chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 9 week old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 4 months old infant patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 9 week old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 0.67
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 8 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 6 month old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 26-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 2 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # L042836 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 2 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # L042836 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 1.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 14 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # L042836 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. The vaccine was purchased via public fund (Medicaid-VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 15 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 28-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. The vaccine was purchased with private pay/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 16 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 14 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter.  Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 17 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 22-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 22-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 0.0
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 6 days old neonate patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot number: K010216, dose, frequency, expiry date were not reported) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003706:
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) who refers to a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL 9, intramuscular, lot # M018810, expiration date: 28-MAY-2018 (strength, dosage, and anatomical location were not reported) for prophylaxis. Other suspect and concomitant medications were not provided. No PQC was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011874.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) who refers to a male patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL 9, intramuscular, lot # M018810, expiration date: 28-MAY-2018 (strength, dosage, and anatomical location were not reported) for prophylaxis. Other suspect and concomitant medications were not provided. No PQC was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011874.
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 patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose and route were not reported) lot # M024677 and expiry date: 18-MAY-2018 for prophylaxis. The vaccine was exposed to a temperature of -13.2 degrees centigrade for 10 hours 2330 minutes. Previous temperature excursions included 7.3 degrees centigrade for 10 hours 30 minutes and 23.7 degrees for 2 hours. the call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the two cases reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004256.
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 patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose and route were not reported) lot # M024677 and expiry date: 18-MAY-2018 for prophylaxis. The vaccine was exposed to a temperature of -13.2 degrees centigrade for 10 hours 2330 minutes. Previous temperature excursions included 7.3 degrees centigrade for 10 hours 30 minutes and 23.7 degrees for 2 hours. the call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the two cases reported by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA004233:
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a health professional via Pfizer (other company # 2016532918) referring to a female patient of unknown age. The pertinent medical history and concomitant therapy were not reported.  On an unknown date in 2012 (reported as "three or four years ago"), the patient was vaccinated with a dose of ZOSTAVAX (also reported as "Zostra vaccine") (lot#, expiration date, dose and route were unspecified) for prophylaxis. On an unknown date, the patient experienced some type of adverse reaction to ZOSTAVAX. The patient did not mention what kind of adverse reaction she had experienced in the past. The outcome of the adverse reaction was unknown.  Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Local swelling, Vaccination site induration, Vaccination site nodule, Vaccination site pruritus
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837,2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date and duration following the vaccination, the patient developed local swelling, induration, vaccination site pruritus and vaccination site reaction (reported as 'within our hot itchy, swelling flat hard baseball size knot'). Patient required emergency room (ER)/ doctor visit. Laboratory investigations was not reported. Corrective treatment was reported as 'no'. The outcome of events was reported as unknown. Follow up information received from a pharmacist on 28-Nov-2016: It was reported that a 39-year-old female patient was vaccinated with Fluzone. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837,2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date and duration following the vaccination, the patient developed local swelling, induration, vaccination site pruritus and vaccination site reaction (reported as 'within our hot itchy, swelling flat hard baseball size knot'). Patient required emergency room (ER)/ doctor visit. Laboratory investigations was not reported. Corrective treatment was reported as 'no'. The outcome of events was reported as unknown. Follow up information received from a pharmacist on 28-Nov-2016: It was reported that a 39-year-old female patient was vaccinated with Fluzone. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (same lot number). This case involves a patient of unknown age and gender, who was vaccinated with a dose of Fluzone Quadrivalent batch number: UI669AA, expiry date: 30-JUN-2017 (dose, dose in series, form, site and frequency of administration were not reported) via intramuscularly on an unknown date (also reported as over the past month). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On unspecified date (also reported as "over the past month"), following vaccination, the patient experienced arm aches and warm to touch swollen. Lab data was not reported. The patient did not receive any corrective treatment. The outcome of the events was reported as unknown. Follow-up information received from a Physician on 28 November 2016. This case involves a 42 years old female patient. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Injection site erythema, Injection site mass, Injection site warmth, Local reaction
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE Quadrivalent batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on 04-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On 06-OCT-2016, two days following the vaccination, the patient experienced local reaction: size of half dollar red spot around site and warm. On an unspecified date (over the past month), following the vaccination, the patient experienced local reaction: lump at site and systemic reaction: noticed cough, not sure related. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Follow up report received from a pharmacist (Director of Pharmacy) on 28-Nov-2016: This case involves a 31-year-old female patient. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Nov-2016. This case involves a 70 year old male patient who was vaccinated with a dose of Fluzone HD Batch number- UI691AA, expiry date- 30-Apr-2017, (dose, dose in series were not reported) intramuscularly in left deltoid on 18-Sep-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 27-Nov-2016, 70 days after the vaccination, the patient was unable to raise the arm and felt sore on left arm. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: Sore throat - Upper respiratory infection. 6 day Z-Pak treatment.
Age: 12.0
Sex: M
Vaccine: HEPAB, IPV, MMRV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child was given TWINRIX instead of pediatric Hepatitis vaccines.
Age: 15.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Ear swelling, Erythema, Inflammation, Rash macular
Clinical narrative: Red ear inflamed and swollen, red blotchy patches on neck and anterior chest.  50 mg Benadryl PO.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Diffuse red, slightly bumpy rash. No fever. Child appears well, per mom.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Mobility decreased, Pain
Clinical narrative: Difficulty moving my left hand, putting clothes on, reaching back. Chronic pain especially at night time while sleeping.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Mobility decreased, Pain, Sleep disorder, Tendonitis
Clinical narrative: I began feeling expected pain on the 9th but it progressively got worse each day after.  Two to three weeks later I could barely move my arm; pulling cloths (tops) off was painful.  I could not sleep on my left arm and when moving covers it was very painful and I could not do it.  I reached out to HR Dept. on 11/25/16 who in turn got me in contact with the company who administered vaccine on 11/28/16.  I went to an orthopedic on 11/30/16 who gave me a steroid shot in the area that was inflamed and referred me to physical therapy.  I am now receiving physical therapy on left shoulder - two appointments thus far.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: I began feeling expected pain on the 9th but it progressively got worse each day after.  Two to three weeks later I could barely move my arm; pulling cloths (tops) off was painful.  I could not sleep on my left arm and when moving covers it was very painful and I could not do it.  I reached out to HR Dept. on 11/25/16 who in turn got me in contact with the company who administered vaccine on 11/28/16.  I went to an orthopedic on 11/30/16 who gave me a steroid shot in the area that was inflamed and referred me to physical therapy.  I am now receiving physical therapy on left shoulder - two appointments thus far.
Age: 23.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: Patient experienced a syncope episode immediately following his vaccination. Patient was laid flat on a gurney with his feet up, and patient did not lose consciousness, but shook a little. Had a blood draw earlier and ate only a pop-tart for breakfast.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose and route unknown) from lot # M023380 with expiry date of 11-MAY-2018 for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected, the reporter did not have further data.; Sender's Comments: , MERCK 1609USA006651:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date between 08-OCT-2016 and 11-OCT-2016, the patients were vaccinated with improperly stored unspecified dose of PNEUMOVAX23 (dosing details were not reported) (lot # M018766, expiry date: 15-OCT-2017 and lot # M032635, expiry date: 05-MAY-2018) for prophylaxis which was stored at temperature of 1 degree centigrade for 4 hours as worst. There were no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Lot number M032635 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent). On 30-NOV-2016, it was reported that a call was placed to the medical assistant, but he/she was unable to provide any further information. Additional information has been requested. Sender's Comments: US-009507513-1610USA005738: US-009507513-1610USA007903: MERCK 1610USA007902: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, injection (dose and route of administration were not provided) with the following lot # and expiration dates: M026306, 30-APR-2018; M005714, 03-OCT-2017; L023230, 28-JUL-2017. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003300: US-009507513-1612USA003298: US-009507513-1612USA003299.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (albumin status unknown for any of the reported lot # at the time of reporting; dose was not provided) with the following lot # and expiration dates: M015931, 30-MAR-2018; M002419, 12-JAN-2018; L037356, 28-SEP-2017; L040961, 19-OCT-2017. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003299: US-009507513-1612USA003300: US-009507513-1611USA010369.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, oral liquid (dose was not provided; lot # L027076 and expiration dates: 25-MAY-2017). No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010369: US-009507513-1612USA003300: US-009507513-1612USA003298.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23, injection (dose and route of administration were not provided; lot # M022086 and expiration date: 09-OCT-2017). No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003299: US-009507513-1611USA010369: US-009507513-1612USA003298.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (strength, lot#, dosage and route unspecified) for prophylaxis. No adverse effect reported. No product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: RED, SWOLLEN ARM. TIGHTNESS OF SKIN, HOT TO TOUCH, PAINFUL. LOCATION WAS FROM SITE TO 6 INCHES BELOW ON THE ARM AND ALONG THE OUTER AND INNER ASPECT CIRCUMFERENTIALLY.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Echocardiogram, Electrocardiogram, Heart rate irregular
Clinical narrative: Irregular heartbeat episode, lasting approx. 18 hours continuously. Not rapid, just irregular. No treatment. No other side effects. I have had isolated irregular heartbeat for years, but never sustained over more than an hour.
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 an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L008996, expiration date 06-NOV-2017 and lot# M025563, expiration date 01-DEC-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011947: US-009507513-1611USA011948: US-009507513-1611USA006995.
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: This spontaneous case received from a physician via a field representative referred to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received a GARDASIL (dose, frequency, lot number and expiry date not reported) and the patient became infertile. Outcome and causality for the event were not reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at/around the injection site.  Difficulty moving arm.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Redness and swelling at/around the injection site.  Difficulty moving arm.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at/around the injection site.  Difficulty moving arm.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Redness, warmth from injection site down to the wrist.  Patient did not feel well and went to the Dr.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Redness, warmth from injection site down to the wrist.  Patient did not feel well and went to the Dr.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth from injection site down to the wrist.  Patient did not feel well and went to the Dr.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Body temperature increased, Computerised tomogram, Dyskinesia, Dysstasia
Clinical narrative: Loss of control of limbs, not able to sit or stand, talking irrationally, 105 temperature.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Electrocardiogram, Thinking abnormal, X-ray
Clinical narrative: Loss of control of limbs, not able to sit or stand, talking irrationally, 105 temperature.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Local reaction, Peripheral swelling, Skin reaction
Clinical narrative: Red local reaction, swelling of arm.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Local swelling, Metabolic function test
Clinical narrative: Red local reaction, swelling of arm.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patients wife called 12/06/2016 and said the flu shot caused her husbands muscle in his left arm to hurt and that he was going to the doctor on 12/7/16. I called patient's wife to check on patient on 12/09/2016 and patient's wife said the doctor did not say anything but she knows it is from the flu shot.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Irritability, Rash
Clinical narrative: Rash on upper body, front and back still visible 4 days later. Irritability, soreness at injection site 4 days later. These symptoms were reported to Primary physician Dr. during a routine office visit on 12/08/2016. Onset time is approximate.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Soreness at injection site with erythema, swelling noted by patient. She went shopping for 4 hours so did not apply ice pack we gave her until later that night and did not take any ibuprofen to help with pain/swelling only Benadryl 25mg. She came to clinic this morning at 9am with no swelling but 2 inch diameter area of erythema, heat and discomfort with movement of left arm. Did not apply ice pack since night before. Reapplied ice pack and told to take one tab of 200mg ibuprofen since no allergies/reactions to this med and to see MD if it exacerbates over weekend.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient reported a 102 degree fever, a really sore arm, and was nauseated.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 64 year old male.  On 14-NOV-2016, the patient was vaccinated with PNEUMOVAX23 for prophylaxis (lot number and expiration not reported). On 15-NOV-2016, the patient experienced fever, body aches and his arm was red and swollen at the injection site. The outcome of  fever, body aches and his arm was red and swollen at the injection site was reported as recovered on 16-NOV-2016. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with a dose of improperly stored VARIVAX lot# M000996, expiration date: 07-JAN-2018 (dose and route of administration were not reported) and lot# M004662, expiration date: 27-JAN-2018 (dose and route of administration were not reported). Temperature excursion lasted 8 hours and temperature decreased to 6 Fahrenheit degrees. Data logger and product quality complaint were not involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA000143.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with a dose of improperly stored PROQUAD lot # L051100, expiration date: 17-JUN-2017, albumin status: rHA (dose and route of administration were not reported) and lot# M007964, expiration date: 15-AUG-2017, albumin status: rHA (dose and route of administration were not reported). Temperature excursion lasted 8 hours and temperature decreased to 6 Fahrenheit degrees. Data logger and product quality complaint were not involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008912.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Information has been received from a 62 year old female patient referring to herself. The patient had upper respiratory infections. Concomitant therapies included gabapentin, lisinopril (manufacturer unknown), VALIUM and ibuprofen. The patient was allergy to penicillin and DURICEF. On 27-NOV-2016, the patient was vaccinated with ZOSTAVAX, (dose and route unknwon) subcutaneously for preventing shingles. On 29-NOV-2016, two days after vaccine was administered, the patient reported her arm was painful and was as red as the inside of a plum around the injection site. The patient also reported she was feeling nauseous on the same date. The patient called her physician's office and was told to come in as soon as possible. The patient did ultrasound on left arm and diagnosed the patient with cellulitis and started her on anitbiotics as treatment. The patient had not recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: Information has been received from a 62 year old female patient referring to herself. The patient had upper respiratory infections. Concomitant therapies included gabapentin, lisinopril (manufacturer unknown), VALIUM and ibuprofen. The patient was allergy to penicillin and DURICEF. On 27-NOV-2016, the patient was vaccinated with ZOSTAVAX, (dose and route unknwon) subcutaneously for preventing shingles. On 29-NOV-2016, two days after vaccine was administered, the patient reported her arm was painful and was as red as the inside of a plum around the injection site. The patient also reported she was feeling nauseous on the same date. The patient called her physician's office and was told to come in as soon as possible. The patient did ultrasound on left arm and diagnosed the patient with cellulitis and started her on anitbiotics as treatment. The patient had not recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Fibrin D dimer, Myocarditis, Sleep disorder
Clinical narrative: Patient was woken from sleep with crushing, burning chest pain, rated a 7/10 on pain scale, blood pressure was 155/90. Wife brought him to local ER, initial troponin level 2.13, recheck 1.5 hours later, 3.11. Transferred to larger city hospital, underwent several tests finally concluding with a cardiac catheterization, Cardiologist team diagnosed patient with myopericarditis.