chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored oral ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 29-SEP-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 08-OCT-2015 the patient was vaccinated with improperly stored oral ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 08-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016,orally (incorrect product storage). The vaccine was administered at public  health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 12-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 09-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of th several reports received from the same reporter. Additional information has been requested.
Age: 0.28
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 3 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 04-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 12-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 weeks old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 06-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 09-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.61
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 7 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 09-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 10-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 10-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 10-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 8 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 12-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 11-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 06-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.43
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 06-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L03087, expiration date: 11-JUN-2018, lot# L035880, expiration date: 11-AUG-2018) (dose and route were not provided). Concomitant medication was not reported. It was also mentioned that no adverse effects were reported, temperature was low 32 degrees F, the time frame was 28 days, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (manufacturer unknown) (lot # reported as L237TJ, expiration date unknown) (dose and route were not provided). Concomitant medication was not reported. It was also mentioned that no adverse effects were reported, temperature was low 32 degrees F, the time frame was 28 days, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Lot number L237TJ is an invalid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015, expiration date: 16-AUG-2017, lot# L043213, expiration date: 28-AUG-2017)(dose and route were not provided). Concomitant medication was not reported. It was also mentioned that no adverse effects were reported, temperature was low 32 degrees F, the time frame was 28 days, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 10-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 in the arm (lot number and expiration date were not provided). The patient's concomitant medications were not reported. On an unspecified date of 2016, the patient developed redness and swelling that occurred on the opposite side of arm where PNEUMOVAX 23 was administered. The patient sought for medical attention and was seen by a physician who diagnosed her as having cellulitis. No product quality issue was involved. At the time of the report, the outcome of cellulitis was unknown. The relatedness between the adverse event and vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Overdose
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 11-MAR-2015 patient was vaccinated with ZOSTAVAX (lot# K008880, expiry 09-SEP-2015) was inadvertently administered another dose of ZOSTAVAX (lot # L036454, expiry 22-DEC-2016) on 05-APR-2016. The outcome of event was unknown. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 13-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2015, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 13-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2015, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 12-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2015, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding 3 unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On 31-MAR-2016, 3 unspecified patients were inadvertently vaccinated with expired doses of PNEUMOVAX 23 (Lot # K009874, expiry date 19-MAR-2016) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 30-SEP-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 8 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender (who was also a physician) via field representative referring to self. The medical history and concurrent conditions of patients was unknown. On an unknown date the patient restarted series with GARDASIL lot, dosing details and route unknown and it was reported time between doses was spaced out too long (inappropriate schedule of vaccine administered). Concomitant medications were not reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not provided. On 04-APR-2016 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # L029480; dose and route not reported), which was expired on 16-MAR-2016 (Expired product administered). No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a healthcare professional (nurse) on 20 April 2015. An 11-year-old male patient whose medical history was not reported had received a dose of MENACTRA manufacturer: SANOFI PASTEUR INC (batch number, dose of vaccine and route of vaccination were not reported) in arm, a dose of TDAP manufacturer: UNKNOWN, (batch number, dose of vaccine and route of vaccination were not reported) in arm and 0.5 ml, first dose of GARDASIL intramuscularly in the opposite arm, manufacturer: OTHER. All these vaccines were administered on 23 March 2015. On 23 March 2015, same day after vaccination patient experienced pain, warmth and swelling the size of soft ball at the injection site. Medical history and drug allergies of the patient were reported as none. Patient sought medical attention on 23 March 2015. The patient received unspecified corrective treatment. Lab investigation was reported as none. At the time of this report, the outcome of the patient was reported as unknown. Documents held by sender: none. Follow-up information received from nurse on 30 June 2015. Patient information was updated. Patient has medical history of ADHD (Attention deficit hyperactivity disorder). Patient received CONCERTA as concomitant medications. Patient was received MENACTRA in left arm (batch number-U4986AA) and TDAP in left arm (batch number- U4971AA) and GARDASIL in right arm. Patient received these vaccines as first doses previously. Patient did not receive any vaccinations 4 weeks prior. Patient has no illness at the time of vaccination. Vaccine administered by was updated. Responsible physician contact information was updated. Patient was vaccinated at private doctor's office/hospital and vaccine purchased at public funds. It was reported that reaction was decreased. It was decided to continue with HPV 2. Patient was premedicated with Benadryl before HPV 2 and took Zyrtec for 3 days after which there was no redness, swelling and discomfort was noted with second dose. At the time of this report, it was reported that pain, redness and swelling subsided on 4 April 2015 and on unspecified date; patient was recovered from the event. List of Documents held by Sender: None.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Myositis, Pain in extremity, X-ray normal
Clinical narrative: Patient received HI-DOSE flu shot and PREVNAR 13 shot on 10/26/15. Contacted our clinic on 11/30/15 and stated that he had soreness in both legs and arms since 4 days after shots. Also stated he had lifted a heavy load of wood on 10/29/15 and wasn't sure if that was the cause of soreness. The patient stated that he went to his dr. on the morning of 11/30/15 and his dr. completed a set of x-rays to make sure he had not pulled something from lifting the load of wood. He stated that the dr. told him the x-rays were negative and that he thought "the shots" had caused his muscles to get inflamed because shots can cause muscle inflammation. He stated that his dr had given him an anti-inflammatory shot and he felt much, much better now. He also stated that his dr. was going to send him for an MRI later in the week just to be sure. The patient said he contacted me just so I would know how to help any other patients that might have the same problem. I have called the patient this am 12/4/15 and I am awaiting a return call to check on him and see if he is still feeling ok.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Myalgia
Clinical narrative: Patient received HI-DOSE flu shot and PREVNAR 13 shot on 10/26/15. Contacted our clinic on 11/30/15 and stated that he had soreness in both legs and arms since 4 days after shots. Also stated he had lifted a heavy load of wood on 10/29/15 and wasn't sure if that was the cause of soreness. The patient stated that he went to his dr. on the morning of 11/30/15 and his dr. completed a set of x-rays to make sure he had not pulled something from lifting the load of wood. He stated that the dr. told him the x-rays were negative and that he thought "the shots" had caused his muscles to get inflamed because shots can cause muscle inflammation. He stated that his dr had given him an anti-inflammatory shot and he felt much, much better now. He also stated that his dr. was going to send him for an MRI later in the week just to be sure. The patient said he contacted me just so I would know how to help any other patients that might have the same problem. I have called the patient this am 12/4/15 and I am awaiting a return call to check on him and see if he is still feeling ok.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Per patient. She received vaccine morning of 11/3/15 in her right arm. Started to itch at the injection site and then developed redness. Pt. had the redness and itching for approx. 11 days.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Metabolic function test normal, Myocardial necrosis marker normal
Clinical narrative: Developed chest pain, classic positional for pericarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Myocarditis
Clinical narrative: Developed chest pain, classic positional for pericarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Electrocardiogram, Pericarditis
Clinical narrative: Developed chest pain, classic positional for pericarditis.
Age: 88.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Asthenia, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: 02/19/2016 Received call from pt's daughter on 4/5/2016 1115 stating that pt c/o rue pain that extends from (R) shoulder to (R) elbow since receiving vaccination on 2/19/2016-c/o contusion at injection site x several days post immunization - pt saw MD for evaluation - MD prescribed physical therapy for pt - pt's daughter stated that pt has not shown any improvement with physical therapy.
Age: 88.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: X-ray
Clinical narrative: 02/19/2016 Received call from pt's daughter on 4/5/2016 1115 stating that pt c/o rue pain that extends from (R) shoulder to (R) elbow since receiving vaccination on 2/19/2016-c/o contusion at injection site x several days post immunization - pt saw MD for evaluation - MD prescribed physical therapy for pt - pt's daughter stated that pt has not shown any improvement with physical therapy.
Age: 88.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: 02/19/2016 Received call from pt's daughter on 4/5/2016 1115 stating that pt c/o rue pain that extends from (R) shoulder to (R) elbow since receiving vaccination on 2/19/2016-c/o contusion at injection site x several days post immunization - pt saw MD for evaluation - MD prescribed physical therapy for pt - pt's daughter stated that pt has not shown any improvement with physical therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient with allergies to sulfa drugs. There was no pertinent medical history. On 31-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L039126; expiration date: 08-JAN-2017; 0.65 ml) subcutaneous. There was no concomitant medication. The pharmacist reported that on 04-APR-2016 the patient returned to the pharmacy stating that on the same day she received ZOSTAVAX, she developed a red, itchy area that was warm to the touch in the area where she received the injection. The pharmacist reported that the patient had been icing the area and using an anti-itch cream (manufacturer unspecified) to treat the area (also reported that no treatment was given for events). No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. The pharmacist requested a lot check for ZOSTAVAX (lot # L039126; expiration date: 08-JAN-2017) as quickly as possible. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient with allergies to sulfa drugs. There was no pertinent medical history. On 31-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L039126; expiration date: 08-JAN-2017; 0.65 ml) subcutaneous. There was no concomitant medication. The pharmacist reported that on 04-APR-2016 the patient returned to the pharmacy stating that on the same day she received ZOSTAVAX, she developed a red, itchy area that was warm to the touch in the area where she received the injection. The pharmacist reported that the patient had been icing the area and using an anti-itch cream (manufacturer unspecified) to treat the area (also reported that no treatment was given for events). No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. The pharmacist requested a lot check for ZOSTAVAX (lot # L039126; expiration date: 08-JAN-2017) as quickly as possible. This is one of several reports from the same reporter. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site pain, Injection site warmth, Vaccination site pain, Vaccination site swelling
Clinical narrative: See additional page(s) for complete text.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Fall, Feeling abnormal
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30 Mar-2016) concerns a male patient of at least adult age (possibly elderly). The patient has a medical history of Guillain-Barre Syndrome (GBS). In Nov-2011, the patient received Afluria (influenza virus vaccine polyvalent; batch no: not reported; dose: 0.5 ml) via the intramuscular route for indication not reported. Five days after Afluria administration, the patient received a flu vaccine (influenza virus vaccine; brand and batch number unspecified). On an unknown date following the second flu vaccination, the patient's GBS symptoms worsened and were aggravated. The GBS became chronic inflammatory demyelinating polyneuropathy (CIDP) about two months later. The patient insists that the flu symptoms worsened and aggravated the pre-existing GBS.  The worsening of symptoms includes falling down, fogginess and loss of balance. The patient is being treated with intravenous immunoglobulin (IVIG) once daily every seven weeks. The outcome was not reported. Reporter's Comments: The reporter stated that worsening of symptoms include falling down, fogginess and loss of balance. Sender's Comments: Company comment: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, CIDP is unlisted.  All other events are also unlisted except GBS (symptoms worsened) and flu symptoms are listed. Causality: Unassessable. Time to onset was not specified. It is likely patient had CIDP at the outset diagnosed as GBS due to the similarity of presentation and as CIDP has recurrences with partial or complete recovery. Flu symptoms are likely due to influenza like illness that can follow vaccination but information such as (time to onset and laboratory diagnosis) is lacking to confirm potential lack of effect. Similarly it is not known if patient received a further dose of seasonal Influenza vaccine or pandemic (H1N1) vaccination within the same week and the effect of this on the reported events. Influenza vaccination is generally not advised in person with known history of GBS.  Overall there is insufficient information to attribute causality to Afluria.