chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy; Patient's left arm where  got the shot, from shoulder down to wrist it was very red; Chills; fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy), VACCINATION SITE ERYTHEMA (Patient's left arm where  got the shot, from shoulder down to wrist it was very red), CHILLS (Chills) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient thought patient had Covid some time back, after going to this big party. Patient felt so sick. It had to have been Covid. But this was in 2020, before patient got any shots.") in 2020. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) in February 2021, Moderna COVID-19 Vaccine (Dose 2) in March 2021 and Moderna COVID-19 Vaccine (3rd dose/1st booster) in October 2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In September 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE PRURITUS (Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy), VACCINATION SITE ERYTHEMA (Patient's left arm where  got the shot, from shoulder down to wrist it was very red), CHILLS (Chills) and PYREXIA (fever). At the time of the report, VACCINATION SITE PRURITUS (Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy), VACCINATION SITE ERYTHEMA (Patient's left arm where  got the shot, from shoulder down to wrist it was very red), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-320123 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Heart palpitations) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Supraventricular tachycardia.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) (seriousness criterion hospitalization). At the time of the report, PALPITATIONS (Heart palpitations) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was on heart medication. Patient was hospitalized after one of the Moderna Covid-19 vaccines. The patient did not specify after which dose that patient was hospitalized. After the first and second booster Moderna Covid-19 monovalent vaccines the patient had heart palpitations. The heart palpitations occurred after the first two booster doses. No treatment medication was provided. Company comment- This is a spontaneous case concerning an adult female patient of unknown age with medical history of supraventricular tachycardia who experienced the unexpected and serious (hospitalization) event of palpitations. Two doses of mRNA-1273 vaccine, given as booster doses of COVID vaccine schedule, were administered. Exact onset date of event and vaccination dates were not provided, hence latency cannot be assessed.  It was reported that after the first and second booster mRNA-1273 vaccines the patient had heart palpitations and was hospitalized after one of them (dose not specified). The patient said that she is on heart medication. No further details were provided for medical review. Medical history of supraventricular tachycardia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Tdap and Hepatitis B (booster). Past adverse reactions to the above products included No adverse event with Hepatitis B and Tdap.    On 19-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023).    It was reported that patient received other vaccines 4 weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that dose was given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023. No reported symptoms. No additional doses, medications, or treatments.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Emotional disorder, Pain
Clinical narrative: mad and upset; hurts; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (19May2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "mad and upset"; PAIN (non-serious), outcome "unknown", described as "hurts".  Additional information: Patient stated that I would like to know, the arm I got my covid vaccine in, a magnet sticks to my arm with my arm along my side what metal was injected into my arm for a magnet to stick to my arm I have a picture to prove it please let me know. Reporter further stated that I know there is something metal in my arm exactly where I had to get the covid vaccine, there is something metal injected in my arm when I put a magnet on it pull and hurts and it stays on my arm and it don't fall off like on my other arm it don't do that so again I am asking you what metal was injected in my arm I really mad and upset about it.   The information on the batch/lot number for BNT162b2 NOS has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CIPROFLOXACIN, on 10May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received vaccine. Patient took other medication in 2weeks. Immediately after 1st dose, had a strong bitter taste in back of throat that didn't go away until patient stopped the medicine. Patient had severe diarrhea starting a few hours after taking first dose. Patient had stomach pain in the upper part of her stomach that was still happening today.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 42-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment from 05May2023 to 09May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle disorder
Clinical narrative: she is having like muscular issues; she is feeling very weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "she is having like muscular issues"; ASTHENIA (non-serious), outcome "unknown", described as "she is feeling very weak".  Additional information: She said she took the Pfizer Booster Vaccine (Pfizer COVID-19 Vaccine). She said she was having like muscular issues that she was feeling very weak.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drug Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known_allergies Morphine", notes: known_allergies Morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient treated with Paxlovid from 07May2023 to 11May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Brain fog, Breast inflammation, Chest pain, Fatigue
Clinical narrative: Memory loss; Brain fog; chest pains; breast inflammation and infection; breast inflammation and infection; fatigue; Prev dose administration date=10Aug2020, prev dose dose number=1 / administration date=02Nov2020, dose number=2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2020 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 10Aug2020, when the patient was 39-year-old, for COVID-19 Immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Nov2020, outcome "unknown", described as "Prev dose administration date=10Aug2020, prev dose dose number=1 / administration date=02Nov2020, dose number=2"; BRAIN FOG (hospitalization, disability) with onset 02Dec2021, outcome "not recovered"; AMNESIA (hospitalization, disability) with onset 02Dec2021, outcome "not recovered", described as "Memory loss"; MASTITIS (hospitalization, disability), BREAST INFLAMMATION (hospitalization, disability) all with onset 02Dec2021, outcome "not recovered" and all described as "breast inflammation and infection"; CHEST PAIN (hospitalization, disability) with onset 02Dec2021, outcome "not recovered", described as "chest pains"; FATIGUE (hospitalization, disability) with onset 02Dec2021, outcome "not recovered". The patient was hospitalized for amnesia, brain fog, chest pain, mastitis, breast inflammation, fatigue (hospitalization duration: 3 day(s)). The events "memory loss", "brain fog", "chest pains", "breast inflammation and infection" and "fatigue" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of amnesia, brain fog, chest pain, mastitis, breast inflammation, fatigue.  Clinical course: No Covid prior vaccination. Covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mastitis, SARS-CoV-2 test
Clinical narrative: Memory loss; Brain fog; chest pains; breast inflammation and infection; breast inflammation and infection; fatigue; Prev dose administration date=10Aug2020, prev dose dose number=1 / administration date=02Nov2020, dose number=2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2020 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 10Aug2020, when the patient was 39-year-old, for COVID-19 Immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Nov2020, outcome "unknown", described as "Prev dose administration date=10Aug2020, prev dose dose number=1 / administration date=02Nov2020, dose number=2"; BRAIN FOG (hospitalization, disability) with onset 02Dec2021, outcome "not recovered"; AMNESIA (hospitalization, disability) with onset 02Dec2021, outcome "not recovered", described as "Memory loss"; MASTITIS (hospitalization, disability), BREAST INFLAMMATION (hospitalization, disability) all with onset 02Dec2021, outcome "not recovered" and all described as "breast inflammation and infection"; CHEST PAIN (hospitalization, disability) with onset 02Dec2021, outcome "not recovered", described as "chest pains"; FATIGUE (hospitalization, disability) with onset 02Dec2021, outcome "not recovered". The patient was hospitalized for amnesia, brain fog, chest pain, mastitis, breast inflammation, fatigue (hospitalization duration: 3 day(s)). The events "memory loss", "brain fog", "chest pains", "breast inflammation and infection" and "fatigue" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of amnesia, brain fog, chest pain, mastitis, breast inflammation, fatigue.  Clinical course: No Covid prior vaccination. Covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish/most fruits" (unspecified if ongoing), notes: Known allergies: Food which includes shellfish and most fruits. The patient took concomitant medications. The following information was reported: DYSPNOEA (medically significant) with onset 22May2021, outcome "not recovered", described as "A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right". The events "a week after i got the shot 1 morning i just couldn't catch my breathe and it's been since 2021 it's now 2 years later and i still can't breathe right" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dyspnoea.   Clinical course: Other medications in two weeks: prescribed medicines for asthma/seasonal allergies. Adverse event: A week after the patient got the shot 1 morning, he just couldn't catch his breath and it's been since 2021 it's now 2 years later and he still couldn't breathe right. AE treatment: Many asthma relieves/steroids/oxygen. Known allergies: Food which includes shellfish and most fruits. Other medical history: Asthma.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary sarcoidosis
Clinical narrative: Pulmonary sarcoidosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Apr2023 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PULMONARY SARCOIDOSIS (medically significant) with onset 20Apr2023 at 20:00, outcome "not recovered". The event "pulmonary sarcoidosis" required physician office visit. Therapeutic measures were taken as a result of pulmonary sarcoidosis: treatment with Z-Pak Antibiotics Cough Meds Nasal Spray.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility female
Clinical narrative: I am not able to get pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 as dose 2, single (Lot number: Fe3599) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot NO: Fe3599, Vaccine location: Left arm), administration date: 05Jan2022, when the patient was 24-year-old, for COVID-19 immunization. The following information was reported: INFERTILITY FEMALE (non-serious) with onset 01Sep2022, outcome "not recovered", described as "I am not able to get pregnant". Therapeutic measures were not taken as a result of infertility female.  Additional information: Patient did not received any other vaccine in four weeks. Patient did not had covid prior vaccination and after vaccination patient did not tested for COVID. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: SEIZURE (disability, medically significant) with onset 01Feb2021 at 13:15, outcome "not recovered", described as "I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.". The events "i went home and had 2 seizures right after i got 2 of my vaccinations. i had received all 3 vaccinations, and i need proof of that." required emergency room visit. It was unknown if therapeutic measures were taken as a result of seizure.  Clinical information : She went home and had 2 seizures right after she got 2 of her vaccinations. She had received all 3 vaccinations, and She need proof of that. Facility type vaccine was hospital. Received other vaccine in four weeks. Received other vaccine in two weeks. No know allergies.  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 information provided in the narrative, a causal association between the event Seizure and the suspect drug cannot be completely excluded. 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: Seizure
Clinical narrative: I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 2021, for COVID-19 immunization, reaction(s): "seizure". The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.". The events "i went home and had 2 seizures right after i got 2 of my vaccinations. i had received all 3 vaccinations, and i need proof of that." required emergency room visit. It was unknown if therapeutic measures were taken as a result of seizure.  Clinical course: Patient reported that she went home and had 2 seizures right after she got 2 of her vaccinations. She had received all 3 vaccinations, and She need proof of that. No know allergies. Received other medications in two weeks. Received other vaccine in four weeks.   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 known drug safety profile, there is reasonable possibility of causal association between the event "SEIZURE " and BNT162B2. 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: I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 2021, for COVID-19 immunization, reaction(s): "seizure". The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.". The events "i went home and had 2 seizures right after i got 2 of my vaccinations. i had received all 3 vaccinations, and i need proof of that." required emergency room visit. It was unknown if therapeutic measures were taken as a result of seizure.  Clinical course: Patient reported that she went home and had 2 seizures right after she got 2 of her vaccinations. She had received all 3 vaccinations, and She need proof of that. No know allergies. Received other medications in two weeks. Received other vaccine in four weeks.   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 known drug safety profile, there is reasonable possibility of causal association between the event "SEIZURE " and BNT162B2. 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: Seizure
Clinical narrative: most recent dose details, dose number=3, Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; most recent dose details, dose number=3, Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Other medical history: Epilepsy; "If covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "most recent dose details, dose number=3, Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: Nasal Swab.  Clinical information: Patient received dose 2 at 01:15 PM. Patient received other vaccine in four weeks and other medications in two weeks. Patient had no known allergies.  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 known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: most recent dose details, dose number=3, Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; most recent dose details, dose number=3, Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Other medical history: Epilepsy; "If covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "most recent dose details, dose number=3, Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: Nasal Swab.  Clinical information: Patient received dose 2 at 01:15 PM. Patient received other vaccine in four weeks and other medications in two weeks. Patient had no known allergies.  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 known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/Date: 01Jan2022/Result: positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Date: 01Jan2022/Result: positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes/Date: 01Jan2022/Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: Nasal Swab.  Additional information: Facility type vaccine was Hospital. Patient received other vaccine in four weeks and other medications in two weeks. Patient had no known allergies.  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 information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2 administration.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Computerised tomogram, Fear, Feeling abnormal, Frustration tolerance decreased
Clinical narrative: frustrated; doesn't make her feel good; Scared; Loss of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: ANOSMIA (non-serious) with onset May2021, outcome "not recovered", described as "Loss of smell"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "frustrated"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "doesn't make her feel good"; FEAR (non-serious), outcome "unknown", described as "Scared". The event "loss of smell" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia.  Additional information: Reason for no lot number: of COVID-19 Vaccine was Complainant does not have the product with them at the time of call. No other conditions provided. Patient got her second COVID-19 Vaccine in May2021. Thought it would go away, but she hasn't been able to smell again. She's getting very frustrated and had seen different doctors and they were still working on the same thing. Her loss of smell hasn't been resolved and it doesn't make her feel good. When she cooks, she can't smell anything anymore. She didn't think the loss of smell would stay. Thought maybe it was a temporary thing. Treatment: Yes, the first doctor did an MRI or CT scan, and checked everything. Clarifies she thinks it was a CT scan, not an MRI. Everything seems to be ok. She was given her some medicine to use, it didn't help. She went to a different doctor and was also given medication and it didn't help. She does not provide the product names of the medications she was given. She can't smell. She can taste. She can tell if something is sweet, but states she can't smell anything. She wanted to get another COVID-19 vaccine because she was due for it, but she's kind of scared. Does not have COVID-19 Vaccine card at time of call to provide any information regarding both doses. She didn't go to the hospital because the doctor told her it would go away and she would be fine. She also thought it would go away too, but it didn't. Vaccine not Administered at Facility. Facility Name was Pharmacy. No Prior Vaccinations (within 4 weeks), Family Medical History Relevant to Adverse Events (AEs) was None. AE required visit to Physician's offices  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy; blotchy red hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose 4 (booster), single (Lot number: GJ7696) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Chronic inflammatory demyelinating polyneuropathy" (ongoing), notes: a neurological genetic disorder; diagnosed: around 7 years ago; "autoimmune deficiency" (ongoing), notes: Diagnosed: 6 or 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EW0162, anatomical location: Right arm), administration date: 15Apr2021, when the patient was 46-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Lot: EW0164, anatomical location: Right arm thinks), administration date: 06May2021, when the patient was 46-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (booster), single, Lot: FD0809, anatomical location: Left arm), administration date: 04Dec2021, when the patient was 46-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 13May2023, outcome "not recovered", described as "Itchy"; URTICARIA (non-serious) with onset May2023, outcome "not recovered", described as "blotchy red hives". Therapeutic measures were not taken as a result of urticaria, pruritus.  Additional information: called about the Pfizer COVID vaccine, went in last week and got the booster, clarified got the Pfizer COVID bivalent vaccine booster, since last week has had blotchy red hives, itchy, nonstop itching. Talked to location where caller got the vaccine and was told to call Pfizer to report this information. Blotchy red hives: Start date of adverse event: Got the shot on 11May2023 in the morning between 9AM and 10AM, Thinks right arm, thinks on 13May2023 the itching started and then noticed the hives around the same time, later that night noticed was a little more red than normal, next day noticed hives on whole body, so hives started either 13May2023 or 14May2023. Not as bright, but still red and itchy. Goes up and down, two days ago stopped itching then came back, had one free day then itching came back. Clarified and confirmed this was patient's 4th dose, 3 prior doses were all the Pfizer COVID vaccine. Going to start traveling more via airlines and has autoimmune deficiency so wanted to make sure caller was covered. Concomitant products: No, nothing out of the ordinary that caller would not normally take. No additional information provided. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No test performed for Thromboembolic Events with Thrombocytopenia Include specific relevant test above. No visit and no investigation performed. The event does not require the initiation of new medication/other treatment/procedure (No not as of yet).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 4 (booster), single (Lot number: as7165b), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial Septal Defect repaired (amplatzer occluder)" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN SODIUM, start date: May2015, stop date: 14May2023. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin"; Cefdinir, reaction(s): "Known allergies: cefdinir"; Lorzone, reaction(s): "Known allergies: lorzone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid (14May2023 to 01Apr2023) as a treatment for Covid-19. Other medication in 2weeks: Yes
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: Lot of pain in chest; Pain in my right arm; Heart rate are very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), on 18May2023 at 16:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 18May2023, outcome "unknown", described as "Heart rate are very high"; CHEST PAIN (non-serious) with onset 18May2023, outcome "unknown", described as "Lot of pain in chest"; PAIN IN EXTREMITY (non-serious) with onset 18May2023, outcome "unknown", described as "Pain in my right arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, "I am just calling because I have been having some side effect with this vaccine. I got the vaccine this Thursday at 4 o'clock and I have been having a lot of pain in my chest and pain in my right arm and that is not the arm I got the vaccine because I got in the left the arm and my heart rate are very high."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: Fm0173) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2020 as dose 1, single (Lot number: 037k20a), in right arm, on 25Jan2021 as dose 2, single (Lot number: 041l20a), in right arm, on 13Nov2021 as dose 3 (booster), single (Lot number: 004f21a), in right arm and on 29Oct2022 as dose 5 (booster), single (Lot number: 052d22a), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Jun2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (20May2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: After testing negative and no symptoms, started showing symptoms 17May2023. Tested positive 20May2023. Product: COVID 19 Treatment: Paxlovid, Treatment start date: 09May2023 to Treatment stop date: 14May2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE,COVID-19 ) and BNT162B2.