chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles 4 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (got chicken pox when 8 months pregnant).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 4 times). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via interactive digital media. The patient took the two vaccines and got shingles 4 times the patient had the worst breakout now. The patient never had the chicken pox vaccine but got chicken pox 8 months pregnant. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1& 2).
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Pulmonary pain
Clinical narrative: I feel weak; dizzy; lungs aching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feelings of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30-APR-2025, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feelings of weakness (Verbatim: I feel weak), dizziness (Verbatim: dizzy) and pulmonary pain (Verbatim: lungs aching). The outcome of the feelings of weakness, dizziness and pulmonary pain were not reported.   It was unknown if the reporter considered the feelings of weakness, dizziness and pulmonary pain to be related to Shingles vaccine.     It was unknown if the company considered the feelings of weakness, dizziness and pulmonary pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient questioned that what if lungs were aching. The patient further stated that he/she got his/her 2nd shot yesterday (day before reporting). The patient felt weak, dizzy with lungs aching in 2025.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vacination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vacination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles, despite having received the vaccine three years ago. The vaccine did not prevent, but they did seem to had a much milder case than most of the comments indicated. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: I got shingles again right after getting the shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: I got shingles again right after getting the shot). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient recently got second dose of Shingrix. The patient now had shingles. The reporter asked could the shingles come from getting the immunization. The reporter asked that the patient did not understand why he/she got shingles again right after getting the shot but thank you for the information.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 1 week).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAY-2025 This case was reported by a patient via interactive digital media. The new shot series made patient sick as a dog for a week.
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Scar
Clinical narrative: Weakness/Loss of strength; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: Weakness/Loss of strength) and headache (Verbatim: Headache). The outcome of the weakness and headache were not reported.   It was unknown if the reporter considered the weakness and headache to be related to Shingrix.     It was unknown if the company considered the weakness and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAY-2025 This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media. The patient received Shingrix vaccine had weakness, headache, loss of strength.  The reporter was ask could he/she took aspirin or Tylenol, was there anything to use to get rid of the scars and  what to did if the second Shingrix dose was missed.
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: local site injection soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: local site injection soreness). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. It was reported as none at all. The patient had Just a little local site injection soreness. The patient got protected soon.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mother got the shot and 10 days later had full blown shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: mother got the shot and 10 days later had full blown shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient got the shot and 10 days later had full blown shingles .  She was in agony the rest of her life.  The reporter said that did they resent the medical industry for her misery at a point in her life that should have been the best time.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had them 3 or 4 times after the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 3 or 4 times after the vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2025  This case was reported by a consumer via interactive digital media.  Patient had Shingles 3 or 4 times after the vaccine and stated that they were really bad.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about   primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Paralysis
Clinical narrative: type of palsy had a reaction to the 15 month shots; This serious case was reported by a other health professional via other manufacturer and described the occurrence of palsy in a 15-month-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevenar 20) for prophylaxis and HIB vaccine for prophylaxis.   On an unknown date, the patient received Infanrix, Prevenar 20 and HIB vaccine. On an unknown date, an unknown time after receiving Infanrix, the patient experienced palsy (Verbatim: type of palsy had a reaction to the 15 month shots) (serious criteria GSK medically significant). The outcome of the palsy was unknown.   It was unknown if the reporter considered the palsy to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     The company considered the palsy to be unrelated to Infanrix and Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAY-2025 The Inbound warm transfer from agent with Pfizer Medical Information, agent relays she has a medical assistant on the line regarding DTaP (Infanrix) , HiB or Prevnar 20. The reporter stated they had a 15 month old female that had a reaction to the 15 month shots.  They are trying to figure out if it is from the DTaP (Infanrix) , HiB or Prevnar 20 vaccine. The caller stated she has no patient information to provide and was just calling on behalf of the provider for information.  The reporter stated the reaction was like a type of palsy. The child was followed by an allergist and this made the allergist think there was an egg or animal component that could have caused the episode.  The caller was unable to clarify palsy further to include location on body. The reporter stated that  the DTaP they get from GSK and HiB they get from Sanofi and does not know what doses in the series these were. The complainant does not have the product with them at the time of call. It was unknown if the reporter considered the palsy to be related to  HiB or Prevnar 20 vaccine.; Sender's Comments: Paralysis  is an unlisted event which  is considered unrelated to GSK vaccine Infanrix and Infanrix PRE-FILLED SYRINGE DEVICE
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient that went beyond 6 months for the second dose of Shingrix; This non-serious case was reported by a consumer via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine on an unknown date 6 months prior).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient that went beyond 6 months for the second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 07-MAY-2025 A doctor had a patient that went beyond 6 months for the second dose of Shingrix which led to incomplete course of vaccination. He wanted to know if the patient needed to re-start the 2 dose series over or if the patient could just get the second dose even though it was past 6 months.
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: they both made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date, For tolerance to 1st dose, refer case US2025AMR056759).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: they both made me sick). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 06-MAY-2025 This case was reported by a patient via  interactive digital media.  The patient stated they both made them sick. This case is 1 of 2 cases created for both doses.; Sender's Comments:  US-GSK-US2025AMR056759:same patient 1 st dose
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling, Wrong technique in product usage process
Clinical narrative: An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if administer Bexsero in that viscous state patients reports pain in the area, swelling and redness.; swelling; redness; viscous state like honey appearance, if she administer Bexsero in that viscous; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain (Verbatim: An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if administer Bexsero in that viscous state patients reports pain in the area, swelling and redness.), swelling (Verbatim: swelling), erythema (Verbatim: redness) and wrong technique in product usage process (Verbatim: viscous state like honey appearance, if she administer Bexsero in that viscous ). The outcome of the pain, swelling and erythema were unknown and the outcome of the wrong technique in product usage process was not applicable.   It was unknown if the reporter considered the pain, swelling and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain, swelling and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date 01-MAY-2025: On 01/MAY/2025 a Sales representative from GSK contacted MI on behalf of an HCP with issue regarding the air bubble in the Bexsero syringe. They could not expel the air bubble, the HCP lets Bexsero warm up for 10 or 15 minutes when she takes out the vaccine from the fridge before giving to patients because otherwise it has a viscous state like honey appearance, if she administer Bexsero in that viscous state patients reports pain in the area, swelling and redness, so it is easier for them to let warm up the vaccine, this led to wrong technique in product usage process. After contacting the HCP MI letter of the Bexsero Air bubble was shared, and HCP did not mention anything about the viscous state like honey appearance of Bexsero and she did not provide anymore details about this patients who experienced pain, swelling and redness.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Lip pain, Oral discomfort, Oral herpes zoster
Clinical narrative: burning lips; sensitive lips; Suspected Oral herpes zoster/I got a mild casr of shingles; sores around lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of oral herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced oral herpes zoster (Verbatim: Suspected Oral herpes zoster/I got a mild casr of shingles) and sores lip (Verbatim: sores around lips). On 21-APR-2025, the patient experienced burning lips (Verbatim: burning lips) and sensitive lips (Verbatim: sensitive lips). The outcome of the oral herpes zoster was not reported and the outcome of the burning lips, sores lip and sensitive lips were not resolved.   It was unknown if the reporter considered the oral herpes zoster, burning lips, sores lip and sensitive lips to be related to Shingrix.     It was unknown if the company considered the oral herpes zoster, burning lips, sores lip and sensitive lips to be related to Shingrix.   Additional Information: GSK receipt date: 07-MAY-2025 Reporter stated that vaccine she got was the Shingrix, and it was for shingles. And she was having, about 5 days after my vaccination, she had burning on her lips and tiny sores around the outside of her lips. At the time of reporting this was been going on about three weeks. a week after her first dose of Shingrix, lips got very sensitive and burning that was April 21, she initially thought it might be cold sores but still had not healed and it didn't respond to cold sore meds. Reporter asked was it possible that she got a mild case of Shingles from the vaccine.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Several adult patients received pediatric dose of Havrix; Several adult patients received pediatric dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patients received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Several adult patients received pediatric dose of Havrix) and underdose (Verbatim: Several adult patients received pediatric dose of Havrix). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAY-2025 The several adult patients received pediatric dose of Havrix which led to Adult use of a child product and Underdose. Seeking information on vaccination next steps.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of Havrix to a 62 years old female patient; pediatric dose of Havrix to a 62 years old female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 62-year-old female patient who received HAV (Havrix pediatric) (batch number 7PK53, expiry date 20-MAR-2026) for prophylaxis.   Previously administered products included Havrix adult (received 1st dose of Havrix on unknown date).   On 04-JAN-2025, the patient received the 2nd dose of Havrix pediatric. On 04-JAN-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Havrix to a 62 years old female patient) and underdose (Verbatim: pediatric dose of Havrix to a 62 years old female patient). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-MAY-2025 The pharmacist called to report that they administered a pediatric dose of Havrix to a 62 years old female patient, which led to adult use of a child product and underdose. This pediatric dose of Havrix was administered on 4/JAN/2025 and was her second dose of the series.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix 1 year ago).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2025 The pharmacist called to inform that a patient had received only one dose of Havrix one year ago (no exact date available), and hadn't received the 2nd dose yet.  The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting the patients did not receive the second dose of Havrix, which led to incomplete course of vaccination.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 4 days after the suspect product(s) administration, outcome "fatal", described as "Died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500056859 same reporter/product/event, different patient;; Reported Cause(s) of Death: Unknown cause of death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe 2 or 3 year back, this is his second time having COVID; caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe 2 or 3 year back, this is his second time having COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe 2 or 3 year back, this is his second time having COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: first time (2 or 3 years ago); (12May2025) positive, notes: second time. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: This is the second time patient is having Covid and taking Paxlovid. First was about maybe 2 or 3 year back, this is his second time having COVID. Clarified, caller took Covid shots, and did not have Covid before that. This is second time patient had Covid. He believes first time was 2 or 3 years ago. Clarified, this is second time testing positive for Covid. Patient is trying to get Paxlovid, again, today. When clarifying this is first time reporting with Pfizer that, this is second time having Covid and taking Paxlovid, caller states, first time, does not know if he paid for it. Prescription was sent to drug store, has to go pick it up. When clarifying when patient tested positive for Covid this second time, he states, was at work Friday, came home with this bad runny nose, thought was just allergy. Then, today, went to work, asked to he if could take Covid test, sure enough, wound up having Covid.  Clarified that on 12May2025 was the day he tested positive again for Covid. That is why he is calling, so he can go pick up the Paxlovid. First dose was 22Jan2021, Second Dose was 18Feb2021 and  another dose was 02Dec2021.When providing date of last dose, 20Jun2021 (pending clarification), he states, that can't be right but, that is what is printed on card.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menopause
Clinical narrative: full menopause; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 04Mar2021 as dose 01, single (Lot number: ENQ205) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Perimenopause" (unspecified if ongoing), notes: only about 6 months or so. Concomitant medication(s) included: ZOLOFT. The following information was reported: MENOPAUSE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "full menopause". Therapeutic measures were not taken as a result of menopause.  Additional Information: The patient was newly in perimenopause, only about 6 months or so. Once she had the vaccine, she was in full menopause. This was diagnosed by an obgyn. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had no known allergies.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches; tired, fatigue; This is a spontaneous report received from an Other HCP.  A 43-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "tired, fatigue".  Additional information: Headaches, tired, fatigue; might be leftover from Covid but it might be the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 2 hrs after the suspect product(s) administration, outcome "fatal", described as "died". The date and cause of death for the patient were unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500099417 same reporter/product/event, different patient;; Reported Cause(s) of Death: Unknown cause of death
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache; Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: VARZOS
Symptoms: Product complaint, Product packaging quantity issue, Underdose
Clinical narrative: diluent to contain only 0.4 ml; reconstitute two of the vaccines in the box with the same results; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7zm55, expiry date 15-NOV-2026) and (batch number 555hwztvaa) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: diluent to contain only 0.4 ml), product packaging quantity issue (Verbatim: reconstitute two of the vaccines in the box with the same results) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the incomplete dose administered, product packaging quantity issue and pharmaceutical product complaint were not applicable.   Additional Information: GSK Receipt Date: 04-MAY-2025 The pharmacist reported that while reconstituting Shingrix vaccine, he/she found the diluent to contain only 0.4 ml which would not yield the 0.5 ml dose for the final vaccine which led to incomplete dose of vaccine administered and product packaging quantity issue. The pharmacist tried to reconstitute two of the vaccines in the box with the same results. The Medical Information team is submitting to safety out of abundant caution.  As this potential product quality complaint (PQC) was noted during reconstitution of two doses within this box, this is being submitted as a potential near miss event.  Even though the pharmacist does not provide patient details or state that the doses were administered, as the vaccine was being reconstituted, it is assumed there was a patients involved.
Age: 53.0
Sex: F
Vaccine: HEP, PNC15, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse events, patient dose invalid for varicella due to having MMR within the last 2 weeks
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: L thigh is red and swollen at injection site.  Also has been fussy and febrile.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Patient administered expired vaccine (lot# W026977; exp 1/4/2025; administered 2/15/2025)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Urticaria, Weight bearing difficulty
Clinical narrative: The vaccine record from pharmacy incorrectly states that the injection was given in my left arm. I objected to that since I am left-handed and he gave me the vaccine in my right arm but obviously never changed the record. I was prepared for my arm to be sore. The next day and for many days after the muscle at the injection site felt like a shard of hot glass had been inserted into it. I could not put any wait on it for months. Now, my arm still hurts at the injection site, not as bad as at first but it is still there and I now have this weird welt on my back on the same side connection to the muscle at the injection site. Also, I have crippling fatigue.
Age: 83.0
Sex: M
Vaccine: COVID19, HEPAB
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Patient presented to pharmacy 05/14/25 to reports itching on back, leg and both hands and has blisters in the webbing of his left and right hands. He reports this began approximately 2 days after receiving the Hepatitis vaccine on 04/25/25. He states that another blister appeared on the outer side of his hand two days ago. He currently has a large, oval-shaped red spot on his left forearm which he states is itchy.
Age: 88.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Mobility decreased
Clinical narrative: PER  PATIENT REPORTED WEAKNESS 10/8, (CLINIC ON 10/3). DECEMBER PT DIAG WITH GUILLAIN BARRE SYNDROME, MOBILITY LOSS
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Out break cold sores on face under eye, nose and lips . Putting abreva cream on them
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eructation, Fatigue, Headache, Nausea
Clinical narrative: 05/12/2025:  Consent form signed by Pt. VIS form provided to Pt. Pt denied having Guillain-Barre Syndrome, allergy to egg components, and previous allergic reaction to flu shot or any vaccine. Pt in stable condition with no visible signs of nervousness/anxiety. Flu shot administered to Pt. Pt tolerated well. After about 20 minutes of Pt waiting in the waiting room, Pt started to experience nausea, unexplainable burping urges. lightheadedness, mild headache, "medicine-taste" in mouth, and warmth to bilateral ears. Water and emesis bag provided to Pt. Vitals signs taken. Pt's blood pressure was 150/95 at 1610. PA-C, consulted throughout visit and advised for Pt to be monitored for improvement. After about 50 minutes of monitoring, Pt's symptoms improved and Pt reported feeling "better" with only tiredness and mild headache remaining. Last blood pressure taken at 1659 was 128/82. Pt was wheeled out to personal car. Pt's mother present throughout this visit and available to drive Pt home. Pt left clinic in stable condition. Advised Pt to seek immediate medical attention, if she experiences any of the following symptoms: - Allergic Reaction Sx (Facial Swelling, Rash, SOB, loss of consciousness, etc) - Chest Pain/Pressure - Sudden Numbness/Weakness - Trouble Speaking/Understanding Speech - Severe Headache - Confusion - Loss of Vision, Mainly in One Eye and/or Facial Drooping - Trouble or Change in Ability to Walk  Vital Signs day of adverse event: 05/12/25 16:10 - T: 98.3 F HR: 92 BP: 150/95 SPO2: 98% 05/12/25 16:15 - HR: 90 BP: 150/92 SPO2: 98% 05/12/25 16:24 - T: 98.4 F BP: 145/91 SPO2: 98% 05/12/25 16:41 - BP: 134/91 05/12/25 16:59 - T: 98.6 F HR: 91 BP: 128/82 SPO2: 96%                                                                                                                                                                                                                                                                                                                       05/13/2025 @ 1510 Spoke with Pt. Pt states "feeling better" from yesterday's episode. She reports feeling tired and a mild headache. Advised Pt to seek immediate medical attention, if she experiences any of the following symptoms: - Allergic Reaction Sx (Facial Swelling, Rash, SOB, loss of consciousness, etc) - Chest Pain/Pressure - Sudden Numbness/Weakness - Trouble Speaking/Understanding Speech - Severe Headache - Confusion - Loss of Vision, Mainly in One Eye and/or Facial Drooping - Trouble or Change in Ability to Walk
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Product after taste, Skin warm
Clinical narrative: 05/12/2025:  Consent form signed by Pt. VIS form provided to Pt. Pt denied having Guillain-Barre Syndrome, allergy to egg components, and previous allergic reaction to flu shot or any vaccine. Pt in stable condition with no visible signs of nervousness/anxiety. Flu shot administered to Pt. Pt tolerated well. After about 20 minutes of Pt waiting in the waiting room, Pt started to experience nausea, unexplainable burping urges. lightheadedness, mild headache, "medicine-taste" in mouth, and warmth to bilateral ears. Water and emesis bag provided to Pt. Vitals signs taken. Pt's blood pressure was 150/95 at 1610. PA-C, consulted throughout visit and advised for Pt to be monitored for improvement. After about 50 minutes of monitoring, Pt's symptoms improved and Pt reported feeling "better" with only tiredness and mild headache remaining. Last blood pressure taken at 1659 was 128/82. Pt was wheeled out to personal car. Pt's mother present throughout this visit and available to drive Pt home. Pt left clinic in stable condition. Advised Pt to seek immediate medical attention, if she experiences any of the following symptoms: - Allergic Reaction Sx (Facial Swelling, Rash, SOB, loss of consciousness, etc) - Chest Pain/Pressure - Sudden Numbness/Weakness - Trouble Speaking/Understanding Speech - Severe Headache - Confusion - Loss of Vision, Mainly in One Eye and/or Facial Drooping - Trouble or Change in Ability to Walk  Vital Signs day of adverse event: 05/12/25 16:10 - T: 98.3 F HR: 92 BP: 150/95 SPO2: 98% 05/12/25 16:15 - HR: 90 BP: 150/92 SPO2: 98% 05/12/25 16:24 - T: 98.4 F BP: 145/91 SPO2: 98% 05/12/25 16:41 - BP: 134/91 05/12/25 16:59 - T: 98.6 F HR: 91 BP: 128/82 SPO2: 96%                                                                                                                                                                                                                                                                                                                       05/13/2025 @ 1510 Spoke with Pt. Pt states "feeling better" from yesterday's episode. She reports feeling tired and a mild headache. Advised Pt to seek immediate medical attention, if she experiences any of the following symptoms: - Allergic Reaction Sx (Facial Swelling, Rash, SOB, loss of consciousness, etc) - Chest Pain/Pressure - Sudden Numbness/Weakness - Trouble Speaking/Understanding Speech - Severe Headache - Confusion - Loss of Vision, Mainly in One Eye and/or Facial Drooping - Trouble or Change in Ability to Walk
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: THE PATIENT CAME IN FOR A COVID-19 BOOSTER. IT WAS INITIALLY NOTED THAT HER LAST SHOT WAS ON 9/23/25, SO A BOOSTER WAS IN ORDER  ACCORDING TO THE GUIDE LINES ( TW MONTHS OR MORE FROM HER LAST SHOT IN THE FALL. LATER WHEN  THE PATIENT GOT HOME ( ABOUT HALF HOUR AFTER SHE LEFT PHARMACY ( 12;30PM) ), HER DAUGHTER NOTICED THAT THE IMMUNIZATION REGISTRY SHOWED A DATE OF 4/1/25 AS HER LAST COVID-19 SHOT. THE PATIENT OR HER DAUGHTER DO NOT REMEMBER A VACCINE  BEING GIVEN ON 4/1/25. NO ADVERSE EVENT REPORTED AT THIS TIME, BUT THE PATIENT MAY HAVE GOTTEN A BOOSTER TOO SOON.
Age: 63.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: PATIENT REPORTS HAVING INJECTION SITE PAIN AND REDNESS THAT RADIATED DOWN LEFT ARM TO RIGHT ABOVE THE ELBOW. REPORTED PAIN WAS COMBINED WITH TINGLING SENSATION AND STATES SHE WAS UNABLE TO LIE DOWN ON THAT SIDE. PATIENT STATES IT TOOK 1-2 WEEKS FOR THE REDNESS AND PAIN TO GO AWAY, THOUGH SHE STILL REPORTS HAVING THE TINGLING SENSATION AND CANNOT LIE DOWN ON THAT SIDE.  PATIENT STATED SHE USED OVER THE COUNTER PAIN MEDICINE TO HELP WITH PAIN.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Blood test, Colonoscopy, Diarrhoea, Haematemesis, Haematochezia
Clinical narrative: Received vaccine at 2 month old checkup and was told she was completely healthy. Next day, symptoms of projectile vomiting, spent 3 days in pediatric hospital. Went home, started severe diarrhea, brought back to doctor and realized the baby had a 20% weight loss. Was admitted back to hospital and spent 3 weeks there. While at hospital the baby had ulcers in colon, bloody stool and bloody vomit.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Large intestinal ulcer, Vomiting projectile, Weight decreased
Clinical narrative: Received vaccine at 2 month old checkup and was told she was completely healthy. Next day, symptoms of projectile vomiting, spent 3 days in pediatric hospital. Went home, started severe diarrhea, brought back to doctor and realized the baby had a 20% weight loss. Was admitted back to hospital and spent 3 weeks there. While at hospital the baby had ulcers in colon, bloody stool and bloody vomit.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Erythema, Eye pruritus, Rash
Clinical narrative: Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness, swelling  and reported itching of the eyes. Administered intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl) by mouth. The rash and facial redness resolved shortly after treatment. The patient was observed for an additional 30 minutes without further incidents. The mother and son went to emergency room where they were observed for an additional 4 hours without incident. Followed up with PCM on 15 APR with complete resolution of symptoms.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Erythema, Eye pruritus, Rash, Swelling face
Clinical narrative: Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness, swelling  and reported itching of the eyes. Administered intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl) by mouth. The rash and facial redness resolved shortly after treatment. The patient was observed for an additional 30 minutes without further incidents. The mother and son went to emergency room where they were observed for an additional 4 hours without incident. Followed up with PCM on 15 APR with complete resolution of symptoms.