chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site plaque, Injection site rash
Clinical narrative: Patient's mom called in because he had a 2-3 inch "red patch" on the back of his right thigh. No fever, still able to walk, was not hot to the touch but did complain when it was touched. Was instructed to have him be seen - once brought in to clinic, the rash was measured and there was a right anterolateral (thigh) with approx 11 cm erythematous flat plaque with an approx 7 cm central area of pink/purple discoloration. No edema, tenderness or warmth appreciated at site. Local skin reaction w/no systemic symptoms. Parent reassured that the reaction would resolve in the next 4-7 days if not gone in a week, call us.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin reaction
Clinical narrative: Patient's mom called in because he had a 2-3 inch "red patch" on the back of his right thigh. No fever, still able to walk, was not hot to the touch but did complain when it was touched. Was instructed to have him be seen - once brought in to clinic, the rash was measured and there was a right anterolateral (thigh) with approx 11 cm erythematous flat plaque with an approx 7 cm central area of pink/purple discoloration. No edema, tenderness or warmth appreciated at site. Local skin reaction w/no systemic symptoms. Parent reassured that the reaction would resolve in the next 4-7 days if not gone in a week, call us.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient experienced an injection site reaction that included redness, warmth, and pruritus. The reaction became worse not better in the days following the vaccination.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain
Clinical narrative: HPV vaccine (2 of 3 in series) given IM, right deltoid. Child return to clinic approx. 40 minutes later c/o (R) sided chest pain. MD evaluated, patient stable, EMS transported patient to ED for further evaluation.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema, induration, pain, right upper arm 3/6 circumferential within a few hours.
Age: 18.0
Sex: F
Vaccine: ANTH, JEV, SMALL, TYP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pustule, Injection site streaking, Injection site swelling
Clinical narrative: 4 Feb 16 - (L) upper arm with raised pustule vanished by 9-20 cm red, warm, inflamed skin with streaking down arm and under arm. Significant (L) axillary lymph node enlargement.
Age: 18.0
Sex: F
Vaccine: ANTH, JEV, SMALL, TYP
Symptoms: Injection site warmth, Lymphadenopathy
Clinical narrative: 4 Feb 16 - (L) upper arm with raised pustule vanished by 9-20 cm red, warm, inflamed skin with streaking down arm and under arm. Significant (L) axillary lymph node enlargement.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received zoster vaccine 02/01/16. Patient call c/o redness and swelling at injection site 02/03/16. Patient seen in office instructed comfort measures.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Patient had temp to 103 (2 hr) post vaccination associated with febrile seizure simple approximately 2-3 minutes.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a 78 year old female patient regarding herself. There were no concurrent conditions, medical history or allergy/drug reactions. On 27-JAN-2016 the patient was vaccinated once with ZOSTAVAX injection (lot reported as L035504, expiry date: 16-DEC-2016) subcutaneously under the arm where the fat hangs down. Patient had no concomitant medications. On 29-JAN-2016 after receiving the vaccination the patient experienced rash which got worse. Approximately on 31-JAN-2016 (reported as Sunday) it was all over her back and was very itchy. The rash was also on her arms and chest. The patient sought medical attention which included an office visit on 01-FEB-2016. Treatment included unspecified shingles medication. Lab diagnostics studies were not performed. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot #L000569, expiration date: 13-JUL-2016 or lot # L022447, expiration date 26-FEB-2017 and with a dose of improperly stored dose of RECOMBIVAX HB lot # L025738, expiration date: 14-AUG-2017 or lot # L029631, expiration date: 14-AUG-2017. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K020185, expiration date: 27-JAN-2016 (dose and route of administration were not reported). There were no known adverse effects reported. Product quality complaint (PQC) was not involved. Additional information is not expected as the reporter did not wish to be contacted.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 6 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the immunization already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.79
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 9 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored oral, ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to multiple unspecified patients of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the patients were administered improperly stored PROQUAD (Merck) lot # L014401, expiry date 23-OCT-2016, lot # L033698, expiry date 28-FEB-2017, lot # L034933, expiry date 11-MAR-2017 (dose number, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was reported as -12 C for 9 hours. Product quality complaint was not involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.76
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 24-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 09-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were administered improperly stored (Merck) VARIVAX lot # L013827, expiry date 21-APR-2017, lot # L019126, expiry date 27-MAY-2017, lot # L034367, expiry date 08-SEP-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was reported as -12C for 9 hours. Product quality complaint was not involved. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 82-year-old female patient who received BOOSTRIX (batch number FB942, expiry date 3rd December 2017). On 24th January 2016, the patient received BOOSTRIX (intramuscular) .5 ml. In January 2016, 5 days after receiving BOOSTRIX, the patient experienced injection site rash and injection site swelling. On 31st January 2016, the patient experienced injection site redness. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site rash and injection site swelling were recovering/resolving and the outcome of the injection site redness was not recovered/not resolved. The reporter considered the injection site rash, injection site swelling and injection site redness to be related to BOOSTRIX. Additional details were received as follows: In January 2016, 5 to 7 days after receiving BOOSTRIX, the patient experienced rash and swelling at the injection site (left arm). Around 31st January 2016, 7 days after receiving BOOSTRIX, the patient started to experience red streaks on arm. The streaks were described as about one inch long. The reporter stated that, the BENADRYL was helping the patient.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date- 22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 18-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Pt received DTaP/Polio vaccines on 2/1/16, mom noticed swelling and redness, went to ED, received BACTRIM Rx and to monitor site.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event, Off label use
Clinical narrative: Information has been received from a registered nurse referring to a currently 5 year old child of unknown gender. There was no information about concurrent condition, medical history or concomitant medication. On 04-FEB-2013 the child was administered a first dose of M-M-R II (lot number, expired date, dose and route were not reported) and a first dose of VARIVAX (Merck) (lot number, expired date, dose and route were not reported) on 16-SEP-2013. This child was then administered a second dose of both M-M-R II  (Lot number J002934; expired date 14-MAR-2015) and VARIVAX (Merck) (lot number reported as J009999; expired date 12-AUG-2015) on 14-APR-2014. Then the child was administered a third dose of both M-M-R II (Lot number L026550; expired date 16-JUL-2017) and VARIVAX (Merck) (Lot number L026410; expired date 15-FEB-2017) (extra dose administered) on 18-JAN-2016. This was outside the labeled recommendations in both the M-M-R II and VARIVAX (Merck) prescribing information (Off label use). No adverse effect reported. Lot # J009999 was not valid for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 28-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4-year-old male patient with 1 sibling and no preexisting allergies, birth defects and medical conditions. On 29-OCT-2015, the patient was vaccinated with the first dose PROQUAD (Merck) lot # K020750, expiration date 30-APR-2016 (dose and route of administration not reported). It was reported that the patient received improperly stored vaccine. There were temporary excursions recorded due to the personnel not setting / clearing the minimum and maximum temperature correctly. No adverse events or symptoms occurred. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Immunisation, Injection site erythema, Pain in extremity
Clinical narrative: LUE pain, redness, swelling, erythema s/p Pneumo23 vaccine at approx 0800 redness starts 12cm below injection site. T 100.6 temporal.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: LUE pain, redness, swelling, erythema s/p Pneumo23 vaccine at approx 0800 redness starts 12cm below injection site. T 100.6 temporal.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a currently 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On an unspecified date, the patient was vaccinated with an improperly stored M-M-R II (lot # K024035, expiry date 26-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable  at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On unknown dates since 16-NOV-2015, unspecified number of patients have been vaccinated with improperly stored PROQUAD (Merck) (reported lot# L032760, expiry date: 24-FEB-2017) (dose, frequency and route were not reported). It was reported that the vaccines were exposed to the temperature between -15C and -10C for 126 hours and 50 minutes, and between -10C and -6.1C for 12 hours. There were no previous temperature excursions. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 06-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 30-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K024035, expiry date 26-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 08-DEC-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 12-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition. medical history and pertinent drug allergies of the patient were not reported. On 30-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PWC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 17-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 29-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified) Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 11-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 23-OCT-2015, the patent was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L031271 and expiration date 19-NOV-2016, (dose and route of administration were not reported). There were no concomitant medications provided. No adverse effects were reported. The reporter described the temperature excursion as follows: "Temperature: Highest of 24F for 15 minutes increment; Time frame: Total out of range was 1 hour and 45 minutes; outcome of excursion; ZOSTAVAX was supported until expiry". There was no previous temperature excursion. There was no product quality issue involved. 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 registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On unknown dates since 16-NOV-2015, unspecified number of patients have been vaccinated with VARIVAX (Merck) lot # K003410, expiry date: 06-MAR-2016) (dose, frequency and route were not reported). It was reported that the vaccines were exposed to the temperature between -15C and -10C for 126 hours and 50 minutes, and between -10C and -6.1C for 12 hours. There were no previous temperature excursions. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 67.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting following self administration of oral typhoid/VIVOTIF. pill #3 Lot # 3003104. Crucell.  Discontinued after emesis contained.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was scheduled physical. Provider ordered six vaccines. Clinic was out of Hep A adult. Hepatitis ped/Adolescent was placed in adult basics. Expiration of vaccine checked not adult/ped on vial. 0.5 mL given instead of. No reaction noted. Patient doctor and charge noticed. Patient rescheduled for adult dose #1.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patient of unknown genders and ages. No concurrent or historical conditions were reported. On a unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L026410 expiration date 15-FEB-2017) dose, route and anatomical location were not provided. No concomitant medications were reported. The temperature of storage was reported as 7 F, time frame of 24 hours, no previous excursion was reported. There was no a data logger. No adverse effects were reported, no further information was provided. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 17-DEC-3025, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to four patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# L021214, expiration date 10-JUN-2017, anatomical location was not reported) 0.5 ml, subcutaneously. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patient with unknown age and gender. On unknown dates, the patients were vaccinated with doses of improper stored VARIVAX (Merck) (lot # L035129, expiration date 14-SEP-2017)( dose and route were not reported). It was reported that the temperature fluctuated periodically with the worse case scenario 1 month. The vaccine was supported until expiry. There was no previous temperature excursion. This was not a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has not been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent condition were reported. On unknown dates the multiple unspecified patients were vaccinated with either 1 or 2 doses of GARDASIL (strength, frequency, route, lot# and expiration date unknown) and completed their HPV series with GARDASIL 9 (strength, frequency, route, lot#, expiration date) (interchange of vaccine products) (wrong drug administered).  No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown) (dose and route were unknown) at an unspecified location as an infant. On an unknown date after the vaccination the patient showed negative titers. The patient was revaccinated at an unspecified location sometime in November 2015. At the time of this report, the event outcome and the causality were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 14-OCT-2015 the patient was vaccinated with improperly stored  RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016)(dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Chromaturia, Somnolence
Clinical narrative: Pt. called today with c/o drowsiness and dark urine after receiving Typhoid vaccine. I encouraged him to call his doctor.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired vaccine (GARDASIL - 12/4/2015). No reaction to expired vaccine.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash, Skin warm, Throat tightness
Clinical narrative: 15 min following vaccine, pt developed rash on chest, itching, warm all over, tightness of throat. Was given IV BENADRYL. IV SOLU-MEDROL, and IV ranitidine. Then rapidly improved.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fever up to 103.2 started 2/4/16 after immunizations were given. Rash on inner thighs and behind knees started today.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017. (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to a 12 month old patient of unknown gender. On 27-JAN-2016 the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (HSA, lot # L003221, expiration date 30-JUL-2016) (dose and route were not reported) and a dose of VARIVAX (Merck) (lot # L017144, expiration date 13-MAY-2017) (dose and route were not reported) at the same office visit (accidental overdose). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates, the patients were vaccinated with doses of improper stored ZOSTAVAX (lot # K026365, expiration date 15-MAR-2016) (dose and route were not reported). It was reported that the temperature fluctuated periodically with the worst case scenario 1 month. The vaccine was supported until expiry. There was no previous temperature excursion. This was not a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.