 the patient was vaccinated with ZOSTAVAX (injection, dose, units, route of administration, anatomical location, lot number were not reported). On 04-AUG-2014, after receiving one dose of ZOSTAVAX the patient experienced flu like symptoms. The reporter stated that the reactions began after eating and on 04-AUG-2014, about an hour after receiving the injection. The patient also experienced vomiting, diarrhea, was not able to sleep well, was sweating, having the chills and experiencing a low grade fever. The reporter stated that the reactions lasted all day on 04-AUG-2014. The patient went in for a visit with his physician, the next day on 05-AUG-2014. The outcome of adverse events was reported as recovered on 05-AUG-2014. There was none lab diagnostics studies performed. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient with none drug reactions or allergies. On 04-AUG-2014 the patient was vaccinated with ZOSTAVAX (injection, dose, units, route of administration, anatomical location, lot number were not reported). On 04-AUG-2014, after receiving one dose of ZOSTAVAX the patient experienced flu like symptoms. The reporter stated that the reactions began after eating and on 04-AUG-2014, about an hour after receiving the injection. The patient also experienced vomiting, diarrhea, was not able to sleep well, was sweating, having the chills and experiencing a low grade fever. The reporter stated that the reactions lasted all day on 04-AUG-2014. The patient went in for a visit with his physician, the next day on 05-AUG-2014. The outcome of adverse events was reported as recovered on 05-AUG-2014. There was none lab diagnostics studies performed. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TD
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL,  1 shot (dose, dose number, route, lot/batch number, expiration date and indication were not reported). Other suspect therapies included TD and MENACTRA (for both dose, dose number, route, lot/batch number, expiration date and indication were not reported) given on the same day (date unspecified) together with GARDASIL . On an unknown date, briefly after being vaccinated, the patient passed out. No laboratory diagnostic studies were performed. The outcome of the event was reported as recovered/resolved within 5 minutes (reported as within 5 minutes patient was fine). The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Dyspnoea, Injection site bruising, Injection site rash, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a consumer refers to her son a 5 year old male patient with allergy to BACTRIM, oats, carrots, peanut oil and bananas. There was no pertinent medical history. On 11-AUG-2014 the patient was vaccinated with the second dose of PROQUAD (Merck) injection, in the left thigh, (lot number, expiration date, route and dosage were not reported). There was not concomitant therapy. The consumer informed that in approximately August 2014 (also reported as within 24 hours) the patient had developed a rash, the size of a half dollar, around the injection site of left thigh. In addition her son had congestion, started coughing and had some difficulty breathing, like he did when he had an allergic reaction. The consumer stated that the nurse at her son's school first noticed his rash and symptoms, also stated that the nurse called to the health department to report the adverse event, since that was where the patient got the PROQUAD (Merck) vaccination. The child was given oral BENADRYL, and was breathing more freely, but some congestion remained. Caller stated that her son's rash was gone, but a bruise remained. The consumer stated that she had not yet called her son's health care provider. Also informed that the patient did not have any adverse effects after the first PROQUAD (Merck). There were not laboratories diagnostics studies performed. The patient sought medical attention by school nurse visit. The outcome of the rash and difficulty breathing was recovered. The outcome of congestion and the bruise was not recovered. The outcome of the cough was unknown. Additional information is not expected because the report refused additional contacted with the physician.
Age: 1.05
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 21-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient. On 07-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to a 26 or less patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date the patients were vaccinated with RECOMBIVAX HB (lot number, expiration date, dosage and route were not reported), that were improperly stored. The nurse stated she knew that RECOMBIVAX HB was one of the vaccines that was administered. Also informed she was still gathering information on how many clients were vaccinated with improperly stored vaccines. No adverse effects were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 21 year old female patient with no drug allergies. The patient's medical history included spontaneous abortion in June 2013, caesarean section and headaches. The patient is gravida 2 and has one child living. The patient became pregnant on 29-JUL-2014 with last menstrual period (LMP): 15-JUL-2014. Estimated Date of Delivery (EDD) is 21-APR-2015. Nurse stated that on 26-AUG-2014 ("yesterday") the patient was vaccinated with her third dose of GARDASIL (0.5 ml intramuscularly in the right arm, lot # K006449, expiration date: 19-JUN-2016). Concomitant therapies included IMITREX. Initial exposure to GARDASIL was at 6 weeks. A urine pregnancy test was taken and was positive. However, nurse stated that patient did not wait for the results, she wanted the GARDASIL vaccination. Nurse also stated that post vaccination, patient told her she knew she was pregnant, due to a home urine pregnancy test, but wanted to get the third dose of GARDASIL completed. Patient was not experiencing any adverse effects. The pregnancy outcome was outcome pending. Additional information is not expected, because there was no consent to contact physician.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 21 year old female patient with no drug allergies. The patient's medical history included spontaneous abortion in June 2013, caesarean section and headaches. The patient is gravida 2 and has one child living. The patient became pregnant on 29-JUL-2014 with last menstrual period (LMP): 15-JUL-2014. Estimated Date of Delivery (EDD) is 21-APR-2015. Nurse stated that on 26-AUG-2014 ("yesterday") the patient was vaccinated with her third dose of GARDASIL (0.5 ml intramuscularly in the right arm, lot # K006449, expiration date: 19-JUN-2016). Concomitant therapies included IMITREX. Initial exposure to GARDASIL was at 6 weeks. A urine pregnancy test was taken and was positive. However, nurse stated that patient did not wait for the results, she wanted the GARDASIL vaccination. Nurse also stated that post vaccination, patient told her she knew she was pregnant, due to a home urine pregnancy test, but wanted to get the third dose of GARDASIL completed. Patient was not experiencing any adverse effects. The pregnancy outcome was outcome pending. Additional information is not expected, because there was no consent to contact physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with PEDVAXHIB (route, dose and lot # were not reported) that was improperly stored. No adverse symptoms reported. The outcome of patients received improperly stored PEDVAXHIB was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ROTATEQ (route, dose and lot # were not reported) for prophylaxis that was improperly stored. No adverse symptoms reported. The outcome of patients received improperly stored vaccine ROTATEQ was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with lupus and no drug reactions/allergies. On 15-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as K003600, expiration date 19-MAR-2015) (dose and route not reported). Concomitant medications included methotrexate, PLAQUENIL and PROLIA. Approximately on 18-AUG-2014, reported as 3 days later, the patient developed an elevated rash at the injection site. The patient saw the pharmacist for medical attention and did not receive treatment for the event. The pharmacist reported that the patient still had the rash at the time of the report. No additional information was provided, VZV packet was declined. No lab diagnostics were performed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 16-MAY-2014 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular, (lot number and expiration date were not reported). The second dose was administered on 17-JUL-2014 and the third dose on 27-AUG-2014, according with the nurse the patient received the third dose of GARDASIL early. Also stated that the patient received the GARDASIL series according to an off label dosing schedule. No adverse effects were reported. Additional information has been requested.
Age: 1.64
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 19 month old patient. On 21-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.