chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: she realized the product had an expiration date of 15Jan2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HBV (Engerix B) (batch number 9255P, expiry date 15-JAN-2024) for prophylaxis.   On 25-JAN-2024, the patient received the 3rd dose of Engerix B. On 25-JAN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: she realized the product had an expiration date of 15Jan2024.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024 The pharmacist reported patient administered the Engerix B and then realized that the vaccine was expired one, which led to expired vaccine used. At the time of reporting no additional doses had been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020, batch number 94B7F, expiry date 25th May 2022) and ZOSTAVAX .   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: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-MAR-2024 The patient had not received the second dose at the time of the call. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the second dose of Shingrix two weeks after the first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   In FEB-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Patient received the second dose of Shingrix two weeks after the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 06-Mar-2024 The reporter was a hospital director. The patient was immunocompetent. The reporter reported that the patient received the second dose of Shingrix vaccine two weeks after the first dose and not 2 months later. The vaccine administration facility was the same as primary Reporter. The lot number and vaccination date for the first dose were asked but declined because caller was not at the facility at moment of call. No side effects were reported. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, SARS-CoV-2 test positive
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; REBOUND COVID POSITIVE TEST; This spontaneous report received from a health care professional by a Business partner (Pfizer Inc.) on 26-FEB-2024 was received on 27-FEB-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, intramuscular, batch number: 041A21A) dose was not reported, administered on 02-APR-2021 11:00 to Left Arm for covid-19 prophylaxis. Non-company suspect vaccine included: tozinameran(Dose number in series 3) ( batch number: FF8841, batch number: HG 4671, form of admin, route of admin, and were not reported) dose was not reported, administered on 31-MAR-2022 11:00 to Left Arm, and dose was not reported, administered on 08-OCT-2023 10:00(Dose number in series 5) to Left Arm for covid-19 prophylaxis. ; and elasomeran ( batch number: 032F21A, batch number: AS7143C, form of admin, route of admin, and were not reported) dose was not reported, administered on 05-NOV-2021(Dose number in series 2) 12:00 to Left Arm, and dose was not reported, administered on 14-SEP-2022 (Dose number in series 4) 06:00 to Left Arm for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included prednisone. On 19-FEB-2024,  following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced rebound covid positive test (Dose number in series 1). On an unspecified date, the patient experienced revaccination with different covid-19 vaccine  (Dose number in series 2). Treatment medications (dates unspecified) included: nirmatrelvir/ritonavir. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable. The patient was recovering from rebound covid positive test, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; COVID REBOUND; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 28-FEB-2024 was received on 29-FEB-2024 and concerned a patient of unspecified age and sex. Initial information was processed with additional information received on 06-MAR-2024. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 16-MAR-2021 12:00 to Left Arm for covid-19 prophylaxis. Non-company suspect vaccine included: elasomeran ( batch number: 047C21A, batch number: 047C21A, batch number: AS7164B, form of admin, route of admin, and were not reported) dose was not reported, administered on 07-SEP-2021 08:00 to Left Arm, dose was not reported (Dose number in series 2), administered on 05-OCT-2021 08:00 to Left Arm, dose was not reported(Dose number in series 3), administered on 26-SEP-2022 03:15 to Left Arm, and dose was not reported(Dose number in series 4), administered on 03-NOV-2023 08:15(Dose number in series 5) to Left Arm for covid-19 prophylaxis. Concomitant medications included celecoxib, estradiol, losartan, and progesterone.  On 22-FEB-2024 18:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced covid rebound (Dose number in series 1),  same symptoms as the first covid -sore throat, stuffy/runny nose, chills, aches. Mild this  time. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced revaccination with different covid-19 vaccine (Dose number in series 2). On FEB-2024, treatment medications included: nirmatrelvir/ritonavir. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from covid rebound, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case was associated with product quality complaint: 90000316238.
Sex: U
Vaccine: COVID19
Symptoms: Red blood cell count, Red blood cell count increased
Clinical narrative: BODY NOW MAKES TOO MANY RED BLOOD CELLS; This spontaneous report received from a consumer who reported hearing a news report (Facebook) which concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s  (Dose number in series 1) (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. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced body now makes too many red blood cells (Dose number in series 1).  Laboratory data (dates unspecified) included: Red blood cell count Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body now makes too many red blood cells was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure systolic, Hypertension
Clinical narrative: 165 Systolic blood pressure; This spontaneous report received from a patient via a J and J social media 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, intramuscular, batch number was not reported) dose (dose series 1), start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to request the batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced 165 systolic blood pressure (dose series 1) after having the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 165 systolic blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:covid-19 vaccine ad26.cov2.s -Hypertension.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure; 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(dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Batch number was not reported and we are unable to perform follow up. No concomitant medications were reported. On an unspecified date, the patient experienced high blood pressure (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laziness, Pain in extremity, SARS-CoV-2 test, Scratch
Clinical narrative: having a sore arm after receiving vaccine and felt "lazy,"; having a sore arm after receiving vaccine and felt "lazy,"; scratchy; On 27AUG2021, she tested positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (On 27AUG2021, she tested positive), PAIN IN EXTREMITY (having a sore arm after receiving vaccine and felt "lazy,"), LAZINESS (having a sore arm after receiving vaccine and felt "lazy,") and SCRATCH (scratchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (On 27AUG2021, she tested positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (having a sore arm after receiving vaccine and felt "lazy,"), LAZINESS (having a sore arm after receiving vaccine and felt "lazy,") and SCRATCH (scratchy). At the time of the report, COVID-19 (On 27AUG2021, she tested positive) and PAIN IN EXTREMITY (having a sore arm after receiving vaccine and felt "lazy,") had resolved and LAZINESS (having a sore arm after receiving vaccine and felt "lazy,") and SCRATCH (scratchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient received any other vaccines in the 4 weeks prior to Covid-19 Vaccine. It was reported that patient had a scratchy, runny nose, and tiny cough. Lots of patients getting positive on COVID. On 27-AUG-2021, she tested positive in the doctor's office. After COVID diagnosis, she stayed in the house for 10 days. The reporter stated that she was well before the 10 days were up. The primary lot number was hard for her to read and described as 0-2-5 or T-A-2-1-A. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-763168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763168:Husband case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I both got the COVID; I both got the COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Dec2021 (unspecified if ongoing), notes: she actually had COVID in Dec2021. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I both got the COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient actually has had COVID before, she actually had COVID in Dec2021 to January to like five days or seven days and she did not get the Paxlovid, she have some kind of monoclonal antibodies treatment. That is what she got as a treatment she said she had to go to the hospital for that. She got vaccinated for COVID after she had the actual it's called the vaccination (Pfizer COVID-19 Vaccine), she actually got COVID and then was treated after that was with monoclonal antibodies and now she has COVID today and she is getting treated today with Paxlovid. Patient was able to get her booster, this was in Jan2022. It was the time to get the second Pfizer and her daughter (could not be further clarified hence split not filed) and she both got the COVID." She was not feeling well at all so, not ready for this. This is the second time patient got it.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pcos" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure with Paxlovid from 17Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccinated for COVID-19 this year, and still got sick with COVID in Feb2024; vaccinated for COVID-19 this year, and still got sick with COVID in Feb2024; This is a spontaneous report received from a Pharmacist.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (2024) and all described as "vaccinated for COVID-19 this year, and still got sick with COVID in Feb2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive, notes: If covid tested post vaccination: Yes. Clinical course: Other vaccine in four weeks was unknown. During discussion with HCP, she mentioned that she had been vaccinated for COVID-19 this year, and still got sick with COVID in Feb2024. She was only sick for a few days, and fully recovered. Patient did not had covid prior vaccination. Patient tested covid post vaccination.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine to the drug ineffective (LOE) and covid 19 cannot be ruled out.
Sex: U
Vaccine: RSV
Symptoms: Dizziness
Clinical narrative: felt lightheaded after the vaccine; This is a spontaneous report received from a Pharmacist. An adult patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt lightheaded after the vaccine". It was unknown if therapeutic measures were taken as a result of dizziness.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Stroke; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2), in Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 35 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous dose details:, [{prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, is bivalent=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administrator route=Intramuscular,, prev dose administration date=Jul2022,, prev dose dose number=1,, prev dose vaccine location=Left arm}]), administration date: Jul2022, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (life threatening, hospitalization, disability, medically significant) with onset 04Mar2024, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "stroke" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Herpes zoster, Myocarditis, Neck pain, Tachycardia
Clinical narrative: myocarditis; droopy eye; shingles on left side; neck pain; severe lockjaw; tachycardia; affected her eyesight/Vision decreased; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 48 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 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered"; EYELID PTOSIS (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "droopy eye"; HERPES ZOSTER (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "shingles on left side"; NECK PAIN (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered"; TRISMUS (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "severe lockjaw"; TACHYCARDIA (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered"; VISUAL IMPAIRMENT (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "affected her eyesight/Vision decreased". The events "myocarditis", "droopy eye", "shingles on left side", "neck pain", "severe lockjaw", "tachycardia" and "affected her eyesight/vision decreased" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of myocarditis, eyelid ptosis, herpes zoster, neck pain, trismus, tachycardia, visual impairment. Clinical course: Patient was completely healthy, female after COVID-19 injections affected her eyesight 10 days after the injection of the last of she developed shingles on left side neck pain, severe lockjaw, droopy eye, myocarditis, and tachycardia had to go to the hospital. All doctors told her it was due to the vaccine. She did not have covid prior to vaccination. Covid was not tested post vaccination. She had no known allergies. No vaccine in four weeks and no medications in two weeks.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Trismus, Visual impairment
Clinical narrative: myocarditis; droopy eye; shingles on left side; neck pain; severe lockjaw; tachycardia; affected her eyesight/Vision decreased; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 48 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 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered"; EYELID PTOSIS (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "droopy eye"; HERPES ZOSTER (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "shingles on left side"; NECK PAIN (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered"; TRISMUS (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "severe lockjaw"; TACHYCARDIA (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered"; VISUAL IMPAIRMENT (hospitalization), 10 days after the suspect product(s) administration, outcome "not recovered", described as "affected her eyesight/Vision decreased". The events "myocarditis", "droopy eye", "shingles on left side", "neck pain", "severe lockjaw", "tachycardia" and "affected her eyesight/vision decreased" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of myocarditis, eyelid ptosis, herpes zoster, neck pain, trismus, tachycardia, visual impairment. Clinical course: Patient was completely healthy, female after COVID-19 injections affected her eyesight 10 days after the injection of the last of she developed shingles on left side neck pain, severe lockjaw, droopy eye, myocarditis, and tachycardia had to go to the hospital. All doctors told her it was due to the vaccine. She did not have covid prior to vaccination. Covid was not tested post vaccination. She had no known allergies. No vaccine in four weeks and no medications in two weeks.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
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 Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (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 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 02Mar2024 to 06Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 16:30 as dose 1, single (Lot number: HG2282) at the age of 40 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE, Batch/Lot No: 046A21A , Location of injection: Arm Right), administration date: 19Mar2021, when the patient was 37-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: 009C21A , Location of injection: Arm Right), administration date: 23Apr2021, when the patient was 37-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot No: GH9693 , Location of injection: Arm Right), administration date: 13Oct2022, when the patient was 39-year-old, for COVID-19 immunization; Moderna (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot No: 045J21A , Location of injection: Arm Right), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Mar2024, outcome "recovered" (08Mar2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Mar2024) Positive; (08Mar2024) Negative; (10Mar2024) Negative; (11Mar2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 04Mar2024 to 08Mar2024.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took covid test and he tested positive; took covid test and he tested positive; This is a spontaneous report received from a Physician from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyper reactive small airway disease" (unspecified if ongoing); "had complications with his open heart surgery" (unspecified if ongoing); "hepatic problems" (unspecified if ongoing); "cytochrome deficiency" (unspecified if ongoing); "hyperactive sinusitis" (unspecified if ongoing); "chronic sinusitis" (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 12Mar2024, outcome "unknown" and all described as "took covid test and he tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Mar2024) Positive, notes: he took covid test and he tested positive for Roche and Abbott; (12Mar2024) Positive, notes: he took covid test and he tested positive for Roche and Abbott. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Physician.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (Booster), Manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 11Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: bliteral extreme foot pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: 12Mar2021, for Covid-19 Immunization, reaction(s): "bliteral extreme foot pain", "weakness", "dizziness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "bliteral extreme foot pain". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Caller was asking if the vaccine can trigger or cause small fiber neuropathy. He was vaccinated 5 times with the COVID vaccine. The first one was on 12MAR2021 while the second one was on 04022021. After this one, he started getting bilateral extreme foot pain and painkillers. Then he got the vaccine 10 days ago and started with the symptoms again.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400064731 Same reporter/patient, similar event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: bilateral extreme foot pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Mar2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 12Mar2021, for COVID-19 Immunisation, reaction(s): "bilateral extreme foot pain", "Weakness", "Dizziness"; BNT162b2 (Dose 2, Single), administration date: 02Apr2021, for COVID-19 Immunisation, reaction(s): "bilateral extreme foot pain"; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose 4, Manufacturer Unknown), for COVID-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "bilateral extreme foot pain". Additional information: Caller is a non HCP. Caller has a Comirnaty question, caller was asking if the vaccine can trigger or cause small fiber neuropathy. He was vaccinated 5 times with the COVID vaccine, the first one was on 12Mar2021, the second one on 02Apr2021, after this one he started getting bilateral extreme foot pain and painkillers. Then he got the vaccine 10 days ago and started with the symptoms again.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021245360 Same reporter/patient, similar event, different dose;US-PFIZER INC-202400064659 Same reporter/patient, similar event, different dose;
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6200), in right arm, on 30Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: FE3594) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden" (unspecified if ongoing); "History of DVT" (unspecified if ongoing); "Pennicillin" (unspecified if ongoing); "Sulfa Products" (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 04Mar2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Initial symptoms for COVID started on 04Mar2024. Symptoms such as fever, cough, sore throat, muscle aches and headache persisted and patietn tested positive on 05Mar2024. (This was the very first time of ever testing positive for COVID). Moderate symptoms lasted until 08Mar2024 and stopped completely on 10Mar2024. Paxlovid was taken from 06Mar2024 to 10Mar2024.
Sex: U
Vaccine: RSV
Symptoms: Gait inability, Housebound, Loss of personal independence in daily activities, Wheelchair user
Clinical narrative: I'm in a wheelchair I can't get out.  I'm homebound, I'm crippled; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 77-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (disability), outcome "unknown", described as "I'm in a wheelchair I can't get out.  I'm homebound, I'm crippled". Therapeutic measures were taken as a result of gait inability. Caller called in seeking assitance with the Abrysvo vaccine. During the call caller stated. "I'm homebound, I'm in a wheelchair I can't get out.  I'm homebound, I'm crippled."   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, RSV
Symptoms: Encephalitis
Clinical narrative: Encephalitis; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENCEPHALITIS (medically significant), outcome "unknown".  Clinical course: During an in-person conversation with Geriatrician (Name) on 10Mar2024 at 4PM, he mentioned that he recently saw a case of encephalitis in one of his patients, following co-administration of an RSV and COVID-19 vaccine. He had no details regarding which RSV vaccine the patient received, or time course, patient outcomes, etc.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event encephalitis; and the suspect drugs BNT162B2 OMI XBB.1.5, and RSV VACCINE PROT.SUBUNIT PREF 2V cannot be 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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: + (positive) test for COVID; + (positive) test for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "+ (positive) test for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400063093 Same patient/ vaccine, different dose/AE.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: Vaccination failure/developed COVID-19 pneumonia; Vaccination failure/developed COVID-19 pneumonia; This is a literature report, Program ID for the following literature source(s).  A 31-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant, life threatening), COVID-19 PNEUMONIA (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Vaccination failure/developed COVID-19 pneumonia". Therapeutic measures were taken as a result of vaccination failure, covid-19 pneumonia. Clinical course: A 31-year-old man exhibited vaccination failure following tozinameran vaccination. Additionally, he exhibited lack of efficacy during treatment with remdesivir, tocilizumab and unspecified steroids for COVID-19 pneumonia and heparin as prophylactic anticoagulant therapy [dosages not stated; not all routes stated]. The man with obesity, vaccinated with two doses of tozinameran [BNT162b2], presented with history of fever and diarrhoea for 3 days. He developed hypoxia, hyperthermia and shock, which required intubation, mechanical ventilation and pressor support. Following examination, he was diagnosed with COVID-19 pneumonia, cytokine storm and myocarditis. Despite vaccination with tozinameran, he developed COVID-19pneumonia, indicating vaccination failure. He was admitted to ICU and was noted with methicillin susceptible Staphylococcus aureus (MSSA) pneumonia. He was treated with remdesivir, tocilizumab andunspecified steroids. Additionally, he received unspecified antibacterials [antibiotics]. Four days after initiation of prophylactic anticoagulation therapy with SC heparin [unfractionated heparin], he had drop in platelet count. He developed rapidly progressing purpura, haemorrhagic necrosis and gangrene with multiple Nikolsky positive blisters on the dorsum of both feet. A disseminated intravascular coagulation (DIC) panel was positive. Following ruling out all, he was diagnosed with purpura fulminans. Despite treatments, by day21, the healthcare proxy decided to make him comfortable in view of poor prognosis (lack of efficacy).  No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19 pneumonia) with the suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Paralysis, Urinary incontinence
Clinical narrative: paralysis; incontinence of urine and bowel; incontinence of urine and bowel; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): LRN4702070.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gall Stones" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing); "Colon Polyps" (unspecified if ongoing); "Paralysis" (unspecified if ongoing); "Lost Weight" (unspecified if ongoing); "Multiple sclerosis" (ongoing); "Reflux" (ongoing); "Gas" (ongoing); "Right Side Foot Drop" (ongoing); "Incontinence Urine" (ongoing); "Incontinence Bowel Movement" (ongoing); "Right Sided weakness" (ongoing); "Falls" (ongoing). Concomitant medication(s) included: TYLENOL; NATURE MADE SUPER B COMPLEX; VITAMIN D [VITAMIN D NOS]. The following information was reported: PARALYSIS (medically significant), outcome "unknown"; URINARY INCONTINENCE (non-serious), ANAL INCONTINENCE (non-serious), outcome "unknown" and all described as "incontinence of urine and bowel".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was administered post excursion with no reported adverse event; IPOL (Punctured) got to 9.4 C for 9 minutes; Reason: The refrigerator would have been opened; Human error: Yes with no reported adverse event; Initial information received on 04-Mar-2024 regarding an unsolicited valid non-serious case received from nurse.  This case is linked to cases 2024SA081647 and 2024SA081652.  This case involves 17 years old male patient and it was reported IPV (VERO) [IPOL] (punctured) got to 9.4 C for 9 minutes; reason: the refrigerator would have been opened; human error: yes with no reported adverse event and vaccine was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Prophylactic vaccination.  On 07-Feb-2024, it was reported that IPV (VERO) (punctured) got to 9.4 C for 9 minutes; reason: the refrigerator would have been opened; human error: yes with no reported adverse event (product storage error) (latency: unknown).  On 27-Feb-2024, the patient(s) received 0.5 ml total of suspect IPV (VERO) suspension for injection of lot W1C751M and expiry: 18-Nov-2025 via intramuscular route in the right arm (strength: standard) (frequency: once) as prophylactic vaccination (immunization).  On 27-Feb-2024, the patient(s) were administered IPV (VERO) post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Nurse confirmed that they have given doses of the IPOL to patients last 27-Feb-2024.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 11-Mar-2024: Case was upgraded from Non-valid to valid case. Suspect details added. Concomitant vaccines added. Patient details added. Text amended accordingly.; Sender's Comments:  US-SA-2024SA082723:01968661 (Master case)