chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: Rash macular, Scab, Skin plaque
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.     The reporter's causality for the events of Skin plaque, Scab and Rash macular with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment medication were provided.   Reporter did not allow further contact This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels). At the time of the report, SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels) outcome was unknown.      No concomitant medication information was provided.  Reporter did not allow further contact
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) and NO ADVERSE EVENT (no adverse event) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A and 064A22A) for COVID-19 vaccination.     Concurrent medical conditions included ADHD and Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA), CLONIDINE, METHYLPHENIDATE HYDROCHLORIDE (RITALINA) and METHYLPHENIDATE HYDROCHLORIDE for an unknown indication.   On 03-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Dec-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.       No treatment information provided.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; We gave 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine).    Concomitant products were not reported.  It was reported that monovalent 4 doses were administered. Vial size was reported as 5.5ml. The vial was initially stored in the refrigerator on 02-Nov-2022. The vial did not undergo any temperature excursions.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681675, US-MODERNATX, INC.-MOD-2022-681659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681675: US-MODERNATX, INC.-MOD-2022-681659:Same reporter
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; We gave 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine).    Concomitant products were not reported.  It was reported that monovalent 4 doses were administered. Vial size was reported as 5.5ml. The vial was initially stored in the refrigerator on 02-Nov-2022. The vial did not undergo any temperature excursions.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681571, US-MODERNATX, INC.-MOD-2022-681675, US-MODERNATX, INC.-MOD-2022-681678 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681571:Same reporter US-MODERNATX, INC.-MOD-2022-681675:Same reporter US-MODERNATX, INC.-MOD-2022-681678:Same reporter
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.  No Medical History information was reported. On 30-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). Concomitant medication was not reported.The vial was initially stored in the refrigerator on 02-Nov-2022 and patient received monovalent vaccine dose on 30-Nov-2022. The vials were unbroken of size 5.5 ml. The vial did not undergo any temperature excursions. Treatment medication as not reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it). At the time of the report, ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it) outcome was unknown.            No concomitant medications were reported.  Patient and patient's mother received booster shot on Monday and both had some tummy issues after receiving it.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient recieved their 1st dose from an expired Moderna Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient recieved their 1st dose from an expired Moderna Monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient recieved their 1st dose from an expired Moderna Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient recieved their 1st dose from an expired Moderna Monovalent vaccine).    No concomitant medications were reported.  It was reported dose administered after 30-day Use by Date or after manufacturer date of expiry and Individual vial was used.    It was reported vial was initially stored in the refrigerator on 30-Nov-2022.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 11:00 as dose 4 (booster), single (Lot number: BI635342) at the age of 63 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LISINOPRIL; HCTZ. Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0140), administration date: 22Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0140), administration date: 12Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: FF8841), administration date: 08Oct2021, when the patient was 62-year-old, for COVID-19 immunization.  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. Specific relevant test for thromboembolic events with thrombocytopenia: None. Comments/Narrative: I had the 3rd booster at withheld on 08Nov2022 around 11:00 AM. At 2:00 AM (09Nov2022) I awake with nausea, chills, vomiting and diarrhea. This lasted until 7 AM, As I was sent home from work due to the side effects, was still a bit nauseous on Thursday, 10Nov2022. By Friday, all side effects had ended (11Nov2022).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash pruritic
Clinical narrative: ; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Lot number: FK9893, Expiration Date: 17Jun2022) at the age of 78 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Non-Hodgkin's lymphoma", start date: 05Jan2005 (unspecified if ongoing), notes: She is only in the one percentile. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FN5318; Route of administration: intramuscular; Anatomical location: right arm), administration date: 06Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FN6918; Route of administration: intramuscular; Anatomical location: right arm), administration date: 01Mar2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2589; Route of administration: intramuscular; Anatomical location: right arm), administration date: 11Oct2021, when the patient was 78-year-old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 15May2022, outcome "not recovered", described as "rash after the 2nd booster received back in May2022/ rash all over her body/ itching/ itches quite a bit"; PAIN (non-serious) with onset 2022, outcome "not recovered", described as "she has pains sometimes from it". The events "rash after the 2nd booster received back in may2022/ rash all over her body/ itching/ itches quite a bit" and "she has pains sometimes from it" required physician office visit. Therapeutic measures were taken as a result of rash pruritic, pain.  The patient did not receive other vaccines within 4 weeks prior to the vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: back fusion surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9265) at the age of 71 years for covid-19 immunization. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure abnormal. The following information was reported: BACK DISORDER (medically significant) with onset 2021, outcome "unknown", described as "back fusion surgery". Therapeutic measures were taken as a result of back disorder. Additional information: Reporter states that in between her first and second doses of the vaccine she had her back fusion surgery and that is why the time between the doses was delayed. Denies any medical conditions relevant to these events.  States that she has a lot of back problems and was taking some unspecified back medications prior to her back surgery.  States that she was not taking any major pain medications, just anti-inflammatory medication on occasion. States that she avoids pills if she can.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337805 same patient drug reporter, different dose and AE;US-PFIZER INC-202201337806 same patient drug reporter, different dose and AE;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9265), on 12Mar2021 as dose 2, single (Lot number: EN6207) and on 16Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: she has been on blood pressure medication for years and has been stable; "back problems" (unspecified if ongoing), notes: States that she has a lot of back problems and was taking some unspecified back medications prior to her back surgery; "back surgery" (unspecified if ongoing), notes: Caller states that she does not do as much as it is after having back surgery a few years ago. Concomitant medication(s) included: LOSARTAN [LOSARTAN POTASSIUM] taken for blood pressure abnormal; AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID". Clinical course details: Covid 19 after vaccines: the caller stated that all of her cases of Covid were mild. She first got Covid in Feb2022. Then again, she got it in Jun2022. In June, she took two home tests that were positive and one (withheld) test that was negative; her doctor said to treat as positive though due to the two home tests being positive. She got Covid a third time in Sep2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive; (Jun2022) positive; (Jun2022) negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337648 Same patient/drug/reporter; different dose and event;US-PFIZER INC-202201337806 Same patient/drug/reporter; different dose and event;US-PFIZER INC-202201337161 Same patient/reporter; different drug and event;
Age: 41.0
Sex: F
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 (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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; patient received Paxlovid as covid-19 treatment from 27Nov2022 to 29Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Nov2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Took Paxlovid for treatment of positive covid test; (Nov2022) Negative, notes: Started testing negative on day 6, after completing dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took Paxlovid from 12Nov2022 to 17Nov2022 for treatment  of positive covid test. Did have symptoms. Started testing negative on day 6, after completing dose of Paxlovid. Tested negative for 8 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech - Dose Number: 4 / Moderna - Dose Number: 3; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), 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: "hypothyroid" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE. Past drug history included: Tetracycline, reaction(s): "known allergies"; Coedine, reaction(s): "known allergies"; Percoset, reaction(s): "known allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech - Dose Number: 4 / Moderna - Dose Number: 3"; 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 which included COVID-19 treatment (Paxlovid) from 20Nov2022 to 24Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Lot number: 6739) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: fk9231), in left arm, on 28Jan2021 as dose 2, single (Lot number: el9262), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: ff8839), in left arm and on 16Jul2022 as dose 4 (booster), single (Lot number: fpf150), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 16Nov2022 to 20Nov2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid-19 cannot be ruled out.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling abnormal, Head discomfort, Headache
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 11 years 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Nov2022, outcome "not recovered", described as "light headache"; CONDITION AGGRAVATED (non-serious) with onset 24Nov2022, outcome "not recovered", described as "Symptoms started on Thursday and it is getting progressively worse"; DIZZINESS (non-serious) with onset 24Nov2022, outcome "not recovered", described as "constant dizziness"; FEELING ABNORMAL (non-serious) with onset 24Nov2022, outcome "not recovered", described as "memory fog"; MUSCULAR WEAKNESS (non-serious) with onset 24Nov2022, outcome "not recovered", described as "weakness in her hands"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "a constant pressure that had not stopped, like her head was about to open". The events "weakness in her hands", "light headache", "constant dizziness", "memory fog" and "a constant pressure that had not stopped, like her head was about to open" required physician office visit. Therapeutic measures were taken as a result of muscular weakness, headache, dizziness, feeling abnormal, head discomfort.    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: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 11 years 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Nov2022, outcome "not recovered", described as "light headache"; CONDITION AGGRAVATED (non-serious) with onset 24Nov2022, outcome "not recovered", described as "Symptoms started on Thursday and it is getting progressively worse"; DIZZINESS (non-serious) with onset 24Nov2022, outcome "not recovered", described as "constant dizziness"; FEELING ABNORMAL (non-serious) with onset 24Nov2022, outcome "not recovered", described as "memory fog"; MUSCULAR WEAKNESS (non-serious) with onset 24Nov2022, outcome "not recovered", described as "weakness in her hands"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "a constant pressure that had not stopped, like her head was about to open". The events "weakness in her hands", "light headache", "constant dizziness", "memory fog" and "a constant pressure that had not stopped, like her head was about to open" required physician office visit. Therapeutic measures were taken as a result of muscular weakness, headache, dizziness, feeling abnormal, head discomfort.    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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenomegaly, Breast mass, Breast pain, Breast swelling, Investigation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP. A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: CTH9703) at the age of 73 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose:, Date: 22Oct2021, number, lot number, expiration date: Pfizer FC3590.), administration date: 22Oct2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (2nd dose:, Date: 23Feb2021, number, lot number, expiration date: EL9267), administration date: 23Feb2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (1st dose:, Date: 26Jan2021, number, lot number, expiration date: Says Pfizer EL9265.), administration date: 26Jan2021, when the patient was 72-year-old, for Covid-19 immunization. The following information was reported: ADRENOMEGALY (non-serious), BREAST SWELLING (non-serious), outcome "not recovered" and all described as "adrenal glands under arm, breast, and arm became swollen"; BREAST PAIN (non-serious), outcome "not recovered", described as "soreness/in a lot of pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "adrenal glands under arm, breast, and arm became swollen"; SENSITIVE SKIN (non-serious), outcome "unknown", described as "noticed sensitivity"; BREAST MASS (non-serious), outcome "unknown", described as "breast lump". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of adenomegaly, breast pain, breast swelling, peripheral swelling, breast mass.  Confirmed all 4 doses were Pfizer. For dose 4 number, lot number, expiration date caller thinks, handwritten on vaccination card. Might have had a blood test but not much to do with this. Had no other shots that day. Had genetic testing done, but no results yet. No additional information provided. Any suggestions for what caller should do for this problem? This was a terrible way to feel after a month after getting shot, makes caller think caller could have breast cancer and then found lump.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Peripheral swelling, Sensitive skin, Ultrasound scan
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP. A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: CTH9703) at the age of 73 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose:, Date: 22Oct2021, number, lot number, expiration date: Pfizer FC3590.), administration date: 22Oct2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (2nd dose:, Date: 23Feb2021, number, lot number, expiration date: EL9267), administration date: 23Feb2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (1st dose:, Date: 26Jan2021, number, lot number, expiration date: Says Pfizer EL9265.), administration date: 26Jan2021, when the patient was 72-year-old, for Covid-19 immunization. The following information was reported: ADRENOMEGALY (non-serious), BREAST SWELLING (non-serious), outcome "not recovered" and all described as "adrenal glands under arm, breast, and arm became swollen"; BREAST PAIN (non-serious), outcome "not recovered", described as "soreness/in a lot of pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "adrenal glands under arm, breast, and arm became swollen"; SENSITIVE SKIN (non-serious), outcome "unknown", described as "noticed sensitivity"; BREAST MASS (non-serious), outcome "unknown", described as "breast lump". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of adenomegaly, breast pain, breast swelling, peripheral swelling, breast mass.  Confirmed all 4 doses were Pfizer. For dose 4 number, lot number, expiration date caller thinks, handwritten on vaccination card. Might have had a blood test but not much to do with this. Had no other shots that day. Had genetic testing done, but no results yet. No additional information provided. Any suggestions for what caller should do for this problem? This was a terrible way to feel after a month after getting shot, makes caller think caller could have breast cancer and then found lump.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "My arm was a little sore after the first shot"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "miserable headache", "felt sick", "pain in my upper arm". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "been unpleasant".  Additional information: The patient had got first Pfizer Covid vaccine. She had given the shot e fire and realized it. She did not even feel it. Then sat there for 15 mins, she was so worried about the possible side effects. The short film she just watched mentioned the most common side effects and that fear / concern came back. Her arm was a little sore after the first shot. On second [Pfizer] Covid vaccines experience was not as good as the first. She did experience pain in upper arm, felt sick had a miserable headache. The two Pfizer boosters, she has received have been unpleasant post injection side effects have been stronger the last one she was miserable. She just kept thinking this suck but had heard that Covid was really horrible so was glad did not have that.   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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2021; TRIAMTERENE HCTZ, start date: Jan2019; VENLAFAXINE HCL, start date: Jan2019; ALLERCLEAR, start date: Jan2017; PROPRANOLOL oral, start date: 09Feb2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Negative; (29Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: I tested negative on 25Nov2022. Felt fine. Began getting cold symptoms the next day. But thought was mild cold. Cough. Stuffy nose. Scratchy throat that cleared up. Headache. Tested positive again on 29Nov2022. It was reported that the event onset was on 27Nov2022 at 2:00 AM. Outcome was reported to be recovering.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Premenstrual pain
Clinical narrative: The second time, the second vaccination I had a delay in my menstrual cycle for over 49 days; cramping from many weeks until I started my menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "The second time, the second vaccination I had a delay in my menstrual cycle for over 49 days"; PREMENSTRUAL PAIN (non-serious), outcome "unknown", described as "cramping from many weeks until I started my menstrual cycle". The event "the second time, the second vaccination i had a delay in my menstrual cycle for over 49 days" required physician office visit. Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: Patient said last to the second shot and she had similar consequences with this like she had similar cramping from many weeks until she started menstrual cycle. And again it was, it took 49 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341646 Same patient, vaccine, different dose and event;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccine brand unknown=Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in right arm, on 21Apr2021 as dose 2, single (Lot number: ERR0169), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Oct2022 at 19:00 as dose 4 (booster), single (Lot number: 060F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Oct2022 at 19:00, outcome "unknown", described as "Vaccine brand unknown=Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures, Paxlovid from 28Nov022 to 29Nov2022, were taken as a result of vaccination failure, covid-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; vaccine brand other= Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 10:00 as dose 1, single (Lot number: ER8730), in left arm, on 12Apr2021 at 10:30 as dose 2, single (Lot number: ER8729), in left arm, on 21Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 06May2022 at 09:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Sep2022 at 09:30 as dose 5 (booster), single (Lot number: A57144b), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022 at 09:30, outcome "unknown", described as "vaccine brand other= Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Return of covid symptoms of congestion, headache and positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid from 19Nov2022 to 23Nov2022).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 10:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 50 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (28Nov2022) Positive, notes: Positive test. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  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.