chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Asthenia, Blood glucose decreased, Confusional state, Loss of consciousness, Muscle spasms
Clinical narrative: After patient received the vaccines, about 5 minute, she became weak and fainted sideway while sitting down. Visible spasms in legs. Was not responding to my inquiries for about 10-15 seconds. When I was getting ready to give Epipen, she came back to consciousness, but was still confused for about 10-15 seconds. Gave her water.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: After patient received the vaccines, about 5 minute, she became weak and fainted sideway while sitting down. Visible spasms in legs. Was not responding to my inquiries for about 10-15 seconds. When I was getting ready to give Epipen, she came back to consciousness, but was still confused for about 10-15 seconds. Gave her water.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: (L) arm warm, tender, swollen. Pt given BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Diet refusal, Fluid intake reduced, Lethargy, Nausea, Pyrexia
Clinical narrative: Fever > 100 while taking TYLENOL, ibuprofen. Nausea and refusing food and liquids. Lethargic. Unable to urinate > 15 hrs. Used thighs this time hoping last reaction was due to small arms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Urinary retention
Clinical narrative: Fever > 100 while taking TYLENOL, ibuprofen. Nausea and refusing food and liquids. Lethargic. Unable to urinate > 15 hrs. Used thighs this time hoping last reaction was due to small arms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Headache, Insomnia, Peripheral swelling
Clinical narrative: 11/11/14- Afternoon swelling and redness on arm, weak. Tonsil swelled up. Headache for 3 to 4 days. Can't sleep. Vertigo.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tonsillar hypertrophy, Vertigo
Clinical narrative: 11/11/14- Afternoon swelling and redness on arm, weak. Tonsil swelled up. Headache for 3 to 4 days. Can't sleep. Vertigo.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Retching
Clinical narrative: After the employee received the vaccinations she took the bus home and approximately 45 minutes later she became nauseous and began "dry heaving".
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 years old patient of unknown gender. On 08-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015 (also reported as 19-MAR-2015) 0.65 ml dose once, subcutaneous (dose number was not reported) for shingles, that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored GARDASIL. Dose, route, lot number and expiration date were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored ROTATEQ, oral. Dose, lot number and expiration date were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015 (also reported 19-MAR-2015) 0.65 ml dose once, subcutaneous (dose number was not reported), that ws exposed to 19.5 F for hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 73 years old patient of unkonwn gender. On 17-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015 (also reported as 19-MAR-2015) 0.65 ml dose once, subcutaneous (dose number was not reported), that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored M-M-R II. Dose, route, lot number and expiration date were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 68 years old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015(also reported as 19-MAR-2015) 0.65 ml dose once, subcutaneous(dose number was not reported), that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint(PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-NOV-2014 the patient was administered a dose of PNEUMOVAX 23 (strength, dose, frequency, route, lot # and indication were not provided). PNEUMOVAX 23 was exposed to temperatures outside of the proper storage range. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27 years old patient of unknown gender. On 26-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 years old patient of unknown gender. On 26-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a "handful" of parents. On an unknown date patients was vaccinated with VARIVAX (Merck) (strength, dose, frequency, route, lot # and indication were not provided). At the practice, over the past year, a "handful" of parents have reported that their child had developed chicken pox after administration of their first dose of VARIVAX (Merck). Nurse had no specific information to share regarding patients, dosing information, or any other details. She further stated that this was word-of mouth, as the parents only called the office with the reports and there was no physical assessment done. No other information available. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several report from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 years old patient of unknown gender. On 22-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2015 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration, White blood cell count increased
Clinical narrative: This spontaneous report was received from a physician and it refers to a 40 year old male patient. The patient had no pertinent medical history. It was reported that the patient had allergy to penicillin. On an unspecified date, reported as "possibly in 2008", the patient was vaccinated with (Oka/Merck) VARIVAX 1350U (dose, lot#, exp. date, route of administration and anatomical location were not reported), 3 years apart from the first vaccination he received the received the second dose of (Oka/Merck) VARIVAX (dose, lot#, exp.date, route of administration and anatomical location were not reported). Concomitant medications included ibuprofen taken as needed. On an unspecified date, approximately in November 2014 (reported as "now") the patient had a negative titer for varicella and high white blood cell count. No treatment was given for the adverse events, the patient was referred to a hematologist. The outcomes of the events were not reported. The relatedness between vaccination with (Oka/Merck) VARIVAX and the events was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse refers to a 16 year old male patient. On 05-SEP-2014 the patient received a dose of PROQUAD (lot # J011330, exp. date 13-MAR-2015, 0.5 ml, subcutaneous) in error. No adverse effects to patient. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 24-OCT-2014 the patient was vaccinated with PROQUAD (Merck) (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in September 2014 the patients were vaccinated with 2 unsupported, improperly stored doses of GARDASIL lot # J010668, exp. date: 29-APR-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in October 2014 the patients were vaccinated with 2 unsupported, improperly stored doses of GARDASIL lot # K005083, exp. date: 04-NOV-2013; 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product expiration date issue
Clinical narrative: This spontaneous report as received from two nurses refers to a patient of unknown age and gender. On 05-NOV-2014 the patient was vaccinated subcutaneously with an expired dose of PNEUMOVAX 23 (0.5ml, lot # J002646, expiration date 11-MAR-2014). No adverse effects were reported. One of the reported nurses stated that she believed that medication error was due to the expiration date formatted with date-month-year. She additionally reported that expiration date was embossed onto the box and it was always difficult to read. She clarified this box did not look any other box. No PQC (product quality complaint) was reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Temperature intolerance
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. The patient concurrent condition included allergy to quinolones. On 31-OCT-2014, the patient was subcutaneously vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) lot # K010732, expiration date 31-OCT-2015, (dose was not reported) to prevent shingles. Concomitant therapies included FLUZONE. The reporting pharmacist mentioned the patient received ZOSTAVAX and FLUZONE on the same day 31-OCT-2014 and the vaccines were administered in opposite arms. On 02-NOV-2014, the patient experienced itchy rash on his back that was sensitive to heat. The patient was not given any treatment. There were no lab diagnostics studies performed. The outcome of the event was reported as not recovered. The patient sought medical attention by contacting his pharmacist. The relatedness between the vaccination with ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Shoulder pain radiating to finger tips, red swollen rash that is continuing to spread, headache, fever, rash is warm, rash currently on back of upper arm - pt is taking diphenhydramine and acetaminophen with no relief - told her to check with her MD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Shoulder pain radiating to finger tips, red swollen rash that is continuing to spread, headache, fever, rash is warm, rash currently on back of upper arm - pt is taking diphenhydramine and acetaminophen with no relief - told her to check with her MD.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in August 2014 the patients were vaccinated with five unsupported, improperly stored doses of GARDASIL lot # K005083, exp. date: 04-NOV-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 63.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client received pneumo vaccine on 11/7/14 on left deltoid, swelling on deltoid then had "big ball" on deltoid, that night traveled down to inner elbow with swelling, redness and pain, and continues.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 14-OCT-2014 the patient was vaccinated with PROQUAD (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 27-OCT-2014 the patient was vaccinated with PROQUAD (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Breakthrough disease with documented varicella on 11/12/14 inspite of having documentation of both VARIVAX vaccines.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling
Clinical narrative: Excessive localized erythematous swelling/reaction to MENVEO.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red swollen bump that is hot to the touch. Questionable cellulitis.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 04-NOV-2014, the patient was vaccinated with two doses of LIQUID PEDVAXHIB, two 0.5 ml doses, intramuscular (lot number not reported) instead of a dose of LIQUID PEDVAXHIB and RECOMBIVAX HB. The reporter stated that and the packaging LIQUID PEDVAXHIB and RECOMBIVAX HB was identical and hence led to the confusion. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was vaccinated with PROQUAD (Merck) (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 16-OCT-2014 the patient was vaccinated with PROQUAD (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 30-JUL-2014, the patient was vaccinated with ZOSTAVAX lot # K000995, expiration date 16-MAR-2015, 0.65 ml, subcutaneously. Other suspect therapies included hydrocortisone (manufacturer unknown) topical cream (strength, dose, frequency and indication were not reported). In approximately 2014 (reported as some time after vaccination), the patient was seen by the pharmacist and complained of a raised, itchy rash. The pharmacist recommended to use hydrocortisone (manufacturer unknown) cream as a treatment. On 15-OCT-2014, the patient returned to the pharmacy and no longer complained of a raised rash, but did present with a flat, purple discoloration at the injection site (onset date on an unknown date in 2014) with no other symptoms present. The outcome of raised itchy rash was reported as recovered/resolved on an unknown date in 2014. The outcome of flat, purple discoloration at the injection site was unknown. The relatedness between adverse events and therapies with ZOSTAVAX and hydrocortisone (manufacturer unknown) cream was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PEDVAXHIB (route, dosage and dose number unknown; lot # reported as K002747 EXP 09-DEC-2016). On 13-OCT-2014 the patient received a dose of PEDVAXHB that was exposed to temperatures outside the proper storage range. No adverse effect was reported. This is one of two reports from the same reporter (1411USA003892). Additional information is not expected since there is no permission to contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (route, dosage and dose number unknown; lot # K005083 exp 04-NOV-2014). On 13-OCT-2014 the patient received a dose of GARDASIL that was exposed to temperatures outside the proper storage range. No adverse effect was reported. This is one of two reports from the same reporter (1411USA006739). Additional information is not expected since there is no permission to contact physician.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in patient stool.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a 15 year old female patient. On an unknown date that patient was vaccinated with her first dose of RECOMBIVAX HB 5/0.5 mcrg/ml, dose/frequency: 0.5 ml (route and lot # not reported) at her birth, and the second dose three weeks later, with the third dose at six months after the first dose. No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Injection site reaction. Redness, sore arm, pain at injection site. Relieve by cold compress applied next day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Secretion discharge
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient. The patient's medical history was not reported. On 30-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous in left deltoid, lot # K003598 and expiry date: 13-MAR-2015. On approximately 30-OCT-2014 the patient developed "a blister with a fluid oozing out of it." The reporter believed that the blister might have developed on the day the patient received ZOSTAVAX but she was not certain of the time the blister appeared. The pharmacist was also not certain where specially the "blister" was located, but she believed it might have been at the patient's injection site. The pharmacist did not observe the blister but she stated the patient sought physician's attention who referred the patient to the pharmacy. The patient also sought attention in unspecified pharmacy. There was no treatment prescribed for the event. By the time of the report the patient did not recover. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to a patient of unknown age and gender. On an unknown date, over one year ago, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided). On 11-NOV-2014 (reported as "now"), the patient was in the office to receive second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) which would be late. No symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. On 22-OCT-2014 the patient was vaccinated with a third dose of GARDASIL (lot number and expiration date were not reported) 0.5 ml, intramuscular. On 01-NOV-2014 the patient was determined to be 6 weeks pregnant. The patient became pregnant with last menstrual period (LMP) of 20-SEP-2014 and estimated delivery date (EDD) of 27-JUN-2015. Initial exposure to GARDASIL was at 4 week. The pregnancy outcome was outcome pending. The patient sought medical attention by visiting the office on an unknown date. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 02-OCT-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (0.5 ml, subcutaneous, lot # J012371, expiry date: 03-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Burning sensation, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Localised reaction, redness, burning, pain starting from site of injection then radiating all over the arm and other visceral parts. No energy for 2 days. Now after 3 days patient feeling better.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pain in extremity
Clinical narrative: Localised reaction, redness, burning, pain starting from site of injection then radiating all over the arm and other visceral parts. No energy for 2 days. Now after 3 days patient feeling better.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Erythema, Induration, Skin lesion, Skin warm
Clinical narrative: Within 24 hours of the vaccination PROQUAD, the had a tennis ball size circular lesion erythematous with blisters in the middle and indurated, and warm to the touch, no fever, no vomiting.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Feeling hot, Induration, Pruritus
Clinical narrative: Started 11/12. Warmth, induration, itching 4 cm, 2 cm.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Flushing, Paraesthesia, Swelling face
Clinical narrative: Pt felt an "electrical shock" when she first received the tetanus. Has facial swelling especially around eyes and lips, flush. Denied breathing or swallowing issues.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 54 year old female patient with for prevention for shingles. On an unspecified date in August 2014 (also reported as sometime in August 2014) the patient was vaccinated with ZOSTAVAX (strength, dosage, route and lot number were not reported) for prevention of shingles. Concomitant therapy was not reported. The physician informed that on unspecified date in August 2014 (also reported as sometime in August 2014) the patient experienced migrating neuropathy and tingling all over her body after receiving ZOSTAVAX. The patient sought medical attention by an office visit. The outcome of the events was not recovered at the time of this report. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 year old female patient without known drug allergies. On 31-OCT-2014 the patient was vaccinated with ZOSTAVAX, 0.5 ml, subcutaneous, lot # reported as K009773, expiration date reported as 09-OCT-2015. There were no concomitant medications. On 31-OCT-2014 the injection site appeared red and swollen but did not appear to be shingles. There were no laboratory diagnostics studies performed. Patient sought medical attention on unknown date. The outcome of the events was not recovered/not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with GARDASIL (dose, lot number and route not provided), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow up information has been received from the nurse on 10-NOV-2014. The nurse reported that an additional excursion has affected the same doses of GARDASIL (lot#J006850, exp 31-MAR-2016) and of ROTATEQ (capture in MARRS # 1411USA003388), and multiple patients have been administered red both products. No adverse effects reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, White blood cell count increased
Clinical narrative: 5-6 hrs post vaccination client reports he felt pain at the injection site and the site was blushed around the deltoid muscle 3" x 5" diameter. Reports pain and redness lasted for period of 5 days. Evaluated in the ER, was prescribed sulfamethoxazole PO x 5 days.
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Td administered on 10/23/14. Frday inj site redness grew from shoulder to elbow with red hot, fever until Monday.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a o health professional refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medication were not reported. On 23-OCT-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot 3 J006242, expiration date:03-AUG-2014) (route was not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Noontime gave Flu vaccine. In 5 minutes while walking back to class had sharp pain down arm and leg. Went to ER. Told PLAQUENIL medication interacted with B strain of Flu. Nerve endings on fire rest of day.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 79 year old male patient. On 23-OCT-2014 the patient was vaccinated with ZOSTAVAX, lot # J013134, expiration date: 17-JAN-2015 (dose, and route of administration were not reported). There were no concomitant medications. In October 2014 the patient experienced an injection site reaction that was slightly larger than the patient's wife vaccination (case # 1411USA001111). Pharmacist advised patient to contact physician. The patient did not receive any treatment for the adverse event. The outcome of the events was unknown. This is one of several received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Disturbance in attention, Influenza like illness, Lethargy, Memory impairment
Clinical narrative: Very lethargic x4 days, flu-like symptoms (nausea and vomiting, diarrhea, body aches, fever) x3 days. Also, since vaccine, have had trouble concentrating and remembering simple things.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Very lethargic x4 days, flu-like symptoms (nausea and vomiting, diarrhea, body aches, fever) x3 days. Also, since vaccine, have had trouble concentrating and remembering simple things.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pupil fixed, Unresponsive to stimuli, Wheezing
Clinical narrative: Pt. wanted 2 vaccines, BOOSTRIX and meningitis. After administering BOOSTRIX, I went back pharmacy to draw up 2nd vaccination about 90 seconds. When returning to pt, he was unresponsive, wheezing, and fixed pupils. We called 911, and he returned to normal state and was nauseated. Upon talking to wife discovered he had hx of fainting. Pt. did not tell me prior.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles on 11/14/14. Prescription was given for Valacyclovir hcl1 g tablet.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Blood glucose normal, Heart rate decreased, Presyncope, Slow response to stimuli
Clinical narrative: IMMUNIZATION CLINIC IS OPERATED IN THE MAIN HOSPITAL. PT WAS ADMINISTERED ANTHRAX VACCINATION IN L DELTOID AND AS ANOTHER VACCINE WAS BEING PREPARED (NOT ADMINISTERED) PT BECAME PRE-SYNCOPAL. PT WAS LOWERED TO FLOOR AND, ALTHOUGH SLOW TO RESPOND INITIALLY, WAS ALERT AND ORIENTED x 3 UPON BEING PLACED SUPINE. PT WAS KEPT SUPINE UNTIL EMERGENCY ROOM PERSONNEL ARRIVED ON SCENE. PT'S VITAL SIGNS IMMEDIATELY FOLLOWING EPISODE WERE AS FOLLOWS: BP 120/71, SPO2 98% RA, HR INITIALLY 41 IMPROVED TO 63 WITHIN 3-5 MINUTES. PT DENIED ANY COMPLAINT AND ADMITTED AFTERWARD THAT HE HAS HAD EPISODES OF SYNCOPE/PRE-SYNCOPE UPON RECEIVING VACCINES IN THE PAST, THE LAST EPISODE BEING APPROX 10 YEARS AGO. PT DID NOT ADMIT THIS HISTORY DURING INTERVIEW PRIOR TO VACCINATION. PT IS CURRENTLY BEING EVALUATED IN THE EMERGENCY ROOM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient did not seek medical treatment yet. Stopped in pharmacy on way to work to show adverse reaction. No other reactions aside from local redness/swelling around injection site so far. Patient was instructed to seek medical attention if rash worsens or other side effects are experienced.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Rash
Clinical narrative: Rash first occurred. Turned to bruise the next day approximatley 3 inches in diameter.  Patient is now having pain 3 days later. The rash has disappeared but bruise remains.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal distension, Constipation, Decreased appetite, Gastrointestinal pain, Headache
Clinical narrative: Massive headache pain. Taking the maximum amount of Aleve each day. Nauseated and no appetite.  Force myself to eat and feel bloated and gastrointestinal pain. Constopation. Sore throat. Drinking herbal tea to soothe my throat and additional water and clear broth. I have had a flu shot for years and never had a reaction. This is so severe I am not sure I will ever get another one again.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: Massive headache pain. Taking the maximum amount of Aleve each day. Nauseated and no appetite.  Force myself to eat and feel bloated and gastrointestinal pain. Constopation. Sore throat. Drinking herbal tea to soothe my throat and additional water and clear broth. I have had a flu shot for years and never had a reaction. This is so severe I am not sure I will ever get another one again.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Pain
Clinical narrative: Headache, severe body aches, malaise, nausea, diarrhea.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Malaise, Pain
Clinical narrative: Body aches, malaise, headache.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Asthenia, Fatigue, Muscle spasms, Muscle twitching, Seizure like phenomena
Clinical narrative: Twitching, seizure like effects, weakness, tired feeling, spasm continued for several days afterwards.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Pt experienced a localized reaction at injection site (red, raised).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Tender, red quarter/silver dollar sized raised area at sight of injection.  Not hot and not bothering the patient.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site pruritus, Pruritus, Visual impairment
Clinical narrative: Severe frontal headache impairing vision, entire head itching profusely radiating down to R shoulder at site of injection.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Nodule, Pain, Pyrexia
Clinical narrative: BEGAN AS WELT WITH SORENESS. OVER NEXT FOUR DAYS, EXPANDED TO 3" x 5" OVAL SHAPED, RAISED 0.5" WITH PALPABLE KNOT. REDNESS, EXTREME TENDERNESS, AND WARMTH. 1-2 DEGREE FEVER. D/DX AS CELLULITIS BY PA ON AFTERNOON OF 11/15/2014. CLINDAMYCIN HCL R00 MG PRESCRIBED.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Swelling, Tenderness, Urticaria
Clinical narrative: BEGAN AS WELT WITH SORENESS. OVER NEXT FOUR DAYS, EXPANDED TO 3" x 5" OVAL SHAPED, RAISED 0.5" WITH PALPABLE KNOT. REDNESS, EXTREME TENDERNESS, AND WARMTH. 1-2 DEGREE FEVER. D/DX AS CELLULITIS BY PA ON AFTERNOON OF 11/15/2014. CLINDAMYCIN HCL R00 MG PRESCRIBED.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Sides of face from ear down started to swell.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness and stiffness in arm, redness, heat, swelling, and pain at injection site. Headache and achy feeling, general tiredness.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Soreness and stiffness in arm, redness, heat, swelling, and pain at injection site. Headache and achy feeling, general tiredness.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Diarrhoea, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, hot, painful injection site. Violent chills for four hours. Migraine for 48 hours. Diarrhea. Phone conversation with physician, told me to wait it out. There is no antidote. Told me not to get flu shots in the future. Pharmacist said the same thing. This was worse than any flu I've ever had!
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Migraine
Clinical narrative: Swollen, hot, painful injection site. Violent chills for four hours. Migraine for 48 hours. Diarrhea. Phone conversation with physician, told me to wait it out. There is no antidote. Told me not to get flu shots in the future. Pharmacist said the same thing. This was worse than any flu I've ever had!
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: Large swelling at injection area.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Dehydration, Hyperhidrosis, Injection site erythema
Clinical narrative: VERY PAINFUL BRIGHT RED SWOLLEN AREA 6-8" ALL AROUND INJECTION AREA, CHILLS, SWEATING, JOINT & MUSCLE PAIN, DEHYDRATION & NAUSEA FOR 3 DAYS.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: VERY PAINFUL BRIGHT RED SWOLLEN AREA 6-8" ALL AROUND INJECTION AREA, CHILLS, SWEATING, JOINT & MUSCLE PAIN, DEHYDRATION & NAUSEA FOR 3 DAYS.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Local swelling, Pain, Pyrexia
Clinical narrative: Fever/Chills, body aches, large red swollen area below the injection site.  Took two Ibuprofen for fever and body aches.
Age: 29.0
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a patient's husband, for VARIVAX (Merck) a Pregnancy registry product, refers to a 29 years old female patient, with no drug reactions/allergies and no pertinent medical history, who received three vaccine shots at the same time while she was pregnant. The patient's history of previous pregnancies and live births is not known. On 25-SEP-2012 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported). Other suspect therapy included: flu vaccine (manufacturer unknown) (dose, route and lot # not reported) given on the same day. Concomitant medication included: DTaP (manufacturer unknown) given on the same day. At the time of when she received these vaccines, she did not know that she was pregnant. It was only last week when they found out that they were 2 months pregnant. The last menstrual period (LMP) was on approximately 13-AUG-2012 and estimated delivery date (EDD) is approximately on 20-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. No treatment was given. The outcome of the pregnancy was pending. The outcome of the fetus was unknown. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention - she spoke to physician. Follow up information has been received from a registered nurse. She stated that physician has no information to share concerning this patient. The complete medical records are unavailable. No further information is available. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored GARDASIL, inj (lot# and expiration date not provided) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 70 year old female patient who is also a registered nurse refers to her. The patient's current condition included hypertension, environmental allergies and seasonal allergies. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiry date not reported) in the left posterior upper arm. Concomitant therapies included atenolol, losartan potassium and HYDRODIURIL. On 04-NOV-2014, the patient's injection site was red, itchy, warm, induration and swollen to the size of a grapefruit. She did not consult her healthcare provider, but she did show her injection site reaction to the pharmacist at her local pharmacy. She reported that the pharmacist stated of never seeing an injection site reaction that bad. She also reported that she did not take any pharmaceutical therapy for the injection site adverse symptoms but treated with cold compresses. On 10-NOV-2014, her injection site was just pink and the swelling has improved. The outcomes of the events injection site itchy, warm, indurated was unknown. She did not experience any other adverse effects and she did not develop a rash. Hence VZVIP was not offered to her. The causality of the events were unknown for ZOSTAVAX. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date "five or more years ago", the patient was vaccinated with the first dose ZOSTAVAX (dose, lot number, expiration date were not reported). On 04-NOV-2014, the patient was vaccinated with the second dose ZOSTAVAX (dose, lot number, expiration date were not reported). No adverse symptoms was reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: YF
Symptoms: Confusional state, Swelling, Tremor
Clinical narrative: Patient states her whole body starting swelling up. She states that she was confused and her whole body was shaking up and down. She refused medical treatment.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Pt came in today said on Friday developed red circle around vaccination site it is warm to touch no pain or itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large erythemic area 8 x 10 cm at injection site with central induration area 3 x 3 cm. Warm to touch. Told to apply ice, TYLENOL or MOTRIN for discomfort (evaluated 11/15/14).
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 patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some times to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 30-SEP-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.