chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient got the shot that was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got the shot that was expired) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (have two autoimmune conditions.).   On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got the shot that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got the shot that was expired) outcome was unknown.      Concomitant medications were not reported.  It was reported that, they would like to know if there had been extension shelf life for lot 048F21A. Patient received a vaccine from lot number 048F21A about an hour ago. They would like to know what the ramifications were of receiving a vaccine that had been expired. Patient got the shot that was expired. Reporter told the vaccination provider lied about the self-life of the vaccine. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: Double vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2022, the patient experienced DIPLOPIA (Double vision). At the time of the report, DIPLOPIA (Double vision) outcome was unknown.            No Concomitant Products were reported. No Treatment information was reported. Patient stated that he got several tests run and they all came back negative.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: no appetite; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) and RIOCIGUAT (ADEMPAS) for an unknown indication.   On 25-Aug-2021, the patient started TREPROSTINIL SODIUM (REMODULIN) (Subcutaneous) .161 microgram/kilogram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (no appetite) and PYREXIA (Fever). At the time of the report, DECREASED APPETITE (no appetite) and PYREXIA (Fever) outcome was unknown.            The patient experienced Headache with Remodulin and outcome reported was unknown. No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Did not receive email confirmation after receiving shipment of Vaccine stating okay to use and Vaccine was administered; Did not receive email confirmation after receiving shipment of Vaccine stating okay to use and Vaccine was administered; This case has been considered invalid as Unspecified number of patients.  Additional Information:-  Is report related to a study or programme? Yes Details:  Selected Report Type: Initial Is the patient also the reporter?: No Reporter type: Pharmacist Reporter email: (Email address withheld)    HCP postal address:  Other Conditions: Not Provided Investigations: Not Provided  Is Pfizer Covid 19 Vaccine Gray Cap a Pfizer product? Yes Pfizer Covid 19 Vaccine Gray Cap manufacturer: unspecified NDC number of Pfizer Covid 19 Vaccine Gray Cap: Not Provided Reason for no lot number: of Pfizer Covid 19 Vaccine Gray Cap: Caller unwilling to complete the report Expiry Date of Pfizer Covid 19 Vaccine Gray Cap: Not Provided Other Products: Not Provided  Additional Context: Warm transfer   Caller's name: (Name withheld) phone number: # zip code: #  The caller is a pharmacist who had a problem with the logger of shipment for Pfizer Covid 19 Vaccine Gray Cap. The caller is reporting a temperature excursion for the same Pfizer Covid 19 Vaccine Gray Cap. The Pfizer Covid 19 Vaccine Gray Cap has been administered to a patient. Caller clarifies the problem is the caller received a shipment of the Pfizer Covid 19 Vaccine Gray Cap on 01Apr2022 at 1018. The pharmacist was asked late last night, 05Apr2022 after several doses of the Pfizer Covid 19 Vaccine Gray Cap had been administered to patients, if the pharmacist received a confirmation via email that the controllant was received. The caller and another pharmacist looked through emails and did not get a confirmation after shipment of Pfizer Covid 19 Vaccine Gray Cap was received that the Pfizer Covid 19 Vaccine Gray Cap was okay to use. The caller clarifies there was no problem with the logger, the logger was fine. Also, there was no temperature excursion, the temperatures were fine. The shipment included 300 doses of the Pfizer Covid 19 Vaccine gray Cap without any problem. The caller just did not receive the confirmation email. Caller is not currently able to provide patient identifiers to document individual report. The caller is not even sure how many doses of the Pfizer Covid 19 Vaccine Gray Cap were administered and doesn't know if there is even an issue. Next time the caller will just email someone at controllant because controllant are on top of it. No further information provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.  Follow-up (11May2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: after receiving the Pfizer vaccine in 2020 I had many irregular and absent period due to the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2020 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: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "after receiving the Pfizer vaccine in 2020 I had many irregular and absent period due to the vaccine". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Their computer had birthday wrong for this patient and received a booster dose from the Gray Cap; Their computer had birthday wrong for this patient and received a booster dose from the Gray Cap; fever; it was at least 100 but it might have been 101; had redness to his arm; warmness to arm/forearm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 3 (booster), single (Lot number: FP4554, Expiration Date: 30Jun2022) at the age of 10 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Two previous doses given of the Pfizer COVID-19 vaccine), for Covid-19 Immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 04May2022, outcome "unknown" and all described as "Their computer had birthday wrong for this patient and received a booster dose from the Gray Cap"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "fever; it was at least 100 but it might have been 101"; ERYTHEMA (non-serious) with onset May2022, outcome "unknown", described as "had redness to his arm"; FEELING HOT (non-serious) with onset May2022, outcome "unknown", described as "warmness to arm/forearm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: 10 years old patient who had a 2 mistake inadvertent administration of the Pfizer COVID-19 Vaccine. Their computer had birthday wrong for this patient and received a booster dose from the Gray Cap.She says that the birthdate for the patient was put in as for a 16 year old. Caller says the patient had a fever this morning so he was left home from school, and his mother gave him Motrin, dosage unknown. She says she talked to the mother around 11:30AM, and he didn't have a fever or whatever. She says he also had redness to his arm and warmness to arm/forearm, but she feels like that is normal. The patient had no other conditions and had no other products.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL 9266), on 18Mar2021 as dose 2, single (Lot number: ER 2613), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FF 2589) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "ragweed allergy" (unspecified if ongoing); "Cats" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 25Apr2022, stop date: 06May2022. Past drug history included: Naltrexone, reaction(s): "allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "PAXAES report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (29Apr2022) Positive, notes: still tested positive but very faint antigen test line. Therapeutic measures were not taken as a result of vaccination failure. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient received other medication in 2 weeks. PCR results came back positive on 26Apr2022 & started Paxlovid that same day. Symptoms decreased over time and still tested positive but very faint antigen test line on Friday 29Apr and symptoms pretty much gone. Ended Paxlovid on Saturday 30Apr. Sniffles, sore throat, and slight cough developed again Monday evening 05Feb22 and have been worsening since then.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 05Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: have had graves disease many years ago; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Allergy to animal dander" (unspecified if ongoing), notes: Known allergies: animal dander. Other medication in 2weeks: No. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 04May2022 at 04:00, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 04May2022 at 04:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) negative, notes: I tested negative Monday and Tuesday; (03May2022) negative, notes: I tested negative Monday and Tuesday; (05May2022) positive, notes: Tested positive quickly on antigen test on Thursday morning. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that, Anti viral details: product Covid 19 Treatment, brand Paxlovid, treatment start date 26Apr2022, treatment stop date 01May2022, indication Treatment of Covid-19 started paxlovid on second, maybe third day of symptoms. Immediately started feeling better and by day after patient finished everything was gone except some minor hives/rashes that came and went. No treatment received for the adverse events.
Sex: M
Vaccine: PPV
Symptoms: Axillary lymphadenectomy, B-cell small lymphocytic lymphoma, Blood test normal, Chronic lymphocytic leukaemia, Lymphadenopathy
Clinical narrative: enlarged lymph node the size of a squashed golf ball in my left armpit; chronic lymphocytic leukemia/small lymphocytic lymphoma; chronic lymphocytic leukemia/small lymphocytic lymphoma; This is a spontaneous report received from contactable reporter(s) (Physician).  A 68-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Jan2020 as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER taken for type 2 diabetes mellitus; JANUVIA taken for type 2 diabetes mellitus. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), LYMPHOCYTIC LYMPHOMA (medically significant) all with onset Mar2020, outcome "unknown" and all described as "chronic lymphocytic leukemia/small lymphocytic lymphoma"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node the size of a squashed golf ball in my left armpit". The patient underwent the following laboratory tests and procedures: Blood test: Normal. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, lymphocytic lymphoma, lymphadenopathy. Clinical course included  In Jan2020, Patient  had a pneumonia vaccine booster and the next morning awoke with an enlarged lymph node the size of a squashed golf ball in my left armpit. In Mar2020, the lymph node was removed and I was diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma. Patient  underwent 28 radiation treatments to the axilla and sub pectoral areas and had 4 treatments with Rituxan. Patient was doing well with no recurrence of enlarged lymph nodes. My blood tests have been normal. I underwent immunization with the Pfizer Covid vaccines in Jan and Feb2021, and boosters with Pfizer vaccines in Aug2021 and Feb2022.    The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN, a causal relation between the reported event chronic lymphocytic leukemia,  lymphocytic lymphoma and the administration of the vaccine cannot be 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: M
Vaccine: PPV
Symptoms: Lymphocytic lymphoma, Radiotherapy
Clinical narrative: enlarged lymph node the size of a squashed golf ball in my left armpit; chronic lymphocytic leukemia/small lymphocytic lymphoma; chronic lymphocytic leukemia/small lymphocytic lymphoma; This is a spontaneous report received from contactable reporter(s) (Physician).  A 68-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Jan2020 as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER taken for type 2 diabetes mellitus; JANUVIA taken for type 2 diabetes mellitus. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), LYMPHOCYTIC LYMPHOMA (medically significant) all with onset Mar2020, outcome "unknown" and all described as "chronic lymphocytic leukemia/small lymphocytic lymphoma"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node the size of a squashed golf ball in my left armpit". The patient underwent the following laboratory tests and procedures: Blood test: Normal. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, lymphocytic lymphoma, lymphadenopathy. Clinical course included  In Jan2020, Patient  had a pneumonia vaccine booster and the next morning awoke with an enlarged lymph node the size of a squashed golf ball in my left armpit. In Mar2020, the lymph node was removed and I was diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma. Patient  underwent 28 radiation treatments to the axilla and sub pectoral areas and had 4 treatments with Rituxan. Patient was doing well with no recurrence of enlarged lymph nodes. My blood tests have been normal. I underwent immunization with the Pfizer Covid vaccines in Jan and Feb2021, and boosters with Pfizer vaccines in Aug2021 and Feb2022.    The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN, a causal relation between the reported event chronic lymphocytic leukemia,  lymphocytic lymphoma and the administration of the vaccine cannot be 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Neuropathy peripheral
Clinical narrative: Neuropathy; Dementia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 63 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: 1, Lot number: EN6199, Route of administration: Left arm), for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot number: EP7533, Route of administration: Left arm), for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; DEMENTIA (medically significant), outcome "unknown". Therapeutic measures were taken as a result of neuropathy peripheral, dementia. Lot# (Booster): FJ8157 or it could be 8757, the patient was not sure. The patient was receiving doctors care and she takes lots of medication for dementia and neuropathy, she has to take medicine for all kind of stuff which she never had to take before (Intent: treatment).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatitis atopic
Clinical narrative: I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse.; I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: DERMATITIS ATOPIC (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse.".  Additional information: Patient stated, I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I've talked to one other person who experienced the same situation as myself and have found some information online that also suggests the vaccine can cause increased symptoms of atopic dermatitis.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatitis atopic
Clinical narrative: I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I have talked to one other person who experienced the same situation; I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I have talked to one other person who experienced the same situation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS ATOPIC (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I have talked to one other person who experienced the same situation".  Additional information: Reporter found some information online that also suggests the vaccine can cause increased symptoms of atopic dermatitis. No age provided by patient. No phone number available.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: We all went for testing and also tested positive.  Clinical course: Patient and her husband are in 70's and her son and daughter in-law and 18 month granddaughter live with her. She is a teacher and tested positive for Corvid. They all went for testing and also tested positive. They all had received Pfizer inoculations and boosters and although their tests are positive, They are all functioning very well. We are so very thankful to Pfizer. Without Pfizer where would be, Hospitalized. Thank you Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110).  A male patient in his 60's received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Customer Verbatim: My husband and I are in our 70's and my son and daughter in-law and 18-month granddaughter live with us. She is a teacher and tested positive for Corvid. We all went for testing and also tested positive. We all had received Pfizer inoculations and boosters and although our tests are positive, we are all functioning very well. We are so very thankful to Pfizer.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200676409 Same product/reporter/AEs, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), 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 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 "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: our tests are positive. Clinical Information: Reporter stated, My husband and I are in our 70's and my son and daughter in-law and 18-month granddaughter live with us. She is a teacher and tested positive for Covid. We all went for testing and also tested positive. We all had received Pfizer inoculations and boosters and although our tests are positive, we are all functioning very well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200676409 Same product/reporter/AEs, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: We all went for testing and also tested positive; We all went for testing and also tested positive; 18 month grand daughter; Off label use; This is a spontaneous report received from a contactable reporter consumer or other non HCP.  An 18-month-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "18 month grand daughter"; OFF LABEL USE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Although our tests are positive.  Clinical information:-Forwarded as an adverse event by the epsilon escalation team on 06May2022 reporter provided verification of contact address on 05May2022. My husband and i are in our 70's and my son and daughter in-law and 18 month grand daughter live with us. She is a teacher and tested positive for Corvid. We all went for testing and also tested positive. We all had received Pfizer inoculations and boosters and although our tests are positive, we are all functioning very well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200676409 Same product/reporter/AEs, different patient
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Pain
Clinical narrative: I can no longer walk without crutches, I can no longer work my flight attendant job; Five days after the second dose I lost the ability to walk unassisted....... I can no longer walk without crutches; I constantly live in excruciating pain 24/7; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), in Sep2021 as dose 2, single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: FA7484), administration date: Aug2021, for COVID-19 Immunization. Prior to the vaccine, patient was a healthy long distance runner, hiker, and flight attendant for 32 years. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability), outcome "not recovered", described as "I can no longer walk without crutches, I can no longer work my flight attendant job"; GAIT DISTURBANCE (disability), outcome "not recovered", described as "Five days after the second dose I lost the ability to walk unassisted....... I can no longer walk without crutches"; PAIN (medically significant), outcome "not recovered", described as "I constantly live in excruciating pain 24/7". Clinical course:  Patient received the mandatory Pfizer Covid Vaccine in Aug2021 and the second dose Sep2021. Five days after the second dose I (patient) lost the ability to walk unassisted.  I can no longer work my flight attendant job and I constantly live in excruciating pain 24/7.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Growth retardation, Weight
Clinical narrative: Felt very weak, very, very weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 94-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 94 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: The caller was diagnosed with Covid in the very beginning, two years ago. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; LOSARTAN taken for blood pressure measurement; LABETALOL taken for blood pressure measurement. Vaccination history included: BNT162b2 (DOSE: 1, lot Number: EL9269, expiration: unknown, route of administration: right arm, Vaccine Name: Pfizer Covid Vaccine), administration date: 10Feb2021, when the patient was 93-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 2, lot Number: EL9289, expiration: unknown, route of administration: right arm, Vaccine Name: Pfizer Covid Vaccine), administration date: 03Mar2021, when the patient was 93-year-old, for Covid-19 immunization; BNT162b2 (DOSE: 3, lot: FF8841, expiration: unknown, route of administration: right arm, Vaccine Name: Pfizer Covid Vaccine), administration date: 25Oct2021, when the patient was 93-year-old, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "Felt very weak, very, very weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The number was unknown ,the patient did not received any other vaccine within 4 week to covid vaccination and did not received any other vaccine on same date. The patient was well prior to vaccination. The reporter inquired that about the fourth dose Pfizer Covid Vaccine stronger than the third dose Pfizer Covid Vaccine and had anybody else complained of being weak after receiving Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Horrible Headache; 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), 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Horrible Headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Rash
Clinical narrative: he developed as horrendous rash to the point that he is not able to sleep; he developed as horrendous rash to the point that he is not able to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 03May2021 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: RASH (non-serious), INSOMNIA (non-serious) all with onset May2021, outcome "not recovered" and all described as "he developed as horrendous rash to the point that he is not able to sleep".  Additional information: Caller said he got his only shot of Pfizer covid vaccine on 03May2021, then 3 days after he developed as horrendous rash to the point that he is not able to sleep. Caller said he has seen a lot of dermatologists and neurologists and none were able to help him with his problem. Caller said he is going to another doctor, an allergist, this afternoon; he wanted to know if a condition like him has been reported with Pfizer and recommendation to treat the said adverse event.  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: Abortion spontaneous
Clinical narrative: have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "have had 5 of my wife's friends who had miscarriages".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200684313 mother/baby case;US-PFIZER INC-202200684312 mother/baby case;US-PFIZER INC-202200684320 mother/baby case;US-PFIZER INC-202200684318 mother/baby case;US-PFIZER INC-202200684314 mother/baby case;US-PFIZER INC-202200684317 mother/baby case;US-PFIZER INC-202200684316 mother/baby case;US-PFIZER INC-202200684319 mother/baby case;US-PFIZER INC-202200684315 mother/baby case
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had my first booster shot of Pfizer covid 19 vaccine Nov2021 then. I got infected with covid 19 Dec2021; I had my first booster shot of Pfizer covid 19 vaccine Nov2021 then. I got infected with covid 19 Dec2021; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "I had my first booster shot of Pfizer covid 19 vaccine Nov2021 then. I got infected with covid 19 Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) infected with covid, notes: I got infected with covid 19 Dec2021. Clinical course: The patient wanted to know whether she can take her second covid 19 vaccine now or do she need to check her antibodies first.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Factor V Leiden mutation, Pulmonary embolism
Clinical narrative: Deep vein thrombosis in right leg first noticed 3 weeks after booster shot; pulmonary embolism in right lung; was tested on 26Apr2022 per PCP's recommendation for factor V Leiden, results showed Positive - Heterozygous for factor V Leiden mutation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 at 09:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IRON; SAW PALMETTO BERRY; MULTI-VITAMINS VITAFIT. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 14Apr2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 14Dec2021, outcome "recovering", described as "Deep vein thrombosis in right leg first noticed 3 weeks after booster shot"; PULMONARY EMBOLISM (medically significant) with onset 14Dec2021, outcome "recovering", described as "pulmonary embolism in right lung"; FACTOR V LEIDEN MUTATION (non-serious) with onset 14Dec2021, outcome "recovering", described as "was tested on 26Apr2022 per PCP's recommendation for factor V Leiden, results showed Positive - Heterozygous for factor V Leiden mutation". The events "deep vein thrombosis in right leg first noticed 3 weeks after booster shot", "pulmonary embolism in right lung" and "was tested on 26apr2022 per pcp's recommendation for factor v leiden, results showed positive - heterozygous for factor v leiden mutation" required physician office visit. The patient underwent the following laboratory tests and procedures: Factor V Leiden mutation: (26Apr2022) Positive, notes: results showed Positive - Heterozygous for factor V Leiden mutation. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism, factor v leiden mutation. Clinical course: The patient had an annual physical with PCP on 02Nov2021 with no problems or concerns noted. He was taking Blood thinners for 3 months as treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications in 2weeks. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid, start date: 21Apr2022, stop date: 26Apr2022. Positive Covid test 8 days after completing Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 2, single (Lot number: El9262), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: 845p21) at the age of 59 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: "Bees and mold" (unspecified if ongoing), notes: allergy to Bees and mold.; "allergy to Bees and mold" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: COVID-19: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2 weeks. Rebound infection after taking Paxlovid for 5 days. Tested negative and felt well then 6 days later worsened cough and malaise and tested positive again. Worse symptoms than original Illness. Device timestamp: 06May2022.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.