chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Rash, Suspected COVID-19
Clinical narrative: SKIN RASH ON LEGS AND ARMS; SUSPECTED COVID-19; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nirmatrelvir/ritonavir (batch number: GJ7115 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose and frequency were not reported from 13-AUG-2023 to 15-AUG-2023 for covid-19 treatment. Concomitant medications included aciclovir for drug used for unknown indication. On 2023, the patient experienced suspected covid-19. On 14-AUG-2023, the patient experienced skin rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from skin rash on legs and arms, and the outcome of suspected covid-19 was not reported. This report was non-serious.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 29-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    On 27-Mar-2023, the patient received first dose of monovalent vaccine (Batch/Lot number: AS1903B and Dose/volume: 25 micrograms).  Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna monovalent was reported as Mono and bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.; No adverse event; Dose administered after 30-day Use by Date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-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 10-Aug-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 (Dose administered after 30-day Use by Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.).    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 2 out of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-737504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737504:Patient 1
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in an adult male 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 immunization.     The patient's past medical history included COVID-19.    On an unknown date, the patient received second 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 URTICARIA CHRONIC (Chronic urticaria). At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Patients got in the sauna every other day for half an hour and worked up a bad sweat, he controled it 90% so it was tolerable. He tried all the antihistamines. He had the reaction after the second dose and the first booster. He also did got COVID.
Age: 36.0
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 a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) had resolved.        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.   Concomitant medication details not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-737197, US-MODERNATX, INC.-MOD-2023-737201 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737201:Second Son Case US-MODERNATX, INC.-MOD-2023-737197:First son case
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient administered a dose from the incorrect vial initially; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient administered a dose from the incorrect vial initially) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 15-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 15-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INCORRECT DOSE ADMINISTERED (Patient administered a dose from the incorrect vial initially). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient administered a dose from the incorrect vial initially) 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 INCORRECT DOSE ADMINISTERED (Patient administered a dose from the incorrect vial initially).    No concomitant medication was reported. It was reported that on 15-Jun-2023, the patient received a single dose of 0.2 mL from vial with the pink cap and the label with the yellow border. Not reported any symptoms and no additional doses have been administered at this time. No treatment medication was reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.     On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 04-Apr-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.) 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 (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.).    Previous dose information was not reported. It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine expiry date was reported as 01-Apr-2023.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure of 200/100; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure of 200/100) 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)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 immunization: Moderna Covid-19 vaccine (dose 1), Moderna Covid-19 vaccine (dose 3, booster) and Moderna Covid-19 vaccine (dose 2). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On an unknown date, the patient received fourth 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 HYPERTENSION (blood pressure of 200/100). At the time of the report, HYPERTENSION (blood pressure of 200/100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/100  high.     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 medication was reported. No treatment medication was reported.
Age: 0.92
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in an 11-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Patient's relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) 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 WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    Patient did not received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 2nd patient out of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:Master Case (Patient 1)
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.; No adverse event; 2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-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 10-Aug-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 (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.).    Reporter was pharmacy tech.  Concomitant product use was not provided by the reporter.  Suspect vaccine manufacturer expiry date was reported as 14-Oct-2023. In the box vial size was 2.5 ml. Dose was administered 30 days beyond use by date. Vial did not undergone any temperature excursions. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 1st out of 2 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737509 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737509:
Sex: M
Vaccine: MENB
Symptoms: Coeliac disease
Clinical narrative: celiac disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), in 2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COELIAC DISEASE (medically significant), outcome "unknown", described as "celiac disease". Clinical course: The patient (reporter's son) (20 years old) was supposed to get Trumenba vaccine. He got 1 dose last year, but then shortly after he was diagnosed with celiac disease. Parent asked, "Before we get his 2nd, is the vaccine gluten free? Since he had 1 dose over a year ago, how many more doses should he get and when should he get them?" The reporter's 20 year old son received a dose of Trumenba a year ago, after that he was diagnosed with Celiac disease and he has yet to receive his second dose which should have been given 6 month after the first. He was asking about getting the second dose. His second dose was late, it was supposed to be give in 6 month after the first.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.  Follow-up (14Aug2023): This is a spontaneous follow-up report received from the same contactable consumer (Patient's mother). Updated information: clinical course added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: experiencing Tinnitus every time he takes the vaccine/with each new vaccine the tinnitus gets a little bit louder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8733) for covid-19 immunisation. The patient's medical history, reported also as family history included: "Hearing loss" (ongoing), notes: has hereditary hearing loss and tinnitus, the ringing in the ears; "Tinnitus" (unspecified if ongoing), notes: has hereditary hearing loss and tinnitus, the ringing in the ears. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "experiencing Tinnitus every time he takes the vaccine/with each new vaccine the tinnitus gets a little bit louder".  Additional information: The reporter stated that the patient had the original two vaccine shots and two boosters from Pfizer but not the bivalent one. The reporter mentioned that the patient has hereditary hearing loss and tinnitus, the ringing in the ears, and with each new vaccine the tinnitus gets a little bit louder. It was reported that it does not come back down, it stays in an elevated level, it has happened every time. The reporter asked how to approach this, if the patient can continue the vaccine, if it will make the tinnitus even louder, and what was causing the patient to have tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Aug2023): This is a spontaneous follow-up report from a contactable consumer. This consumer (Wife) reported for a 70- Years-Old Male patient (Husband). Updated information included: Reporter information, patient information (Age, unit, weight, height and race added), dosage regimen (Start date, stop date, lot number added) and vaccination facility information (Vaccination facility name, city, state and Vaccine Administered at Facility? Added).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276720 same reporter/patient/suspect vaccine/event; different dose;US-PFIZER INC-202300276920 same patient/reporter/AE, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: with each new vaccine the tinnitus gets a little bit louder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "wears hearing aids" (ongoing), notes: for about 20 years. The patient's medical history, reported also as family history included: "hearing loss" (ongoing), notes: hereditary hearing loss and tinnitus; wears hearing aides and has for about 20 years; "tinnitus; ringing in the ears" (ongoing), notes: hereditary hearing loss and tinnitus; wears hearing aides and has for about 20 years. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6206, administered in the left arm), administration date: 10Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "with each new vaccine the tinnitus gets a little bit louder"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733, administered in the left arm), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "with each new vaccine the tinnitus gets a little bit louder". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "with each new vaccine the tinnitus gets a little bit louder". Therapeutic measures were not taken as a result of tinnitus.  Follow-up (15Aug2023): This is a spontaneous follow-up report received from a same contactable consumer.  Updated Information: reporter details, patient details (identifiers, age, height, weight, race), relevant medical history added, historical vaccine details, suspect vaccine details (vaccination date, lot number, anatomical location), event details (treatment information) and concomitant therapy details.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276720 same patient/reporter/AE, different vaccine dose;US-PFIZER INC-202300276919 same patient/reporter/AE, different dose;
Age: 54.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EW0150), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "lichen sclerosis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Known allergies: Buckwheat" (unspecified if ongoing); "Known allergies: rhubarb cause anaphalaxis" (unspecified if ongoing), notes: cause anaphalaxis; "anaphalaxis" (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: (11Aug2023) Positive, notes: home rapid test. Therapeutic measures were taken as a result of covid-19.  On 16Aug2023, investigation results for lot number EW0150 were reported as follows: The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine Injectable lot EW0150 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0150, fill lot EP8690, and the formulated drug product lot EP8587. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.  Follow-up (16Aug2023): This is a follow-up report from Product Quality Complaint Group providing investigation results for lot number EW0150.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300277247 same patient/reporter; different vaccine dose/event;
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: White blood cell count increased
Clinical narrative: increase of white blood cell count after being administered with PREVNAR 20; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 67-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Aug2023 at 16:30 as dose 1, 0.5 ml single (Lot number: GA5916, Expiration Date: 31Jan2024) at the age of 67 years, in left deltoid for immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "diabetic " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 16Aug2023, outcome "unknown", described as "increase of white blood cell count after being administered with PREVNAR 20".  Additional information: the indication was also reported as over 65 and never had a pneumonia vaccine. The NDC number of Prevnar 20 was 0005-2000-02. The vaccination was given probably around 1630. The patient did not received any vaccinations within four weeks. The patient's wife said that she could not find anything about it in a package insert and the patient's wife did not say the event was from the vaccine. She was not sure if they increase in white blood cell count was found on 16Aug2023 or 15Aug2023, but thought it was 16Aug2023. The patient was also diabetic based off of his medication list.  Follow-up (16Aug2023): This is a spontaneous follow-up report received from a contactable pharmacist, program ID. Updated Information: reporter information, patient information, medical history, suspect vaccine information, event onset date.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site was swollen, hot to the touch, and red.; injection site swelling, pain, redness, and hot to touch; injection site was swollen, hot to the touch, and red.; injection site was swollen, hot to the touch, and red.; 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 76-year-old female patient received PF-06928316 (ABRYSVO), on 07Aug2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE oral (ongoing). Vaccination history included: Moderna covid vaccine (Moderna COVID vaccine), for immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Aug2023, outcome "recovering", described as "injection site swelling, pain, redness, and hot to touch"; VACCINATION SITE WARMTH (non-serious) with onset 07Aug2023, outcome "unknown", VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 07Aug2023, outcome "recovering" and all described as "injection site was swollen, hot to the touch, and red.".  Additional information: the patient had a very painful big red blotch on arm and much of the pain has gone away but not all, still notices some swelling, injection site swelling, pain, redness, and hot to touch. Clarifying that hot to touch was early on, pain was early on, some of the swelling has gone down, but redness at point of entry of vaccine still remains but is not as red. Very painful big red blotch on arm: Area is still visible and there isn't the kind of pain that there was. Thought about taking a photo of the area, has been massaging the area, but still red. The patient doesn't take other medications, eats well, exercises.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose number unknown (booster), single (Lot number: GL0446) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zofran, reaction(s): "Known allergies: Zofran"; Sulpha drugs, reaction(s): "Known allergies: Sulpha drugs". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Aug2023 to 13Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278886 Same patient, different drug/ AE;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: Ew0158), in left arm, on 02May2021 as dose 2, single (Lot number: Ew0175), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2023 as dose 4 (booster), single (Lot number: 042H22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Jan2023, outcome "unknown", described as "vaccine brand other Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
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 non-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 01May2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures as a result of Drug ineffective, Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278988 Same patient, different product, different dose/event;
Age: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Apr2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 68 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), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had Paxlovid Treatment from 03Aug2023 to 07Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278910 Same patient, different drug/AE.;
Age: 28.0
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(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 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: "Selective IgA deficiency" (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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 07Aug2023 to 11Aug2023. Patient did not have known allergies.  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.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE, COVID-19 and the suspected drug cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300278919 Same patient, different drug/AE;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Selective IgM immunodeficiency
Clinical narrative: antibody deficiency which is an IGM deficiency; has to get her walker to get up; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (17Aug2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot: EN6280), administration date: 20Feb2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "allergic reaction with swelling in the throat", "allergic reaction with swelling in the throat", "very dizzy and lightheaded", "some tightness in her chest"; BNT162b2 (Dose 2, single, Lot: EW0150), administration date: 07Apr2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "1st dose was administered on 20Feb2021 / 2nd dose administered on 07Apr2021"; BNT162b2 (Dose 3, single, Lot: PFMPC0FD8448), administration date: 07Sep2021, when the patient was 77-year-old, for COVID-19 Immunization. The following information was reported: SELECTIVE IGM IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "antibody deficiency which is an IGM deficiency"; DYSSTASIA (non-serious), outcome "unknown", described as "has to get her walker to get up". The event "antibody deficiency which is an igm deficiency" required physician office visit. Therapeutic measures were taken as a result of selective igm immunodeficiency.  Clinical course details: The patient height is 5 feet tall and shrinking. The patient was treated with oncologist for her antibody deficiency which is an IGM deficiency with immunoglobulins. States the doctors office said she had a 5th dose also but she does not have the date, lot number for that to provide as she does not have a patient card for that dose. Caller asked Whenther it's booster shot that may coming out because she doesn't want to have any adverse reactions. What she guesses she wants to know is what they are thinking on this new vaccine and do they think there will be an adverse effect or adverse effects with it as she is scared to go ahead and get it if there are any adverse effects as she has less people helping at her house now.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278841 Same patient, different vaccine dose/event;
Age: 70.0
Sex: M
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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Apr2023 at 12:00 as dose 6 (booster), single (Lot number: Gk3268) at the age of 70 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 included: "Thyroid cancer" (unspecified if ongoing); "bladder cancer" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Covid-19 treatment from 05Aug2023 to 10Aug2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300279221 same patient, different product and event;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2 NOS), in Jan2023 as dose number unknown, single (Lot number: AS7170B) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetic" (unspecified if ongoing), notes: Other medical history: pre-diabetic; "Asthma" (unspecified if ongoing), notes: Other medical history: asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from  08Aug2023 to 13Aug2023 were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid treatment) were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.