chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.; No adverse event; Dose administered after manufacturer date of expiry to 12 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients) and PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.).    No concomitant medications were reported.  A Moderna vaccine that expired on 24April2022, was given past the expiration date through the month of June to 12 patients.  Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator.The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547:Same reporter/event
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccines were removed from the freezer on date of appointments to be used,; No adverse event; Dose administered after manufacturer date of expiry to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient), PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used,) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used,) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient), PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used,) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient) and PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used,).    No concomitant medications were reported. Total 200 doses and 20 vials were administered. The vials were initially stored in the refrigerator on 05-May-2022, 06-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-Jun-2022. Reporter explained that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Ear infection. Concurrent medical conditions included Drug allergy (Amoxicillin) and Penicillin allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccines were removed from the freezer on date of appointments to be used, and any unused; No adverse event; Dose administered after manufacturer date of expiry to  patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient) and PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused).    No concomitant drug was reported. Number of dose or vials reported as 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022, 6-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-June-2022. It was reported that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. Vial did not undergoes temperature excursion. No Treatment medications were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry to 12 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator).    No concomitant medications were reported. Number of doses/vials was reported as 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022, 6-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-June-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and the unused portion was put back in refrigerator. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Fatigue, Illness
Clinical narrative: Sick from first two Moderna COVID vaccine injections; Hair loss; Fatigue; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick from first two Moderna COVID vaccine injections), ALOPECIA (Hair loss), FATIGUE (Fatigue) and ARTHRALGIA (Aching joints) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Psoriatic arthritis.    The patient's past medical history included Shingles in 2018. Concurrent medical conditions included Ankylosing spondylitis and Psoriatic arthritis.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick from first two Moderna COVID vaccine injections), ALOPECIA (Hair loss), FATIGUE (Fatigue) and ARTHRALGIA (Aching joints). At the time of the report, ILLNESS (Sick from first two Moderna COVID vaccine injections) had resolved and ALOPECIA (Hair loss), FATIGUE (Fatigue) and ARTHRALGIA (Aching joints) had not resolved.            No concomitant medication was reported. Patient was not enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of fatigue, aching joints and hair loss with HUMIRA (ADALIMUMAB) was a reasonable possibility. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 7-Feb-21 and second dose on 27-Feb-21; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21).    No concomitant medications was reported.  The reporter informed that, no adverse event was known.  No treatment drug details was reported.   This case was linked to MOD-2022-620425, MOD-2022-608992 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Third dose administered  0.3ml; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Third dose administered  0.3ml) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FF8839) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 30-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Third dose administered  0.3ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Third dose administered  0.3ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Third dose administered  0.3ml).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-620415, MOD-2022-608992 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 30-Jan-21 and second dose on 20-Feb-21; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21).    Concomitant medication information was not provided by the reporter.  The reporter informed that, no adverse events was known.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-608998, MOD-2022-620515 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; Third dose administered 0.3ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Third dose administered 0.3ml) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 301458A) for COVID-19 prophylaxis.     Patient had ever been diagnosed or tested positive for COVID-19 was unknown. Acute illness at the time of vaccination and up to one month prior was reported as unknown. Chronic and long standing health condition was reported as unknown.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 07-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Third dose administered 0.3ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Third dose administered 0.3ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Third dose administered 0.3ml).    No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-620475, MOD-2022-608998 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: Injection site redness(very small red bruised dot around site of injection); Fever of 38.8 overnight (12-15 hours after the vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 38.8 overnight (12-15 hours after the vaccine)) and VACCINATION SITE ERYTHEMA (Injection site redness(very small red bruised dot around site of injection)) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced PYREXIA (Fever of 38.8 overnight (12-15 hours after the vaccine)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness(very small red bruised dot around site of injection)). At the time of the report, PYREXIA (Fever of 38.8 overnight (12-15 hours after the vaccine)) and VACCINATION SITE ERYTHEMA (Injection site redness(very small red bruised dot around site of injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Transplant rejection
Clinical narrative: Patient experienced acute cellular rejection ater Moderna vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Liver transplant.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) (seriousness criterion medically significant). At the time of the report, TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) to be related.    Company comment: This is a literature-non-study case concerning a 71-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant and treatment medications were reported.   This case was linked to MOD-2022-621477, MOD-2022-621478 (E2B Linked Report).; Sender's Comments: Company comment: This is a literature-non-study case concerning a 71-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. MOD-2022-621477:Patient 2: 50 years male MOD-2022-621478:Patient 3: 61 years female
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Transplant rejection
Clinical narrative: Acute cellular rejection; This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Acute cellular rejection) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   Acute cellular rejection in liver transplantation recipients following vaccination against coronavirus disease 2019: A case series. Liver Transpl.    The patient's past medical history included Liver transplantation.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (Acute cellular rejection) (seriousness criterion medically significant). At the time of the report, TRANSPLANT REJECTION (Acute cellular rejection) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TRANSPLANT REJECTION (Acute cellular rejection) to be related.    Company comment: This is a literature-non-study case concerning a 50-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant and treatment medications were reported.   This case was linked to MOD-2022-621440, MOD-2022-621478 (E2B Linked Report).; Sender's Comments: Company comment: This is a literature-non-study case concerning a 50-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. MOD-2022-621478:Patient 3: 61 years female MOD-2022-621440:Patient 1: 71 years male
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Rhinorrhoea
Clinical narrative: tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?; tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; This case has been considered invalid as Reporter with No First-hand Knowledge.Information received PRD 01Aug2022/SRD 02Aug2022. Measurable supplier - Pfizer colleague. Case was conservatively upgraded as valid as a HCP reporter was added. Reporter #31 and #32 added.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician), Program ID.  A 79-year-old male patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "brain problem" (unspecified if ongoing), notes: he's had brain problem for a year or two now. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), FATIGUE (non-serious), COUGH (non-serious) all with onset 20Jul2022, outcome "unknown" and all described as "had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "unknown" and all described as "tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive, notes: President (name) tested positive for Covid this morning after being vaccinated and having 2 booster shots; (19Jul2022) Negative, notes: had last tested negative on Tuesday. 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.  SUSPECT PRODUCT is under agreement with regulatory authority.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?; tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; This case has been considered invalid as Reporter with No First-hand Knowledge.Information received PRD 01Aug2022/SRD 02Aug2022. Measurable supplier - Pfizer colleague. Case was conservatively upgraded as valid as a HCP reporter was added. Reporter #31 and #32 added.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician), Program ID.  A 79-year-old male patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "brain problem" (unspecified if ongoing), notes: he's had brain problem for a year or two now. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), FATIGUE (non-serious), COUGH (non-serious) all with onset 20Jul2022, outcome "unknown" and all described as "had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "unknown" and all described as "tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive, notes: President (name) tested positive for Covid this morning after being vaccinated and having 2 booster shots; (19Jul2022) Negative, notes: had last tested negative on Tuesday. 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.  SUSPECT PRODUCT is under agreement with regulatory authority.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, COVID-19, Cough, Drug ineffective, Nasal congestion
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Cough worsened; Sore throat; Stuffy nose; GI upset; Vomiting; Aggressive Cough; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (boster), single (Lot number: FF2589) at the age of 30 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's relevant medical history included: "Con Willebrands Disease" (unspecified if ongoing); "PCOD" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX DM, start date: 23Jul2022. The following information was reported: COUGH (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Aggressive Cough"; ABDOMINAL DISCOMFORT (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "GI upset"; OROPHARYNGEAL PAIN (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Stuffy nose"; VOMITING (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering"; COUGH (non-serious) with onset 23Jul2022, outcome "recovering", described as "Cough worsened"; DRUG INEFFECTIVE (medically significant) with onset 23Jul2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 23Jul2022 at 12:00, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Negative, notes: Started with an aggressive cough on 22July around 10:00, negative COVID antigen test; (23Jul2022) Positive, notes: Cough worsened on 23July, positive test taken at 12:00 this day. Therapeutic measures were taken as a result of covid-19, cough, cough, oropharyngeal pain, nasal congestion, abdominal discomfort, vomiting.  Clinical course: Patient received treatment with Paxlovid for the adverse events which was prescribed on 25July. Patient had no known allergies.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Vomiting
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Cough worsened; Sore throat; Stuffy nose; GI upset; Vomiting; Aggressive Cough; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (boster), single (Lot number: FF2589) at the age of 30 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's relevant medical history included: "Con Willebrands Disease" (unspecified if ongoing); "PCOD" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX DM, start date: 23Jul2022. The following information was reported: COUGH (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Aggressive Cough"; ABDOMINAL DISCOMFORT (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "GI upset"; OROPHARYNGEAL PAIN (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Stuffy nose"; VOMITING (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering"; COUGH (non-serious) with onset 23Jul2022, outcome "recovering", described as "Cough worsened"; DRUG INEFFECTIVE (medically significant) with onset 23Jul2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 23Jul2022 at 12:00, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Negative, notes: Started with an aggressive cough on 22July around 10:00, negative COVID antigen test; (23Jul2022) Positive, notes: Cough worsened on 23July, positive test taken at 12:00 this day. Therapeutic measures were taken as a result of covid-19, cough, cough, oropharyngeal pain, nasal congestion, abdominal discomfort, vomiting.  Clinical course: Patient received treatment with Paxlovid for the adverse events which was prescribed on 25July. Patient had no known allergies.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Fatigue, Psoriasis, Pyrexia, Skin exfoliation
Clinical narrative: itchy and scaly ears; itchy and scaly ears; Plaque psoriasis flare-up; Fatigue and fever after first dose of covid vaccine; Fatigue and fever after first dose of covid vaccine; 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-163-4484013-00.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years intramuscular for covid-19 immunisation; risankizumab RISANKIZUMAB, since 01Oct2019 (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PYREXIA (non-serious) all with onset Mar2021, outcome "recovered" (2021) and all described as "Fatigue and fever after first dose of covid vaccine"; EAR PRURITUS (non-serious), SKIN EXFOLIATION (non-serious), outcome "unknown" and all described as "itchy and scaly ears"; PSORIASIS (non-serious), outcome "not recovered", described as "Plaque psoriasis flare-up". The action taken for risankizumab was dosage not changed.  Additional information: Solicited report from the privacy by a consumer of a 51-years-old female with events of non-serious fatigue and fever after first dose of covid vaccine and plaque psoriasis flare up with Skyrizi (Risankizumab). There was no reported medical history. On an unknown date, the patient experienced plaque psoriasis and flare up. On an unspecified date in Mar2021, the patient experienced fatigue and fever after first dose of covid vaccine. On an unspecified date in 2021, the fatigue and fever after first dose of covid vaccine was resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered as suspect. On an unspecified date in Mar2021, the patient had fatigue and mild fever after first dose of Pfizer vaccine. She had occasional itchy and scaly ears, especially after travel. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial. Primary reporter contact for lot number information was unsuccessful.  Causality for Risankizumab: The reporter's causality for the event(s) of fatigue and fever after first dose of covid vaccine onset in Mar2021 with Risankizumab was not related and no reasonable possibility. The reporter's causality for the event(s) of plaque psoriasis flare up with Risankizumab was probable and a reasonable possibility. The reporter's causality for the event(s) with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was not reported.  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: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm 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), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01Aug2022) Positive, notes: I tested again and was positive on August 01 2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Started process on 21Jul2022 completed process 5 days later wore a mask for 5 days. Day 6 after completing Paxlovid patient started having the same symptoms headache sore congestion achy body so he tested again and was positive on 01Aug2022. The patient did not received any other medications within 2 weeks prior to vaccination and the patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
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 a contactable reporter(s) (Nurse).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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), 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: "COPD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "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 treated with Paxlovid, Orally stopped on 25Jul2022.  Clinical course: Reinfection after Paxlovid regimen started on 01Aug2022 and not recovered. Known allergies: NKDA (No known drug allergy)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Flu like symptoms; fatigue; 1st dose:Date: 20May2021. 2nd dose: Date: 11Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Lot number: EC3180) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot number: EW0171), administration date: 20May2021, when the patient was 22-year-old, for COVID-19 immunization, reaction(s): "Flu like symptoms", "Fatigue". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Aug2021, outcome "unknown", described as "1st dose:Date: 20May2021. 2nd dose: Date: 11Aug2021"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms"; FATIGUE (non-serious), outcome "recovered".  Additional information: Caller had 3 total doses of the Pfizer COVID-19 vaccine. Provided vaccination information from vaccination card. Just besides feeling general fatigue and flu like symptoms which caller stated everyone experiences. Caller confirmed he had general fatigue and flu like symptoms with the 1st and 2nd doses of the Pfizer COVID-19 vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 15Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ALCL Alk+ (history)" (unspecified if ongoing), notes: Other medical history: ALCL Alk+ (history); "TMD" (unspecified if ongoing), notes: Other medical history: TMD; "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codiene, reaction(s): "Known allergies Codiene", notes: Known allergies: Codiene. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: two negative tests; Negative, notes: two negative tests; Positive, notes: Tested positive with mild symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Severe allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergies".  Additional information: Description of Event Outcome: My son was strongly advised not to get a 2nd vaccination after receiving a letter of opinion from two doctors due to side effects (severe allergies) after the first vaccination of Pfizer. But he was currently in the process of receiving permanent residency and the Immigration Dep was demanding the results of his 2nd vaccination as a required document. Therefore, wanted the official letter of Pfizer so that he can continue the permanent residency process without getting the 2nd vac.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.