chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine had been in the refrigerator for more than 30 days; No adverse event; patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator), PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A and 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator), PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator) and PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days).    Concomitant medications were not reported. Patient received vaccine past 30 day use by date in refrigerator. On 06-Sep-2022 vial was initially stored in the refrigerator. The vial size was 2.5ml. There was no adverse reactions for dose 1. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Feeling dizzy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Feeling dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Feeling dizzy). At the time of the report, DIZZINESS (Feeling dizzy) outcome was unknown.            No concomitant medications were provided. The Patient does not reports any adverse reactions after first booster dose. No treatment medication was provided.   This case was linked to MOD-2022-661563, MOD-2022-661585, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Feeling dizzy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Feeling dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Feeling dizzy). At the time of the report, DIZZINESS (Feeling dizzy) outcome was unknown.            No concomitant medications were provided. The Patient does not reports any adverse reactions after first booster dose. No treatment medication was provided.   This case was linked to MOD-2022-661563, MOD-2022-661585, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very fatigued; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (17Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lowers the immune system" (unspecified if ongoing), notes: Lowers the immune system; "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for immune system disorder, osteoporosis. Past drug history included: Bnt162b2, start date: 12Mar2021, stop date: 12Mar2021, for COVID-19 immunization, reaction(s): "numbness". Vaccination history included: BNT162b2 (Dose 1), administration date: 12Mar2021, for COVID-19 immunization, reaction(s): "she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms", "she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Very fatigued". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired Havrix administered; 1st dose 20 years ago, 2nd dose on 11Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received 20 years ago).   On 11th October 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's Comments: The pharmacist and also patient called to report that 2nd expired Havrix dose was given on yesterday. The HCP (Health care professional) also reported that 1st dose was administered 20 years ago. The reporter wanted to know does patient need to restart the series.  The vaccine administration facility was the same as primary reporter. The date of birth was not asked during conversation. The lot number obtained from research as HCP was not aware of this information. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. The patient received 2nd dose of Havrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 019B21A, 032F21A and 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            No concomitant medication were reported.  Patient experienced second episode of sore left arm on 6-APR-2021 and third episode of sore left arm on 12-APR-2022. Patient had no adverse reactions reported with third dose.                No treatment information was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022; No adverse event; Patient was administered expired bivalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, 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 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022).    Concomitant product use was not provided by the reporter.  On 13-SEP-2022, the vial was initially stored in the refrigerator.  Vial size was 2.5ml.  The vial did not undergone any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661310 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661310:same reporter
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 13-Sep-2022, date of administration of vaccine 18-Oct-2022; No adverse event; Patient was administered expired bivalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 13-Sep-2022, date of administration of vaccine 18-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, 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 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 13-Sep-2022, date of administration of vaccine 18-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 13-Sep-2022, date of administration of vaccine 18-Oct-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 13-Sep-2022, date of administration of vaccine 18-Oct-2022).    No concomitant medication was provided.  Patient received Moderna for the primary doses.  The patient had Moderna bivalent booster that expired on 13-Oct-2022.   Dose administered after 30-day use by date  Vial was initially stored in the refrigerator 13-Sep-2022 and the vial size was 2.5 ml.  Vial did not undergo any temperature excursions.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661306 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661306:same reporter
Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Eye discharge, Eye irritation, Nausea, Off label use
Clinical narrative: Eyes became very scratchy and matter began to build up; Eyes became very scratchy and matter began to build up; Nauseous; Threw up; Chills; Pfizer Covid bivalent vaccine and flu shot received on the same day; Pfizer Covid bivalent vaccine and flu shot received on the same day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Oct2022 at 14:00, outcome "unknown" and all described as "Pfizer Covid bivalent vaccine and flu shot received on the same day"; CHILLS (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered"; EYE IRRITATION (non-serious), EYE DISCHARGE (non-serious) all with onset 11Oct2022 at 18:00, outcome "recovered" and all described as "Eyes became very scratchy and matter began to build up"; NAUSEA (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered", described as "Nauseous"; VOMITING (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered", described as "Threw up". Therapeutic measures were not taken as a result of eye irritation, eye discharge, nausea, vomiting, chills.  Additional information: Patient has no known allergies. She did not receive any other vaccines within 4 week prior vaccination. She had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Vomiting
Clinical narrative: Eyes became very scratchy and matter began to build up; Eyes became very scratchy and matter began to build up; Nauseous; Threw up; Chills; Pfizer Covid bivalent vaccine and flu shot received on the same day; Pfizer Covid bivalent vaccine and flu shot received on the same day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Oct2022 at 14:00, outcome "unknown" and all described as "Pfizer Covid bivalent vaccine and flu shot received on the same day"; CHILLS (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered"; EYE IRRITATION (non-serious), EYE DISCHARGE (non-serious) all with onset 11Oct2022 at 18:00, outcome "recovered" and all described as "Eyes became very scratchy and matter began to build up"; NAUSEA (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered", described as "Nauseous"; VOMITING (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered", described as "Threw up". Therapeutic measures were not taken as a result of eye irritation, eye discharge, nausea, vomiting, chills.  Additional information: Patient has no known allergies. She did not receive any other vaccines within 4 week prior vaccination. She had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypertension, Palpitations
Clinical narrative: Having like heart palpitations and 'got over the cranny'; getting just like high blood pressure.; like you are going to get like anaphylaxis / he was relaxed as it just seemed like mental / it was like self-limitation, after the vaccine (COVID-19 Vaccine); This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: PALPITATIONS (non-serious), outcome "unknown", described as "Having like heart palpitations and 'got over the cranny'"; HYPERTENSION (non-serious), outcome "unknown", described as "getting just like high blood pressure."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "like you are going to get like anaphylaxis / he was relaxed as it just seemed like mental / it was like self-limitation, after the vaccine (COVID-19 Vaccine)". Additional information: Patient reported that like his friend was telling him, like you are going to get like anaphylaxis or something. He went into his car and after, he was having like heart palpitations and 'got over the cranny'. But he was relaxed as it just seemed like mental and once you calm down then and he did not really have a reaction and that was not anaphylaxis. It was like constantly he was getting just high blood pressure. Also stated that it was like self-limitation, after the vaccine (COVID-19 Vaccine). The causality as reported by the physician: He did not believe/thought that his reaction was due to the COVID Vaccine (COVID-19 Vaccine).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 19:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 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: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "reflux" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SINGULAIR; PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Drixoral for drug use for unknown indication, reaction(s): "Known allergies: Drixoral". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Oct2022 at 18:30, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative, notes: I tested negative and had no symptoms three times starting on Sunday, 09Oct2022; (13Oct2022) Positive, notes: Then in the afternoon of Thursday, 13Oct2022, I started to have symptoms, took another test and tested positive immediately; (Oct2022) Negative, notes: I tested negative and had no symptoms three times starting on Sunday, 09Oct2022; (Oct2022) Negative, notes: I tested negative and had no symptoms three times starting on Sunday, 09Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient tested negative and had no symptoms three times starting on Sunday, 09Oct2022. Then in the afternoon of Thursday, 13Oct2022, she started to have symptoms, took another test and tested positive immediately. Patient was treated with Paxlovid from 04Oct2022 to 08Oct2022 for treatment of COVID-19. Patient was on Birth control.  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.
Age: 67.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: BV6J2527) at the age of 67 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 was not reported. Concomitant medication(s) included: STATIN EZ, start date: 01Nov2021, stop date: 08Oct2022. Past drug history included: Tetracycline, reaction(s): "Known allergies Tetracycline", notes: Known allergies Tetracycline; Doxycycline, reaction(s): "Known allergies Doxycycline", notes: Known allergies Doxycycline.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 5: Moderna bivalent, Dose 1,2,3 & 4: Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 06Jan2021 as dose 2, single (Batch/Lot number: unknown), on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: gels" (unspecified if ongoing), notes: Known allergies: Propylene glycol and gels; "Asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "hashimotos thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 06Sep2022; METOPROLOL; OMEPRAZOLE; LEVOTHYROXINE; LIPITOR, stop date: 07Oct2022; AUGMENTINE [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM], start date: 06Oct2022, stop date: 15Oct2022; LEVALBUTEROL [LEVOSALBUTAMOL HYDROCHLORIDE], start date: 25Aug2022; BUDESONIDE, start date: 28Aug2022; NYSTATIN, start date: 11Oct2022. Past drug history included: Propylene glycol, reaction(s): "Allergy", notes: Known allergies: Propylene glycol and gels. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Sep2022, outcome "unknown", described as "Dose 5: Moderna bivalent, Dose 1,2,3 & 4: Pfizer / BioNTech"; VACCINATION FAILURE (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. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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 available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events.
Sex: M
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 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) 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: "HBP" (unspecified if ongoing), notes: other medical history: HBP. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received the vaccine and also other medications in 2 weeks.  The patient has received treatment as a result of AE which was Paxlovid from 06Oct2022 to 11oct2022.    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.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Overdose, Product preparation error
Clinical narrative: Received undiluted dose of vaccine; Received undiluted dose of vaccine; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 16Oct2022 at 13:00 as dose 1, 0.2 ml single (Lot number: FT1551) at the age of 5 years, in left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Oct2022, outcome "unknown"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 16Oct2022 at 13:00, outcome "unknown" and all described as "Received undiluted dose of vaccine".  Additional information: The reporter stated her 5 year old daughter received a dose of the vaccine that was not diluted. Reporter tried to clarify if this was the Orange Cap vaccine that the patient received but this was unknown by the caller as the vaccine was administered by a pharmacy. Reporter was just concerned about any long term side effects for her daughter. Stated that she was taking the patient to the pediatrician on reported date (17Oct2022, at 10:45) but has not been to the physician's office at time of call. This was the first dose of the Pfizer BioNTech Covid 19 Vaccine for the patient. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available) was reported as none. No additional Vaccines were administered on same date of the Pfizer Suspect. Prior vaccinations (within 4 weeks) or any other vaccinations prior to the first administration date of the suspect vaccine was reported as none. No AE(s) following prior vaccinations. Upon receipt of FU(17Oct2022), reporter updated, the patient hasn't had any reactions in terms of respiratory or anything. Patient was doing okay on the day of reporting and patient just complained of a headache.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Moderona / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206) and on 30Mar2021 as dose 2, single (Lot number: ER8733) at the age of 74 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 as dose 3 (booster), single (Lot number: 939903) and on 31Mar2021 as dose 4 (booster), single (Lot number: 066R21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOSARTAN, start date: May2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 4:Moderna / Dose Number: 3:Moderona / Dose Number: 2:Pfizer / Dose Number 1:Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2weeks. Patient received COVID 19 Treatment, Paxlovid, start date: 02Oct2022, stop date: 07Oct2022, Indication: Treatment of COVID-19. Adverse event: Rebound Covid infection. First new symptom on 13Oct2022; tested postive for Covid on 15Oct2022.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site had redness; was sore to the touch for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Wheat" (unspecified if ongoing), notes: Known allergies: Wheat. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 04Oct2022 at 11:00, outcome "recovered" (07Oct2022), described as "Injection site had redness"; VACCINATION SITE PAIN (non-serious) with onset 04Oct2022 at 11:00, outcome "recovered" (07Oct2022), described as "was sore to the touch for 3 days". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no other vaccine in four weeks. The events did not result in emergency room, physician office visit or intensive care unit.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: little bit of fever but it only went up 1 degree; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing), notes: Type II diabetes diagnosed 7 years ago. Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6201), administration date: 24Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "soreness to that area", "swelling in arm"; BNT162b2 (DOSE 2, SINGLE, Lot: EN6208), administration date: 16Mar2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "soreness to that area", "swelling in arm". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "little bit of fever but it only went up 1 degree". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236628 same patient and product, different doses;US-PFIZER INC-202201236854 same patient and product, different doses;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: little bit of fever but it only went up 1 degree; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing), notes: Type II diabetes diagnosed 7 years ago. Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6201), administration date: 24Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "soreness to that area", "swelling in arm"; BNT162b2 (DOSE 2, SINGLE, Lot: EN6208), administration date: 16Mar2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "soreness to that area", "swelling in arm". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "little bit of fever but it only went up 1 degree". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236628 same patient and product, different doses;US-PFIZER INC-202201236854 same patient and product, different doses;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: other doses were just swelling in arm, soreness to that area; swelling in arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 16Mar2021 as dose 2, single (Lot number: EN6208) and on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing), notes: Type II diabetes diagnosed 7 years ago. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "other doses were just swelling in arm, soreness to that area"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in arm".  Additional Information: Patient had other conditions. Patient took metformin for her diabetes. Took 2 500mg in the morning and 2 500mg in the evening. Patient took no other products. It was reported that the other doses were just swelling in arm, soreness to that area and the first of the booster she had a little bit of fever but it only went up 1 degree. No additional Vaccines were administered on same Date. There were no prior Vaccinations (within 4 weeks). There were no AE(s) following prior vaccinations. Patient's Medical History and Family Medical History was reported as no. No relevant Tests and investigations were done. The report was not related to a study or programme.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: other doses were just swelling in arm, soreness to that area; swelling in arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 16Mar2021 as dose 2, single (Lot number: EN6208) and on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing), notes: Type II diabetes diagnosed 7 years ago. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "other doses were just swelling in arm, soreness to that area"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in arm".  Additional Information: Patient had other conditions. Patient took metformin for her diabetes. Took 2 500mg in the morning and 2 500mg in the evening. Patient took no other products. It was reported that the other doses were just swelling in arm, soreness to that area and the first of the booster she had a little bit of fever but it only went up 1 degree. No additional Vaccines were administered on same Date. There were no prior Vaccinations (within 4 weeks). There were no AE(s) following prior vaccinations. Patient's Medical History and Family Medical History was reported as no. No relevant Tests and investigations were done. The report was not related to a study or programme.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Expired product administered
Clinical narrative: One patient recieved a vaccine, three days after the expiration date of 30Sep2022; Upset stomach; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 03Oct2022 as dose 3 (orange cap; booster), single (Lot number: FL2757, Expiration Date: 30Sep2022) at the age of 8 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine Name: First Pfizer Covid vaccine, Lot Number/Expiry Date: FL0007/ 28Jan2022, Anatomical Location: not provided), administration date: 02Dec2021, when the patient was 7-year-old, for COVID-19 immunization; BNT162b2 (Vaccine Name: Second Pfizer Covid vaccine, Lot Number/Expiry Date: FL0007/ unknown, Anatomical Location: not provided), administration date: 03Jan2022, when the patient was 7-year-old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 03Oct2022, outcome "unknown", described as "One patient recieved a vaccine, three days after the expiration date of 30Sep2022"; ABDOMINAL DISCOMFORT (non-serious) with onset Oct2022, outcome "unknown", described as "Upset stomach". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: When they calculated the 10-week expiry date in the refrigerator, this was 27Oct2022. However, the expiry date according to the manufacture date was 30Sep2022. A dose of this vaccine was administered to a patient 3 days after 30Sep2022. She spoke with patient, and everything was alright except, the patient had an upset stomach. The patient's doctor told the patient to take an over-the-counter stomach medication: Reporter states patient did not specify name of medication, or if the medication had been taken at the time of the phone call. Upset stomach: past couple of days, between the dates of 07Oct2022 and 11Oct2022. Reporter states it was unknown if the stomach upset, was continuing. Reporter seriousness for One patient received a vaccine, three days after the expiration date of 30Sep2022 and stomach upset: Not Serious. Patient did not visited to emergency Room and physician Office. Patient had no prior Vaccinations (within 4 weeks).
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Vaccination site haematoma
Clinical narrative: big hematoma in the injection site; vaccine may not have been properly administered because it looked like it spilled outside the needle; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE HAEMATOMA (non-serious), outcome "unknown", described as "big hematoma in the injection site"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "vaccine may not have been properly administered because it looked like it spilled outside the needle".  Additional information: It was reported that, the patient received the dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, but was not sure that all the vaccine was administered. The vaccine might not had been properly administered because it looked like it spilled outside the needle.   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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: sore underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9262) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nightmares" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE taken for blood pressure abnormal (ongoing); CLONAZEPAM taken for anxiety, start date: 2016 (ongoing). The following information was reported: AXILLARY PAIN (non-serious) with onset 24Jan2021, outcome "unknown", described as "sore underarm".  Additional information: Caller mentioned that she had no other side effects from the first three doses of the vaccine other than a sore underarm the next day and  stated that she kept moving her arm and it cleared up and was better.