chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atypical pneumonia
Clinical narrative: felt like he may have walking Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15May2021 as dose  2, single (Lot number: ER9449) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD - was a smoker and gave that up 9 years ago; "He had Pneumonia", start date: Dec2019 (unspecified if ongoing); "Had open heart surgery", start date: Mar2020 (unspecified if ongoing); "Smoker" (unspecified if ongoing), notes: was a smoker and gave that up 9 years ago; "Hospitalization" (unspecified if ongoing), notes: Almost 3 years ago, he was hospitalized with Pneumonia. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: ER9449), administration date: 24Apr2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "Pneumonia", "Feels like he has walking pneumonia". The following information was reported: ATYPICAL PNEUMONIA (medically significant), outcome "unknown", described as "felt like he may have walking Pneumonia".  Clinical course The patient was hospitalized due to Pneumonia and was trying to find some info about Prevnar 13. Initially was asking about Prevnar 20 from a US commercial. The patient received dose 1 as on 24Apr2021 lot ER9449 and dose 2 on 15May2021 as lot ER9449. He had Pneumonia twice and has a history of COPD. He did not receive Prevnar 20. He got the Moderna COVID-19 vaccine booster as dose 3 on 23Dec2021. He confirmed that he never received the Prevnar 13. Almost 3 years ago, he was hospitalized with Pneumonia and 2 years and 2 months ago hospitalized with Pneumonia. He got a feeling he has walking pneumonia now. He is trying to wait until end of school year, end of Nov2022, to see if he needs to get into the hospital again. He was interested in the 20. He had Pneumonia in Dec2019, Prior to getting Pfizer COVID Vaccine. He had open heart surgery in Mar2020. He had pneumonia before COVID even started and was in the hospital with it. He had not going to blame it on the vaccine. When Pharmacist first answered at Pfizer Medical Information, he was trying to find out if Prevnar 20 and she could not find out. He wanted to ask her if it was something good for him and was it available, but she couldn't find out. Few weeks ago is when he felt like he may have walking Pneumonia. He confirmed he has not received any medical treatment. Outcome not provided. COPD - was a smoker and gave that up 9 years ago. He was diagnosed when 2 year ago, prior to getting the vaccines. COVID has done a number on him for dates. He feels like he lost 3 years of his life.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236849 similar report from same reporter;
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood pressure measurement, Echocardiogram, Heart rate
Clinical narrative: sore underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Lot number: EL9266) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nightmares" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: Caller states that because of that the doctor put her on the Clonazepam for anxiety in 2016. Concomitant medication(s) included: CLONAZEPAM taken for anxiety, start date: 2016; AMLODIPINE BESYLATE taken for blood pressure measurement. Vaccination history included: BNT162b2 (First Dose of the Pfizer Covid Vaccine: Received by the caller on 23Jan2021; Lot Number: EL9262; Administered in the caller's left arm.), administration date: 23Jan2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "sore underarm". The following information was reported: AXILLARY PAIN (non-serious) with onset 14Feb2021, outcome "not recovered", described as "sore underarm". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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's relevant medical history included: "Microscopic colitis" (unspecified if ongoing); "Drug allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE, start date: 19Sep2022. Past drug history included: Amoxicillin, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and for reported events -drug ineffective and COVID-19                             cannot be excluded
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 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. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. Patient received the vaccine. Other medications in two weeks was reported as No.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". 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. The report was about COVID-19 treatment. Patient received COVID-19 treatment as Paxlovid from 16Oct2022.   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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 82.0
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) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 25Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing), notes: Mild to moderate Kidney disease.Diagnosed about 3 years ago, caused by high blood pressure.; "high blood pressure" (unspecified if ongoing), notes: Mild to moderate Kidney disease. Diagnosed about 3 years ago, caused by high blood pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), 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: Positive; Positive, notes: She tested positive for Covid twice. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course information: She does not know if she should stop taking the medication or not. She's gotten the Covid vaccines and has been vaccinated and boosted twice and has taken two days worth of medication. She plans on taking it at least one more day because she knows it has good results.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Reporter stated that he has received a total of 4 Pfizer Reporter stated that he has received a total of 4 Pfizer/he had Covid 8 weeks ago; Reporter stated that he has received a total of 4 Pfizer Reporter stated that he has received a total of 4 Pfizer/he had Covid 8 weeks ago; The initial case was missing the following minimum criteria (Other- Info not qualifying for AE reporting- Medical Information). Upon receipt of follow-up information on [19Oct2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Reporter stated that he has received a total of 4 Pfizer Reporter stated that he has received a total of 4 Pfizer/he had Covid 8 weeks ago". Clinical course: He has received a total of 4 Pfizer Covid-19 vaccines- Dose 1, Dose 2, Dose 3 (1st booster) and Dose 4 (2nd booster). Reporter stated that he called Pfizer because he had Covid 8 weeks ago and wanted to know when he can get his 3rd booster shot (Dose 5) and was not reporting any adverse events. Reporter did not know where his vaccine card was and was not able to provide any dates or lot numbers for when he received the Pfizer Covid-19 vaccine Dose 1, Dose 2, Dose 3 (1st booster) and Dose 4 (2nd booster). Reporter did not provide any additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: compromised immune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series; Manufacture unknown), for Covid-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "compromised immune system".  Additional information: Reporter stated he and his wife received the flu vaccine on 14Oct2022 (4 days ago) and asked if there should be a waiting period for them to get the bivalent Pfizer-Biontech Covid vaccine. Reporter wanted to know 'what was the track record of any side effect for seniors/people in his age group' and asked for the "latest update on the booster, the bivalent with Omicron BA.4/BA.5 strain." Reporter asked if the bivalent Pfizer-Biontech Covid vaccine was released over a month ago and mentioned he and his wife are both 86 and his wife has a compromised immune system.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, SARS-CoV-2 test
Clinical narrative: achiness to the injection arm, put ice on it and it was gone within an hour; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 72 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: Diagnosed for 20 years; "High cholesterol" (ongoing), notes: for the last 10 years; "Arthritis" (unspecified if ongoing), notes: Diagnosed for last 5 years. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, NDC: Unknown, Lot: EM9810, Exp: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "slight Headache", "Had achiness to the injection arm"; BNT162b2 (DOSE 2, SINGLE, NDC: Unknown, Lot: ER2613, Exp: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 25Mar2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "slight Headache", "Had achiness to the injection arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "achiness to the injection arm, put ice on it and it was gone within an hour". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient had high cholesterol Sort of has high cholesterol. States it wasn't really high, she had a stressful job. Had high cholesterol for the last 10 years and Arthritis Diagnosed for last 5 years. It's been bothering her. She just has an ache to the arm and maybe a slight fever to other vaccines, but does not provide any product names. She has taken many vaccinations as she travels a lot. Has never gotten really sick.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240143 Same patient and drug, different event separated in time;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient tested positive; patient tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller stated the doctor tested her and the patient tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller was called on behalf of his wife about Paxlovid. Caller stated the doctor tested her and the patient tested positive. Patient takes cough syrup. Caller has heard that there's an EUA for Paxlovid. The caller stated that his wife had received the primary series as well as two booster doses. Caller's wife has an underlying problem and wants to know if Paxlovid will help her. Caller asked, "Is Paxlovid for those who didn't receive the vaccine. Patient was about to get the bivalent booster dose. Caller stated that the patient can't get the booster because she tested positive, and they have to wait for 3 weeks. Caller stated that he was trying to figure out if it was necessary to take Paxlovid even if the patient has been vaccinated and boosted twice. The chance of getting a serious complication was minimal. Caller can't determine if Paxlovid was specifically for those unvaccinated people. Caller wanted to know if one is fully vaccinated. Is Paxlovid going to help. Is it necessary to still take Paxlovid to be fully protected.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: every time I got a vaccine or a booster, my PSA readings go up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "every time I got a vaccine or a booster, my PSA readings go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller mentioned that he already 2 doses of the Pfizer Covid-19 Vaccine and the booster dose. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. Patient read several things saying they've been test and show high PSA levels, He had 2 vaccines and 2 boosters and then the Paxlovid, because he contracted Covid 19, he had a chart showing when I've taken the vaccine and when he got back his PSA readings back and every time he got a vaccine or a booster, his PSA readings go up. He also heard that they go up when you contract Covid 19, but there's no information about Paxlovid because it's so new, but when you have covid 19 and you feel terrible, anything that helps is considered. He wanted to know if the chemical make up of Paxlovid is the same as the booster and the vaccine. He also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average, He was wondering if you heard anything about that. He figured you might have heard about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
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 contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GH9694) at the age of 28 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 at 12:45 as dose 1, single (Lot number: EP6955), in left arm, on 18Apr2021 at 12:30 as dose 2, single (Lot number: ER8731), in left arm and on 02Nov2021 at 17:45 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19". Clinical course: After taking a full 5 day course of Paxlovid, and testing negative on an antigen test multiple times subsequentially for 7 days, the patient had tested positive again for Covid and was experiencing rebound symptoms from 18Oct2022 at 06:30 am. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: testing negative on an antigen test multiple times subsequentially for 7 days; (2022) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of covid-19, which included PAXLOVID, acetaminophen (TYLENOL), and ibuprofen (ADVIL) all from 04Oct2022 to 09Oct2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
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 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 11:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Dec2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Seasonal allergies: dust" (unspecified if ongoing); "Seasonal allergies: mold" (unspecified if ongoing); "Seasonal allergies: ragweed" (unspecified if ongoing); "Seasonal allergies: grass" (unspecified if ongoing); "Seasonal allergies: cat" (unspecified if ongoing); "Seasonal allergies: allery to rabbits, guinea pigs" (unspecified if ongoing); "Seasonal allergies: some dogs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative; (10Oct2022) Negative; (12Oct2022) Negative; (16Oct2022) Positive, notes: two rapid tests confirmed that I was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "Known allergies: naproxen". 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: COVID 19 Treatment; Positive, notes: Covid reinfection. Other medication in 2weeks: Unknown. Anti-viral details: Product: Covid 19 Treatment, Brand: Paxlovid [Treatment start date: 08Oct2022, Treatment stop date: 12Oct2022, Indication: Treatment of Covid-19]. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: every time I got a vaccine or a booster, my PSA readings go up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up", "I contracted Covid 19". The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "every time I got a vaccine or a booster, my PSA readings go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that he already 2 doses of the Pfizer Covid-19 Vaccine and the booster dose. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. Reporter stated "he read several things saying they've been test and show high PSA levels, he had 2 vaccines and 2 boosters and then the paxlovid, because he contracted Covid 19, he have a chart showing when he was taken the vaccine and when he got back my PSA readings back and every time he got a vaccine or a booster, my PSA readings go up. He also heard that they go up when you contract Covid 19, but there's no information about Paxlovid because it's so new, but when you have covid 19 and you feel terrible, anything that helps is considered. Has Pfizer heard anything, he curious, he mentioned this to urologist, but he wanted to know if there's a correlation that you've heard about, with Paxlovid and the vaccine and the booster. He mentioned he didn't know if he received the bivalent or monovalent formulation, he received it when it just came out and his most recent booster was on 25Mar2022. He took Paxlovid took 2 months ago, on 12Aug2022. He wanted to know if the chemical make up of Paxlovid is the same as the booster and the vaccine. he also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average, he was wondering if you heard anything about that. he figured you might have heard about it. Offered warm transfer to DSU, reporter declined stating he had a phone meeting with his urologist, but that he may reporter back later.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication with in two weeks. Patient received the treatment Paxlovid from 10Oct2022 to 15Oct2022. There was no known allergies.4 days after testing negative and having no symptoms the Covid symptoms have returned. The patient had  a bad cough and runny nose and very tired. No temperature as of now which I originally had.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Fatigue, Haemoglobin, Haemoglobin decreased
Clinical narrative: low iron; Haemoglobin: 5.9; tired; 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 66-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Lot number: EN6200) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (first dose was 31Jan2021 of LOT: EL9261, NDC/EXP: not provided), administration date: 31Jan2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: BLOOD IRON DECREASED (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "low iron"; HAEMOGLOBIN DECREASED (medically significant), outcome "unknown", described as "Hemoglobin 5.9". FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: Blood iron: low iron; Haemoglobin: 5.9, notes: Result: 5.9, Unit: Not provided; 10.5, notes: Dropped to 10.5 initially; Low, notes: It was so low; 5, notes: hemoglobin drops to 5. Therapeutic measures were taken as a result of blood iron decreased.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: El8982), in left arm, as dose 2, single (Lot number: En6203), in right leg and as dose 3 (booster), single (Lot number: 30135BA), in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anal inflammation, Chapped lips, Gingival bleeding, Lip swelling
Clinical narrative: Rash on body; bleeding gums; loss of taste buds; swollen and cracked lips; swollen and cracked lips; inflamed anus; blistered penis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Egg whites" (unspecified if ongoing), notes: Known allergies: Egg whites. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Severe allergic reaction to anti-inflammatory drugs", notes: Severe allergic reaction to anti-inflammatory drugs , that I had taken on previous occasions. Meloxicam; Methylprednisolone, reaction(s): "Severe allergic reaction", notes: Severe allergic reaction to anti-inflammatory drugs , that I had taken on previous occasions. Meloxicam , and methylprednisolone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: RASH (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "Rash on body"; GINGIVAL BLEEDING (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "bleeding gums"; PENILE BLISTER (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "blistered penis"; ANAL INFLAMMATION (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "inflamed anus"; AGEUSIA (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "loss of taste buds"; LIP SWELLING (medically significant), CHAPPED LIPS (medically significant) all with onset 06Oct2021 at 12:00, outcome "recovered" and all described as "swollen and cracked lips". The events "rash on body", "bleeding gums", "loss of taste buds", "swollen and cracked lips", "inflamed anus" and "blistered penis" required physician office visit. Therapeutic measures were not taken as a result of rash, gingival bleeding, ageusia, lip swelling, chapped lips, anal inflammation, penile blister.  Clinical Information: Severe allergic reaction to anti-inflammatory drugs that I had taken on previous occasions. Meloxicam and methylprednisolone. Rash on body, bleeding gums, loss of taste buds, swollen and cracked lips, inflamed anus and blistered penis. No prior covid vaccination. No covid tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Penile blister, Rash
Clinical narrative: Rash on body; bleeding gums; loss of taste buds; swollen and cracked lips; swollen and cracked lips; inflamed anus; blistered penis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Egg whites" (unspecified if ongoing), notes: Known allergies: Egg whites. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Severe allergic reaction to anti-inflammatory drugs", notes: Severe allergic reaction to anti-inflammatory drugs , that I had taken on previous occasions. Meloxicam; Methylprednisolone, reaction(s): "Severe allergic reaction", notes: Severe allergic reaction to anti-inflammatory drugs , that I had taken on previous occasions. Meloxicam , and methylprednisolone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: RASH (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "Rash on body"; GINGIVAL BLEEDING (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "bleeding gums"; PENILE BLISTER (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "blistered penis"; ANAL INFLAMMATION (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "inflamed anus"; AGEUSIA (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "loss of taste buds"; LIP SWELLING (medically significant), CHAPPED LIPS (medically significant) all with onset 06Oct2021 at 12:00, outcome "recovered" and all described as "swollen and cracked lips". The events "rash on body", "bleeding gums", "loss of taste buds", "swollen and cracked lips", "inflamed anus" and "blistered penis" required physician office visit. Therapeutic measures were not taken as a result of rash, gingival bleeding, ageusia, lip swelling, chapped lips, anal inflammation, penile blister.  Clinical Information: Severe allergic reaction to anti-inflammatory drugs that I had taken on previous occasions. Meloxicam and methylprednisolone. Rash on body, bleeding gums, loss of taste buds, swollen and cracked lips, inflamed anus and blistered penis. No prior covid vaccination. No covid tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Mild symptoms and tested positive for COVID.  Runny nose, slight fever and cough; Mild symptoms and tested positive for COVID.  Runny nose, slight fever and cough; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2 (booster), single (Lot number: 330268D), in left arm and on 01Aug2022 as dose 3 (booster), single (Lot number: Lp7139) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 18Mar2021 as dose 1 , single (Lot number: 1805025) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: STATIN [ATORVASTATIN CALCIUM]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Oct2022, outcome "recovering" and all described as "Mild symptoms and tested positive for COVID.  Runny nose, slight fever and cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information: The patient had no covid prior vaccination. Patient was covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: 5th booster dose of BNT162B2 administered; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6204), administration date: 11Mar2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733), administration date: 31Mar2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EW0172), administration date: 15Nov2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number FJ6369), administration date: 25Apr2022, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; flu (With the flu shot, just a sore arm, nothing to whine or complain about.), administration date: 26Oct2021, when the patient was 75-year-old, for Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Oct2022, outcome "recovered" (07Oct2022), described as "sore arm"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 06Oct2022 at 16:00, outcome "unknown", described as "5th booster dose of BNT162B2 administered".  Additional information: It was reported the person got bivalent vaccine and had no side effects other than sore arm. She had no problems with the first 4 doses, there was a bit of sore arm and she had less of a sore arm with this one and it was maybe just overnight and by the next night was fine. It was nothing she really noticed that evening and when she went to bed was when she noticed it, it was a little less than the others. It was totally gone at most in 24 hours. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician office.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241911 same reporter/patient/AE, different dose;US-PFIZER INC-202201241912 same reporter/patient/AE, different dose;US-PFIZER INC-202201241913 same reporter/patient/AE, different dose;US-PFIZER INC-202201241914 same reporter/patient/AE, different dose;
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: General tiredness, sore arm; General tiredness, sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY SERIES COMPLETED, UNKNOWN MANUFACTURE), for Covid-19 immunization; Bnt162b2 (Dose 3, other vaccine same date vaccine location= Left arm), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 19Oct2022 at 06:00, outcome "recovering" and all described as "General tiredness, sore arm". Therapeutic measures were not taken as a result of fatigue, pain in extremity.  Additional information: Facility type vaccine workplace clinic. No other vaccine in four weeks. Adverse event start time was 06:00 AM. No any treatment for AE. Covid was not prior vaccination. Covid was not tested post vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8733) at the age of 74 years 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: EN6204, ), administration date: 11Mar2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that, The patient had no problems with the first 4 doses, there was a bit of sore arm and she had less of a sore arm with this one and it was maybe just overnight and by the next night was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/AE, different dose;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204), administration date: 11Mar2021, when the patient was 74-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733), administration date: 31Mar2021, when the patient was 74-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; flu shot, administration date: 26Oct2021, for Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The patient had no problems with the first 4 doses. The patient did not receive other vaccines within four weeks prior to COVID vaccine. No investigation were conducted. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No additional vaccines administered on same date of the pfizer suspect.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/AE, different dose;