chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Intestinal obstruction
Clinical narrative: Bowel obstruction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4420988-00.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 01Nov2017 (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), for Covid-19 immunization; Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: INTESTINAL OBSTRUCTION (medically significant) with onset May2022, outcome "recovering", described as "Bowel obstruction". The action taken for adalimumab was dosage not changed.  The reporter considered "bowel obstruction" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of intestinal obstruction. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL1284), in right arm, on 19Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 05Oct2021 at 17:00 as dose 3 (booster), single (Lot number: 301458A) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI 24 FE, start date: 01Jun2021; BUPROPION, start date: 01Sep2021; CETIRIZINE, start date: 01Mar2019. Past drug history included: Fluconazole, reaction(s): "known allergies;Fluconazole - mild rash"; Fluconazole, reaction(s): "mild rash", notes: known allergies; Fluconazole - mild rash. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: BrCa1 gene: Positive; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received other medications in two weeks.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EN6199), in left arm, in Mar2021 as dose 2, single (Lot number: ER2613), in left arm, in Oct2021 as dose 3 (booster), single (Lot number: EC3184), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID-19". 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.  Clinical course: Other medication in 2 weeks: Yes. Patient received Paxlovid from 23May2022 to 28May2022 for treatment of COVID-19. Rebound COVID 6 days following last Paxlovid dose was on 03Jun2022. Patient not had any known allergies.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 6 days of extreme nausea. Slowly got better after 6 days.  (Reporting on this because she reacted more severely to Dose 2).
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Echocardiogram normal, Fatigue, Heart rate increased
Clinical narrative: Extreme nausea, fatigue, weakness, and high heart rate started a few days after injection. Saw ER doc, primary doctor, cardiologist. She took a few weeks to recover and then proceeded to get similar nausea and fatigue week long episodes (1-2 most months) until April 2022.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Extreme nausea, fatigue, weakness, and high heart rate started a few days after injection. Saw ER doc, primary doctor, cardiologist. She took a few weeks to recover and then proceeded to get similar nausea and fatigue week long episodes (1-2 most months) until April 2022.
Sex: F
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 contactable reporter(s) (Other HCP).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (unspecified date) negative, notes: Viral rebound after completion of Paxlovid, documented with negative test; (07Jun2022) Positive, notes: new + test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: other medication was received in 2 week, product: COVID 19 Treatment, brand: Paxlovid  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Aspirin" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". 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: 64.0
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) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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) and as dose 3 (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) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient started Paxlovid as treatment of Covid-19 from 25May2022 and stopped on 30May2022. The patient had rebound of COVID-19 5 days after completing treatment with Paxlovid. No other medication in 2weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive; (05Jun2022) Positive, notes: tested positive for Covid 6 days post Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Other medication in 2weeks were none. The patient received anti-viral product for COVID 19 Treatment, brand: Paxlovid, treatment start date: 24May2022, treatment stop date: 29May2022, lot number:1024502. Pfizer BioNTech for dose 1 and dose 2 vaccine and for Moderna dose 3 lot unknown reason was not available or provided to reporter at the time of report completion. The adverse event was reported as tested positive for Covid 6 days post Paxlovid. The patient went to get tested because she felt worse that she did when she went to got tested 24May2022. Adverse event start date: 05Jun2022, AE resulted in: None of the above, Patient recovered: Not Recovered, Treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: I feel like crap; she was in bed all day, she felt like she had the flu or something; fever; soreness with every shot she has had; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 06Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Additional Information for Other medicines cholesterol pill: started years ago. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Lot/Batch no: EM9810), administration date: 04Feb2021, when the patient was 74-year-old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in extremity"; BNT162b2 (DOSE 2, Lot/Batch no: EN6200), administration date: 24Feb2021, when the patient was 74-year-old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in extremity"; BNT162b2 (DOSE 3, Lot/Batch no: FF2589), administration date: 08Oct2021, when the patient was 74-year-old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in extremity". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Jun2022, outcome "recovered" (Jun2022), described as "soreness with every shot she has had"; FEELING ABNORMAL (non-serious) with onset 07Jun2022, outcome "unknown", described as "I feel like crap"; PYREXIA (non-serious) with onset 07Jun2022, outcome "recovered" (Jun2022), described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Jun2022, outcome "unknown", described as "she was in bed all day, she felt like she had the flu or something". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported her weight to be 126lb and was administered with dosage of a 2nd covid booster. After administration patient reported that, "I feel like crap, she was in bed all day, she felt like she had the flu or something". She reported that, she and her husband (210 lb) got the same dosage covid, but her symptoms were much worse outcome than her husband. The patient reported that, about 2am she was felt pretty ragged and she felt more ragged as the day wore on and she laid around most of the day. The patient also took half a sleeping pill as she needed to get some sleep and she took 2 Tylenol during the day and again night. She also added that her husband is "twice her size" and it "doesn't make sense that they both received the same dosage and wanted to know how was the dose  for the Pfizer Covid 19 vaccine adjusted as per weight.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Blood urea, COVID-19, Drug ineffective, Dyspnoea, Electrocardiogram
Clinical narrative: get the Covid Virus at Christmas time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; had just a mild cold; he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years, on 05Apr2021 as dose 2, single (Lot number: ER8737) and on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history included: "SIBO" (unspecified if ongoing), notes: SIBO, Small Intestinal Bacteria Overload.; "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus", start date: 1982 (ongoing). Concomitant medication(s) included: LEVEMIR taken for blood glucose decreased; NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had just a mild cold"; DYSPNOEA (non-serious), outcome "unknown", described as "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless". The events "had just a mild cold" and "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood urea: High; Electrocardiogram: 44 bpm; SARS-CoV-2 test: Positive.  Clinical information: Caller stated he did get the Covid Virus at holiday time. Caller stated everyone there was getting it. Caller stated he thought he had just a mild cold so he said that was fine, he hadn't had a cold since 2016 so he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless. Caller stated he continued but it was not a pleasant experience, but going downhill was fine because he was in good condition. Caller stated he talked to his doctor and found out he had Covid and he was going to have side effects for 3 months.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200811906 Same patient, different event/dose
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: get the Covid Virus at Christmas time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; had just a mild cold; he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years, on 05Apr2021 as dose 2, single (Lot number: ER8737) and on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history included: "SIBO" (unspecified if ongoing), notes: SIBO, Small Intestinal Bacteria Overload.; "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus", start date: 1982 (ongoing). Concomitant medication(s) included: LEVEMIR taken for blood glucose decreased; NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had just a mild cold"; DYSPNOEA (non-serious), outcome "unknown", described as "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless". The events "had just a mild cold" and "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood urea: High; Electrocardiogram: 44 bpm; SARS-CoV-2 test: Positive.  Clinical information: Caller stated he did get the Covid Virus at holiday time. Caller stated everyone there was getting it. Caller stated he thought he had just a mild cold so he said that was fine, he hadn't had a cold since 2016 so he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless. Caller stated he continued but it was not a pleasant experience, but going downhill was fine because he was in good condition. Caller stated he talked to his doctor and found out he had Covid and he was going to have side effects for 3 months.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200811906 Same patient, different event/dose
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Blood glucose abnormal, Blood glucose decreased, Electrocardiogram
Clinical narrative: get the Covid Virus at Christmas time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; had just a mild cold; he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years, on 05Apr2021 as dose 2, single (Lot number: ER8737) and on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history included: "SIBO" (unspecified if ongoing), notes: SIBO, Small Intestinal Bacteria Overload.; "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus", start date: 1982 (ongoing). Concomitant medication(s) included: LEVEMIR taken for blood glucose decreased; NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had just a mild cold"; DYSPNOEA (non-serious), outcome "unknown", described as "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless". The events "had just a mild cold" and "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood urea: High; Electrocardiogram: 44 bpm; SARS-CoV-2 test: Positive.  Clinical information: Caller stated he did get the Covid Virus at holiday time. Caller stated everyone there was getting it. Caller stated he thought he had just a mild cold so he said that was fine, he hadn't had a cold since 2016 so he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless. Caller stated he continued but it was not a pleasant experience, but going downhill was fine because he was in good condition. Caller stated he talked to his doctor and found out he had Covid and he was going to have side effects for 3 months.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200811906 Same patient, different event/dose
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Cardiac flutter, Dyspnoea
Clinical narrative: get the Covid Virus at Christmas time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; had just a mild cold; he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years, on 05Apr2021 as dose 2, single (Lot number: ER8737) and on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history included: "SIBO" (unspecified if ongoing), notes: SIBO, Small Intestinal Bacteria Overload.; "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus", start date: 1982 (ongoing). Concomitant medication(s) included: LEVEMIR taken for blood glucose decreased; NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had just a mild cold"; DYSPNOEA (non-serious), outcome "unknown", described as "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless". The events "had just a mild cold" and "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood urea: High; Electrocardiogram: 44 bpm; SARS-CoV-2 test: Positive.  Clinical information: Caller stated he did get the Covid Virus at holiday time. Caller stated everyone there was getting it. Caller stated he thought he had just a mild cold so he said that was fine, he hadn't had a cold since 2016 so he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless. Caller stated he continued but it was not a pleasant experience, but going downhill was fine because he was in good condition. Caller stated he talked to his doctor and found out he had Covid and he was going to have side effects for 3 months.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200811906 Same patient, different event/dose
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Pfizer / BioNTech: Dose Number: 3, 2, 1; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 3, 2, 1; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER7833), in left arm, on 19Apr2021 as dose 2, single (Lot number: EN0150), in left arm and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL, start date: Nov2018; ATORVASTATIN, start date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 3, 2, 1; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Negative. 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: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, 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) from product quality group. The reporter is the patient.  An 88-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 88 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 which included treatment with Paxlovid (treatment start date: 26May2022, treatment stop date: 01Jun2022).
Age: 38.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 38 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) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE, start date: 25May2022, stop date: 26May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Adverse event Return of symptoms and testing positive (on Binax rapid test) after previous cessation of symptoms and negative tests. Symptoms returned on Day 10 of infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Other medication in 2 weeks. Patient took treatment of Paxlovid started on 28May2022 and stopped on 02Jun2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2 weeks. The patient was treated with Paxlivid from 23May2022 to 27May2022 for COVID-19. The vaccine lot number was unknown as unable to locate or read the details. The patient did not had any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: after shopping and going to the gym 04Jun sx fatigue; HA myalgias; mild congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, single, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False), administration date: 17Feb2021, when the patient was 37-year-old, for covid-19 immunization; BNT162b2 (Dose 1, single, prev dose brand unknown: False,, prev dose lot number: EL3247,, prev dose lot unknown: False,, ), administration date: 27Jan2021, when the patient was 37-year-old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "HA myalgias"; FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown", described as "after shopping and going to the gym 04Jun sx fatigue"; NASAL CONGESTION (non-serious) with onset 04Jun2022, outcome "unknown", described as "mild congestion". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, myalgia, nasal congestion.  Additional information: If was unknown if patient received other vaccine in four weeks. If was unknown if patient had covid prior vaccination. Patient tested for covid post vaccination.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR test/ Positive; PCR test/ Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "unknown" and all described as "PCR test/ Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events and suspect drug BNT162B2 cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Result: Positive /Nasal Swab; Result: Positive /Nasal Swab; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 07Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 07Jun2022, outcome "not recovered" and all described as "Result: Positive /Nasal Swab". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Negative, notes: Nasal Swab; (07Jun2022) Positive, notes: Nasal Swab.  Clinical course: The patient had trip returning 05Jun2022, then had HA fever congestion moderate 06Jun PM then + Ag test 07Jun am with high fever. It was unknown if the patient had Covid prior vaccination. Post vaccination the patient was tested with Covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: then sx HA fever congestion moderate 06Jun PM; fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ([{prev_dose_product=COVID 19,, prev_dose_brand_unknown=True,, prev_dose_brand_name_unknown=C, COVID19 Vaccine,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_dose_number=2},), for covid-19 immunization; Covid-19 vaccine ([{prev_dose_product=COVID 19,, prev_dose_brand_unknown=True,, prev_dose_brand_name_unknown=C, OVID19 Vaccine,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_dose_number=1},), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 06Jun2022, outcome "unknown", described as "fever"; NASAL CONGESTION (non-serious) with onset 06Jun2022, outcome "unknown", described as "then sx HA fever congestion moderate 06Jun PM". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of nasal congestion, pyrexia.  Additional information: Unknown If other vaccine in four weeks. Unknown if covid prior vaccination. Yes covid tested post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Herpes zoster oticus, SARS-CoV-2 test
Clinical narrative: Loss of hearing/ Continuous problem with hearing; Loss of hearing, possibly shingles infected; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Aug2021 as dose 2, single (Lot number: FC3181) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, Batch/Lot No: 6780 (as reported)), administration date: 26Jul2021, when the patient was 28-year-old, for COVID-19 immunisation. The following information was reported: HERPES ZOSTER OTICUS (disability, medically significant) with onset 12Nov2021, outcome "recovered with sequelae", described as "Loss of hearing, possibly shingles infected"; DEAFNESS (disability, medically significant) with onset 12Nov2021, outcome "recovered with sequelae", described as "Loss of hearing/ Continuous problem with hearing". The events "loss of hearing/ continuous problem with hearing" and "loss of hearing, possibly shingles infected" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, herpes zoster oticus which included anti viral and steroids.  Additional information: The patient had no other vaccines in four weeks. She had no known allergies and was not aware of any medical history.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: AE(s) following prior vaccinations: States any vaccines her arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: takes cholesterol medication. The patient took concomitant medications. Vaccination history included: Shingles (States the last one was shingles a couple of years before.), for Immunization; Flu shot (States she had more soreness with her last flu shot.), for Immunization, reaction(s): "soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "AE(s) following prior vaccinations: States any vaccines her arm is sore".  Additional information: Patient had no prior vaccinations (within 4 weeks). Stated the last one was shingles a couple of years before. Stated any vaccines her arm is sore, like the flu shot. Reported that at 75 her arms are somewhat muscular and so she assumed that might be why and other people say they get a sore arm and she believes it is more about the needle going in and not the medication. Stated she had more soreness with her last flu shot back in the fall. Patient takes cholesterol medication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: AE(s) following prior vaccinations: States any vaccines her arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6200) at the age of 74 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: takes cholesterol medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose:1, lot EM9810.), administration date: 04Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "States any vaccines her arm is sore"; Flu shot (States she had more soreness with her last flu shot.), for Immunization, reaction(s): "soreness"; Shingles (States the last one was shingles a couple of years before), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "AE(s) following prior vaccinations: States any vaccines her arm is sore".  Additional information: Reporter stated that, the vaccination was given on Monday and yesterday her husband had a sore arm and she was in bed all day, she felt like she had the flu or something. The caller mention that that was not unusual as it happened with a couple of her friends. Agent relays the callers husband weighs #withheld and the caller is #withheld. The caller provided weights as she had a question about why the dose for the Pfizer Covid 19 vaccine was not adjusted for weight and that she addressed that. Agent relays the caller mentioned that her symptoms were much worse outcome than her husband. The caller states they are both 75 years old and in relatively good health.   No  follow-up attempts are possible. No further information is expected.    .
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: AE(s) following prior vaccinations: States any vaccines her arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: takes cholesterol medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot EM9810, AE(s) following prior vaccinations: States any vaccines her arm is sore), administration date: 04Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "AE(s) following prior vaccinations: States any vaccines her arm is sore"; BNT162b2 (Dose 2, lot EN6200, AE(s) following prior vaccinations: States any vaccines her arm is sore), administration date: 24Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "AE(s) following prior vaccinations: States any vaccines her arm is sore"; Shingles (States the last one was shingles a couple of years before.), for Immunization; Flu shot (States she had more soreness with her last flu shot), for Immunization, reaction(s): "soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "AE(s) following prior vaccinations: States any vaccines her arm is sore".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Feeling abnormal, Insomnia, Rash
Clinical narrative: Rashes; Blister; Difficulty in sleeping; I had such drug, that Pfizer injection that poisoned me and spread infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: RASH (non-serious), outcome "unknown", described as "Rashes"; BLISTER (non-serious), outcome "unknown"; INSOMNIA (non-serious), outcome "unknown", described as "Difficulty in sleeping"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I had such drug, that Pfizer injection that poisoned me and spread infection".  Additional information: Call was transferred from Transferring agent stated, "I do have a caller on the hold. I do have a caller on the hold. This caller needs an interpreter. The concern is he is experiencing side effects from the COVID-19 vaccine such as rashes, blister and difficulty in sleeping." While paraphrasing the name, consumer stated, "My name? I need to speak the interpreter. I don't understanding this sorry, I need the translator. Yeah, I need to speak with translator, I need someone who speak my language." No, I do not understand. I had such drug, that Pfizer injection that poisoned me and spread infection. Call my cell phone .QR Comment: Reporter type could not be probed over the call. Hence, captured as consumer or other non health professional by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.