chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Infanrix to an 11 y/o patient instead of Boostrix; administration of Infanrix to an 11 y/o patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Infanrix. On 28-JUL-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: administration of Infanrix to an 11 y/o patient instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: administration of Infanrix to an 11 y/o patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter was a medical assistant. The reporter reported the administration of Infanrix to an 11-year-old patient instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received an extra dose of Shingrix.; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient inadvertently received an extra dose of Shingrix.).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter reported that his patient inadvertently received an extra dose of Shingrix, which led to extra dose administered. The reporter did not provide complete information.  No additional details outside of those provided in this report. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had 4 recent shingles outbreaks; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 4 recent shingles outbreaks). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 06-SEP-2023 The reporter asked was there any data on redosing Shingrex after someone had gotten 2 doses if they continue to had shingles outbreaks?  The patient who claimed to had gotten 2 doses of the shingles shot in 2019 but was unsure if it was Shingrex or Zostavax.  They have had 4 recent shingles outbreaks. Would additional doses of Shingrex help? All available information had been submitted to safety.  No further information available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received the first dose of Shingrix 2 years ago and never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received the first dose of Shingrix 2 years ago and never got the second dose).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter called to ask for information about a patient who received the first dose of Shingrix 2 years ago and never got the second dose. The healthcare professional asked if the patient needs to restart the series. The reporter did not provide information about first Shingrix dose (lot number, expiration date, date of administration). The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: accidently received  Boostrix instead of Infanrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTPA (last series of DTAP).   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: accidently received  Boostrix instead of Infanrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 07-SEP-2023 The health care professional (HCP) did not have any other details and would call back with more information. They were on the last series of DTAP. The patient accidently received  Boostrix instead of Infanrix, which led to wrong vaccine administered  The reporter consented to follow up The case is linked with US2023122484, by same reporter.; Sender's Comments:  US-GSK-US2023122484:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Received boostrix instead of Infanrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTPA (last series of DTAP).   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Received boostrix instead of Infanrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 07-SEP-2023 The health care professional (HCP) did not have any other details and would call back with more information. They were on the last series of DTAP. The patient accidently received  Boostrix instead of Infanrix, which led to wrong vaccine administered  The reporter consented to follow up The case is linked with US2023122482, by same reporter.; Sender's Comments:  US-GSK-US2023122482:Same reporter
Sex: F
Vaccine: RSV
Symptoms: Euphoric mood, Hyperhidrosis
Clinical narrative: whole body is drenched in sweat; buzzy feeling in her head; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling high in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-AUG-2023, the patient received Arexvy (intramuscular, right arm). In AUG-2023, 4 days after receiving Arexvy, the patient experienced feeling high (Verbatim: buzzy feeling in her head). On an unknown date, the patient experienced sweating (Verbatim: whole body is drenched in sweat).  The patient was treated with ambiguous medication nos (Claritin (Nos)). The outcome of the feeling high and sweating were not resolved.   It was unknown if the reporter considered the feeling high and sweating to be related to Arexvy.     It was unknown if the company considered the feeling high and sweating to be related to Arexvy.   Additional Information: GSK Receipt date: 08-SEP-2023 The patient reported that she receiving her AREXVY vaccine on 28 August 2023 and after 3 or 4 days later she began experiencing sweats once or twice per day, in which her whole body was drenched in sweat.  She also reports a buzzy feeling on her head that was improved with Claritin but did come back when the Claritin wore off.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included: migraine. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) 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 (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case was reported for patient 10th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master Case, Patient 10
Sex: U
Vaccine: COVID19
Symptoms: Miliaria
Clinical narrative: Heat rash on their leg after taking the Moderna COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of MILIARIA (Heat rash on their leg after taking the Moderna COVID vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient do not have a history of reactions to any medications/vaccines prior to this.  Previously administered products included for Product used for unknown indication: J&J (Dose 1). Past adverse reactions to the above products included No adverse event with J&J.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MILIARIA (Heat rash on their leg after taking the Moderna COVID vaccine). At the time of the report, MILIARIA (Heat rash on their leg after taking the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
Sex: U
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient in question did not experience any symptoms or adverse reactions due to this early administrations of the live vaccines; the patient received FLUMIST intranasal live vaccine on 10/24/2009, and then received first doses of MMR II and VARIVAX on 11/17/2009, which falls below the 28 day waiting period to administer live vaccines according to the prescribing information; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was unknown.   On 24-OCT-2009, the patient received influenza vaccine live reassort 3v (FLUMIST) intranasal (dose, indication, lot# and expiration date were not reported). On 17-NOV-2009, the patient was administered the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliters (ml) (two dose series) and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml (two dose series) (route of administration, lot#, and expiration date were not reported); both administered as prophylaxis.   It was reported that the vaccines were administered below the 28-day waiting period between live vaccines according to the prescribing administration (inappropriate schedule of product administration). The patient did not experience any symptom or adverse reaction due to this early administration of the vaccines (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Hypertension
Clinical narrative: High blood pressure; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (High blood pressure) in a 56-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. A57165B) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 13-Oct-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In October 2022, the patient experienced HYPERTENSION (High blood pressure). The patient was treated with AMLODIPINE for Blood pressure high, at a dose of 5 milligram. At the time of the report, HYPERTENSION (High blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: The test prior to the booster was taken at home and was low normal. and Bp reflects a rise.  Blood pressure has remained high..     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It was reported that Bp was low normal prior to the booster. An increase was noted at the doctor office 2 weeks following booster.  Patient was now on high-blood-pressure medication.  It was unknown if the patient experienced any additional symptoms/events.   It is unknown if there were additional lab data/results available.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain
Clinical narrative: drove me right into the bone and I went ouch; Intravenous in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), on 12Feb2020 as dose 1, single (Lot number: EN6200) intravenous, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Smoke cigarettes" (not ongoing), notes: I was smoking 2 packs a day.; "Equilibrium issue" (ongoing); "high blood pressure" (ongoing). Concomitant medication(s) included: MECLIZINE [MECLOZINE] oral taken for balance disorder (ongoing); AMLODIPINE oral taken for hypertension (ongoing). The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Feb2020, outcome "unknown", described as "Intravenous in the arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "drove me right into the bone and I went ouch".  Additional information: Patient had all 3 shots and booster and it worked. When probed for route of administration: Consumer stated, "Intravenous in the arm, injection in the arm." As of 14Aug2023, the time for administration of dose 1 BNT162b2 was at AM. The Pfizer vaccines that the patient received for Covid worked well. The patient had no triggered effects. The patient got the booster when it was available for extra protection. It was reported that the doses 1, 2 and 3 were wonderful. Reported the prior Vaccinations within 4 weeks was none. Relevant/specific relevant tests were none. As of 06Sep2023, the patient stated that "the only time I had a problem is one of the people that administered it, she drove me right into the bone and I went ouch what were you doing but other then that, the product is, I think it is wonderful". The patient like to have some more this year.  Follow-up (14Aug2023): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported in response to non-HCP letter sent in cross reference case that included: Updated information included: Reporter details, patient details (name and age group), relevant medical history details, concomitant drug details and additional information was updated.  Follow-up attempts are completed. No further information is expected.  Follow-up (06Sep2023): This is a spontaneous follow-up report received from a contactable Consumer. Updated information: reaction detail (added event: drove me right into the bone and I went ouch) and clinical course details.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263551 same patient/drug, different dose/events (Dose 3);US-PFIZER INC-202300263550 Same Patient/Product, Different Dose/Event (Dose 2);
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: after initial positive test; (07Sep2023) positive, notes: 4 days after end of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid rebound. 9 days after initial positive test. 4 days after end of paxlovid. Known allergies: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Investigation, Vaccination failure
Clinical narrative: i got the COVID; i got the COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9261, Expiration Date: 31May2021), on 08Mar2021 as dose 2, single (Lot number: EN6206, Expiration Date: 30Jun2021) and on 18Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "i got the COVID". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; eye pressure: High. Clinical course: Consumer (Nurse Practitioner) stated, "I have had a question about the Pfizer booster shot, I was able to get the first two Pfizer COVID-19 Vaccines without any reactions or side effect at all and I got the Bivalent without any reaction at all but when I got the COVID, the Pfizer COVID Booster shot and this was in Dec2021, three week after I got that shot.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid 19, vaccination failure cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dental caries, Glaucoma, Ophthalmological examination
Clinical narrative: i got the COVID; i got the COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9261, Expiration Date: 31May2021), on 08Mar2021 as dose 2, single (Lot number: EN6206, Expiration Date: 30Jun2021) and on 18Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "i got the COVID". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; eye pressure: High. Clinical course: Consumer (Nurse Practitioner) stated, "I have had a question about the Pfizer booster shot, I was able to get the first two Pfizer COVID-19 Vaccines without any reactions or side effect at all and I got the Bivalent without any reaction at all but when I got the COVID, the Pfizer COVID Booster shot and this was in Dec2021, three week after I got that shot.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid 19, vaccination failure cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tooth fracture
Clinical narrative: i got the COVID; i got the COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9261, Expiration Date: 31May2021), on 08Mar2021 as dose 2, single (Lot number: EN6206, Expiration Date: 30Jun2021) and on 18Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "i got the COVID". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; eye pressure: High. Clinical course: Consumer (Nurse Practitioner) stated, "I have had a question about the Pfizer booster shot, I was able to get the first two Pfizer COVID-19 Vaccines without any reactions or side effect at all and I got the Bivalent without any reaction at all but when I got the COVID, the Pfizer COVID Booster shot and this was in Dec2021, three week after I got that shot.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid 19, vaccination failure cannot be excluded.
Sex: F
Vaccine: RSV
Symptoms: COVID-19
Clinical narrative: came down with Covid; 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 70-year-old female patient received pf-06928316 (ABRYSVO), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "unknown", described as "came down with Covid". Therapeutic measures were taken as a result of covid-19.  Additional information: Caller stated she and her husband received the Pfizer RSV vaccine last Friday on 01Sep2023. Caller stated, immediately after getting the vaccine, they both came down with Covid and are now both on Paxlovid. Caller stated she does not think getting Covid has anything to do with getting the vaccine, as they were out.   The reporter considered "came down with covid" not related to pf-06928316.  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.; Sender's Comments: COVID-19 is considered unrelated to ABRYSVO but represents an intercurrent viral infection.,Linked Report(s) : US-PFIZER INC-202300296340 same reporter/product/AE, different patient;
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: spleen removed 09Jan2022 from blood clots; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 21-year-old male patient received bnt162b2 (BNT162B2), on 15Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 25May2021, when the patient was 20-year-old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 09Jan2022, outcome "recovering", described as "spleen removed 09Jan2022 from blood clots". The event "spleen removed 09jan2022 from blood clots" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis including Splenectomy.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event thrombosis with BNT162b2 can not be fully excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: encountered Covid back; encountered Covid back; 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "also had Covid before" (unspecified if ongoing), notes: minor level attack. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" and all described as "encountered Covid back". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: She had already taken 5 days of Paxlovid and tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Caller asked if she should got another Covid vaccine or should she just wait and hope her symptoms go away. Caller mentioned she had 1 booster shot last year.  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: Linked Report(s) : US-PFIZER INC-202300296425 same patient, different drug/AE;US-PFIZER INC-202300296536 same patient, different drug/AE;
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 31 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative; (Sep2023) Negative; (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 28Aug2023 to 01Sep2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300296465 Same reporter/patient,different drug/AE.;
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 28-year-old male patient received bnt162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Aug2023 to 21Aug2023.  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-202300296470 Same reporter/patient, different drug/event.;
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 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (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: (2023) Negative, notes: Tested negative on day 9; (2023) Positive, notes: positive on day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The Patient had received the Paxlovid as a treatment of COVID-19 on 31Aug2023 to 05Sep2023.  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: Linked Report(s) : US-PFIZER INC-202300296468 Same reporter/patient,different drug/AE.;
Age: 45.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), on 21Apr2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 22Aug2023 to 24Aug2023.  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-202300296516 Same patient, different drug/AE;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose: 1 and 2: Pfizer/Dose 3: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetes" (unspecified if ongoing); "controlled blood pressure" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "prostate cancer surgery", start date: 2014 (unspecified if ongoing); "known allergies: horse serum" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lamisil, reaction(s): "known allergies: oral Lamisil"; Simvastatin, reaction(s): "known allergies: simvastatin"; Atropine, reaction(s): "known allergies: atropine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Nov2021, outcome "unknown", described as "Dose: 1 and 2: Pfizer/Dose 3: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 07Sep2023 to 08Sep2023.  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-202300296453 same patient, different drug/event;
Age: 57.0
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) (Consumer or other non HCP). 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 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6206), on 24Mar2021 as dose 2, single (Lot number: ER8727), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587) and on 31Mar2022 as dose 4 (booster), single (Lot number: FJ6369) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imitrex, reaction(s): "Known allergies: Imitrex"; Enalapril, reaction(s): "Known allergies: Enalapril". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 01Sep2023 to 06Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296510 same reporter/patient, different drug/event (Paxlovid case);
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand other: Moderna, vaccine dose number: 4; vaccine brand: Pfizer / BioNTech, vaccine dose number: 3; 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 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8132), in left arm, on 25Apr2021 as dose 2, single (Lot number: RW0170), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 3302680) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Sep2022 as dose 4 (booster), single (Lot number: AS7162B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obese" (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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other: Moderna, vaccine dose number: 4; vaccine brand: Pfizer / BioNTech, vaccine dose number: 3". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 27Aug2023 to 01Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296454 same patient different drug/event;