chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8727), on 15Apr2021 as dose 2, single (Lot number: FP7533) and on 19Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation; paracetamol (TYLENOL), from 30Dec2022 (Batch/Lot number: unknown) to 04Jan2023. The patient's relevant medical history included: "Known allergies: iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (06Jan2023) Negative, notes: I did a home test; (09Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 31Dec2022 to 05Jan2023, the patient received Paxlovid as treatment of COVID-19. The patient started Paxlovid the day tested positive. The patient started with the evening dose and took for 5 days as directed ending the morning of 05Jan2023. Patient did a home test on 06Jan2023, 5 days after day of onset, it was negative. When patient woke up 07Jan2023, patient was feeling stopped up which was completely new, more fatigued than previously and very out of it. This continued to get worse each day until patient decided to test again on 09Jan2023, it was positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Wrong product administered
Clinical narrative: Acute DVT (tibial vein lower left extremity); bivalent administration date= 07Jan2023, administration time= 02:45 PM, as dose number= 1,; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 at 14:45 as dose 1, single (Lot number: GJ6743) at the age of 52 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Hypertension (controlled)" (unspecified if ongoing), notes: other medical history: Hypertension (controlled). Concomitant medication(s) included: LOSARTAN POTASSIUM AND HCTZ. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 07Jan2023 at 14:45, outcome "unknown", described as "bivalent administration date= 07Jan2023, administration time= 02:45 PM, as dose number= 1,"; DEEP VEIN THROMBOSIS (medically significant) with onset 09Jan2023 at 10:00, outcome "recovering", described as "Acute DVT (tibial vein lower left extremity)". The event "acute dvt (tibial vein lower left extremity)" required emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, wrong product administered.  Clinical Course: Other medications in two weeks: Losartan Potassium-hctz (100-12.5 mg), Vitamins. AE treatment was Oral anticoagulants.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the event deep vein thrombosis with the suspect can not be ruled out completely. 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
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018756 Same reporter/patient, different drug (vaccine dose)/event.;
Sex: U
Vaccine: UNK
Symptoms: Retinal detachment
Clinical narrative: detached retina; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: RETINAL DETACHMENT (medically significant), outcome "unknown", described as "detached retina".  Clinical course: It was reported that, the patient had a detached retina, the Pfizer vaccine and no other medical reason doctors could find for a detached retina.  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 available information, the reported serious event Retinal detachment cannot be excluded for the suspect product 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.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Laboratory test
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 82 years for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 24Nov2022, outcome "unknown", described as "Stroke". The patient was hospitalized for cerebrovascular accident (start date: 24Nov2022, discharge date: 27Nov2022, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Lab work: unknown result, notes: Lab work: Reporter stated, "Many (Further name and results of lab tests were not clarified over the call). Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Reporter stated, he want to report an adverse reaction or he was not sure it is but he was reading on the CDC website and it said the new variant can cause Stroke.Then probed for the adverse event: Reporter stated, A stroke. And he was the one that had the stroke. Medical conditions and Concomitant medications Reporter stated, nothing, he has no health issues. Reporter stated, "Many (Further name and results of lab tests were not clarified over the call hence tab left unchecked). He was hospitalized. This event happened on 24Nov2022. Not today it happened. Treatment: Reporter stated, Nothing, you mean like TPA? He had no, no any sort of that kind of treatment. He is now taking a Baby Aspirin." Discharge date: Reporter stated, "Whatever, 4 days later. He was there 4 days, discharged on 27Nov2022 (27Nov2022) in the evening."
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2 NOS), on 04Oct2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing), notes: Relevant past drug history. Reaction: Allergy. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: The patient received Paxlovid as treatment for Covid 19 from 05Jan2023 to 09Jan2023. Device Date: 14Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 82.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 14Dec2022 to 18Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Headaches; 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 NOS), on 13Jan2023 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: HEADACHE (non-serious) with onset Jan2023, outcome "not recovered", described as "Headaches".  Additional information: This was the First case out of 2 split cases. Consumer stated, "We got Pfizer shot yesterday and my husband and I have headaches which was ok but he has, he was 78, he has a terrible, terrible pain in his stomach and nausea. Is that accepted for one of the side effects, I have been reading, but I cannot find the stomachache." When paraphrased the concern: Consumer stated, "Yes, we still have headaches. I mean, I feel ok like, but he has been up all night with the stomach and wants to throw up." Consumer wanted to make sure if she did not have to do anything for him serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Headache, Nausea, Sleep disorder
Clinical narrative: Headaches; terrible pain in his stomach; he has been up all night with the stomach/stomach ache; Nausea; wants to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2 NOS), on 13Jan2023 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: HEADACHE (non-serious) with onset Jan2023, outcome "not recovered", described as "Headaches"; NAUSEA (non-serious) with onset Jan2023, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2023, outcome "not recovered", described as "terrible pain in his stomach; he has been up all night with the stomach/stomach ache"; VOMITING (non-serious) with onset Jan2023, outcome "not recovered", described as "wants to throw up".  Additional information: It was reported that, reporter stated, "they got Pfizer shot yesterday and her husband and she have headaches which was ok, but her husband was 78 and he had a terrible, terrible pain in his stomach and nausea. She wanted to ask if it is accepted for one of the side effects, she have been reading, but she could not find the stomachache. When paraphrased the concern: Reporter stated, that the patient still had headaches and he has been up all night with the stomach and wants to throw up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 81 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: "Known alergies: Many" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Jan2023.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand other = Moderna; Vaccine administration date = 05Aug2022/ Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 21Oct2021; 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 78-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Aug2022 as dose 4 (booster), single (Lot number: A51866), in left arm and on 25Oct2022 as dose 5 (booster), single (Lot number: 020H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient had no allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Aug2022, outcome "unknown", described as "Vaccine brand other = Moderna; Vaccine administration date = 05Aug2022/ Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 21Oct2021". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 18Dec2022.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Had a dizzy reaction to the Pfizer Covid 19 Vaccine; Has had a very bad time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: DIZZINESS (non-serious), outcome "unknown", described as "Had a dizzy reaction to the Pfizer Covid 19 Vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Has had a very bad time.".  Additional information: Two years ago caller received three doses of the Pfizer Covid-19 Vaccine. Had a dizzy reaction to the Pfizer Covid 19 Vaccine. Ever since, has had a very bad time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018909 same reporter/patient/AE, different dose;US-PFIZER INC-202300018910 same reporter/patient/AE, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; dose 5 Moderna, all previous Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old 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; elasomeran (MODERNA COVID-19 VACCINE), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known allergies: Mangoes" (unspecified if ongoing); "known allergies:  peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "unknown", described as "dose 5 Moderna, all previous Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 02Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; 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 52-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 10:00 as dose number unknown, single (Lot number: FK9893) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 29Dec2022 to 02Jan2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Jan2023.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2021 as dose 3 (booster), single (Lot number: 301308A), in left arm, on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm and on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8732), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (09Jan2023) Negative; (13Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was administrated from 31Dec2022 to 05Jan2023 for treatment of COVID-19 via oral. The symptomatic with Covid symptoms occurred again on 09Jan2023 and tested negative, then tested positive for Covid on 13Jan2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5, and the reported events covid 19, vaccination failure cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received other medication in 2 weeks.Treatment start date was reported 06Jan2023 and treatment stop date was 07Jan2023.  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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (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 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid from 04Jan2023 to 09Jan2023 as treatment of COVID-19.  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.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Covid rebound after taking paxlovid; Covid rebound after taking paxlovid; 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 female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Other medical history: Diabetes type 2. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid rebound after taking paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 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 51-year-old male patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: Cerebrovascular accident
Clinical narrative: suffered about 2 months ago massive strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2022, outcome "unknown", described as "suffered about 2 months ago massive strokes".  Clinical Course: Consumer stated, "I am watching the news I am in (city name withheld) and they are talking about the Pfizer Vaccine leading to strokes (Further clarifications unknown). I am 76-years-old gentleman and just suffered about 2 months ago massive strokes and I have taken only Pfizer Vaccines, the originals and all of the boosters (Pfizer COVID-19 Vaccine) and now I am concerned about it I would like Pfizer to call me back as soon as possible."  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EK9231), in right arm, on 25Feb2021 as dose 2, single (Lot number: EL8982), in left arm, on 20Aug2021 as dose 3 (booster), single (Lot number: EW0812), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: Still spreading 3 days after re-testing positive; (11Jan2023) Positive, notes: Tested positive 6 days after completing 5 day course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 23Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took Paxlovid, from 04Jan2023 to 08Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Yes other medication in 2 weeks and no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), 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), 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: "Other medical history: Limited circulation in right leg" (unspecified if ongoing), notes: Other medical history: Limited circulation in right leg; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid as treatment from 01Jan2023 to 06Jan2023 for COVID-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Bladder cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High LDL" (unspecified if ongoing), notes: Other medical history: High LDL; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel. The patient's concomitant medications were not reported. Past drug history included: Tagamet, reaction(s): "known allergies: Tagamet", notes: known allergies: Tagamet.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jan2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Negative, notes: Was Negative for Covid tests by 30Dec; (Jan2023) Negative, notes: Was negative again by the 10Jan; (Jan2023) Positive, notes: positive covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Kiwi fruit" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) positive, notes: tested positive for covid again; (Jan2023) negative, notes: testing negative for covid 19 twice; (Jan2023) negative, notes: testing negative for covid 19 twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: 4 days after finishing Paxlovid and testing negative for covid 19 twice, I started feeling sick on 13Jan2023 and tested positive for covid again.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 at 16:00 as dose 3 (booster), single (Lot number: EW0217) at the age of 54 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2021 at 13:00 as dose 1, single (Lot number: 003B21A), in right arm, on 04Oct2021 at 13:00 as dose 2, single (Lot number: 041B21A), in right arm, on 21May2022 at 10:00 as dose 4 (booster), single (Lot number: 037A22B), in right arm and on 26Nov2022 at 15:30 as dose 5 (booster), single (Lot number: 024H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021 at 16:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product=COVID 19 Treatment, Brand=Pfizer, Treatment start date=03Jan2023, Treatment stop date=08Jan2023, Indication=Treatment of COVID-19. No known allergies reported. No other medication in 2 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9268), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "cardiac arrhythmia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative, notes: I tested negative the next day (07Dec); (11Dec2022) Positive, notes: I went back to urgent care & tested positive again (11Dec). Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pericarditis" (unspecified if ongoing), notes: Other medical history: Pericarditis. Concomitant medication(s) included (in 2weeks ): DAYQUIL/NYQUIL, start date: 03Jan2023, stop date: 04Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for Covid 19 from 04Jan2023 to 09Jan2023 and patient did not have any known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.