chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Product storage error
Clinical narrative: No additional AEs reported; administration of vaccines involved in a temperature excursion; This spontaneous report was received from a medical assistant referring to a 3-year-old female patient.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 16-FEB-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U024090, expiration date reported as 28-OCT-2022 but upon internal validation established as 28-OCT-2023, intramuscular in the left arm for prophylaxis (dose and vaccination scheme frequency were reported as "1") (product storage error). The patient had received 2 previous doses of the vaccine.         The vaccine was stored in a temperature of 1.35 degree Celsius for 1 hour as recorded by a data logger. There was no previous temperature excursion reported.  This is one of three reports received from the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Breast pain, COVID-19, Erythema, Pain
Clinical narrative: Neck pain; Rib pain; given subcutaneously in back of right arm; given subcutaneously; pain in arm, radiated to neck and ribs; swelling at the site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7k4lx, expiry date unknown) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 14th February 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the patient experienced neck pain and rib pain. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the neck pain, rib pain, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, pain in arm, neck pain and rib pain to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself. The patient reported that instead of intramuscularly, she was given the vaccine subcutaneously in the back of her right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient experienced pain in her arm the same day and had not resolved.  Less than 2 months after receiving Shingrix, the arm pain had radiated to her neck and also to her ribs.  The patient also experienced swelling at the site on the same day as the dose but it resolved after 5 days.  The consent to follow up was given.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Neck pain; Rib pain; given subcutaneously in back of right arm; given subcutaneously; pain in arm, radiated to neck and ribs; swelling at the site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7k4lx, expiry date unknown) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 14th February 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the patient experienced neck pain and rib pain. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the neck pain, rib pain, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, pain in arm, neck pain and rib pain to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself. The patient reported that instead of intramuscularly, she was given the vaccine subcutaneously in the back of her right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient experienced pain in her arm the same day and had not resolved.  Less than 2 months after receiving Shingrix, the arm pain had radiated to her neck and also to her ribs.  The patient also experienced swelling at the site on the same day as the dose but it resolved after 5 days.  The consent to follow up was given.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site swelling, Musculoskeletal chest pain, Neck pain, Pain
Clinical narrative: Neck pain; Rib pain; given subcutaneously in back of right arm; given subcutaneously; pain in arm, radiated to neck and ribs; swelling at the site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7k4lx, expiry date unknown) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 14th February 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the patient experienced neck pain and rib pain. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the neck pain, rib pain, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, pain in arm, neck pain and rib pain to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself. The patient reported that instead of intramuscularly, she was given the vaccine subcutaneously in the back of her right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient experienced pain in her arm the same day and had not resolved.  Less than 2 months after receiving Shingrix, the arm pain had radiated to her neck and also to her ribs.  The patient also experienced swelling at the site on the same day as the dose but it resolved after 5 days.  The consent to follow up was given.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Neck pain; Rib pain; given subcutaneously in back of right arm; given subcutaneously; pain in arm, radiated to neck and ribs; swelling at the site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7k4lx, expiry date unknown) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 14th February 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the patient experienced neck pain and rib pain. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the neck pain, rib pain, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, pain in arm, neck pain and rib pain to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself. The patient reported that instead of intramuscularly, she was given the vaccine subcutaneously in the back of her right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient experienced pain in her arm the same day and had not resolved.  Less than 2 months after receiving Shingrix, the arm pain had radiated to her neck and also to her ribs.  The patient also experienced swelling at the site on the same day as the dose but it resolved after 5 days.  The consent to follow up was given.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: After receiving COVID 19 Vaccine at Pharmacy and waiting 15 min. My son walked home, which is only 5 min away. He laid down on the couch. I found him a short time later having a stroke. He was taken to Hospital diagnosed with blood clots, and paralyzed on his whole right side.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Hemiplegia, Thrombosis
Clinical narrative: After receiving COVID 19 Vaccine at Pharmacy and waiting 15 min. My son walked home, which is only 5 min away. He laid down on the couch. I found him a short time later having a stroke. He was taken to Hospital diagnosed with blood clots, and paralyzed on his whole right side.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: After receiving COVID 19 Vaccine at Pharmacy and waiting 15 min. My son walked home, which is only 5 min away. He laid down on the couch. I found him a short time later having a stroke. He was taken to Hospital diagnosed with blood clots, and paralyzed on his whole right side.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monoplegia, Myelitis transverse
Clinical narrative: Patient developed low back pain and lower extremity weakness starting on 2/27/22. Went to the ER that day and was eventually diagnosed with acute transverse myelitis
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Magnetic resonance imaging spinal, Muscular weakness, Myelitis transverse
Clinical narrative: Patient developed low back pain and lower extremity weakness starting on 2/27/22. Went to the ER that day and was eventually diagnosed with acute transverse myelitis
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Decreased appetite, Eye disorder, Headache
Clinical narrative: first shot: felt a little under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "first shot: felt a little under the weather". Therapeutic measures were taken as a result of malaise. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767789 Same patient and drug, different event separated in time
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: first shot: felt a little under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "first shot: felt a little under the weather". Therapeutic measures were taken as a result of malaise. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767789 Same patient and drug, different event separated in time
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: first shot: felt a little under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "first shot: felt a little under the weather". Therapeutic measures were taken as a result of malaise. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767789 Same patient and drug, different event separated in time
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Pain, Palpitations
Clinical narrative: Chest pressure & palpitations, entire body feeling sore/fatigue since getting vaccine and continued over the course of months since getting shot!
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: received the pfizer vaccine the 2 doses only had diarrhea for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "received the pfizer vaccine the 2 doses only had diarrhea for 2 days". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Epilepsy, Seizure
Clinical narrative: epilepsy; Information has been received from Food and Drug Administration (FDA) in response to request on 04-FEB-2022.  This spontaneous report was received from a consumer who was patient's parent, guardian or caregiver, and refers to a 16-year-old non-pregnant female patient. Her concurrent conditions included type 1 diabetes. The patient's concomitant medications included insulin lispro (HUMALOG). She was reported to be allergic to peanuts. No information regarding the patient's medical history was provided.  On 21-DEC-2017, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# N0015089 upon internal validation was established to be not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) and does not match any Company product, expiration date was not provided; dose and site were not provided), administered intramuscularly (IM) for prophylaxis.   On 12-SEP-2018 at 09:30:00, the patient experienced epilepsy (reported as seizure diagnosed as epilepsy), and as a result visited emergency room or urgent care (also reported as doctor or other healthcare professional office/clinic visit). The patient was treated with levetiracetam (KEPPRA). The outcome of the epilepsy was reported as not recovered.  The causality assessment relationship between epilepsy and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The Agency considered the event to be non-serious.  Follow-up information was received from a clinical supervisor via an inbound telephone call on 16-MAR-2022. The clinical supervisor was unable to locate a patient for this case as there were several females age 16 that were administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on the day this anonymized patient received her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine. No additional information was available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a patient received improperly stored vaccine; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided   On 15-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U020239, expiration date 28-JUN-2023 for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion of 6.4 degree Fahrenheit (F) for a period of 30 minutes (Product storage error). The vaccine did not undergo a previous temperature excursion. The patient did not experience any adverse event.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ 0 known adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccine temps went out of range. Vaccine given; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 12-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, formulation, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On 02-FEB-2022, the patient was vaccinated intramuscularly, in her left deltoid, with an improperly stored (product storage error) second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number U007667 with an expiration date of 23-MAY-2023 (dose was not reported) for prophylaxis. There were no additional adverse event details. Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. The improper storage was recorded by digital data logger.   This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Age: 15.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccines went out of range - temp. Vaccines given despite temp excursion.; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 15-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On 28-JAN-2022, the patient was vaccinated with an improperly stored doses HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number U007667 with an expiration date of 23-MAY-2023 second dose, intramuscularly, in her right deltoid (dose, strength and formulation were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX), lot number: U020239, expiry date: reported as 23-JUN-2023, but upon internal validation, established as 28-JUN-2023, second dose, subcutaneously, in her left arm (strength, dose and formulation, were not reported) for prophylaxis (product storage error). There were no known patient's adverse events (no adverse event). Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Temperature excursion details for varicella virus vaccine live (Oka/Merck) (VARIVAX) were not provided. Digital Data Logger was involved.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA002574: US-009507513-2202USA007813:
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccines went ot of temp range. Vaccines were given despite temp excursion.; This spontaneous report was received from a licensed practical nurse (LPN) regarding a 16-year-old female patient. Her concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, formulation, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On 15-JAN-2021, the patient was vaccinated intramuscularly, in her left deltoid, with an improperly stored (product storage error) the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number T028929, with an expiration date of 08-MAR-2023 (dose, strength and formulation were not reported) for prophylaxis and vaccinated intramuscularly, in her right deltoid, with the first dose of meningococcal vaccine b rfhbp/nada/nhba omv(BEXSERO) lot number: ABXA92AZ, expiry date: 28-FEB-2022 (dose and formulation were not reported) for prophylaxis. Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes, respectively. There were no previous excursions reported. Temperature excursion details for meningococcal vaccine b rfhbp/nada/nhba omv(BEXSERO) were not provided. Digital data logger was involved. There were no additional adverse event details.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574:
Age: 10.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Temp excursion - vaccines given despite temp excursion; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 10-year-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, formulation, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On unknown dates, the patient was vaccinated with first, second, third and fourth doses of influenza vaccine (INFLUENZA) (doses, formulations, anatomical locations, routes of administration, lot numbers and expiry dates were not provided for all doses) for prophylaxis. On 05-NOV-2021, the patient was vaccinated intramuscularly, in his right deltoid, with an improperly stored (product storage error) second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe lot number 1687290, with an expiration date of 06-SEP-2022 (dose was not reported) for prophylaxis and vaccinated intramuscularly, in his right deltoid, with the fifth dose of influenza vaccine (INFLUENZA) lot number: FT779, expiry date: 30-JUN-2022 (dose and formulation were not reported) for prophylaxis. There were no additional adverse event details. Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Temperature excursion details for influenza vaccine (INFLUENZA) were not provided. The improper storage was recorded by digital data logger.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Temp excursion happened - Vaccines given despite; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 12-year-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On 04-NOV-2021, the patient was inadvertently vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) second dose, intramuscularly in left deltoid, lot number S023475, with an expiration date of 26-MAR-2022 (dose, strength and formulation were not reported) for prophylaxis and meningococcal vaccine a/c/y/w conj (diptox) (MENACTRA) first dose, intramuscularly in right deltoid lot number: U7191AA, expiry date: 18-JAN-2023 (strength, dose and formulation, were not reported) for prophylaxis (product storage error). There were no additional adverse event details and no known patient's adverse events (no adverse event). Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Temperature excursion details for meningococcal vaccine a/c/y/w conj (diptox) (MENACTA) were not provided. Digital Data Logger was involved.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ no known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccines went out of temp range. Vaccines given despite the temp excursion; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 15-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On 09-NOV-2021, the patient was vaccinated inadvertently with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) second dose, intramuscularly in left deltoid lot number T028929, with an expiration date of 08-MAR-2023 (dose, strength and formulation were not reported) for prophylaxis (product storage error). There were no additional adverse event details and no known patient's adverse events (no adverse event). Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Digital Data Logger was involved.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Mumps antibody test negative, Rubella antibody negative, Varicella virus test negative
Clinical narrative: Patient has negative titers to the Mumps, Rubella and Varicella.; Patient has negative titers to the Mumps, Rubella and Varicella; Patient has negative titers to the Mumps, Rubella and Varicella; This spontaneous report was received from nurse practioner referring to an 18-year-old female. The patient's pertinent medical history included scoliosis. The patient was not taking any concomitant medications. The patient did not have any drug allergies and reactions.   On 10-JAN-2006, the patient vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number, expiration date, and route of administration, dose, vaccination scheme, and anatomical location of vaccination were not reported) and first dose of varicella virus vaccine live (oka/merck) (VARIVAX), (lot number, expiration date, and route of administration, dose, vaccination scheme, and anatomical location of vaccination were not reported) for prophylaxis.   On 03-DEC-2007, the patient vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number, expiration date, and route of administration, dose, vaccination scheme, and anatomical location of vaccination were not reported) and second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number, expiration date, and route of administration, dose, vaccination scheme, and anatomical location of vaccination were not reported) administered for prophylaxis.   On 25-FEB-2022, the patient had negative titers to the Mumps, Rubella, and Varicella. the reporter stated that she received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and two doses of varicella virus vaccine live (oka/merck) (VARIVAX) in the past. the patient was not given treatment for the negative titers to the Mumps, Rubella and Varicella.  At the time of reporting, the outcome of mumps antibody test negative, varicella virus test negative and rubella antibody negative was unknown.        The causal relationship between mumps antibody test negative, varicella virus test negative and rubella antibody negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; pediatric dose of RECOMBIVAX HB was inadvertently given to an adult; pediatric dose of RECOMBIVAX HB was inadvertently given to an adult; This spontaneous report was received from a nurse referring to an adult patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 03-MAR-2022, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 milliliter, lot number U005271, expiration date 21-NOV-2022 for prophylaxis (route of administration not provided) (incorrect dose administered and product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; a 15 year old patient received their 3rd dose of the GARD ASIL 9 series today (04MAR2022) and their second dose of the series was administered in 2019; This spontaneous report as received from a medical assistant refers to a 15-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 04-MAR-2022, the patient received third dose of this vaccine, lot # U008900, expiration date: 12-AUG-2021, 0.5 mL (route of administration was not reported) for prophylaxis. No adverse event was reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; a dose of VARlVAX has been administered to administered to a patient while being improperly stored on 03MAR2022; This spontaneous report was received from a certified medical assistant and refers to a 15-month-old patient of unknown gender. The patient's concurrent conditions, concomitant medications, medical history and drug allergies were not provided.  On 03-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) in dose 0,5 ml, (lot # U022320, expiration date 15-JUL-2023) (formulation, route of administration and injection site were not provided) for prophylaxis. The temperature to which the vaccine was exposed was 13.4 degrees of Celsius (C) and the time frame was reported as 7 hours 55 minutes 0 seconds. No previous temperature excursion was reported. It was unknown if digital data logger was involved. No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administered an expired dose; This spontaneous report was received from other health professional referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 09-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T006167, expiration date 19-FEB-2022, for prophylaxis (expired product administered) (strength, dose, frequency and route of administration were not reported) . Concomitant therapies included sterile diluent. No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired PROQUAD was administered; No other adverse events reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 10-MAR-2022 (also reported as today), the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, lot # T030760, expiration date on 08-MAR-2022, for prophylaxis (strength, route of administration and anatomical location were not reported) (expired product administered). No other adverse events were reported (no adverse event). Additionally, it was reported that dose was properly stored up through time of administration.        This was one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA003811: US-009507513-2203USA003857:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of PROQUAD administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.  On 10-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number: T030945, expiration date: 09-MAR-2022 (expired product administered), dose 0,5 ml, subcutaneously (SQ) (formulation and injection site was not provided) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No further AE/No PQC; administration of pediatric doses of RECOMBIV AX HB to 3 adults; administration of pediatric doses of RECOMBIV AX HB to 3 adults; This spontaneous report was received from a medical assistant, referring to an adult patient of unknown exact age and gender. Information about medical history, concomitant medications, concurrent conditions and drug allergies was not provided.  On 27-JAN-2022, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 5mcg/0.5ml, 1 dose, lot# U001837 was confirmed to be valid, expiration date reported as 21-NOV-2022, however upon internal validation was established as 28-APR-2023 (route and site of administration not provided) for prophylaxis. It was reported that the dose administered was a pediatric dose (incorrect dose administered, product administered to patient of inappropriate age). No additional adverse events reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004223: US-009507513-2203USA004333:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 was administered after a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-MAR-2022, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, dose: 0.5 mL, lot number: T036812, expiration date: 28-APR-2023 (strength, formulation, anatomical location and route of administration were not reported) for prophylaxis (product storage error).  There was a reported temperature excursion of the vaccine of -4.8 degrees Celsius for 1 hour. There were no previous temperature excursions reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or PQC.; an expired GARDASIL 9 administered to a patient; This spontaneous report was received from a medical student, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 14-MAR-2022, the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S022599, expiration date on 25-FEB-2022, for prophylaxis (strength, route of administration and anatomical location were not reported) (expired product administered). No other adverse events were reported (no adverse event). Additionally, it was reported that no temperature excursion.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; Product storage error; This spontaneous report was received from a medical assistant referring to a 7-month-old male patient.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 16-FEB-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742467, expiration date 05-OCT-2022, orally for prophylaxis (dose and vaccination scheme frequency were not reported) (product storage error). The patient had received two previous doses of the vaccine.        Information regarding the temperature and time frame of the excursion were not provided. No additional adverse events reported.   This is one of three reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Pain at the injection site on both doses; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.      Additional details reported were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received her first dose of Shingrix a few years ago (date unknown). On the date of her vaccination the patient felt intense pain at the injection site which did resolve in a few days. The patient referred to pain with injection on both doses although she noted the second was worse. She did not have any dates specifically though. The patient was provided medical advice disclaimer and referred to healthcare professional.  The patient was provided information per content on alternative dosing schedules. And was offered (package insert) PI. Patient would contact her pharmacy for dates of vaccination and would call back to provide the information. The consent to follow up was given. The permission to contact healthcare and pharmacy was provided. For tolerance to 2nd dose, refer case US2022046145.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046145:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itchy skin reaction; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was unknown.   It was unknown if the reporter considered the itchy skin to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. Several weeks after receiving Shingrix, the patient experienced itchy skin reaction.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Sister in law has shingles after vaccination; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's relative. The age at vaccination was not reported. The patient received doses of shingles vaccine and Covid vaccines and experienced shingles. On an unknown date, unknown after receiving Covid vaccine, the patient experienced vaccination failure and shingles. It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to COVID-19 vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with case US2022AMR047516, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR047516:Same Reporter
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Brother in law has shingles in his eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's brother in law. The age at vaccination was not reported. The reporter stated that, the patient had shingles in his eye after receiving Shingles vaccine and COVID vaccines. It was unknown if the reporter considered the suspected vaccination failure and ophthalmic herpes zoster to be related to COVID-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR047508, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR047508:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had shingles in Oct, I also had the one shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details reported were as follows: The age at vaccination was not reported. The patient received one Shingles shot and had shingles in October. The patient still had lot of problems. The follow-up would not possible as no contact details were available.