chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023 at 9:10 AM, 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 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.).    No concomitant medications were reported. It was reported that one dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD. The dose was administered past the 12-hour vial puncture. The vial was first punctured on 13-Feb-2023 at 2pm and the dose was given on 14-Feb-2023 at 9:10am. The vaccine was in the fridge the whole time and was not exposed to room temperature for greater than 24 hours. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2023: Live Significant Follow-up appended: Start date of the suspect product, Event verbatim updated and  Narrative updated.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected).    No concomitant medications were reported. It was reported that it was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product label issue, Product storage error, Product temperature excursion issue
Clinical narrative: temperature excursions of vaccine; Product storage error; No adverse event; A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration; 2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration), EXPIRED PRODUCT ADMINISTERED (2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions of vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:No known allergies.  Concomitant products included PNEUMOCOCCAL VACCINE from 10-Feb-2023 to an unknown date and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) from 10-Feb-2023 to an unknown date for an unknown indication.    On 10-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Feb-2023, the patient experienced PRODUCT LABEL ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration) and EXPIRED PRODUCT ADMINISTERED (2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions of vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration), EXPIRED PRODUCT ADMINISTERED (2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions of vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was initially stored at refrigerator on 09-Jan-2023. vial size was initially 2.5 ml.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date).    Concomitant medications details were not reported by the reporter.  Reportedly, reporter liked to know if the Moderna primary series with a use by date of 10-Feb-2023 would still be viable if the vial was stored in the refrigerator unopened and was opened on 10-Feb-2023. There was a possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; booster dose in October 2021/ I'm immunocompromised, too; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too).    No concomitant medications were reported. Age of the patient, DOB and age group were mentioned as unknown. It was reported that on Sep-2022, patient received Moderna Bivalent booster dose also. No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It had been a while since reporter friend had Covid-19 and was still coughing and had congestion. The Reporter did not have any other information to report about friend. No dates of administration of the vaccine or other adverse reactions after each Moderna Covid-19 vaccine are known of at that time. No lot numbers of the vaccine are known of at that time. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.).    No concomitant medications were reported.  It was reported that Moderna vaccine was placed in fridge on 19-Jan-2023. The vaccine has not experienced any temperature excursions.   No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered a booster dose of the Moderna COVID-19 vaccine yesterday more than 12 hours after the initial vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of the Moderna COVID-19 vaccine yesterday more than 12 hours after the initial vial puncture) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 02-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE on 23-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 13-Feb-2023, 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 13-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of the Moderna COVID-19 vaccine yesterday more than 12 hours after the initial vial puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of the Moderna COVID-19 vaccine yesterday more than 12 hours after the initial vial puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of the Moderna COVID-19 vaccine yesterday more than 12 hours after the initial vial puncture).    No concomitant medications were reported. The vaccine was initially punctured on 10-FEB-2023 and administered on 13-FEB-2023. No treatment medications were reported.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Laboratory test, Tremor
Clinical narrative: quivers/my whole body shaking; I tried to get up using my elbows & it got worse - condition worsed; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (quivers/my whole body shaking) and CONDITION AGGRAVATED (I tried to get up using my elbows & it got worse - condition worsed) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Cardiac operation NOS (10 yrs ago) in 2013.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced TREMOR (quivers/my whole body shaking) and CONDITION AGGRAVATED (I tried to get up using my elbows & it got worse - condition worsed). The patient was treated with PARACETAMOL (TYLENOL) in January 2021 for Shaking, at an unspecified dose and frequency. At the time of the report, TREMOR (quivers/my whole body shaking) had not resolved and CONDITION AGGRAVATED (I tried to get up using my elbows & it got worse - condition worsed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Inconclusive. On an unknown date, Laboratory test: Inconclusive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient took Moderna Covid shots in Jan & Feb-2021 & the f/u shot in Nov-2021. Around Jan & Feb patient started having little quivers in thighs.They got stronger. Patient was awakened by whole body shaking. Patient tried to get up using elbows & it got worse. Patient took Tylenol & went to sit down. 2 weeks before Christmas, it started happening every week, 3 - 4 times/week. And it usually happens between 1a - 4a. Patient saw to Dr, because it was getting worse. Doctor took blood work & all kinds of tests & Doctor said, doctor would call patient if found anything. Doctor never did call patient. But Doctor doesn't know what's causing it. Patient sure not going to take another vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023).    No concomitant product was reported. No treatment information was reported.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose) on 08-Nov-2021 and COVID-19 VACCINE (2nd dose) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 11-Nov-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose).    No concomitant medication was provided.  Nurse reported that they incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose on 11-Nov-2022. Believed that patient got their primary series outside. The dose that was given was at 0.25 ml of the monovalent vaccine (the one for 6-11 years old with the FOR BOOSTER ONLY label). Patient had not reported any adverse event post vaccination.   Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: he had a side effect from the second shot of his Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (he had a side effect from the second shot of his Moderna vaccine) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he had a side effect from the second shot of his Moderna vaccine). At the time of the report, IMMUNISATION REACTION (he had a side effect from the second shot of his Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient states he had a side effect from the second shot of his Moderna vaccine. Patient said the vaccine destroyed his life and not safe for everybody.  No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Drug ineffective, Feeling abnormal, Suspected COVID-19
Clinical narrative: caught long COVID; caught long COVID; had not taste; had not smell; it was really bizarre; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caught long COVID"; AGEUSIA (medically significant), outcome "unknown", described as "had not taste"; ANOSMIA (medically significant), outcome "unknown", described as "had not smell"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it was really bizarre".  Clinical course: Caller mentioned: "I had both shots of the vaccine and one booster, then I was in the hospital, caught long COVID, had not taste or smell for like a year, it was really bizarre, then I felt better, I went to get the Pfizer booster, because I was in the Doctor's office yesterday." Caller stated that his doctor is not open today and the only choice would be to go to the Hospital, but he really does not want to go the Hospital and then described his symptoms as being "not constant or consistent, long stop, kind of comes and goes and then is not, is irritating, is not life threating." Caller also asked: Can I start with a cool compress, that is not going to hurt me, or I can consider calling.   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-202300063621 Same reporter/patient, same drug/different dose, different AEs;
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: The patient is treated for Covid-19 with paxlovid from 02feb2023 to 07Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: G12524) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Lot number: ER8730), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 as Paxlovid from 30Jan2023 to 04Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 to vaccination failure and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood glucose increased, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Female consumer states she has Covid and has been taking Paxlovid since Friday; Female consumer states she has Covid and has been taking Paxlovid since Friday; blood sugar has been over 400; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Covid-19" (unspecified if ongoing), notes: She was one of the first people in (Withheld) to get Covid when it first started; "coma for 3.5 weeks" (unspecified if ongoing) notes: she was hospitalized on a ventilator and in a coma for 3.5 weeks. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Female consumer states she has Covid and has been taking Paxlovid since Friday"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar has been over 400". The patient underwent the following laboratory tests and procedures: Blood glucose: over 400, notes: all weekend; currently 401; SARS-CoV-2 test: Positive, notes: she has Covid and has been taking Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Female consumer states she has Covid and has been taking Paxlovid since Friday. She has 1 and a half days left. She has been taking it while also taking Metoprolol and Carbamazepine. She states that she does not think there are any interaction between Paxlovid and Metoprolol but that she now sees where is says on the paperwork not to take Paxlovid if you take Carbamazepine. She would like more information on this.  She also states that she has taken 4 Pfizer Covid vaccines. She was one of the first people in (Withheld) to get Covid when it first started and she was hospitalized on a ventilator and in a coma for 3.5 weeks. She states that she doesn't want the Covid to get that bad again. She has not had many problems since. States that her blood sugar has been over 400 all weekend and it is currently 401. States that she read that Covid 19 can cause diabetes by attaching the pancreas in 30-40% of adults.   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.
Age: 66.0
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) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: Fl3249), on 10Mar2021 as dose 2, single (Lot number: En6205), on 05Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 13Apr2022 as dose 4 (booster), single (Lot number: Fp4554) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: 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; Negative; Positive, notes: 3 days later symptoms returned and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid. Clinical course: 2 days after completing 5 day Paxlovid treatment tested negative 3 days later symptoms returned and tested positive.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 11:00 as dose 5 (booster), single (Lot number: 6h9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: El3249), on 09Mar2021 as dose 2, single (Lot number: En6205), on 15Oct2021 at 11:00 as dose 3 (booster), single (Lot number: Fe3590), in left arm and on 13Apr2022 at 11:00 as dose 4 (booster), single (Lot number: Fp4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Treated for high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Negative, notes: After testing negative 2 days after completion of 5 day paxlovid treatment; (11Feb2023) Positive, notes: 3 days later symptoms reappeared and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After testing negative 2 days after completion of 5 day paxlovid treatment, 3 days later symptoms reappeared and tested positive
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: (13Feb2023) Positive, notes: Positive test on 9th day. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks.  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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna; 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FR9893) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 010M20A), in left arm, on 10May2021 as dose 2, single (Lot number: 040M21A), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: 091D21A), in left arm and on 12Sep2022 at 12:00 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High Triglycerides" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: Jan2010; LOSARTAN, start date: Mar2020. Past drug history included: Novocaine, reaction(s): "Known allergies: Novocaine"; Codeine sensitive, reaction(s): "Known allergies: codeine sensitive". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20May2022, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: rigors; headache; low grade temp; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:30 as dose 5 (booster), single (Lot number: GJ3275) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "elevated intraocular pressure" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing), notes: nausea, rash; "Known allergies: lobster" (unspecified if ongoing), notes: vomit/diarrhea; "Known allergies: tetracycline" (unspecified if ongoing), notes: g.i. The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "Drug allergy", notes: nausea/vomit/itch. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), Vaccine administration time=09:30 AM, Vaccine lot number=FK9894, Vaccine location=Left arm), administration date: 08Apr2022, when the patient was 62-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 3 (BOOSTER), Vaccine administration time=04:00 PM, Vaccine lot number=CJ511-06, Vaccine location=Left arm), administration date: 05Oct2021, when the patient was 61-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 2, Vaccine administration time=11:45 AM, Vaccine lot number=EL3246, Vaccine location=Left arm), administration date: 14Jan2021, when the patient was 61-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 1, Vaccine lot number=EH9899, Vaccine location=Left arm), administration date: 22Dec2020, when the patient was 60-year-old, for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "rigors"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "low grade temp". Patient got rigors/headache/low grade temp reaction after Covid vaccinations, which were severe enough that she scheduled time off work.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia (problem sleeping); can't sleep; insomnia is getting worse; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: EW0150) at the age of 71 years intramuscular for COVID-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Prostate" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Back pain" (unspecified if ongoing), notes: He doesn't think this is due to the vaccine; "Pain on knee" (unspecified if ongoing), notes: He doesn't think this is due to the vaccine. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; FINASTERIDE taken for prostate infection; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EL3249; intramuscular), administration date: 09Jan2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EL3247; intramuscular), administration date: 30Jan2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Insomnia (problem sleeping); can't sleep; insomnia is getting worse". The event "insomnia (problem sleeping); can't sleep; insomnia is getting worse" required physician office visit. Therapeutic measures were taken as a result of insomnia.   Additional Information: The patient received the vaccines because it was recommended at a hospital for people who have retired. The Pfizer COVID-19 vaccine has caused the patient insomnia. He received his third COVID-19 vaccine on 05Oct2021 and after a week and a half (15Oct2021) he has insomnia (problem sleeping) and can't sleep and wants to know if Pfizer has a medicine to help him sleep. The insomnia was 12 days after (as reported), and he thought was for one night but started that week of 15Oct2021. He thinks the insomnia is getting worse. Before, he took half an alprazolam (XANAX) to sleep and now needs 1.5 to sleep. The adverse event did not require visit to emergency room. The patient has a doctor and asks for more medicine from the psychiatrist as he is taking 1.5 and sometimes 2 and was told couldn't give him more medicine and he can't afford a private doctor. The patient wanted to know which medication Pfizer recommends treating this problem. They are now recommending the fourth dose, but he is afraid to take another one. The other dose has not been given for fear of more side effects. The patient had no vaccines since then.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER BIONTECH COVID-19 VACCINE), on 01Oct2022 as dose 4 (booster), single (lot number unknown) at the age of 30 years, in left arm for covid-19 immunisation; covid-19 vaccine, as dose 1, single (lot number unknown), as dose 2, single (lot number unknown) and as dose 3 (booster), single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset 2023, outcome "not recovered" and described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 01Feb2023 to 06Feb2023.  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.