chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Protonex, reaction(s): "Known allergies: Protonex"; Nexium, reaction(s): "Known allergies: Nexium"; Vioxx, reaction(s): "Known allergies: Vioxx"; Celebrex, reaction(s): "Known allergies: Celebrex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=04May2023, Treatment stop date=09May2023.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Apr2023 at 17:00 as dose 6 (booster), single (Lot number: GJ3268) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid (lot number GG4082)  from 09May2023 to 14May2023.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Received paxlovid treatment 03May2023 to 07May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300192795 Same patient, different drug and different event;
Sex: F
Vaccine: COVID19
Symptoms: Recurrent cancer
Clinical narrative: contact claims covid vaccine booster caused her cancer to come back; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing), notes: contact claims covid vaccine booster caused her cancer to come back. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1 (not bivalent)), for Covid-19 immunization. The following information was reported: RECURRENT CANCER (medically significant), outcome "unknown", described as "contact claims covid vaccine booster caused her cancer to come back". It was unknown if therapeutic measures were taken as a result of recurrent cancer. Additional information: Most recent dose 2 of COVID 19 was not bivalent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Recurrent cancer" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervous system disorder, Sedation
Clinical narrative: After each dose, new neurological symptoms manifested; I felt like I was sedated; My whole body was shutting down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID. A female patient in her 60's received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Vivaxim, administration date: 2008, for Immunization, reaction(s): "Guillain-Barre syndrome"; Dukoral, administration date: 2008, for Immunization, reaction(s): "Guillain-Barre syndrome". The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "After each dose, new neurological symptoms manifested"; SEDATION (non-serious), outcome "unknown", described as "I felt like I was sedated"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "My whole body was shutting down".  Additional information: She was no stranger to neurological vaccine side effects. In 2008, she developed Guillain-Barre syndrome due to taking Vivaxim and Dukoral for travel. Her legs gave out, and she was bedridden, although her symptoms disappeared after she went on supplement protocols. In 2021, COVID-19 vaccinations were mandated in her workplace, so she got the COVID-19 vaccine to keep her job. After each dose, new neurological symptoms manifested. Before 2021, she ran more than three miles daily and could cycle up to 46 miles on her bike despite being in her 60s. But her life changed 15 minutes after she got her first of two COVID-19 vaccine doses. "I felt like I was sedated," she told about her experience after the first dose. "My whole body was shutting down."   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: just tested positive for covid and had the three Covid-19 vaccine from Pfizer; just tested positive for covid and had the three Covid-19 vaccine from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just tested positive for covid and had the three Covid-19 vaccine from Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: It was reported that he just tested positive for covid and had the three Covid-19 vaccine from Pfizer. He hasd question about the updated version of the booster shot and he was asking it was still going to protect him.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Facial pain, Investigation, Multiple sclerosis, Musculoskeletal pain
Clinical narrative: MS symptoms; painful arms, legs,hands and feet; painful butt; painful chest; painful face; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "MS symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful arms, legs,hands and feet"; MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "painful butt"; CHEST PAIN (non-serious), outcome "unknown", described as "painful chest"; FACIAL PAIN (non-serious), outcome "unknown", described as "painful face"; PRURITUS (non-serious), outcome "unknown", described as "itching". The patient underwent the following laboratory tests and procedures: test: Unknown results. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: It was reported that patient had revolted immune system against the last booster Dec2022. Patient had MS symptoms but nerves are normal. Patient had every test. Patient lost 4 months of his life and afraid will never be normal again. Patient was not an antivaxer. Patient was the first one to stand up for the vaccine and on high doses of gabapentin and still feel the numb and itching and painful face, arms, hands, chest, butt, legs and feet. Patient just turned 68 and was an active person. Patient was scared for the rest of his life.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: MS symptoms; painful arms, legs,hands and feet; painful butt; painful chest; painful face; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "MS symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful arms, legs,hands and feet"; MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "painful butt"; CHEST PAIN (non-serious), outcome "unknown", described as "painful chest"; FACIAL PAIN (non-serious), outcome "unknown", described as "painful face"; PRURITUS (non-serious), outcome "unknown", described as "itching". The patient underwent the following laboratory tests and procedures: test: Unknown results. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: It was reported that patient had revolted immune system against the last booster Dec2022. Patient had MS symptoms but nerves are normal. Patient had every test. Patient lost 4 months of his life and afraid will never be normal again. Patient was not an antivaxer. Patient was the first one to stand up for the vaccine and on high doses of gabapentin and still feel the numb and itching and painful face, arms, hands, chest, butt, legs and feet. Patient just turned 68 and was an active person. Patient was scared for the rest of his life.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got Covid tested Positive Twice; Got Covid tested Positive Twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Apr2023, outcome "unknown" and all described as "Got Covid tested Positive Twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14Apr2023) Positive. Clinical course: Patient had the first 3 Vaccines. Then had 2 boosters the last one on 24Oct2022. On 14Apr2023 patient Covid tested Positive Twice. Had several of the symptoms that go with it. Never lost  taste completely. Patient was sick and at home for 7-10 days. Wanted to know if need another booster if that gave him more protection due to having Covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Bad reaction; 3 days of feeling terrible (malaise); This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2023NVX-US-000000511 (RA) A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Bad reaction; 3 days of feeling terrible (malaise)".  Additional information: Bad reaction; 3 days of feeling terrible (Malaise). On 26Apr2023, an initial spontaneous safety report was received from a consumer via the contact center. Event Abated After Use Stopped or Dose Reduced? Didn't apply. Event Reappeared After Reintroduction?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: still got COVID; still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID". Clinical course: Patient received all shots, never went out without a mask but still got COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Pulmonary thrombosis
Clinical narrative: blood clots on both lungs; I was playing tennis and could not breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "blood clots on both lungs"; DYSPNOEA (non-serious), outcome "unknown", described as "I was playing tennis and could not breathe". The event "blood clots on both lungs" required emergency room visit. The events "i was playing tennis and could not breathe" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: blood clots on both lungs, notes: They did a ct scan and said I had blood clots on both lungs.  Clinical course: Patient reported "I am a 78 year old woman who played tennis twice a week and was in excellent physical condition. At the end of Mar2023 I was playing tennis and could not breathe. I drove to my doctors office and he said needed the emergency room as I might be having a heart attack. They did a CT scan and said I had blood clots on both lungs. It was a serious but I managed to live. The only thing I could attribute it to was that I had that latest Pfizer booster on 06Jan.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Pentacel was given 5/12/23 that was noted to have expired on 5/4/23 with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on 12-May-2023 that was noted to have expired on 04-Apr-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-May-2023, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE for Suspension for injection (dosage, frequency, strength, lot number: not reported and expiry date: 04-Apr-2023) via unknown route in unknown administration site for immunization. Information on the batch number was requested and on the same day Pentacel was given, that was noted to have expired with no reported adverse event (expired product administered).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 guidelines. 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: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: A Pharmacist reported that over the weekend an expired dose of MENACTRA was given to a consumer with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old patient of an unknown gender and a pharmacist reported that over the weekend an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was given to a consumer 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 in May 2023, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE for solution of injection (strength, frequency: not reported and expiry date: 24-apr-2023, lot: U7273BB) via intramuscular route in the arm NOS for immunization and a pharmacist reported that over the weekend an expired dose of menactra was given to a consumer with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 guidelines. 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: 0.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered PENTACEL to a pediatric patient that expired with no reported AE; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 3 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that expired with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Mar-2023 the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot: UJ668AA; expiry date: 13-May-2023) via intramuscular route in unknown administration site for immunisation.  On 15-May-2023, the patient received an unknown expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot: UJ668AA; expiry date: 13-May-2023) via intramuscular route in unknown administration site for immunisation with no reported ae (expired product administered) (same day latency).   It was reported that The patient did not experience anything and is still under the care and monitoring of the said physician. 3 vaccines were administered prior to PENTACEL but the reporter did not disclose the information about this.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered pentacel to a pediatric patient that expired with no reported ae.  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 guidelines. 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of DAPTACEL with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and gender patient who had received an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-May-2023, the patient received an unknown expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired dose of daptacel with no reported adverse 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: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large raised red circle where the vaccine was given
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Fatigue, Malaise, SARS-CoV-2 test positive
Clinical narrative: Covid19 positive tests with medium symptoms, no hospitalization
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion. Product administered.; This spontaneous report was received from an administrator referring to a patient (unknown age and gender). The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 11-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1x dose, lot #W025273, expiration date: 10-AUG-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided) that underwent a temperature excursion at temperature of -10C for 59 minutes (Product storage error). There was no previous temperature excursion. No additional AEs (No adverse event).
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; patient was given a dose of VAXNEUVANCE after the dose was stored improperly; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #w027275, expiration date: 09-JUL-2024, administered as prophylaxis (strength, and route of administration were not provided), after the dose was stored improperly on 02-MAY-2023 at a temperature of 34 Fahrenheit degrees for 7 hours (Product storage error). No additional adverse events nor previous temperature excursions were reported.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given days before 6 months; This non-serious case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 24-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   Previously administered products included Havrix 1440 (2nd dose was given before 6 month.).   On 12-APR-2023, the patient received the 2nd dose of Havrix 1440 adult (intramuscular). On 12-APR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given days before 6 months). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date 11-MAY-2023 The patient received 1st dose on an unknown date. 2nd dose was administered before completion of 6 months from 1st dose. No reaction was reported. The reporter consented to follow up. The patient received the two dose of Hvirix less than 6 months of time period, which led to drug dose administration interval too short. This case is linked with US2023061660 case, by same reporter.; Sender's Comments:  US-GSK-US2023061660:Same reporter, different patient
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Transfusion
Clinical narrative: Anemia; This non-serious case was reported by a consumer via call center representative and described the occurrence of anemia in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anemia (Verbatim: Anemia). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). The outcome of the anemia was resolved.   It was unknown if the reporter considered the anemia to be related to Shingrix.     It was unknown if the company considered the anemia to be related to Shingrix.   Additional Information: GSK receipt date: 08-May-2023 The patient received the Shingrix 5 year ago from reporting. The reporter stated that the patient received a blood transfusion a year ago from reporting due to anemia.  The patient recovered from anemia.  The reporter did not consent to follow-up.  The reporter did not give permission to contact healthcare professional. No other information known.
Sex: M
Vaccine: VARZOS
Symptoms: Viral load increased
Clinical narrative: the patients viral load was 20 in January, 116 in March, Increased viral load to 368; This non-serious case was reported by a other health professional via call center representative and described the occurrence of viral load increased in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cabotegravir, rilpivirine (Cabenuva) suspension for injection for product used for unknown indication.   Previously administered products included Triumeq (The patient had received Dovato and Triumeq (historical drugs) prior to starting Cabenuva) and Dovato.   In APR-2023, the patient received Shingrix. In JAN-2023, the patient started Cabenuva. In APR-2023, less than a month after receiving Shingrix and between 2 and 4 months after starting Cabenuva, the patient experienced viral load increased (Verbatim: the patients viral load was 20 in January, 116 in March, Increased viral load to 368). The action taken with Cabenuva was unknown. The outcome of the viral load increased was unknown.   It was unknown if the reporter considered the viral load increased to be related to Shingrix, Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device and Cabenuva Vial Adaptor Device.     It was unknown if the company considered the viral load increased to be related to Shingrix, Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device and Cabenuva Vial Adaptor Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023  Manager called on behalf of an healthcare professional (Case Manager).   The patient received the first dose of Cabenuva (600/900) in January, the second dose in February and the third dose on 27th April 2023.  The patient also received Shingrix 2 weeks prior to receiving the third dose of Cabenuva.  The viral load had increased to 368 just prior to the third dose of Cabenuva, the patient's viral load was 20 in January and 116 in March. The reporter did not consent to follow-up.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Swelling
Clinical narrative: Allergies: Pneumococcal Vaccines Swelling; Pneumococcal Vaccines Swelling; This spontaneous report was received from a nurse practitioner via Pfizer and refers to a female patient of unknown age.  The patient's medical history and concomitant therapies were not reported. Her concurrent conditions included allergy to amlodipine (swelling), enalapril (nausea and vomiting), hydrochlorothiazide (cramps), lisinopril and to statins.  On an unknown date, the patient was vacinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiration date, anatomical injection site and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (allergy to vaccine) as swelling. The outcome of the events was not reported.  The events were considered to be related to the suspect vaccine.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2305USA004158:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: Availability issues with the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eosinophilic asthma. Concomitant products included covid-19 vaccine (Covid Vaccine).   In NOV-2022, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue (Verbatim: Availability issues with the vaccine). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt date: 09-MAY-2023 The patient was self-reported this case. The patient called in regarding a question about starting Nucala. Upon discussion, the patient reported he had taken 2 doses of Shingrix but that he had a couple of years between the first and second dose due to availability issues with the vaccine. The Patient did not recall dates of the Shingrix vaccines or the sites of the injections.  He received a covid vaccine on the same day as his second Shingrix dose sometime in November 2022. The patient received second dose of Shingrix late than recommended period due to availability issues, which led to product supply issue. The reporter did consented to follow up.
Age: 83.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 83-year-old male patient who received HAB (Twinrix) (batch number h3sg9, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (patient received twinrix first dose on 3-NOV-2022).   On 06-MAY-2023, the patient received the 2nd dose of Twinrix. On 06-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long 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: 10-MAY-2023. Afterhours Voicemail registered pharmacist called and left voicemail stating a patient who started Twinrix received their 1st dose on 3-NOV-2022 and got second dose on 6-MAY-2023, a little over 6 month mark.  They asked what to do for 3rd dose, would it be 6 months from 2nd dose or did they need to started series over.  The reporter asked would 2nd dose on May 6th be considered 1st of series. The reporter consented to follow up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to drug dose administration interval too long.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Injection site pain, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: The vaccine occured at 12 pm. The patient was given the vaccine and counseled. She stated she felt  naseaus and "felt like the room was closing in" on her. She was advised to wait in the pharmacy for 15 mins. Shortly after, she fainted and slumped over. She was blacked out for about 30 seconds then became responsive. Pt was evaluated & was still breathing - CPR was not preformed. Her BP was monitored and feet elevated until paramedics arrived. Everything was normal and refused further care.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: The vaccine occured at 12 pm. The patient was given the vaccine and counseled. She stated she felt  naseaus and "felt like the room was closing in" on her. She was advised to wait in the pharmacy for 15 mins. Shortly after, she fainted and slumped over. She was blacked out for about 30 seconds then became responsive. Pt was evaluated & was still breathing - CPR was not preformed. Her BP was monitored and feet elevated until paramedics arrived. Everything was normal and refused further care.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Nausea
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Nausea-Mild
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia
Clinical narrative: Stomach upset, early satiety, and diarrhea for 3-4 days; Fevers (Tmax 101.5F)
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve incompetence, Cardiac operation, Echocardiogram abnormal, Heart valve incompetence, Heart valve operation
Clinical narrative: I had normal to mildly leaking cardiac valves in January 2021. By October 2021, the aortic mitral and tricuspid valves were all moderate to severe leakage with open-heart surgery needed to repair 2 and replace 1 valve in May 2022. The only difference in my normal health, diet, exercise, etc. was I had 2 Covid-19 vaccinations in January 2021 and a booster in October 13,2021. The difference showed in an echogram in January 2021 and then subsequent one end of October 2021. My local cardiologist and those at clinic were concerned that this had advanced so quickly.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart valve replacement, Mitral valve incompetence, Tricuspid valve incompetence
Clinical narrative: I had normal to mildly leaking cardiac valves in January 2021. By October 2021, the aortic mitral and tricuspid valves were all moderate to severe leakage with open-heart surgery needed to repair 2 and replace 1 valve in May 2022. The only difference in my normal health, diet, exercise, etc. was I had 2 Covid-19 vaccinations in January 2021 and a booster in October 13,2021. The difference showed in an echogram in January 2021 and then subsequent one end of October 2021. My local cardiologist and those at clinic were concerned that this had advanced so quickly.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Erythema, Flushing, Hypersensitivity
Clinical narrative: I had a local reaction (red, raised, circular burning itching) to the Moderna vaccine with each injection (total of 4). A few days after the last injection I had a severe allergic reaction including numbness in my lips, ears, face and neck. Also, flushing, severe burning sensation (worse than menopause!,) raised/red/itching hives on my back and face and chest and anxiety. It lasted for approximately 30 minutes and completely resolved until the next day at approximately the same time. This happened daily and my PCP could not diagnose or treat it. I went to the allergy clinic where they did labs (all negative) and started me on Singular which seemed to help marginally. I tried oral and im steroids with marginal relief. The severe reaction continued daily, regardless of interventions, until approximately 2 months ago, when the intensity began to lessen and shortly after the frequency lessened. They continue to this day with mild symptoms 2-4 times per week. I just learned about this site today.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Laboratory test normal, Local reaction, Pruritus
Clinical narrative: I had a local reaction (red, raised, circular burning itching) to the Moderna vaccine with each injection (total of 4). A few days after the last injection I had a severe allergic reaction including numbness in my lips, ears, face and neck. Also, flushing, severe burning sensation (worse than menopause!,) raised/red/itching hives on my back and face and chest and anxiety. It lasted for approximately 30 minutes and completely resolved until the next day at approximately the same time. This happened daily and my PCP could not diagnose or treat it. I went to the allergy clinic where they did labs (all negative) and started me on Singular which seemed to help marginally. I tried oral and im steroids with marginal relief. The severe reaction continued daily, regardless of interventions, until approximately 2 months ago, when the intensity began to lessen and shortly after the frequency lessened. They continue to this day with mild symptoms 2-4 times per week. I just learned about this site today.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: I had a local reaction (red, raised, circular burning itching) to the Moderna vaccine with each injection (total of 4). A few days after the last injection I had a severe allergic reaction including numbness in my lips, ears, face and neck. Also, flushing, severe burning sensation (worse than menopause!,) raised/red/itching hives on my back and face and chest and anxiety. It lasted for approximately 30 minutes and completely resolved until the next day at approximately the same time. This happened daily and my PCP could not diagnose or treat it. I went to the allergy clinic where they did labs (all negative) and started me on Singular which seemed to help marginally. I tried oral and im steroids with marginal relief. The severe reaction continued daily, regardless of interventions, until approximately 2 months ago, when the intensity began to lessen and shortly after the frequency lessened. They continue to this day with mild symptoms 2-4 times per week. I just learned about this site today.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was improperly stored upon arrival to facility. Pt had no adverse symptoms from receiving the vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Pain in extremity, Pallor
Clinical narrative: Pt received both of her vaccines on 5/15/2023. Pt tolerated vaccines well in room with nurse and mom. When asked by RN pt stated she feels fine and has no concerns other than some arm soreness. Mom and pt walked out of room, up to the receptionist check out desk, where pt then passed out. Per mom, pt tapped mom on the shoulder and told her, while at the check out desk, that she did not feel good, mom said she looked at the pt. Her faced drained of color and turned white and then she passed out and fell on the ground. Immediately 3 nurses and Dr. came to the side of the pt and mom.  Vitals- BP, HR, O2 were checked. Pt told to lay on the ground still. Calmed mom and pt down during this time. Re-checked BP, HR, O2 - 5 minutes later. Pt able to slowly sit up, and was put in a wheelchair, and taken to a room in the office, where she was monitored for another 20  minutes. Pt given graham crackers and orange juice, as she had not eaten anything in the morning. During the 20 minutes BP taken 3 more times within defined limits. At the end of the 20 minutes pt felt better and was able to walk out of the office to her and mom's car.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Wheelchair user
Clinical narrative: Pt received both of her vaccines on 5/15/2023. Pt tolerated vaccines well in room with nurse and mom. When asked by RN pt stated she feels fine and has no concerns other than some arm soreness. Mom and pt walked out of room, up to the receptionist check out desk, where pt then passed out. Per mom, pt tapped mom on the shoulder and told her, while at the check out desk, that she did not feel good, mom said she looked at the pt. Her faced drained of color and turned white and then she passed out and fell on the ground. Immediately 3 nurses and Dr. came to the side of the pt and mom.  Vitals- BP, HR, O2 were checked. Pt told to lay on the ground still. Calmed mom and pt down during this time. Re-checked BP, HR, O2 - 5 minutes later. Pt able to slowly sit up, and was put in a wheelchair, and taken to a room in the office, where she was monitored for another 20  minutes. Pt given graham crackers and orange juice, as she had not eaten anything in the morning. During the 20 minutes BP taken 3 more times within defined limits. At the end of the 20 minutes pt felt better and was able to walk out of the office to her and mom's car.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye discharge, Eye infection, Fatigue, Malaise
Clinical narrative: I did not have a adverse reaction to the vaccine.  On 04/16, I began not feeling well and tired all day. I developed a cough on 04/17. On 04/21, I woke up with my left eye was swollen and glued shut like I had conjunctivitis. I went to an urgent care facility and got antibiotics for the infection. The eyedrops they gave me for the eyes did not work so I had to get another prescription.  I tested negative for COVID-19 on 04/16/2023.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, SARS-CoV-2 test negative, Swelling of eyelid
Clinical narrative: I did not have a adverse reaction to the vaccine.  On 04/16, I began not feeling well and tired all day. I developed a cough on 04/17. On 04/21, I woke up with my left eye was swollen and glued shut like I had conjunctivitis. I went to an urgent care facility and got antibiotics for the infection. The eyedrops they gave me for the eyes did not work so I had to get another prescription.  I tested negative for COVID-19 on 04/16/2023.