chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This serious case was reported by a consumer via call center representative and described the occurrence of facial paralysis in a 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 facial paralysis (Verbatim: Facial paralysis) (serious criteria GSK medically significant). The outcome of the facial paralysis was unknown.   It was unknown if the reporter considered the facial paralysis to be related to Shingrix.     The company considered the facial paralysis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-JUN-2025 The patient's friend reported this case The patient experienced facial paralysis after receiving the Shingrix injection.; Sender's Comments: Facial paralysis is a listed event which is considered related to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Ehlers-Danlos syndrome, Erythema, Feeling hot, Pain in extremity
Clinical narrative: Painful arm; large red; hot; swollen; weakness; Ehlers-Danlos syndrome; This non-serious case was reported by a consumer and described the occurrence of Ehlers Danlos syndrome in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 06-JUN-2025, the patient received the 2nd dose of Shingrix. On 07-JUN-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: Painful arm), erythema (Verbatim: large red), feeling hot (Verbatim: hot), swelling (Verbatim: swollen) and weakness (Verbatim: weakness). In JUN-2025, the patient experienced Ehlers Danlos syndrome (Verbatim: Ehlers-Danlos syndrome). The outcome of the Ehlers Danlos syndrome was not reported and the outcome of the pain in arm, erythema, feeling hot, swelling and weakness were not resolved.   It was unknown if the reporter considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix.     It was unknown if the company considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2025 Reporter stated that patient received second dose of Shingrix and had painful arm. Also stated patient had large red, hot, swollen and weakness. Patient had Ehlers-Danlos syndrome.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Painful arm; large red; hot; swollen; weakness; Ehlers-Danlos syndrome; This non-serious case was reported by a consumer and described the occurrence of Ehlers Danlos syndrome in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 06-JUN-2025, the patient received the 2nd dose of Shingrix. On 07-JUN-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: Painful arm), erythema (Verbatim: large red), feeling hot (Verbatim: hot), swelling (Verbatim: swollen) and weakness (Verbatim: weakness). In JUN-2025, the patient experienced Ehlers Danlos syndrome (Verbatim: Ehlers-Danlos syndrome). The outcome of the Ehlers Danlos syndrome was not reported and the outcome of the pain in arm, erythema, feeling hot, swelling and weakness were not resolved.   It was unknown if the reporter considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix.     It was unknown if the company considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2025 Reporter stated that patient received second dose of Shingrix and had painful arm. Also stated patient had large red, hot, swollen and weakness. Patient had Ehlers-Danlos syndrome.
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate decreased, Pain
Clinical narrative: Low heart rate; General aches and pains; This non-serious case was reported by a consumer via sales rep and described the occurrence of heart rate low in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart disease, unspecified (had heart disease).   On an unknown date, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, 36 hrs after receiving Shingrix, the patient experienced heart rate low (Verbatim: Low heart rate) and general body pain (Verbatim: General aches and pains). The outcome of the heart rate low was resolved and the outcome of the general body pain was not reported.   The reporter considered the heart rate low to be related to Shingrix. It was unknown if the reporter considered the general body pain to be related to Shingrix.     The company considered the heart rate low to be related to Shingrix. It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2025 A female patient had general aches and pains, low heart rate approximately 36 hours post vaccination. As per the reports, patient had a previous history of heart disease
Vaccine: TDAP, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administration of adacel outside of the recommended interval with no reported adverse event;  This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of interchange of vaccine products in a 52-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) (batch number U8122AA, expiry date 30-APR-2026) for prophylaxis.   On 06-MAR-2025, the patient received Boostrix. On 29-APR-2025, the patient received Adacel (intramuscular use, right arm) .5 ml. On an unknown date, an unknown time after receiving Boostrix, the patient experienced interchange of vaccine products (Verbatim: administration of adacel outside of the recommended interval with no reported adverse event). The outcome of the interchange of vaccine products 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: 02-JUN-2025 The reporter reported that, the patient received an unknown dose (0.5 ml) of adacel via intramuscular route in the right arm for immunization and then, the patient received an unknown dose of Boostrix vaccine which led to interchange of vaccine products.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Sleep disorder, Vaccination failure
Clinical narrative: suspected vaccination failure; I developed shingles again all across my back and now it is locating down my left buttock; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had shingles twice).   In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received the 1st dose of Shingrix. In MAY-2025, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I developed shingles again all across my back and now it is locating down my left buttock). The patient was treated with valaciclovir (Valacyclovir). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 09-JUN-2025 The patient reported that he was going to be 72 years old this August. He/she had received the two Shingrix vaccines because he/she had shingles twice before. About one month ago, he/she developed shingles again, across his/her back, and then it spread down his/her left buttock. It was extremely painful, more than his/her previous two incidents of shingles. His/her physician prescribed Valacyclovir, and he/she was taking that. His/her question was whether it would be recommended to get another booster dose of the Shingrix vaccine. This episode was so painful that he/she could hardly sleep, much worse than the previous ones. This case was considered as suspected vaccination failure since the details regarding 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HEPAB, MENB, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HAB (Twinrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Twinrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Twinrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: product Storage Error). The outcome of the incorrect storage of drug 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: 05-JUN-2025 The Other Health Professional requested stability data for the following vaccines Bexsero, Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Twinrix, Engerix-B, and Rotarix (liquid formulation) that had been stored at 9.6 degree Celsius for 30 minutes which led to, incorrect storage of drug. There had been no prior temperature excursions. Patient involvement was suspected, as the excursion had occurred on Monday, June 2, 2025. The number of patients affected, and the number of vaccines administered remained unknown.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Liver function test abnormal
Clinical narrative: Possible Twinrix second dose administration out of the recommended time interval; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 04-JUN-2025, the patient received the 2nd dose of Twinrix. On 04-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Possible Twinrix second dose administration out of the recommended time interval). The outcome of the drug dose administration interval too long 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: 05-JUN-2025 The patient called to asked if it was okay that she "went up high, from the bottom line to almost the top" in a certain liver test (she couldn't recall which specific measurement) after receiving Twinrix as a second dose. Although she mentioned that she was "feeling okay." The patient received 2nd dose of Twinrix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidentally administered a pediatric dose of Engerix-B to an adult patient; accidentally administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 37-year-old female patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis.   On 02-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 02-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult patient) and accidental underdose (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult patient). The outcome of the adult use of a child product and accidental 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: 06-JUN-2025 Registered Nurse called to report that they accidentally administered a pediatric dose of Engerix-B to an adult female patient (37 years old), which led to adult use of a child product and accidental underdose.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: one of the patients did not receive the full vaccination; one of the patients did not receive the full vaccination; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication (Verbatim: one of the patients did not receive the full vaccination) and inappropriate dose of vaccine administered (Verbatim: one of the patients did not receive the full vaccination). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 05-JUN-2025 and 06-JUN-2025 The reporter had a customer one day before the reporting date who informed that their patient did not receive both components of the Shingrix vaccine. The back office coordinator called and they had identified 7 patients that were given the Shingrix vaccination, however they discovered that their component vials did not match, so then they determined that one of the 7 patients only received the adjuvant part of Shingrix, so they did not know which patient received just the adjuvant, it was misadministered, which led to inappropriate preparation of medication and  inappropriate dose of vaccine administered. Honestly, he did not tell that which, he/she was assuming it was the adjuvant part, he did not tell which vial, let's just say one of the patients did not receive the full vaccination, they only received 1 vial. The reporter did not do any of the patient's information, did know that this was all of their first shots in the series. Field representative did not have lot number or expiration date of the vaccines, but she mentioned: the back office coordinator would know that. Caller did not know either date of administration for any of the 7 patients.  Field representative gave vaccine service center phone number to the healthcare provider, but they do not know if the healthcare provider already called.  Field representative mentioned that the healthcare provider requested for protocols for the 7 patients, but for that the representative did a medical query already, so they covered, and no medical information case was open during this call; the caller was only contacting us today to report the adverse event to Safety Team.  Field representative gave consent from her side to follow up with Safety Team, but she also mentioned that she does not have further details.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1 dose of Shingrix and not the full series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th December 2021).   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: received 1 dose of Shingrix and not the full series). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 06-JUN-2025 Pharmacist reported that a male patient that received 1 dose of Shingrix on 20th December 2021 (not the full series) and he had now a prescription for a Shingrix shot which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient did not receive both components of the Shingrix vaccine; patient did not receive both components of the Shingrix vaccine; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: patient did not receive both components of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: patient did not receive both components of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 06-JUN-2025 Reporter asked about the protocol if patient did not receive both components of the Shingrix vaccine during their first dose in the series, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: BEXSERO was exposed to 5 excursions in 2024 and 2025  (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient 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 incorrect storage of drug (Verbatim: BEXSERO was exposed to 5 excursions in 2024 and 2025  (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions.). The outcome of the incorrect storage of drug 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: 06-JUN-2025 Medical assistant  reported that Bexsero was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76 celsius and they were above range for 1 hour and 15 minutes in total 75 minutes.  No other excursions.  The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments:  US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: FLULAVAL was exposed to 5 excursions in 2024 and 2025  (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: FLULAVAL was exposed to 5 excursions in 2024 and 2025  (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions). The outcome of the incorrect storage of drug 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: 06-JUN-2025 MA reports that Flulaval was exposed to 5 excursions in 2024 and 2025  (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions. The majority of all vaccines reported were administered to patients.; Sender's Comments:  US-GSK-US2025071800:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect GSK-US2025071801:Same reporter, Different suspect
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: kinrix was exposed to 5 excursions in 2024 and 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: kinrix was exposed to 5 excursions in 2024 and 2025). The outcome of the incorrect storage of drug 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: 06-JUN-2025 Medical assistant reported that kinrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76 celsius and they were above range for 1 hour and 15 minutes in total 75 minutes.  No other excursions.  The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments:  GSK-US2025071804:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect
Vaccine: RVX
Symptoms: Product storage error
Clinical narrative: Rotarix was exposed to 5 excursions in 2024 and 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: Rotarix was exposed to 5 excursions in 2024 and 2025). The outcome of the incorrect storage of drug 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: 06-JUN-2025 Medical assistant reported that Rotarix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024).  Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes).  No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call.  This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a patient was given another dose of AREXVY vaccine today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 06-JUN-2025, the patient received the 2nd dose of Arexvy. On 06-JUN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient was given another dose of AREXVY vaccine today). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 06-JUN-2025 Licensed Practical Nurse called to report a patient was given another dose of Arexvy vaccine today, which led to Extra dose administered. First dose was administered 21-03-2025. Licensed practical nurse wanted to know if there as any safety concern or guidance about this situation.  No further information was obtained in this call. The reporter was consented to follow up.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: didn't respond to the vaccine; This non-serious case was reported by a consumer via sales rep and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B adult, the 2nd dose of Engerix B adult and the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, Engerix B adult and Engerix B adult, the patient experienced therapy non-responder (Verbatim: didn't respond to the vaccine). The outcome of the therapy non-responder 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: 06-JUN-2025 The reporter would like to know the rate of non-responsiveness to hepatitis b vaccine. He himself said he did not respond to the vaccine. For more information, please contact the field agent, the vaccine administration facility was the same as primary reporter.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-month-old female patient who received HBV (Engerix B) (batch number 4D333, expiry date 14-AUG-2026) for prophylaxis.   On 19-MAY-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025). The outcome of the incorrect storage of drug 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: 11-JUN-2025 Nurse requested stability data for Havrix, Kinrix, Boostrix, Infanrix, Engerix-B stored at 18.8 Celsius for 9 hours 20 minutes on 17th May 2025 which led to incorrect storage of drug. Excursion caught when doing monthly quality check.  No prior excursions.  Engerix-B had been used in patients.
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix 720) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis.   On 10-JUN-2025, the patient received Havrix 720. On 10-JUN-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used 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:11-JUN-2025 The registered nurse reported that yesterday a patient received an expired dose of Havrix vaccine, which led to expired vaccine used
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix in April 2022 and did not complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in APR 2022, batch no 3527M, expiry date 03-JUN-2023).   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: received Shingrix in April 2022 and did not complete the series). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-JUN-2025 The pharmacist reported that the patient received 1st dose of Shingrix and asked do we need now to restart the series or can she get the second dose 3 years later. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Thrombosis
Clinical narrative: blood clots in both legs and passed away on Sept 18, 2024; following a fall on April 12, 2024/passed away on Sept 18, 2024; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in both legs and passed away on Sept 18, 2024) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Apr-2024,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FALL (following a fall on April 12, 2024/passed away on Sept 18, 2024). On an unknown date, the patient experienced THROMBOSIS (blood clots in both legs and passed away on Sept 18, 2024) (seriousness criteria death and medically significant). The patient died on 18-Sep-2024. The reported cause of death was blood clots in both legs. An autopsy was not performed. At the time of death, FALL (following a fall on April 12, 2024/passed away on Sept 18, 2024) outcome was unknown.            No concomitant medications were reported.  No autopsy was done, but nursing home staff suggested a possible link to the vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.; Reporter's Comments: Company comment: Event fall was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Blood clots in both legs
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did not even get Covid for 5 years/my husband gets it; did not even get Covid for 5 years/my husband gets it; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not even get Covid for 5 years/my husband gets it". The clinical course was reported as follows: The reporter said that they always had gotten their vaccines through Pfizer, and their boosters. They did not even get Covid for 5 years, when everybody around them got it, and finally, her husband gets it.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Injection site oedema
Clinical narrative: NOTED TO HAVE ERYTHEMIC AREA AT INJECTION SITE SLIGHT EDEMA
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did not work; did not work; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not work". Clinical course: The COVID vaccine that media and politicians claimed was effective did not work.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Right thigh redness and tenderness for 1 week after reaction. Redness getting as big as 10 inches in diameter per pt's guardian
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: pt was given an adult dose of hep b and should have received a peds dose.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received the Hib vaccine on 5/20/2025; however, it was administered with sterile water instead of the manufacturer-supplied diluent. The vaccine was given by a Medical Assistant in the office. The error was disclosed to the parents on 6/11/2025 by Dr. The parent did not report any symptoms or adverse reactions.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash papular
Clinical narrative: Raised red rash on his left leg that hurts when you touch it- it was about a half dollar size of redness yesterday 6/12/25 evening. No other symptoms.  Dr. recommended to apply cold compress and give benadryl 9mL if redness continues and to f/u tomorrow if redness worsens by afternoon.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient complains of left upper arm pain since vaccination.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Given on 2/05/25 was stored in the freezer, we didn't know it was suppose to store in fridge recieved on 9/18/24 , patient did not experience any signs or symptoms of adverse event was not seen again until 5/12/25
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Blood gases normal, Brief resolved unexplained event, Cyanosis, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: After vaccines infant was very sleepy, felt warm but no temperature measured, and on 6/1/25 around 6 pm infant while feeding on a bottle infant had an episode of generalized body shaking, eyes rolling back, perioral cyanosis and bilateral hand cyanosis that lasted for about 3 minutes under the care of an aunt. After possible seizure infant returned back to her baseline. On 6/2/25 mother took infant for an evaluation at Hospital and infant was admitted for work up and evaluation overnight 6/2/25 to 6/3/25.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Electroencephalogram normal, Eye movement disorder, Skin warm, Somnolence, Tremor
Clinical narrative: After vaccines infant was very sleepy, felt warm but no temperature measured, and on 6/1/25 around 6 pm infant while feeding on a bottle infant had an episode of generalized body shaking, eyes rolling back, perioral cyanosis and bilateral hand cyanosis that lasted for about 3 minutes under the care of an aunt. After possible seizure infant returned back to her baseline. On 6/2/25 mother took infant for an evaluation at Hospital and infant was admitted for work up and evaluation overnight 6/2/25 to 6/3/25.
Age: 28.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Pain, Sleep disorder
Clinical narrative: Patient stated deep joint pain.  Pain is achy and hurts to sleep.  Patient stated he is able to articulate arm, but experiences pain when them arm is raised above his paid.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient began experiencing pain in left shoulder/arm about 1 week after receiving the vaccine.  He reported this to the pharmacy 37 days after the vaccine was administered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Disturbance in attention, Dyspnoea, Exercise tolerance decreased, Nasopharyngitis
Clinical narrative: The evening of the vaccination, my vision was dull and I couldn?t focus mentally on anything like conversations or anything else. My heart was pounding and my family decided that I should go to bed and rest from the shot, which is what I did. The next day I felt somewhat better, with just cold-like symptoms, but also the flutters and pounding in my heart. For the next few weeks whenever I would experience any stress, such as making the tiniest decision about what to eat, I would get heart palpitations. This lasted for quite a long time and during this time I was more winded doing any exercise type of tasks.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Visual impairment
Clinical narrative: The evening of the vaccination, my vision was dull and I couldn?t focus mentally on anything like conversations or anything else. My heart was pounding and my family decided that I should go to bed and rest from the shot, which is what I did. The next day I felt somewhat better, with just cold-like symptoms, but also the flutters and pounding in my heart. For the next few weeks whenever I would experience any stress, such as making the tiniest decision about what to eat, I would get heart palpitations. This lasted for quite a long time and during this time I was more winded doing any exercise type of tasks.
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt. received HIB instead of Menveo. No signs or symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine expiring on 6/7/25 administered on 6/12/25.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site rash, Rash
Clinical narrative: rash on the injection site, right vastus lateralis and on the face which was fading
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dyspnoea, Syncope, Tachycardia, Tremor
Clinical narrative: tachycardia rate 160, chills, shaking, shortness of breath, syncope x 1. symptoms lasted 3 days slowly resolved over time.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient presented with a hot, red and tender area on arm. Affected area was approx 3 inches down her arm. Patient's husband is a physician who treated the area with a warm compress and benadryl.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Swelling face
Clinical narrative: Left facial swelling and soreness.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Condition aggravated, Dyspnoea, Oropharyngeal pain
Clinical narrative: 9am-employee received 1st dose of Heplisav.  11:15am-front staff came to my office informing me that the person was having an allergic reaction and that she was standing outside.  I went outside and asked her how she was feeling.  Client was found outside on the stairwell in no apparent distress. She stated that she felt short of breath and that her throat hurt. Explained that most allergic reactions happen within 30 minutes of receiving the vaccine but could be later.   She stated that her symptoms had been going on for about an hour.  She informed me that she had used her inhaler for asthma and was trying not to be anxious about it.  Client was outside near her car because she was going to go to the Emergency room.  Hospital was within 2 miles of employment.  She wanted to drive herself to the Emergency Room and get checked out.  Client still appeared in no apparent distress and left to go to the Emergency Room.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Child was accidentally given MMR with MMRV on same day , parents were informed and DOH was consulted
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Child's mother emailed on 6/13/25 with concerns about child having pain in her arm when she moves and sleeps. Mother was advised to take child to primary care provider for evaluation.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, C-reactive protein, Joint swelling, Laboratory test, Mobility decreased
Clinical narrative: 5/15/25 significant swelling and aching p ain in joints limiting mobility. location of pain varied from knee, fingers, wrist, etc. after MMR vaccination
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: 5/15/25 significant swelling and aching p ain in joints limiting mobility. location of pain varied from knee, fingers, wrist, etc. after MMR vaccination
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC20
Symptoms: Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: one day after vaccines (5/15/2025), had "facial" rash with eyes swollen. no breathing issues or difficulty swallowing noted. symptoms resolved on its own within 3 days. No treatment and did not seek medical intervention.  Left deltoid  with redness, swelling, and "knot" at injection site. on 6/13/2025, mom states left deltoid discoloration improved but knot still present.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC20
Symptoms: Rash
Clinical narrative: one day after vaccines (5/15/2025), had "facial" rash with eyes swollen. no breathing issues or difficulty swallowing noted. symptoms resolved on its own within 3 days. No treatment and did not seek medical intervention.  Left deltoid  with redness, swelling, and "knot" at injection site. on 6/13/2025, mom states left deltoid discoloration improved but knot still present.