chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 330268D) at the age of 28 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: home test and came back strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid from 05Jul2022 to 09Jul2022 for COVID 19 Treatment. Patient felt better with 1 day after starting paxlovid. Patient completed 5 days and the symptoms were gone completely. 6 days after the last dose of PAXLOVID, patient started to have symptoms again, so patient took the home test and came back strongly positive. Patient was having worse symptoms than the first time. The first time I had sore throat only but now I have runny nose, congestion, headache, and fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive agaiin for Covid. Mild Covid syptoms; tested positive agaiin for Covid. Mild Covid syptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: Oct2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive agaiin for Covid. Mild Covid syptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive agaiin for Covid; (16Jul2022) positive, notes: tested positive agaiin for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from  06Jul2022 to 10 Jul2022 for the treatment of Covid- 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 30145B4) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; LEVOTHYROXINE.  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 antibody test: (unspecified date) Unknown results; (14Jul2022) got a rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took paxlovid.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The patient started Paxlovid on 06Jul2022 for COVID-19 Treatment and stopped on 11Jul2022. Patient did not take any other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19  cannot be completely excluded.
Age: 66.0
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) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 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 renal disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical courses: No other medication in 2 weeks. Anti viral details: COVID 19 Treatment from 05Jul2022 to 10Jul2022. Rebound COVID (on 15Jul2022 09:00 AM) 5 days after completing Paxlovid. No treatment received. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association and lack of effect the causal association  of suspect  cannot be excluded for reported events.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: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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).  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient received a treatment with Anti-viral Paxlovid, took Paxlovid for 5 days, at 9th day, felt runny nose. No other medical was taken by the patient within 2 weeks of vaccination.  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: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 60-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; TAMSULOSIN; JARDIANCE; LISINOPRIL; ROSUVASTATIN; LANTUS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 19Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive; (15Jul2022) Positive. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are needed. No further information is expected.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SILDENAFIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient took sildenafil as other medication in 2weeks product. The patient did not receive any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 42-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: I tested negative when treatment ended,; (17Jul2022) Positive, notes: positive again 6 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral treatment with Paxlovid received from 06Jul2022 to 11Jul2022 for covid-19.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2021 at 11:30 as dose 3 (booster), single (Lot number: FC3181), in left arm, on 02Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FJ6369), in left arm and on 03Jul2022 at 11:00 as dose 5 (booster), single (Lot number: FM0173) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 at 08:45 as dose 1, single (Lot number: 020B21A), in left arm and on 27Apr2022 at 11:00 as dose 2, single (Lot number: 09C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE], start date: May2020, stop date: 14Jul2022; OMEPRAZOLE, start date: Jan2021, stop date: 14Jul2022; B-12 NATURE MADE, start date: May2020, stop date: 14Jul2022; ACETAMINOPHEN, start date: 13Jul2022, stop date: 13Jul2022; IRON, start date: May2020, stop date: 14Jul2022. Past drug history included: Ampicillin, reaction(s): "known allergies: Allergic to ampicillin", notes: known allergies: Allergic to ampicillin; Vicodin, reaction(s): "known allergies: vicodin", notes: known allergies: vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 62-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 21Nov2021 as dose 3 (booster, single) (Lot number: FH8027), in left arm and on 03May2022 as dose 4 (booster, single) (Lot number: FJ4989) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 04Jul2022. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Negative, notes: Negative test on day 6; (Jul2022) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Positive, notes: Positive test still on day 12 (today). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received antiviral COVID-19 treatment with Paxlovid from 05Jul2022 to 09Jul2022. The patient finished Paxlovid on day 5. Negative test on day 6. Symptoms returned with Paxlovid rebound on day 10. No fever, but stuffy nose and sore throat. Positive test still on day 12 (today), but symptoms were improving. Only treatment included Musinex and Azelistine spray.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) negative, notes: Antigen testing was negative starting 11Jul2022; (14Jul2022) positive, notes: but testing was positive on 14Jul2022 until the present day; (15Jul2022) positive, notes: but testing was positive on 14Jul2022 until the present day; (16Jul2022) positive, notes: but testing was positive on 14Jul2022 until the present day. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Report about covid treatment: Yes If vaccine received: Yes, Other medication in 2weeks: Yes, COVID symptoms resumed after completing Paxlovid course. (08Jul2022). Antigen testing was negative starting 11Jul2022, but testing was positive on 14Jul2022 until the present day. Mild symptoms resumed (coughing, runny nose) and now seem to be in remission. If treatment ae: No.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Investigation, Nausea, Pyrexia
Clinical narrative: feeling dizzy and weak; feeling dizzy and weak; Fever; Nausea; throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 1, single (Lot number: FJ4911) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing), notes: Concomitant Products: No but has smoked weed, not sure if that matters; "ADHD" (unspecified if ongoing), notes: Tests: Did a mental health test online 4 days ago that said he had ADHD. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 14Jul2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 14Jul2022, outcome "not recovered"; DIZZINESS (non-serious), ASTHENIA (non-serious) all with onset 14Jul2022, outcome "not recovered" and all described as "feeling dizzy and weak"; VOMITING (non-serious) with onset 14Jul2022, outcome "unknown", described as "throwing up". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, asthenia, pyrexia, nausea, vomiting.  Additional information: Caller asks if they are someone is going to tell him what he can treat this with. Caller advised that he could be transferred to address any questions with the vaccine but that they would not be able to provide any specific medical advice.  Caller states that, If they cant help or give advice, he  thinks will end the call.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feeling dizzy and weak; feeling dizzy and weak; Fever; Nausea; throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 1, single (Lot number: FJ4911) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing), notes: Concomitant Products: No but has smoked weed, not sure if that matters; "ADHD" (unspecified if ongoing), notes: Tests: Did a mental health test online 4 days ago that said he had ADHD. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 14Jul2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 14Jul2022, outcome "not recovered"; DIZZINESS (non-serious), ASTHENIA (non-serious) all with onset 14Jul2022, outcome "not recovered" and all described as "feeling dizzy and weak"; VOMITING (non-serious) with onset 14Jul2022, outcome "unknown", described as "throwing up". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, asthenia, pyrexia, nausea, vomiting.  Additional information: Caller asks if they are someone is going to tell him what he can treat this with. Caller advised that he could be transferred to address any questions with the vaccine but that they would not be able to provide any specific medical advice.  Caller states that, If they cant help or give advice, he  thinks will end the call.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fatigue, Illness, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: since he got the shot he does this thing with his throat; he has this thing that he swallows; tired; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "since he got the shot he does this thing with his throat"; DYSPHAGIA (non-serious), outcome "unknown", described as "he has this thing that he swallows"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ILLNESS (non-serious), outcome "unknown", described as "got sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter (patient's mother) noticed something since he had the shot, the 2 shots, and he had that thing that he swallows. She always saw him but he was never doing that until after the shot. She asked him to see the doctor as he had been doing that since the shot. He got the shot about maybe 4-6 months ago and ever since he got it, she had noticed that he was doing that. Stated it was hard to explain it. It was every few minutes that he was doing it. It aggravates her to see that. Reported that it was the same or getting worse but it's not getting better. He was about 6 foot tall. Reported that his symptoms started right after got the shot she thinks the 2nd dose (in upper arm), that if she had made a big deal after the 1st, he wouldn't have gotten the 2nd and he was not getting the 3rd dose. Also reported that he got Covid after he got the shots. He was diagnosed about 1 month ago, he and his girlfriend both live together and both got sick with it. He was improved but was tired a lot. The patient had no other conditions and did not receive any other products. The patient had no additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) were none and no events following them. The patient had no medical history (including any illness at time of vaccination) and family medical history relevant to AE.  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: Weight
Clinical narrative: since he got the shot he does this thing with his throat; he has this thing that he swallows; tired; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "since he got the shot he does this thing with his throat"; DYSPHAGIA (non-serious), outcome "unknown", described as "he has this thing that he swallows"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ILLNESS (non-serious), outcome "unknown", described as "got sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter (patient's mother) noticed something since he had the shot, the 2 shots, and he had that thing that he swallows. She always saw him but he was never doing that until after the shot. She asked him to see the doctor as he had been doing that since the shot. He got the shot about maybe 4-6 months ago and ever since he got it, she had noticed that he was doing that. Stated it was hard to explain it. It was every few minutes that he was doing it. It aggravates her to see that. Reported that it was the same or getting worse but it's not getting better. He was about 6 foot tall. Reported that his symptoms started right after got the shot she thinks the 2nd dose (in upper arm), that if she had made a big deal after the 1st, he wouldn't have gotten the 2nd and he was not getting the 3rd dose. Also reported that he got Covid after he got the shots. He was diagnosed about 1 month ago, he and his girlfriend both live together and both got sick with it. He was improved but was tired a lot. The patient had no other conditions and did not receive any other products. The patient had no additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) were none and no events following them. The patient had no medical history (including any illness at time of vaccination) and family medical history relevant to AE.  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, SARS-CoV-2 test, Weight
Clinical narrative: since he got the shot he does this thing with his throat; he has this thing that he swallows; tired; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "since he got the shot he does this thing with his throat"; DYSPHAGIA (non-serious), outcome "unknown", described as "he has this thing that he swallows"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ILLNESS (non-serious), outcome "unknown", described as "got sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter (patient's mother) noticed something since he had the shot, the 2 shots, and he had that thing that he swallows. She always saw him but he was never doing that until after the shot. She asked him to see the doctor as he had been doing that since the shot. He got the shot about maybe 4-6 months ago and ever since he got it, she had noticed that he was doing that. Stated it was hard to explain it. It was every few minutes that he was doing it. It aggravates her to see that. Reported that it was the same or getting worse but it's not getting better. He was about 6 foot tall. Reported that his symptoms started right after got the shot she thinks the 2nd dose (in upper arm), that if she had made a big deal after the 1st, he wouldn't have gotten the 2nd and he was not getting the 3rd dose. Also reported that he got Covid after he got the shots. He was diagnosed about 1 month ago, he and his girlfriend both live together and both got sick with it. He was improved but was tired a lot. The patient had no other conditions and did not receive any other products. The patient had no additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) were none and no events following them. The patient had no medical history (including any illness at time of vaccination) and family medical history relevant to AE.  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: Dysphagia, Fatigue, Illness, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Caller states he got Covid after he got the shots; Caller states he got Covid after he got the shots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in 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 "unknown" and all described as "Caller states he got Covid after he got the shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Weight: 165-170 lbs.  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-202200972851 Same patient/product; different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: Caller states he got Covid after he got the shots; Caller states he got Covid after he got the shots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in 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 "unknown" and all described as "Caller states he got Covid after he got the shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Weight: 165-170 lbs.  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-202200972851 Same patient/product; different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Caller states he got Covid after he got the shots; Caller states he got Covid after he got the shots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in 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 "unknown" and all described as "Caller states he got Covid after he got the shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Weight: 165-170 lbs.  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-202200972851 Same patient/product; different dose/event;
Age: 48.0
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 11Oct2021 as dose 3 (booster),  single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 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) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Known allergies: Sulfa; "Cephalosporins allergy" (unspecified if ongoing), notes: Known allergies: Cephalosporins. Concomitant medication(s) included: TIROSINT taken for thyroid disorder. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Negative, notes: Rebound if symptoms 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti-viral Paxlovid drug for COVID 19 Treatment started from 08Jul2022 and stopped on 13Jul2022.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: Other medical history: OSA; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "morbid obesity" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "PAF" (unspecified if ongoing), notes: Other medical history: PAF,. The patient took concomitant medications. There are no known allergies. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (17Jul2022) Positive, notes: Positive rapid Covid detected 6 days after completion of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment orally for COVID-19 from 07Jul2022 to 11Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular periods for a few months after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Irregular periods for a few months after vaccination". Therapeutic measures were not taken as a result of menstruation irregular.   Additional information: If other vaccine in four weeks, covid prior vaccination, covid tested post vaccination; were all unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: 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) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose number unknown, single (Lot number: EW0158), in left arm and on 12Nov2021 as dose number unknown, single (Lot number: FH8020) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (06Jul2022) Negative, notes: negative Covid tests after 5 days of Paxlovid treatment (06Jul2022 to 10Jul2022); (10Jul2022) Negative, notes: Home Covid tests stayed Negative from 10Jul2022 to 14Jul2022; (14Jul2022) Negative, notes: Home Covid tests stayed Negative from 10Jul2022 to 14Jul2022; (15Jul2022) Positive, notes: on 15Jul2022 and tested Covid positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna Dose Number: 1, Pfizer / BioNTech Dose Number: 2; Moderna Dose Number: 1, Pfizer / BioNTech Dose Number: 2; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EN6201) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 03ZHZ1A) for immunisation. The patient's relevant medical history included: "controlled HTN" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "GERD" (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"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Moderna Dose Number: 1, Pfizer / BioNTech Dose Number: 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 09Jul2022 and treatment stop date was 13Jul2022, Indication was Treatment of Covid-19. AE treatment: Starting another course of Paxlovid. Patient had no Known allergies: NKDA (No Known Drug Allergy)  No follow-up attempts are possible. No further information is expected.; 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
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(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Aug2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 at 12:00 as dose 3(booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "(Remission) Ulcerative colitis" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies:sulfa drugs, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound started 4-5 days after negative test/completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received anti viral treatment (Pfizer Paxlovid) from 05Jul2022 to 09Jul2022 for COVID 19 Treatment. There was a rebound started 4-5 days after negative test/completion of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 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: "GERD" (unspecified if ongoing), notes: other medical history: GERD; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten; "known allergies: Lactose" (unspecified if ongoing), notes: known allergies: Lactose; "known allergies: Fructan" (unspecified if ongoing), notes: known allergies: Fructan. Concomitant medication(s) included: PEPCID AC; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient received Paxlovid as treatment of COVID-19 from 04Jul2022 to 08Jul2022. COVID rebound on day 4 (on 11Jul2022 at 04:00 PM) after Paxlovid treatment completed. COVID symptoms (nasal congestion, headaches, diarrhea, cough, fatigue, foggy thinking) came back with a vengeance and have been growing stronger 6 days since they restarted.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.