chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: It's Been Over  A month , Do I Need to Restart The Series; Initial report received on 29-Jan-2025.    A pharmacist reported that a female (age, race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose after more than one month.   No medical history or concomitant medications were reported.   On 01-Sep-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot #, expiration date, NDC # 43528-002-05, route, and site not available). At the time of reporting, more than one month after receiving the first dose, the patient had not received the next dose.    No additional information was reported.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had both shingle vaccines and still got 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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: I had both shingle vaccines and still got shingles). The outcome of the vaccination failure and shingles were not reported.   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-JAN-2025 The patient had  both shingle vaccines and still got shingles.  Very painful feels like rubbing crushed glass on your skin.  This case was considered as suspected vaccination failure since the details regarding 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 vaccine Shingles vaccine (1st dose )and Shingles vaccine(2nd dose).
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose; adult patient was administered a pediatric dose of the Engerix-B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis.   On 14-JAN-2025, the patient received Engerix B pediatric. On 14-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose) and adult use of a child product (Verbatim: adult patient was administered a pediatric dose of the Engerix-B vaccine). The outcome of the accidental underdose and adult use of a child product were unknown.   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: 14-JAN-2025 The reporter called to report an adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose, which led to an adult use of a child product and accidental underdose. Reporter asked about to advise whether to give another pediatric dose (and when) or when to administer an adult Engerix-B dose. The vaccine administration facility was the same as primary reporter.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo to a pair of twins, and the dosage was 0.5. But it had expired 31-Dec-2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis.   On 31-JAN-2025, the patient received Menveo .5 ml. On 31-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo to a pair of twins, and the dosage was 0.5. But it had expired 31-Dec-2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2025 The registered nurse reported they had a medical assistant that administered Menveo to a pair of twins (patients), but it had expired, which led to an expired vaccine used.  The reporter wanted to know what to do about this situation. The vaccine administration facility was the same as primary reporter. This case was linked with US2025013442, reported by the same reporter for different patient (second twin).; Sender's Comments:  US-GSK-US2025013442:twin patients with same initials
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered today an expired Kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 31-JAN-2025, the patient received Kinrix (left arm). On 31-JAN-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered today an expired Kinrix vaccine). The outcome of the expired vaccine used was unknown.   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: 31-JAN-2025 The reporter reported that a patient received today (on the day of reporting) an expired Kinrix vaccine which led to an expired vaccine used. The injection was administered in the left arm. No additional event was reported.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood creatinine, Eosinophil count
Clinical narrative: developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome was polymyalgia rheumatica. it got super extreme after the second shot to point of me going to the urgent care. was on a cane for 3 weeks before going to urgent care. will be fighting PMR for years til remission.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Immature granulocyte count, Lymphocyte count
Clinical narrative: developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome was polymyalgia rheumatica. it got super extreme after the second shot to point of me going to the urgent care. was on a cane for 3 weeks before going to urgent care. will be fighting PMR for years til remission.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Myalgia
Clinical narrative: developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome was polymyalgia rheumatica. it got super extreme after the second shot to point of me going to the urgent care. was on a cane for 3 weeks before going to urgent care. will be fighting PMR for years til remission.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neutrophil count, Platelet count, Polymyalgia rheumatica, Red blood cell count, Red blood cell nucleated morphology
Clinical narrative: developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome was polymyalgia rheumatica. it got super extreme after the second shot to point of me going to the urgent care. was on a cane for 3 weeks before going to urgent care. will be fighting PMR for years til remission.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red cell distribution width, Walking aid user, White blood cell count
Clinical narrative: developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome was polymyalgia rheumatica. it got super extreme after the second shot to point of me going to the urgent care. was on a cane for 3 weeks before going to urgent care. will be fighting PMR for years til remission.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A half of the adult dosage of Hepatitis A was administered to 16 year old; This non-serious case was reported by a consumer via patient support programs and described the occurrence of adult product administered to child in a 16-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult .5 ml. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: A half of the adult dosage of Hepatitis A was administered to 16 year old). The outcome of the adult product administered to child was unknown.   Additional Information: GSK Receipt Date: 08-JAN-2025 A half of the adult dosage of Hepatitis A was administered to 16 year old, which led to adult product administered to child.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivers; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient had Shingles several years ago).   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 shivers (Verbatim: shivers). The outcome of the shivers was not reported.   It was unknown if the reporter considered the shivers to be related to Shingrix.     It was unknown if the company considered the shivers to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JAN-2025 This case was reported by a patient via interactive digital media. Patient had shingles several years ago and then got the shot to prevent them.  Patient had the first shot to prevent shingles and had the shivers and asked if they should still get the Second shot.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: not received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccination in October 2022).   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: not received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-JAN-2025 Patient he got his 1st dose of Shingrix in October 2022 but has not received the 2nd dose. The patient inquired if he can get the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: she never came back for the 3rd dose; 2nd on 19July2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix (received 1st dose of Engerix on 12th July 2022).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On 19-JUL-2023, the patient received the 2nd dose of Engerix B. On 19-JUL-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd on 19July2023). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: she never came back for the 3rd dose). The outcome of the incomplete course of vaccination and drug dose administration interval too long were unknown.   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: 10-JAN-2025 The reporter reported that a patient received the 1st and 2nd dose of Engerix-B in year 2023.  She never came back for the 3rd dose.  And now, she was on dialysis and Engerix-B dose in adult formulation was 1 ml given in 0, 1 and 6 months but adult dialysis patient got 2 ml and doing 4 times.  She did received 1 ml twice in year 2023, she never completed the 3rd dose. The 1st dose was received on 12th July 2022 and 2nd dose was received on 19th July 2023, which led to Drug dose administration interval too long. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 65 year-old female patient received Engerix-B pediatric dose; 65 year-old female patient received Engerix-B pediatric dose by mistake; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 65-year-old female patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   On 13-JAN-2025, the patient received the 1st dose of Engerix B pediatric. On 13-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 65 year-old female patient received Engerix-B pediatric dose) and accidental underdose (Verbatim: 65 year-old female patient received Engerix-B pediatric dose by mistake). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 13-JAN-2025 The patient received Engerix-B pediatric dose by mistake as a possible first dose in the series, which led to adult use of a child product and accidental underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; has had shingles; 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.   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 vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has had shingles). The outcome of the vaccination failure and shingles were not reported.   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: 29-JAN-2025 This case was reported by the patient via interactive digital media. The patient said that she was vaccinated and has had shingles.  Reporter believed the vaccine lessened the pain though. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. This was 1 of 3 linked cases reported by the same reporter for different patients.; 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 vaccine Shingles vaccine. US-GSK-US2025AMR013185:same reporter different patient US-GSK-US2025AMR013183:same reporter different patient
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Pruritus, Rash, Throat tightness
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10037087:PRURITUS; 10037844:RASH; 10043517:THROAT CONSTRICTION; Narrative: Pt is a 29 yo male. Per available records, there is documentation going back as far as 12/13/2019 that pt has a documented allergy to the flu shot. This appears to have been first documented by the clinic. The reported ADR is throat swelling and urticaria upon administration of the influenza vaccine. Unfortunately, all other information is unknown and/or not available to this writer. Other Relevant HX: Other: RASH; AIRWAY CONSTRICTION
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Reported Symptoms: 10039906:SEIZURE; Narrative: Pt is a 77-year-old male who received the COVID and shingles vaccine on the same day (5/3/22) at the Health Dept on 5/3/22 at 10am. Per notes, pt started to feel bad 1-2 hours after. Pt then presented to the ED and was subsequently hospitalized that same day on 5/3/22 following a witnessed seizure. Per notes, he had shaking in the head and upper body and was not responsive during that event. He was in a hospital. He was seen by neurosurgery and neurology there. He was started on Keppra and dexamethasone. He does not recall anything about the seizure but his daughter witnessed it. Of note, pt had received COVID vaccines prior to event including: Moderna (1/23/21), Moderna (2/10/21), Pfizer (10/23/21). Of note, in July 2024, pt had another seizure and was sent to the ER. In the note records, it is stated that pt "has known seizure disorder secondary to his meningioma and falls with his neurosurgeon for this. Nursing staff discussed with his long-term care facility staff and he has not had any of his seizure medication approximately 2 weeks. Likely cause for his possible seizure today." Other Relevant HX: Other: SEIZURE
Age: 80.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Patient recievd Covid-19 vaccine (Pfizer) and high dose flu (Sanofi) on 10/24/2023. Reports rash following injections. Unclear of which vaccine may have caused rash. No documentation if treatment was received. Other Relevant HX: Other: RASH
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Nasal congestion
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016256:FATIGUE; 10028735:NASAL CONGESTION; Narrative: Patient received influenza vaccine on 9/26/24. Per allergies/adverse reactions tab in system, patient reported cough, nasal congestion, and fatigue with the influenza vaccine. Other Relevant HX: Patient previously received the influenza vaccine: 09/29/2022, 10/15/21, 10/18/2023, 9/24/2020, 10/04/2019, 09/28/2018, 10/26/2017, 10/21/2016, 10/05/2015, 11/05/2014, 10/08/2023, 10/03/2012, 09/20/2011, 10/26/2010, 11/12/2009 and 12/2008 Other: COUGH; NASAL CONGESTION; FATIGUE
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Systems: 10037844:RASH; Narrative: Other Relevant HX: RASH
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema
Clinical narrative: Reported Symptoms: 10016025:FACE EDEMA; Narrative: Pt reported had history of facial swelling from influenza vaccine in 2023 so had to decline 2024 vaccine. patient has allergy to eggs and blamed the reaction on eggs although eggs no longer a risk for allergic reaction from flu shots. Provider flagged pt's chart with allergy to flu shot with comment "due to egg allergy". Other Relevant HX: EDEMA OF FACE
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Diarrhoea, Dizziness
Clinical narrative: Reported Symptoms: 10004070:BALANCE DIFFICULTY; 10012727:DIARRHEA; 10013573:DIZZINESS; Narrative: Pt has a long documented history of receiving an annual flu shot (at least since 2003). Pt has received high dose flu shots since 2017. Pt received his annual flu shot on 10/4/24. At an appointment that happened to come a few days later, pt shared that he had experienced diarrhea and feeling off balance for the day after receiving the shot. Pt said he used walker during this time. No other complaints or actions regarding this event were documented. Other Relevant HX: Other: DIARRHEA; OFF BALANCE
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Reported Symptoms: 10043517:THROAT CONSTRICTION; Narrative: Other Relevant HX: Other: AIRWAY CONSTRICTION
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Reported Symptoms: 10023698:LARGE ARM SWELLING; Narrative: Other Relevant HX: Other: SWELLING OF ARM
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Angioedema, Erythema, Erythema multiforme, Joint swelling
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; 10038198:REDNESS; 10042691:SWELLING OF FACE; 10043528:THROAT TIGHTNESS; Narrative: Pt has a long history of receiving an annual flu shot (since at least 2007) with no prior severe reaction documented. Pt received high dose flu shots since 2020. Pt was administered his annual shot on 10/8/24. The next day (10/9/24) the pt presented to urgent care reporting that he thought he was having a reaction to the flu shot. Per pt, he had hives to his beltline and posterior neck that started the evening he received the shot. It was also noted the left side of his face was swollen with slight redness, hands/wrist slightly swollen, no redness noted on hands, and redness and rash noted on belt waist line. Pt was then sent to the emergency room in an ambulance due to severe swelling in his throat. He was treated at the ER with solu medrol, benadryl, and NS. He was sent home with prednisone and an epi pen. ER provider recommended to hold lisinopril should it be the causative agent until f/u with primary care. Pt had been taking lisinopril from 2016 - 2024 without prior complaints. Pt presented to the ED again, the following week on 10/23/24. Pt stated he woke up with left face swelling and hives on his left leg. Pt reported using his epi pen at home, but that it did not help his facial swelling. Pt noted he went to a new restaurant the night before, started magnesium 2 weeks prior, and started glipizide 2 months ago. Pt was given benadryl, solu medrol and famotidine. Facial swelling
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Pharyngeal swelling, Pruritus, Rash, Swelling face
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; 10038198:REDNESS; 10042691:SWELLING OF FACE; 10043528:THROAT TIGHTNESS; Narrative: Pt has a long history of receiving an annual flu shot (since at least 2007) with no prior severe reaction documented. Pt received high dose flu shots since 2020. Pt was administered his annual shot on 10/8/24. The next day (10/9/24) the pt presented to urgent care reporting that he thought he was having a reaction to the flu shot. Per pt, he had hives to his beltline and posterior neck that started the evening he received the shot. It was also noted the left side of his face was swollen with slight redness, hands/wrist slightly swollen, no redness noted on hands, and redness and rash noted on belt waist line. Pt was then sent to the emergency room in an ambulance due to severe swelling in his throat. He was treated at the ER with solu medrol, benadryl, and NS. He was sent home with prednisone and an epi pen. ER provider recommended to hold lisinopril should it be the causative agent until f/u with primary care. Pt had been taking lisinopril from 2016 - 2024 without prior complaints. Pt presented to the ED again, the following week on 10/23/24. Pt stated he woke up with left face swelling and hives on his left leg. Pt reported using his epi pen at home, but that it did not help his facial swelling. Pt noted he went to a new restaurant the night before, started magnesium 2 weeks prior, and started glipizide 2 months ago. Pt was given benadryl, solu medrol and famotidine. Facial swelling
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; 10038198:REDNESS; 10042691:SWELLING OF FACE; 10043528:THROAT TIGHTNESS; Narrative: Pt has a long history of receiving an annual flu shot (since at least 2007) with no prior severe reaction documented. Pt received high dose flu shots since 2020. Pt was administered his annual shot on 10/8/24. The next day (10/9/24) the pt presented to urgent care reporting that he thought he was having a reaction to the flu shot. Per pt, he had hives to his beltline and posterior neck that started the evening he received the shot. It was also noted the left side of his face was swollen with slight redness, hands/wrist slightly swollen, no redness noted on hands, and redness and rash noted on belt waist line. Pt was then sent to the emergency room in an ambulance due to severe swelling in his throat. He was treated at the ER with solu medrol, benadryl, and NS. He was sent home with prednisone and an epi pen. ER provider recommended to hold lisinopril should it be the causative agent until f/u with primary care. Pt had been taking lisinopril from 2016 - 2024 without prior complaints. Pt presented to the ED again, the following week on 10/23/24. Pt stated he woke up with left face swelling and hives on his left leg. Pt reported using his epi pen at home, but that it did not help his facial swelling. Pt noted he went to a new restaurant the night before, started magnesium 2 weeks prior, and started glipizide 2 months ago. Pt was given benadryl, solu medrol and famotidine. Facial swelling
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Per provider note: "Patient states that he developed hives and fever from the first dose of the shingles vaccine and does not want a second dose." Other Relevant HX: Other: URTICARIA; FEVER
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Systems: 10037087:PRURITUS; 10046735:URICARIA; Narrative: Patient notes that after booster dose of Johnson and Johnson Covid-19 Vaccine she developed localized hives like reaction to the arm with in 12 hours of injection. Other Relevant HX: Other: URTICARIA
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA;  Narrative: Other Relevant HX: Other: ANGIOEDEMA
Age: 81.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported Symptoms: 10018767:GULLIAN-BARRE SYNDROME;  Narrative: 81 yo male patient in NAD who follows with the Blue team for his PCP comes in today for follow up post hospitalization. Developed Guillian-Barre after flu and COVID shot. Patient was treated at Medical Center and then was at rehab 10/19-11/12. Other Relevant HX: Other: GUILLAIN BARRE
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME;  Narrative: Other Relevant HX: Other: GUILLAIN BARRE
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Patient states that he had an allergic reaction the same day as flu shot 1/3/2018. Small hives to arms and legs. And has not resolved with Benadryl or lotions. Other Relevant HX: Other: URTICARIA
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA;  Narrative: Other Relevant HX: Other: DIARRHEA (2/26/21@16:00)
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Reported Symptoms: 10000081:ABDOMINAL PAIN;  Narrative: Per nurse call: She did report flank pain the day after her vaccine that lasted until yesterday. She states that the pain was relentless.it is gone today but she was asked to call her pcp to discuss. She does not have any of the other symptoms as above. Other Relevant HX: Other: ABDOMINAL PAIN
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure inadequately controlled, Condition aggravated, Tremor
Clinical narrative: Severely shaking hands after second; Uncontrollable blood pressure; This non-serious case was reported by a consumer via patient support programs and described the occurrence of blood pressure inadequately controlled in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure (controlled). Concomitant products included carvedilol.   On 01-NOV-2022, the patient received the 2nd dose of Shingrix. On 03-NOV-2022, 2 days after receiving Shingrix, the patient experienced blood pressure inadequately controlled (Verbatim: Uncontrollable blood pressure). On 15-DEC-2022, the patient experienced tremor of hands (Verbatim: Severely shaking hands after second). The outcome of the blood pressure inadequately controlled was not resolved and the outcome of the tremor of hands was resolving.   It was unknown if the reporter considered the blood pressure inadequately controlled and tremor of hands to be related to Shingrix.     It was unknown if the company considered the blood pressure inadequately controlled and tremor of hands to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2025 The patient had controlled blood pressure for more than 25 years with one medication. The patient's doctors have since changed the medication 7 times and finally put the patient on a Beta Blocker with bad side effects. The patient had been to the ER twice for extremely high Blood Pressure in the last two years.  The patient never had an issue until receiving the two shots of Shingrix.  The patient have more to share in future conversations. The patient had severely shaking hands after second dose. The symptoms were not treated. Consented to follow up.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given influenza vaccine at 4 months of age; This non-serious case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   Concurrent medical conditions included bronchiolitis. Concomitant products included salbutamol sulfate (Albuterol Sulfate).   On 05-FEB-2025, the patient received FluLaval 2024-2025 season .5 ml. On 05-FEB-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient was given influenza vaccine at 4 months of age). The outcome of the inappropriate age at vaccine administration was unknown.   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-FEB-2025 The reporter reported that the 4 months old patient received Flulaval vaccine which led to, inappropriate age at vaccine administration. The expiry date of Flulaval vaccine was unknown. The patient received Albuterol sulfate for bronchiolitis.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got them/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 vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got my shingle shots and still got them). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JAN-2025 This case was reported by a patient via interactive digital media. At the time of reporting patient stated that he/she got shingle shots and still got them. 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 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. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination 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 Vaccination 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: 25-JAN-2025 This case was reported by a patient via interactive digital media. At the time of reporting patient stated that he/she got the shots and had shingles right now. The follow-up could not be possible as no contact details were available. 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; he got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he got the shingles). The outcome of the vaccination failure and shingles were not reported.   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: 01-FEB-2025 This case was reported by a patient via interactive digital media. Reporter's husband got the Shingles shot and a few years later he got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Ive never been so sick in my life; 104 temp for days; 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 Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date).   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: Ive never been so sick in my life) and fever (Verbatim: 104 temp for days). The outcome of the sickness was not reported and the outcome of the fever was resolved.   It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine.     It was unknown if the company considered the sickness and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-FEB-2025 The case was received from the patient via interactive digital media. The reporter had never been so sick in his/her life.  The reporter reported that the second vaccine nearly killed him/her.  The reporter had 104 temperature for days.  The reporter thought the first dose was bad, but the second shot was horrible.  The reporter reported that beware and plan round being sick.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: tiredness). The outcome of the tiredness was not reported.   It was unknown if the reporter considered the tiredness to be related to Arexvy.     It was unknown if the company considered the tiredness to be related to Arexvy.   Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had received a dose Arexvy vaccine and experienced tiredness. The reporter had a question how long was tiredness.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest tube insertion, Computerised tomogram thorax abnormal, Dyspnoea, Pneumothorax spontaneous, Pulmonary embolism
Clinical narrative: presented with progressive shortness of breath, found to have spontaneous pneumothorax and pulmonary emboli superimposed on his chronic interstitial lung disease
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Product substitution error
Clinical narrative: Private vaccine supplied influenza vaccine given instead of  state supplied influenza vaccine. Correct vaccine, correct dose, just incorrect stock.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported a sore arm that was painful to move and swelling.  A large red rash around 4-4.5 inches in diameter was reported around the vaccination site. Patient did not report a fever, but was concerned about cellulitis
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea, Hypoxia, Respiratory failure
Clinical narrative: Name:    Medical Record #:   Age:  75 y.o.  DOB:   Admit date: 1/28/2025   Discharge date: 1/31/2025   Attending Physician at the Time of Discharge: DO   Primary Care Physician:  DO  Reason for Admission: hypoxia   Brief Summary of Hospital Stay: 75 y.o. female with ESRD on hemodialysis presented to ED with difficulty breathing.  Admitted with covid infection causing acute hypoxic respiratory insufficiency.  She was started on dexamethasone with gradual improvement. She underwent usual hemodialysis while admitted.  Problem list: Acute respiratory insufficiency with hypoxia due to covid pneumonia              -dexamethasone through 2/4              -guaifenesin, incentive spirometry, mobilize ESRD on hemodialysis              -T/Th/Sat Coronary artery disease              -aspirin, atorvastatin              -metoprolol, Imdur Hypertension              -amlodipine  Diabetes mellitus type 2              -increase tresiba to 15U while on decadron, back to 8U after              -home humalog Hypothyroid              -levothyroxine   Although leaving today, this patient will require ongoing assessment and treatment, with adjustments to the plan as appropriate.  Medicine is complicated and unforseen changes in status may occur.  Discharged to Home.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was incorrectly given a High dose influenza vaccine instead of a regular dose influenza vaccination for the season.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Haemodialysis, Nausea, Vomiting
Clinical narrative: Name:   Medical Record #:   Age:  59 y.o. DOB:    Admit date: 2/1/2025  Discharge date:  02/03/2025  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: PAC  Reason for Admission:  Nausea/vomiting  Hospital Course:  This is a 59-year-old female with significant history of ESRD on HD TTS, type 2 diabetes, and hypertension who presented due to intractable nausea/vomiting.  Workup was significant for COVID-19 infection.  Nausea and vomiting improved with antiemetic therapy.  Patient was not hypoxemic during hospitalization.  Chest x-ray did not demonstrate any infiltrates.  Patient was started on remdesivir while inpatient.  Prior to discharge, patient was able to ambulate and did not desaturate.  Hemodialysis schedule was kept while inpatient.  Disposition upon discharge is stable and improving.  Patient was discharged with Tessalon Perles and Atrovent for supportive care for COVID-19 infection.  Patient was provided with a work note per her request. Discharged to Home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Bundle branch block left, Bundle branch block right, COVID-19, Cardioversion
Clinical narrative: Name:  Age:  78 y.o.  Admit date: 1/30/2025   Discharge date: Feb 3, 2025   Attending Physician at the Time of Discharge: MD  Reason for Admission: Patient presenting with shortness of breath and cough for 2 weeks. HR at clinic was in the 170s so he was sent to the ER.   ER lab workup notable for stable CKD, initial troponin elevated at 31 (delta of negative 4). RVP positive for both Flu A and COVID. Initial EKG noted SVT with wide QRS tachycardia, RBBB and LAFB (bifascicular block) and T wave abnormality (possible inferior ischemia). CXR unremarkable.   Patient given adenosine and initially converted to NSR. Patient then went back into SVT, amiodarone bolus given with conversion to NSR. Patient again flipped into SVT, cardiology consulted and recommended amiodarone drip and admission.    Brief Summary of Hospital Stay:  Principal Problem:   Paroxysmal SVT (supraventricular tachycardia) / flutter with RVR. Likely due to viral infections with COVID and Flu. Did not have much resolution with IV amio and currently on low dose bblocker. Cards had given Dig push x2 and HR has settled and is now NSR> Conitnue lopressor. On eliquis.  CXR neg. F/u Cardiologist Dr.    Influenza A - on Tamiflu. Mucinex. Encourage IS, flutter.    COVID infection - no hypoxia and chest clear. No need for steroids/remdesevir unless hypoxia.    Hypokalemia - replaced.  Active Problems:   Chronic renal insufficiency -CKD 3a - stable.    Benign paroxysmal positional vertigo   Dyslipidemia associated with type 2 diabetes mellitus - on statin.    Essential hypertension - monitor BP.    Hypothyroid - TSH ok. On synthroid.    Malignant neoplasm of prostate - stable. On flomax.    Diabetes mellitus - BS stable.  Resume home meds.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Electrocardiogram QRS complex prolonged, Electrocardiogram T wave abnormal
Clinical narrative: Name:  Age:  78 y.o.  Admit date: 1/30/2025   Discharge date: Feb 3, 2025   Attending Physician at the Time of Discharge: MD  Reason for Admission: Patient presenting with shortness of breath and cough for 2 weeks. HR at clinic was in the 170s so he was sent to the ER.   ER lab workup notable for stable CKD, initial troponin elevated at 31 (delta of negative 4). RVP positive for both Flu A and COVID. Initial EKG noted SVT with wide QRS tachycardia, RBBB and LAFB (bifascicular block) and T wave abnormality (possible inferior ischemia). CXR unremarkable.   Patient given adenosine and initially converted to NSR. Patient then went back into SVT, amiodarone bolus given with conversion to NSR. Patient again flipped into SVT, cardiology consulted and recommended amiodarone drip and admission.    Brief Summary of Hospital Stay:  Principal Problem:   Paroxysmal SVT (supraventricular tachycardia) / flutter with RVR. Likely due to viral infections with COVID and Flu. Did not have much resolution with IV amio and currently on low dose bblocker. Cards had given Dig push x2 and HR has settled and is now NSR> Conitnue lopressor. On eliquis.  CXR neg. F/u Cardiologist Dr.    Influenza A - on Tamiflu. Mucinex. Encourage IS, flutter.    COVID infection - no hypoxia and chest clear. No need for steroids/remdesevir unless hypoxia.    Hypokalemia - replaced.  Active Problems:   Chronic renal insufficiency -CKD 3a - stable.    Benign paroxysmal positional vertigo   Dyslipidemia associated with type 2 diabetes mellitus - on statin.    Essential hypertension - monitor BP.    Hypothyroid - TSH ok. On synthroid.    Malignant neoplasm of prostate - stable. On flomax.    Diabetes mellitus - BS stable.  Resume home meds.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home.