chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the patient received the fluzone quad instead of fluzone hd with no reported adverse event; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71 years old male patient who received the influenza quadrival a-b vaccine [fluzone qiv] instead of fluzone hd with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml total of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot: UT7751JA ; expiry date: 30-Jun-2023) via intramuscular route in right deltoid for Immunization.  On an unknown date the patient received the fluzone quad instead of fluzone hd with no reported adverse event (wrong product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: lowest temperature reached 23.1 F and the total excursion lasted 112 hours with no reported adverse event; Initial information was received  on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 7 months old male patient who experienced lowest temperature reached 23.1 f and the total excursion lasted 112 hours with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot: UJ664AAA, Expiry date: 04-May-2022) via unknown route in unknown administration site (form, strength: unknown) for immunization.  On 30-Dec-2022 the patient experienced lowest temperature reached 23.1 f and the total excursion lasted 112 hours with no reported adverse event (product storage error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  At time of reporting, the outcome was Not Recovered for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Bronchitis, Chest X-ray abnormal, Malaise, Pneumonia
Clinical narrative: Pneumonia; Bronchitis; Quite ill; This spontaneous case was received on 31-Dec-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-06748) and concerned a 70-year-old, male patient.   The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported.  On 11-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (2022-2023) (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) to prevent flu. The batch number was not reported.  On an unspecified date in 2022, reported as 'a couple of weeks' and 'two weeks after' receiving Fluad Quadrivalent, the patient was ill as she had bronchitis and pneumonia. The patient was not hospitalized but she got unspecified antibiotics and steroid prednisone.  On an unspecified date in 2022, the patient had an X-ray done, and it showed some residual changes from pneumonia that were improving.  On an unspecified date in 2022, after several weeks, the patient recovered from all events.  The reporter did not provide causality assessment. The patient wanted to know if bronchitis and pneumonia were associated with the flu vaccine as he did not believe it was related to the vaccine.  The event of pneumonia was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 70-year-old patient developed pneumonia, bronchitis, and illness reportedly a couple of weeks or two weeks after receiving the suspect product Fluad Quadrivalent. Underlying medical history of chronic obstructive pulmonary disease contributed to the development of the events. Based on unsuggestive temporal relationship, biological implausibility, and confounding factor (medical history) causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A 70-year-old patient developed pneumonia, bronchitis, and illness reportedly a couple of weeks or two weeks after receiving the suspect product Fluad Quadrivalent. Underlying medical history of chronic obstructive pulmonary disease contributed to the development of the events. Based on unsuggestive temporal relationship, biological implausibility, and confounding factor (medical history) causal role of the suspect vaccine is assessed as not related.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Blood test normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, Chillblains
Clinical narrative: Left hand had itchy rash: did video visit with walkin clinic on 1/13/21. the rash worsened and became present in right hand after 2nd dose of Moderna COVID vaccine on 2/3/21. red bumps with white in center on palm side of hands, and flat purple blotches of various sizes on nonpalm side of hands, pain. 2/10/21: video visit with Dermatologist and rx'd lidex advised to go to ER if my fingers started to turn black  3/31/21 rheumatology consult: Dr. 4/21 palms of hand start feeling like little thin shards of glass are poking my palms when I make a fist 5/19 Heme/Onc consult w/Dr.  finger and had rashes/symptoms  are fading 7/1/21 Derm consult: Dr.  Dr.  dx'd fingers as Chilblains
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Electrophoresis protein abnormal, Full blood count normal, Immunoglobulins decreased, Immunology test, Laboratory test normal
Clinical narrative: Left hand had itchy rash: did video visit with walkin clinic on 1/13/21. the rash worsened and became present in right hand after 2nd dose of Moderna COVID vaccine on 2/3/21. red bumps with white in center on palm side of hands, and flat purple blotches of various sizes on nonpalm side of hands, pain. 2/10/21: video visit with Dermatologist and rx'd lidex advised to go to ER if my fingers started to turn black  3/31/21 rheumatology consult: Dr. 4/21 palms of hand start feeling like little thin shards of glass are poking my palms when I make a fist 5/19 Heme/Onc consult w/Dr.  finger and had rashes/symptoms  are fading 7/1/21 Derm consult: Dr.  Dr.  dx'd fingers as Chilblains
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lichenoid keratosis, Metabolic function test normal, Pain, Rash erythematous, Rash macular
Clinical narrative: Left hand had itchy rash: did video visit with walkin clinic on 1/13/21. the rash worsened and became present in right hand after 2nd dose of Moderna COVID vaccine on 2/3/21. red bumps with white in center on palm side of hands, and flat purple blotches of various sizes on nonpalm side of hands, pain. 2/10/21: video visit with Dermatologist and rx'd lidex advised to go to ER if my fingers started to turn black  3/31/21 rheumatology consult: Dr. 4/21 palms of hand start feeling like little thin shards of glass are poking my palms when I make a fist 5/19 Heme/Onc consult w/Dr.  finger and had rashes/symptoms  are fading 7/1/21 Derm consult: Dr.  Dr.  dx'd fingers as Chilblains
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Red blood cell sedimentation rate normal, Skin discolouration, Urine analysis normal, X-ray limb normal
Clinical narrative: Left hand had itchy rash: did video visit with walkin clinic on 1/13/21. the rash worsened and became present in right hand after 2nd dose of Moderna COVID vaccine on 2/3/21. red bumps with white in center on palm side of hands, and flat purple blotches of various sizes on nonpalm side of hands, pain. 2/10/21: video visit with Dermatologist and rx'd lidex advised to go to ER if my fingers started to turn black  3/31/21 rheumatology consult: Dr. 4/21 palms of hand start feeling like little thin shards of glass are poking my palms when I make a fist 5/19 Heme/Onc consult w/Dr.  finger and had rashes/symptoms  are fading 7/1/21 Derm consult: Dr.  Dr.  dx'd fingers as Chilblains
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Xerosis
Clinical narrative: Left hand had itchy rash: did video visit with walkin clinic on 1/13/21. the rash worsened and became present in right hand after 2nd dose of Moderna COVID vaccine on 2/3/21. red bumps with white in center on palm side of hands, and flat purple blotches of various sizes on nonpalm side of hands, pain. 2/10/21: video visit with Dermatologist and rx'd lidex advised to go to ER if my fingers started to turn black  3/31/21 rheumatology consult: Dr. 4/21 palms of hand start feeling like little thin shards of glass are poking my palms when I make a fist 5/19 Heme/Onc consult w/Dr.  finger and had rashes/symptoms  are fading 7/1/21 Derm consult: Dr.  Dr.  dx'd fingers as Chilblains
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Shot site, 3 inches+ surrounding, red and hot to the touch.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Blood pressure increased, Palpitations, Stress, Tremor
Clinical narrative: Elevated blood pressure, resting heart rate over 90-110, increased anxiety and stress, subtle body trembling, palpitations.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, VARZOS, VARZOS
Symptoms: Myalgia, Paraesthesia, Pyrexia
Clinical narrative: -Fever, achy muscles, tingly feeling in both arms and both legs
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Heart rate irregular
Clinical narrative: Irregular heartbeat , severe & frequent premature atrial contractions, heart racing uncontrollably, blood pressure spikes
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations, Supraventricular extrasystoles
Clinical narrative: Irregular heartbeat , severe & frequent premature atrial contractions, heart racing uncontrollably, blood pressure spikes
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Prevnar 20 when not prescribed.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improper storage of product in use; This spontaneous report was received from an administrator referring to a 13-month-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  It was reported that aricella virus vaccine live (oka/merck) (VARIVAX) was under temperature excursion (TE) on 05-NOV-2022. On 11-NOV-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/once, lot #W011623, expiration date: 06-APR-2024, for prophylaxis (strength, and route of administration were not provided) (product storage error). There was no additional adverse event (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE's were reported; received a dose of RECOMBIVAX HB after expiry; This spontaneous report was received from a nurse, referring to a patient with unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were not reported.  On 03-JAN-2023, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) (0.5 milliliter (ml), lot number U008328 has been verified to be a valid lot number, expiration date was reported as 16-DEC-2022, anatomical location was not provided) intramuscularly for prophylaxis (expired product administered). No additional adverse event (AE) details were provided and no additional AE's were reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The pharmacist reported that an underdose of Shingrix had been administered to a patient.  The date of administration was not specified by the healthcare professional.  The healthcare professional did not provide more information since they no longer worked in the facility where the vaccine was administered. The reporter asked to remain anonymous and did not consent to follow-up.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: injected a bivalent booster instead of first primary series.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: patient only received half of his Moderna bivalent vaccine dose; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose).    The reporter does not report any other adverse reactions.  The reporter does not had any information on the patients other Moderna Covid-19 vaccines.  Concomitant medications were not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got sick as a dog with the flu I'm never getting the flu shot again; Initial information received on 02-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got sick as a dog with the flu i'm never getting the flu shot again while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at unknown (formulation, strength, dose, expiry date, lot number, route, administration site)  for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick as a dog with the flu i'm never getting the flu shot again (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick as a dog with the flu I'm never getting the flu shot again).  At time of reporting, the outcome was Unknown for the event got sick as a dog with the flu i'm never getting the flu shot again.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: just got over three week bout of flu; Initial information received on 01-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who just got over three week bout of flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in Oct-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of just got over three week bout of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (just got over three week bout of flu).  Outcome: Unknown
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Heart rate, Heart rate increased
Clinical narrative: HEART RATE WENT UP TO 186; GOT COVID; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient got covid (duration was 5 days). On an unspecified date, the patient experienced heart rate went up to 186. Laboratory data (dates unspecified) included: Heart rate went up to 186. As per reporter, "I am a one and done also. 1 J and J vaccine 3/6/202. My heart rate went up to 186. I am done with the vaccines. Got covid in JUL-2022. Mild case took the antiviral meds was better in 5 days. I was lucky. God was watching over me." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got covid on 2022, and the outcome of heart rate went up to 186 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230104518- heart rate went up to 186.Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided No treatment information provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Arthralgia, Back pain, Blood creatine, Blood creatinine normal
Clinical narrative: Patient presented to hospital with chief complaint of left shoulder pain. Over the past three days before ED admission, patient noted an increased amount of pain along with neck pain that is chronic. Back pain was noted as well. At time of ED admission, patient was on vancomycin treatment for C. Difficile-- slowly improving. her first high-sensitivity troponin was noted to be elevated at 124 with repeat at 144 one hour later. Patient was transferred to hospital for further work-up. Upon presentation at hospital admission, patient had worsening of left arm pain. EKG at that time showing ST elevation in the anterior leads and she was given nitroglycerin with improvement of pain. Case was discussed with cardiology on-call and the Cath Lab was activated for ST elevated myocardial infarction. Patient underwent left heart catheterization on the nigh of 12/31/2022 with noted 90% stenosis of the left anterior descending artery. Two 3.5 Xience stents were placed with return of TIMI-3 flow postintervention. ST elevated myocardial infarction of the left anterior descending artery status post drug-eluting stent. Left heart catheterization with drug-eluting stent placed in the LAD. Other coronary arteries without significant blockages. The patient was started on Plavix along with statin  therapy and was transferred back to the floor. Patient was monitored in the hospital until 1/2 without significant arrhythmias or recurrence of her pain. She tolerated medication adjustments without issues. She was deemed not appropriate candidate for ACE/ARB due to her renal transplant status and concern for renal function. Additionally she could not tolerate beta-blocker therapy due to low blood pressures. She did tolerate statin therapy. She is not placed on aspirin due to both Coumadin and now Plavix therapy. Ultrasound was obtained of the right groin prior to discharge due to some discomfort in that area but there was no evidence of pseudoaneurysm for catheter insertion site. Patient was deemed medically stable for discharge on 1/2/2023. The patient was discharged to home 1/2/2023 and has been referred to cardiology along with cardiac rehab. She is asked to maintain on warfarin along with Plavix. Plavix should continue for 1 year. She does not require aspirin at this time. Lipitor has been started in the setting of myocardial infarction. Patient was vaccinated with Janssen Ad26.CoV2.S Vaccine on 10/04/2022. As of 1/2/2023, the patient is 90 days out from their Janssen Ad26.C0V2.S vaccine. Per MD, this event is unrelated to the Janssen Ad26.CoV2.S vaccine administered on 10/04/2022 and is not related to any known side effects of the vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Catheterisation cardiac abnormal, Clostridium difficile infection, Coronary arterial stent insertion, Coronary artery stenosis
Clinical narrative: Patient presented to hospital with chief complaint of left shoulder pain. Over the past three days before ED admission, patient noted an increased amount of pain along with neck pain that is chronic. Back pain was noted as well. At time of ED admission, patient was on vancomycin treatment for C. Difficile-- slowly improving. her first high-sensitivity troponin was noted to be elevated at 124 with repeat at 144 one hour later. Patient was transferred to hospital for further work-up. Upon presentation at hospital admission, patient had worsening of left arm pain. EKG at that time showing ST elevation in the anterior leads and she was given nitroglycerin with improvement of pain. Case was discussed with cardiology on-call and the Cath Lab was activated for ST elevated myocardial infarction. Patient underwent left heart catheterization on the nigh of 12/31/2022 with noted 90% stenosis of the left anterior descending artery. Two 3.5 Xience stents were placed with return of TIMI-3 flow postintervention. ST elevated myocardial infarction of the left anterior descending artery status post drug-eluting stent. Left heart catheterization with drug-eluting stent placed in the LAD. Other coronary arteries without significant blockages. The patient was started on Plavix along with statin  therapy and was transferred back to the floor. Patient was monitored in the hospital until 1/2 without significant arrhythmias or recurrence of her pain. She tolerated medication adjustments without issues. She was deemed not appropriate candidate for ACE/ARB due to her renal transplant status and concern for renal function. Additionally she could not tolerate beta-blocker therapy due to low blood pressures. She did tolerate statin therapy. She is not placed on aspirin due to both Coumadin and now Plavix therapy. Ultrasound was obtained of the right groin prior to discharge due to some discomfort in that area but there was no evidence of pseudoaneurysm for catheter insertion site. Patient was deemed medically stable for discharge on 1/2/2023. The patient was discharged to home 1/2/2023 and has been referred to cardiology along with cardiac rehab. She is asked to maintain on warfarin along with Plavix. Plavix should continue for 1 year. She does not require aspirin at this time. Lipitor has been started in the setting of myocardial infarction. Patient was vaccinated with Janssen Ad26.CoV2.S Vaccine on 10/04/2022. As of 1/2/2023, the patient is 90 days out from their Janssen Ad26.C0V2.S vaccine. Per MD, this event is unrelated to the Janssen Ad26.CoV2.S vaccine administered on 10/04/2022 and is not related to any known side effects of the vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment elevation, Hypotension, Musculoskeletal discomfort, Neck pain, Pain in extremity
Clinical narrative: Patient presented to hospital with chief complaint of left shoulder pain. Over the past three days before ED admission, patient noted an increased amount of pain along with neck pain that is chronic. Back pain was noted as well. At time of ED admission, patient was on vancomycin treatment for C. Difficile-- slowly improving. her first high-sensitivity troponin was noted to be elevated at 124 with repeat at 144 one hour later. Patient was transferred to hospital for further work-up. Upon presentation at hospital admission, patient had worsening of left arm pain. EKG at that time showing ST elevation in the anterior leads and she was given nitroglycerin with improvement of pain. Case was discussed with cardiology on-call and the Cath Lab was activated for ST elevated myocardial infarction. Patient underwent left heart catheterization on the nigh of 12/31/2022 with noted 90% stenosis of the left anterior descending artery. Two 3.5 Xience stents were placed with return of TIMI-3 flow postintervention. ST elevated myocardial infarction of the left anterior descending artery status post drug-eluting stent. Left heart catheterization with drug-eluting stent placed in the LAD. Other coronary arteries without significant blockages. The patient was started on Plavix along with statin  therapy and was transferred back to the floor. Patient was monitored in the hospital until 1/2 without significant arrhythmias or recurrence of her pain. She tolerated medication adjustments without issues. She was deemed not appropriate candidate for ACE/ARB due to her renal transplant status and concern for renal function. Additionally she could not tolerate beta-blocker therapy due to low blood pressures. She did tolerate statin therapy. She is not placed on aspirin due to both Coumadin and now Plavix therapy. Ultrasound was obtained of the right groin prior to discharge due to some discomfort in that area but there was no evidence of pseudoaneurysm for catheter insertion site. Patient was deemed medically stable for discharge on 1/2/2023. The patient was discharged to home 1/2/2023 and has been referred to cardiology along with cardiac rehab. She is asked to maintain on warfarin along with Plavix. Plavix should continue for 1 year. She does not require aspirin at this time. Lipitor has been started in the setting of myocardial infarction. Patient was vaccinated with Janssen Ad26.CoV2.S Vaccine on 10/04/2022. As of 1/2/2023, the patient is 90 days out from their Janssen Ad26.C0V2.S vaccine. Per MD, this event is unrelated to the Janssen Ad26.CoV2.S vaccine administered on 10/04/2022 and is not related to any known side effects of the vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count increased, Troponin increased, Ultrasound scan normal
Clinical narrative: Patient presented to hospital with chief complaint of left shoulder pain. Over the past three days before ED admission, patient noted an increased amount of pain along with neck pain that is chronic. Back pain was noted as well. At time of ED admission, patient was on vancomycin treatment for C. Difficile-- slowly improving. her first high-sensitivity troponin was noted to be elevated at 124 with repeat at 144 one hour later. Patient was transferred to hospital for further work-up. Upon presentation at hospital admission, patient had worsening of left arm pain. EKG at that time showing ST elevation in the anterior leads and she was given nitroglycerin with improvement of pain. Case was discussed with cardiology on-call and the Cath Lab was activated for ST elevated myocardial infarction. Patient underwent left heart catheterization on the nigh of 12/31/2022 with noted 90% stenosis of the left anterior descending artery. Two 3.5 Xience stents were placed with return of TIMI-3 flow postintervention. ST elevated myocardial infarction of the left anterior descending artery status post drug-eluting stent. Left heart catheterization with drug-eluting stent placed in the LAD. Other coronary arteries without significant blockages. The patient was started on Plavix along with statin  therapy and was transferred back to the floor. Patient was monitored in the hospital until 1/2 without significant arrhythmias or recurrence of her pain. She tolerated medication adjustments without issues. She was deemed not appropriate candidate for ACE/ARB due to her renal transplant status and concern for renal function. Additionally she could not tolerate beta-blocker therapy due to low blood pressures. She did tolerate statin therapy. She is not placed on aspirin due to both Coumadin and now Plavix therapy. Ultrasound was obtained of the right groin prior to discharge due to some discomfort in that area but there was no evidence of pseudoaneurysm for catheter insertion site. Patient was deemed medically stable for discharge on 1/2/2023. The patient was discharged to home 1/2/2023 and has been referred to cardiology along with cardiac rehab. She is asked to maintain on warfarin along with Plavix. Plavix should continue for 1 year. She does not require aspirin at this time. Lipitor has been started in the setting of myocardial infarction. Patient was vaccinated with Janssen Ad26.CoV2.S Vaccine on 10/04/2022. As of 1/2/2023, the patient is 90 days out from their Janssen Ad26.C0V2.S vaccine. Per MD, this event is unrelated to the Janssen Ad26.CoV2.S vaccine administered on 10/04/2022 and is not related to any known side effects of the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot, now 3 weeks with it/suspected vaccination failure; I'm 3 weeks with it; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-JAN-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot and he/she was 3 weeks with it. Additional supportive information: 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Sores on top of head; Itchy patch; This case was reported by a consumer via interactive digital media and described the occurrence of skin ulcer in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin ulcer and pruritus. On an unknown date, the outcome of the skin ulcer and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the skin ulcer and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was vaccinated for the shingles and had surgery in 23rd August 2022 was put on IV antibiotics through a PICC line there was an allergic reaction with that now oral antibiotic were being taken. The reporters question was now had sores on the top of head itchy with pat. The follow-up could not be possible as no contact details were available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles on face, around eye and temple; Residual pain; Rash around temple area; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. In October 2022, 2 months after receiving Shingrix, the patient experienced shingles, pain and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27 DEC 2022 Reporter's comment: This case was reported by the pharmacist. The pharmacist reported that received first dose of Shingrix vaccine late August 2022.  Approximately two months later the patient developed shingles on face around left eye and temple area.  The patient was treated with Valtrex, but still had some residual pain and slight rash around left temple. The first dose was administered at a different pharmacy so the reporter did not have the exact date or lot number expiration date information.  At the time of reporting, the second dose has not been administered. Additional supportive information: The case has been linked to US2022AMR194482, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR194482:Same reporter - Shingrix
Age: 46.0
Sex: M
Vaccine: HEPAB
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Heplisav-B and Twinrix administered on same day; Twinrix 1st dose in 2017, 2nd on 27Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 46-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2017).   On 27th December 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced accidental overdose and drug dose administration interval too long. On an unknown date, the outcome of the accidental overdose 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: 27 DEC 2022 Reporters comment: This case was reported by the pharmacist. The pharmacist reported that another pharmacist administered a dose of Twinrix to a patient on 27th December 2022 and instead of pulling a flu vaccine to also gave the patient, inadvertently administered Heplisav-B. This was the patient's second dose of Twinrix, however pharmacist stated the patient was off schedule because the first dose was back in 2017.   Additional supportive information: As patient received Twinrix and Heplisav B which contained Hepatitis B in both vaccine which led to accidental overdose of hepatitis B component and received 2nd dose lately which led to drug dose administration interval too long. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; subcutanoues route of adminstartion; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th December 2022, the patient received Havrix adult (subcutaneous) and Havrix Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and intramuscular formulation administered by other route. On an unknown date, the outcome of the expired vaccine used and intramuscular formulation administered by other route were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022193700   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's comments: The Healthcare Professional (HCP) had reported that a female patient was administered an expired dose of Havrix on 27 December 2022, which was expired on 16 December 2022. The reporter had consented to follow-up via regular mail. Additional supportive information: At the time of reporting, the patient had received an expired dose of Havrix adult vaccine via subcutaneous route, which led to expired vaccine used and Intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022193700:Same reporter / FU1
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Pruritus, Rash
Clinical narrative: shingles; allergic reaction; rash in his crouch area/A few days later the rash spread on both legs from his crouch to his knees; itching in crouch area; This case was reported by a consumer via call center representative and described the occurrence of rash in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number he4p7, expiry date 25th January 2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date.).   On 19th December 2022, the patient received the 2nd dose of Shingrix. In December 2022, 2 days after receiving Shingrix, the patient experienced rash, pruritus, shingles and allergic reaction. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the pruritus, shingles and allergic reaction were unknown.   The reporter considered the rash, shingles and allergic reaction to be related to Shingrix. It was unknown if the reporter considered the pruritus to be related to Shingrix.     Additional Information: GSK receipt date: 28-DEC-2022 Reporters comment: The reporter was the patient and he stated that after the 2nd dose of Shingrix, approximately 2-7 days later, he started itching/rash in his crouch area.  A few days later, the rash spread on both legs from his crouch to his knees. The reporter was concerned that the outbreak could be shingles or an allergic reaction to the vaccination The reporter consent to follow up.
Sex: M
Vaccine: HEP
Symptoms: Product complaint, Wrong technique in device usage process
Clinical narrative: Patient was stuck twice; syringe was difficult to administer to patient; Plunger was difficult to depress, tilted from perpendicular, lot of resistance; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in device usage process in a adolescent male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the wrong technique in device usage process, syringe issue and pharmaceutical product complaint 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: 03-Jan-2023: Reporter's Comment: HCP called to report that while an experienced nurse was administering Engerix B pediatric prefilled syringe vaccine, the plunger was difficult to depress. The needle was changed, and the plunger was able to move up and down; but, said syringe was difficult to administer to patient. The patient had to be stuck twice. (AE filed) There was also a second syringe in the same 10 count box that had a similar appearance with the plunger being tilted from perpendicular. There were also 3 other syringes remaining in the 10 count box that the HCP was not comfortable using. They were returning 4 prefilled syringes total. The one with patient involvement was discarded and can not be returned. HCP stated that they use the vaccines for children. HCP was able to pull down on the plunger but it felt askew from perpendicular. HCP could push out air, but once the needle was in the patient's arm, there was a lot of resistance with the plunger. HCP had to re-maneuver to get it to advance. There were no any blockages visible in the syringe body or barrel. There were no abnormal particles observed in the vaccine. Luer Lok needle was used. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 04-JAN-2023 Reporter's Comments: The reporter consented to follow up. Additional Supportive Information: An expired dose of Twinrix was administered to a patient, which led to expired vaccine used.