chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) 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)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant medications were reported.   It was reported that, nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter. It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.  It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL. No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose); No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)).    Concomitant medications were not reported.   It was reported that approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster. It was reported when first administered Bivalent boosters. So, the nurse assumed the same dose as the second booster and they administered 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that no adverse event was reported. This case was for one of the patient among the 100 patients who were administered an invalid dose of the Moderna COVID-19 bivalent booster.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was provided.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case( Same reporter)
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant medications were reported. No treatment details were reported.  Patient received underdose of 0.25 ml Moderna Bivalent Booster.  It was reported that, nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Same reporter (Master case)
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter. No treatment medication reported by reporter.  Patient received underdose of 0.25 ml Moderna Bivalent Booster.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Same reporter (Master case)
Sex: U
Vaccine: PNC13, PPV
Symptoms: Immunodeficiency
Clinical narrative: Patient 65+ received both Prevnar 13 and PPSV23 previously but now has an immunocompromising condition; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An elderly patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown,single (Batch/Lot number: unknown) for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Patient 65+ received both Prevnar 13 and PPSV23 previously but now has an immunocompromising condition".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event immunodeficiency with the suspect product Prevenar -13 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: U
Vaccine: COVID19
Symptoms: Body temperature, Seizure
Clinical narrative: Seizure; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 0.2 ml single (Batch/Lot number: unknown) and as dose 2, 0.2 ml 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: SEIZURE (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: unknown results.  VAERS is a passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination. VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities preferred terms (MedDRA PTs) by VAERS staff. Reports of serious events to VAERS were reviewed by CDC and FDA physicians to form a consensus clinical impression based on available data. VAERS reports were described by serious and nonserious status, demographic characteristics, and MedDRA PTs. VAERS is a passive reporting system and is subject to reporting biases and underreporting, especially of nonserious events.  No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event seizure with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200058294 Same article/drug, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Febrile convulsion
Clinical narrative: Febrile seizure; This is a literature report.  A child patient received BNT162b2 (BNT162B2), 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: FEBRILE CONVULSION (medically significant), outcome "unknown", described as "Febrile seizure". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results.  VAERS is a passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination. VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities preferred terms (MedDRA PTs) by VAERS staff. Reports of serious events to VAERS were reviewed by CDC and FDA physicians to form a consensus clinical impression based on available data. VAERS reports were described by serious and nonserious status, demographic characteristics, and MedDRA PTs. VAERS is a passive reporting system and is subject to reporting biases and underreporting, especially of nonserious events.  No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event febrile convulsion with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200058294 Same article/drug, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Osteoporosis
Clinical narrative: Osteoporosis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), 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 complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: OSTEOPOROSIS (non-serious), outcome "unknown".  Additional information: Reporter mentioned that, she received the booster of the Pfizer-BioNTech Covid 19 Vaccine monovalent and she had some bad reactions due to this vaccine (no date regarding when she received it was provided and no adverse events were specified). She was concerned that she might have allergic reactions if she receive the bivalent and wanted to know what are the reported adverse events and if deaths have been reported for the Pfizer-BioNTech Covid 19 vaccine bivalent. She mentioned that, she has osteoporosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 21Aug2022 at 14:00 as dose 5 (booster), single (Lot number: FP7138) at the age of 29 years, 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: "Generalized Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "chronic moderate Asthma" (unspecified if ongoing); "Known allergies: Lavender" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 01Mar2022, stop date: 13Sep2022; BUSPIRONE, start date: 01Apr2022, stop date: 12Sep2022; ESCITALOPRAM, start date: 01Jun2022, stop date: 20Sep2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2022, stop date: 20Sep2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: She had a side effect on her legs with the previous vaccine; 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 female patient received BNT162b2 (BNT162B2), 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. Past drug history included: Allergic to citric acid, reaction(s): "She said she is allergic to citric acid"; Allergic to citric acid, reaction(s): "her throat closes". The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "She had a side effect on her legs with the previous vaccine".  Additional information: Caller was asking about the bivalent vaccine, she heard there are two new ingredients added so she was wondering if those contain citric acid. She said she was allergic to citric acid. If she gets citric acid, her throat closes. She said that, she had a side effect on her legs with the previous vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Inappropriate schedule of product administration, Pericardial effusion, Pericarditis
Clinical narrative: Pericarditis; Pericardial Effusion with surgical drainage; Fibromyalgia; Dose 1: 21Dec2020; Dose 2: 07Jan2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 at 08:00 as dose 2, single (Lot number: EL1284) at the age of 58 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure; "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Vaccination history included: BNT162b2 (lot number=EH 9899, administration time=09:00 AM, dose number=1, location=Right arm), administration date: 21Dec2020, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Jan2021, outcome "unknown", described as "Dose 1: 21Dec2020; Dose 2: 07Jan2021"; FIBROMYALGIA (hospitalization, disability, life threatening) with onset 20Jan2021 at 12:00, outcome "recovering"; PERICARDIAL EFFUSION (hospitalization, disability, life threatening) with onset 20Jan2021 at 12:00, outcome "recovering", described as "Pericardial Effusion with surgical drainage"; PERICARDITIS (hospitalization, disability, life threatening) with onset 20Jan2021 at 12:00, outcome "recovering". The patient was hospitalized for pericarditis, pericardial effusion, fibromyalgia (hospitalization duration: 6 day(s)). The events "pericarditis", "pericardial effusion with surgical drainage" and "fibromyalgia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pericarditis, pericardial effusion, fibromyalgia. Adverse events were Pericarditis, Pericardial Effusion with surgical drainage, Hospitalization 1 week (as reported), recurrent Pericarditis, post vaccine syndrome (ongoing), Fibromyalgia. AE treatment: Surgical Pericardial drainage. The patient did not have COVID prior vaccination, was not COVID tested post vaccination. The patient had no known allergies.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Body temperature, Incorrect dose administered, Off label use, Product use issue, Pyrexia
Clinical narrative: Fever of 99.4; Inappropriate dose of Vaccine administered; Off label use; Product use for unapproved combination; This is a spontaneous report received from 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 19Sep2022 at 05:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 62 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 19Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT; CLARITIN [CLARITHROMYCIN]. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 19Sep2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 19Sep2022, outcome "unknown", described as "Product use for unapproved combination"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 19Sep2022 at 05:30, outcome "unknown", described as "Inappropriate dose of Vaccine administered"; PYREXIA (non-serious) with onset 20Sep2022 at 18:00, outcome "recovering", described as "Fever of 99.4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Patient had no covid prior vaccination and not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Wound infection
Clinical narrative: Dry eyes; Wound infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4433870-00 (Agency).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Non-Tobacco User" (unspecified if ongoing); "Abstains from Alcohol" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: CEPHALEXIN AMEL; CLONAZEPAM; LITHIUM CARBONATE; METFORMIN; METHOTREXATE; PRAMIPEXOLE; VALTREX S. The following information was reported: DRY EYE (medically significant), outcome "unknown", described as "Dry eyes"; WOUND INFECTION (medically significant), outcome "not recovered".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE; SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Sep2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative; (Sep2022) Negative; (Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 10Sep2022 to 14Sep2022. Per clinical course, the patient tested negative three times after treatment with PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chest pain, Chills, Pyrexia
Clinical narrative: temperature of a 102 that got up too; he had very bad chills; aches in his chest and abdomen; aches in his chest and abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 as dose number unknown (booster), single (Lot number: EL9267) at the age of 87 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DONEPEZIL; FAMOTIDINE; GABAPENTIN; ATORVASTATIN; HYDROCHLOROTHIAZIDE; TRAZODONE. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious), ABDOMINAL PAIN (non-serious) all with onset 2022, outcome "recovered" and all described as "aches in his chest and abdomen"; CHILLS (non-serious) with onset 2022, outcome "recovered", described as "he had very bad chills"; PYREXIA (non-serious) with onset 2022, outcome "recovered", described as "temperature of a 102 that got up too". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, chest pain, abdominal pain.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Tiny pin point of blood in his arm after the administration; 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 male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Tiny pin point of blood in his arm after the administration"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Tiny pin point of blood in his arm after the administration"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "Tiny pin point of blood in his arm after the administration". The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Tiny pin point of blood in his arm after the administration".  Additional information: Caller explained that, for the first four doses, he did not had any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177784 same patient/drug/event, different dose number;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; BUPROPION; SERTRALINE; HUMALOG; OMEPRAZOLE; METFORMIN. Vaccination history included: Pertussis vaccine, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: Tested positive after being completely negative; (20Sep2022) Positive, notes: Tested positive after being completely negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; contracted COVID-19; contracted COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 02245892.  A male patient received BNT162b2 (PFIZER COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset May2022, outcome "unknown" and all described as "contracted COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown results, notes: contracted COVID-19 around May2022. The patient received two of the elasomeran and BNT162b2 booster shots contracted COVID-19 around May2022. 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: Cerebrovascular accident, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; doctor said probably caused his stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02245892.  A male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Moderna covid-19 vaccine (Dose: 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose: 2), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Mar2022, outcome "unknown", described as "doctor said probably caused his stroke"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". 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: Menstruation irregular
Clinical narrative: Daughter received the primary series last year. She received the booster in November. Since then, she has not had her period.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent.  A 16-year-old female patient 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. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "Daughter received the primary series last year. She received the booster in November. Since then, she has not had her period.".  Additional information: The patient received the primary series last year. She received the booster in Nov2021. Since then, she has not had her period. Her period was not regular when she received the booster, however, it was non existent at this time. The patient has also gone through some weight loss. The only difference from everyday life was the fact that the patient received the Pfizer BioNTech Covid-19 vaccine booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19 Vaccine; Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH6964) at the age of 72 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK9231), on 01Feb2021 as dose 2, single (Lot number: EL9262), on 29Aug2021 as dose 3 (booster), single (Lot number: EW0185) and on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma. Concomitant medication(s) included: FINASTERIDE (ongoing); TAMSULOSIN (ongoing); QVAR taken for asthma (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "not recovered" and all described as "Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive, notes: Unit: Not Provided. Tested positive for Covid 19 on a self test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 63 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Jan2021, stop date: 10Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: previous no symptoms and negative test; (Sep2022) Positive; (20Sep2022) Positive, notes: 20Sep with retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ5682) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient had no known allergies and no other medical history. The patient also do not have other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: rash under my breasts that is very bad and red; body hives all over the place from head to toe; 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 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 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: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for Covid-19 Immunization, reaction(s): "I never had issue"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for Covid-19 Immunization, reaction(s): "I never had issue". The following information was reported: URTICARIA (non-serious) with onset 20Sep2022, outcome "unknown", described as "body hives all over the place from head to toe"; RASH ERYTHEMATOUS (non-serious) with onset 20Sep2022, outcome "unknown", described as "rash under my breasts that is very bad and red".  Additional information: Caller received the Pfizer Covid-19 Bivalent vaccine on 12Sep at (facility name withheld). Caller reported that she has never ever had a problem with shots in her life. Yesterday 20Sep, she developed a rash under her breasts that was very bad and red, and she had body hives all over the place from head to toe. Caller was not sure if this was an adverse reaction to the vaccine, laundry detergent, soap, or something she ate. Caller provided that she received the Pfizer Covid-19 primary vaccines as well. Caller was querying what she should do about her body hives, if she should go to a dermatologist or her doctor. She was not allowed to return to work.  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.