chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable other HCP via Pfizer sales representative. A female patient of an unknown age and race received PREVNAR 13 at single dose on unknown date for immunization. Relevant medical history and concomitant medication were not reported. On unknown date after the vaccination the patient experienced arm hurt. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: MENB, TD
Symptoms: Body temperature increased, Chills, Feeling abnormal, Nasal congestion, Pain
Clinical narrative: Late evening after vaccination, patient complained of feeling bad. No temperature taken at that time.  After midnight, he developed testicular pain, also had body aches and chilling. The morning of 1.9.18, he had a temperature of 102. Advil was given throughout the day on 1.9.18. Still had temperature spikes during the day. Patient's parents provided Advil at midnight on 1.9.18. According to his mother, patient told his family he was feeling better yesterday. This morning, patient's mother reports he has nasal congestion.
Age: 22.0
Sex: M
Vaccine: MENB, TD
Symptoms: Pyrexia, Testicular pain
Clinical narrative: Late evening after vaccination, patient complained of feeling bad. No temperature taken at that time.  After midnight, he developed testicular pain, also had body aches and chilling. The morning of 1.9.18, he had a temperature of 102. Advil was given throughout the day on 1.9.18. Still had temperature spikes during the day. Patient's parents provided Advil at midnight on 1.9.18. According to his mother, patient told his family he was feeling better yesterday. This morning, patient's mother reports he has nasal congestion.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Antinuclear antibody positive, Biopsy stomach abnormal, Blood immunoglobulin E increased, Chest X-ray
Clinical narrative: Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits.  Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax, Echocardiogram, Endoscopy upper gastrointestinal tract abnormal
Clinical narrative: Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits.  Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Gastric emptying study, Gastritis, Gastrointestinal tube insertion, Hepatobiliary scan, Laboratory test
Clinical narrative: Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits.  Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Malaise, Malnutrition, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits.  Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia, Ultrasound abdomen, Vomiting, Weight decreased
Clinical narrative: Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits.  Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.
Age: 19.0
Sex: F
Vaccine: TYP, YF
Symptoms: Feeling abnormal, Feeling of body temperature change, Headache, Pain
Clinical narrative: Pt. mom called stating that pt. has an all over "yucky" feeling since getting vaccines. She got shots on 1-8-18, took a nap when she got home. Mom states napping is not unusual. When she awoke, she stated feeling of body aches, hot and cold alternating and headache. Mom said that she took her temperature twice and did not have a fever. She spoke to her doctor's office they said it was from the vaccines and that she should be seen when she has a sore neck. I encouraged mom to have her seen by the doctor to evaluated for other illness as well as possible vaccine reaction. Mom was very thankful for the conversation.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning to a female patient (age not reported). No medical history, concomitant medications nor concurrent conditions were reported. In 2007, the patient was vaccinated with dose 1 of GARDASIL (strengths, route, site, lot number and expiration date not reported) for prophylaxis. In 2015, was vaccinated with dose 2 of GARDASIL (strengths, route, site, lot number and expiration date not reported) for prophylaxis. In 2016, was vaccinated with dose 1 of GARDASIL (strengths, route, site, lot number and expiration date not reported) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 24 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 13-DEC-2017, the patient was vaccinated with PROQUAD Therapy type rHA (recombinant human albumin), 0,5 ml subcutaneous (lot # N020010, expiration date: 13-JAN-2019) for prophylaxis. The vaccine was administered to a patient of inappropriate age. The reporter stated that there was nothing seriously wrong with patient receiving the vaccination and that the patient has not had any untoward effects since receiving the vaccination.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in August 2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, (dose, lot# and expiration was not reported). On an unknown date in November 2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, (dose, lot# and expiration was not reported). On 27-DEC-2017 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly, (dose, lot# and expiration was not reported). No known adverse effects were reported. No causality assessment was provided.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 1.0
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 17 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (Lot # M020073, Expiry date was not reported) and LIQUID PEDVAXHIB 1 dose unit (Lot # M025193, Expiry date : 21-MAR-2019) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 19 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (Lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (Lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently  6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-OCT-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (Lot # M044350, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 39.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 39 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 24.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-MAY-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit ( lot # M008589, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 15 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-OCT-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) and PEDVAXHIB 1 dose unit (Lot # M047666, Expiry date was not reported), on 13-APR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ 1 dose unit (Lot # M005733, Expiry date: 01-OCT-2017) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 9 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date: 01-OCT-2017), subsequently on 25-JUL-2017 and 18-SEP-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 11 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-APR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date: 01-OCT-2017), subsequently on 23-JUN-2017 and 18-AUG-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 8 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date : 01-OCT-2017), subsequently on 28-AUG-2017 and 27-OCT-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733 and M031650, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 7 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date: 01-OCT-2017), subsequently on 29-SEP-2017 and 28-MAY-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733 and M031650, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with non-expired sterile diluent. No adverse effect was reported.
Sex: U
Vaccine: MMR, MMRV, HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2018, The patient was inadvertently vaccinated with a dose of PROQUAD injection, 0.5 ml, by subcutaneous route, lot number N002325, expiration date 19-JUL-2018, with M-M-R II lot number M040558, expiration date 03-OCT-2018 (strength, dose and route of administration were not reported) both for prophylaxis. It was reconstituted with sterile diluent (STERILE DILUENT) lot number # M044949, expiration date 18-JUN-2019. No adverse effects reported.
Sex: U
Vaccine: MMR, MMRV, HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2018, The patient was inadvertently vaccinated with a dose of PROQUAD injection, 0.5 ml, by subcutaneous route, lot number N002325, expiration date 19-JUL-2018, with M-M-R II lot number M040558, expiration date 03-OCT-2018 (strength, dose and route of administration were not reported) both for prophylaxis. It was reconstituted with sterile diluent (STERILE DILUENT) lot number # M044949, expiration date 18-JUN-2019. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 28-OCT-2014 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 07-NOV-2014, the patient was treated at physician's for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed diclofenac and gabapentin for management of his painful symptoms. On or about 25-NOV-2014, he had additional treatment for ongoing and worsening symptoms which was then diagnosed as post-herpetic neuralgia, a chronic condition or nerve pain and damage secondary to shingles infections. The patient was prescribed prednisolone along with continuing tramadol for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 16-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-Aug-2016, the patient was treated at the physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed prednisone for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Influenza, Pain, Pyrexia
Clinical narrative: This serious initial spontaneous case, was received from other non-healthcare professional on 25-Sep-2017, concerning a male patient of unspecified age. On 13-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient experienced chills followed by fever, in several episodes. On 22-Sep-2017, the most severe episode occurred with fever raised to 103.9 F. The patient also experienced aches and pains and he felt as if he was having the flu. On 25-Sep-2017, at 1:00 pm, chills began and stopped at 03:00 pm. It was reported that the patient wrapped himself in blanket and fever began with flu symptoms. The patient was treated with TYLENOL. Chills were stopped. The outcome of the event flu symptoms was not recovered.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Influenza, Sinusitis, Vomiting
Clinical narrative: This initial serious spontaneous case was received on 16-Oct-2017, from a non-other health professional (consumer), concerning a 60-year-old, adult, female patient. On 25-Sep-2017, the patient was administered with the influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 26-Sep-2017, the patient experienced flu symptoms-bronchitis, sinus infection and vomiting. As of 09-Oct-2017 (reported as 09-Sep-2017), it was reported that, the patient was recovering from the events.
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Influenza, Malaise
Clinical narrative: This initial spontaneous case, was received on 24-Oct-2014, from a pharmacist, concerning a male patient of unspecified age. On an unspecified date, the patient was administered with FLUAD (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, the patient was administered with non-company product PNEUMOVAX 23 (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient was given PNEUMOVAX 23 as booster dose along with FLUAD high dose. After vaccination the patient felt ill because of flu. Outcome of the event flu was not reported.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Mother called immunization clinic today to discuss vaccines and report child's reaction to the vaccine given on 10-18-17. She reported Redness, swelling, pain, warmth at the injection site for up to 5 days.  Along with a rash around the injection site.  Mother also states that her daughter is sensitive to sunscreens, detergents, among other things.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure decreased, Cold sweat, Dyspnoea
Clinical narrative: Employee received vaccine at 9:10 am and left the facility to return to work shortly after. Employee drove approximately 16 blocks and felt like her blood pressure was dropping. Employee was having a difficult time breathing. Employee parked her car into a parking lot. Employee had liquid BENADRYL with her and took 5 mls. Employee called 911 for assistance. The 911 connected employee to the local fire department. The fire department provided information regarding the closest hospital locations. Employee then called her supervisor who directed employee to return to the employee immunization clinic. Employee returned to the clinic at 9:45 am. Employee was assessed by this nurse. Vital signs at 10:00 am: Blood pressure: 118/78, pulse: 64, respirations: 16. Breathing was normal, skin: cool, clammy and intact. Employee was able to talk and swallow normally. Patient alert and oriented to person, place and time. Vital signs repeated at 10:20 am: B/P: 108/68, pulse 60, respirations: 16, skin: warm, dry and intact. Employee oriented to person, place and time. V/S at 11:00 am: B/P: 104/62. pulse: 64, respirations: 16, skin warm, dry and intact. Employee oriented to person, place and time.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: Vaccines were given to the wrong patient, no adverse effects have been noted so far on patient to date.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2 Hep B shots at same time!! No reaction yet - should not had gotten 2 hep b shots at one time.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Influenza like illness, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: 01/03/18 = received vaccine for pneumonia, and around midnight, I woke up with chills and fever. Took TYLENOL for fever and muscle pain for 4 days. Right arm is swollen to date 01/08/18. Flu-like symptom.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case received on 27-Sep-2017, reported by a pharmacist concerning a patient of unspecified age. Patient's medical history was not reported. On an unspecified date, the patient received FLUAD (TIV) (dose, route of administration, anatomical site, batch number, expiry date not reported) (explicitly coded as inappropriate age at vaccine administration). The outcome of the event was not reported. This report was considered as non-serious.
Age: 10.0
Sex: U
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received on 07-Sep-2017 from a pharmacist, concerning a 10-year-old child. The patient's medical history and concomitant medications were not reported. On 07-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. It was reported that, no adverse effects were noted. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure via eye contact, Eye irrigation, Headache, Syringe issue, Vision blurred
Clinical narrative: This initial spontaneous case was received on 29-Sep-2017, reported by a pharmacist and concerning 42-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 29-Sep-2017, pharmacist while administering FLUAD (dose: 0.5 ml, batch number: 178601, expiry: Apr-2018, PTC number: 1024959, route of administration and indication was not reported) to a patient the syringe tip cracked and it squirted into her eye (explicitly coded as occupational exposure while administering product) caused headache and blurred vision. The pharmacist wanted to know what to do. As a treatment, the pharmacist flushed her eyes with refreshed eye drops. It was reported that, no vaccine was administered or squirted onto the patient. As per the PTC (product technical complaint) investigation performed, package condition, syringe were not damaged and no crack in hub, no signs of leakage was observed and it was concluded that, FLUAD batch 178601 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. The sample was not available for analysis. No trends were identified, and that remained the only complaint for FLUAD batch 178601. As a result, no internal root cause had been determined as the most likely root cause and the complaint was considered as not determinable. Since internal root cause was ruled out. Outcome of the events were not reported. This reporter considered the events as non-serious. Non-significant follow-up report received on 29-Sep-2017: PTC reference number (1024959) was updated. Amended narrative accordingly. Follow up received on 20-Nov-2017: The PTC investigation results were update. The narrative was amended accordingly.
Age: 61.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from a Pharmacist on 02-Oct-2017, concerning a 61-year-old adult male patient. On 30-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, lot number: 178601, route of administration: intramuscularly, anatomical location: deltoid muscle of the upper arm, expiry date: Apr-18). It was reported that the patient received FLUAD. No issues were reported since administration. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up received on 09-Oct-2017: Pharmacist reported that, the vaccine was administered intramuscularly in the deltoid muscle of the upper arm with lot no: 178601 and expiry: Apr-18.
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received on 02-Oct-2017 from a pharmacist, concerning a 62-year-old adult male patient. The patient's current condition included diabetes and HTN (hypertension) since an unspecified date. Concomitant medications included LANTUS SOLOSTAR pen, quinapril hydrochloride, metformin hydrochloride, amlodipine besilate, HCTZ, and pravastatin sodium for an unknown indication. On 30-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178901 (as reported), expiry date: May-2018), explicitly coded as inappropriate age at vaccine administration. It was reported that, no adverse effects were noted. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up received on 13-Oct-2017: Batch no. and expiry date of the vaccine was added. Concomitant medications were added and hypertension was added as current condition. Narrative amended accordingly.
Age: 23.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist, on 20-Sep-2017, concerning a 23-year-old adult female patient. On 20-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number (as reported 178601), expiry date (April-2018): not reported). It was reported that FLUAD was suggested for 65 and over (explicitly coded to inappropriate age at vaccine administration). It was reported that, there was no adverse event after receiving the vaccine. The outcome of the event was not reported. The reporter assessed the event as non-serious. Follow up received on 22-Sep-2017: It was reported that, there was no adverse event after receiving the vaccine. The narrative was amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Pain and swelling lt axil.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed severe cellulitis on Left arm. Left arm, pain, swelling and redness to the elbow. She also had chills and nausea. She denies fevers. She went to the ER on 1/7/18 and was started on antibiotics. I followed up with patient 1/10/18 and she is healing each day, but still has a few more days of antibiotics.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Patient developed severe cellulitis on Left arm. Left arm, pain, swelling and redness to the elbow. She also had chills and nausea. She denies fevers. She went to the ER on 1/7/18 and was started on antibiotics. I followed up with patient 1/10/18 and she is healing each day, but still has a few more days of antibiotics.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: This person was given the vaccine at his workplace. It was reported to RN, on 1-9-18 from that workplace, that the person had a reaction to the vaccine on the same day he received it: 10-2-17.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: INFANT DECEASED.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Appetite disorder, Pyrexia
Clinical narrative: Patient had moderate abdominal pain location was epigastric. Patient associated symptoms were change in appetite and fever (max temp of 102F). Mother was giving patient TYLENOL for the fever. Dr. whom the patient followed up with instructed mother to continue MOTRIN, considered PEPTO-BISMOL warm compresses and probiotics.