chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Experienced confirmed COVID infection; Experienced confirmed COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 11:00 as dose 1, single (Lot number: EL3248), in right arm, on 11Mar2021 at 09:00 as dose 2, single (Lot number: EL3248), in right arm and on 22Nov2021 at 13:00 as dose 3 (booster), single (Lot number: EW0176) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 30May2022, outcome "recovering" and all described as "Experienced confirmed COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Lab Notes:Nasal Swab; (01Jun2022) Positive, notes: Lab Notes: Nasal Swab. Therapeutic measures were not taken as a result of sars-cov-2 test positive, vaccination failure.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed COVID received 4th dose about 4 weeks before COVID; Developed COVID received 4th dose about 4 weeks before COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 62-year-old female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension controlled by ARB. Concomitant medication(s) included: SYNTHROID; WEGOVY; DIURETIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Developed COVID received 4th dose about 4 weeks before COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Developed Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed COVID received 3rd dose Nov2021; Developed COVID received 3rd dose Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 26-year-old female patient received BNT162b2 (COMIRNATY), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Developed COVID received 3rd dose Nov2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Developed COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for Covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: IVERMECTIN, start date: 26May2022, stop date: 26May2022; AZITHROMYCIN, start date: 29May2022, stop date: 31May2022. Other medication in 2 weeks was reported as yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID-19 Treatment. Therapeutic measures were taken as a result of Covid-19. Anti-viral details: Product: COVID-19 Treatment, Brand: Paxlovid, Indication: Treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "recovered" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: Facility type vaccine: Doctor's office/urgent care, The patient did not take any other vaccine in four weeks. The patient took other medications in two weeks. Adverse event: cough, congestion, sinus pressure, fatigue, headache, body ache. Adverse event start date: 21May2022. If patient recovered: Recovered. If treatment AE: Unknown. The patient did not had Covid prior vaccination. The patient tested Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200792393 Same patient and drug, different event separated in time
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PAD" (unspecified if ongoing), notes: other medical history: PAD; "fibriods" (unspecified if ongoing); "hx of iron deficiency anemia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "COVID-19"; NASAL CONGESTION (medically significant) with onset 01Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (01Jun2022) Positive, notes: positive Covid 19 test on 01Jun2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasal congestion; 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary Embolism with Pleural Effusion; Pulmonary Embolism with Pleural Effusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: FLU VACCINE VII, on 14Oct2021 as unk unk, single. Past drug history included: Known allergies: augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: BNT162b2 (Dose 02, Lot number: EL3248), administration date: 24Mar2021, when the patient was 41-year-old, for COVID-19 Immunization; BNT162b2 (Dose 01, Lot number: EL3248), administration date: 03Mar2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), PLEURAL EFFUSION (non-serious) all with onset 05Mar2022, outcome "recovered with sequelae" and all described as "Pulmonary Embolism with Pleural Effusion". The event "pulmonary embolism with pleural effusion" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary embolism, pleural effusion. Clinical course: Yes other vaccine in four weeks. Yes COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (27May2022) Negative; (31May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication received in 2 weeks. Treatment of COVID-19 with Paxlovid Brand Treatment start date from 22May2022, Treatment stop date: 27May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 19Nov2014, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: covid free for 4-5 days, then covid again; Negative, notes: then paxlovid, tested negative; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received other medication in 2 weeks, CRESTOR. After having covid, then PAXLOVID, tested negative after several days, was then covid free for 4-5 days, then covid again. Patient stated that, "So mad I ever took the PAXLOVID". Patient was treated for COVID with PAXLOVID, treatment start date on 23May2022 and treatment stop date on 27May2022. Adverse event start date was on 01Jun2022 and adverse event start time was at 10:00 PM (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccinated and boostered but I tested positive yesterday for covid; very limited symptoms or anything; basically have no symptom; vaccinated and boostered but I tested positive yesterday for covid; very limited symptoms or anything; basically have no symptom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 49 years intramuscular, 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. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 31May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccinated and boostered but I tested positive yesterday for covid; very limited symptoms or anything; basically have no symptom". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On 20May2022, I tested positive for Covid and started to experience mild symptoms; On 20May2022, I tested positive for Covid and started to experience mild symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 11Feb2021 as dose 1, single (Lot number: EN6201) at the age of 67 years, in right arm, on 04Mar2021 as dose 2, single (Lot number: EN6198) at the age of 67 years, in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 3W308D) at the age of 68 years, in left arm and on 13Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 4895) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "On 20May2022, I tested positive for Covid and started to experience mild symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive; (20May2022) Positive; (25May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid to treated vaccination failure, covid-19. Treatment start date:20May2022, treatment stop date: 25May2022.
Sex: U
Vaccine: PNC20
Symptoms: Off label use, Pain in extremity, Peripheral swelling, Product administered to patient of inappropriate age, Tenderness
Clinical narrative: 3 year old child have a reaction to the Prevnar 20; 3 year old child have a reaction to the Prevnar 20; increased swelling, pain, and tenderness in the arm; increased swelling, pain, and tenderness in the arm; increased swelling, pain, and tenderness in the arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 3-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2022 as dose number unknown single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 2022, outcome "unknown" and all described as "3 year old child have a reaction to the Prevnar 20"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 2022, outcome "unknown" and all described as "increased swelling, pain, and tenderness in the arm". Additional information: The doctor stated back in March he had a Pfizer Rep came to his office and told him that the Prevnar 20 was replacing the Prevnar 13 so he has only been ordering and giving the Prevnar 13. He placed his first order for Prevnar 20 in March and has only had that vaccine since he received the 20. And he has done that based on the recommendations of the Rep that came to the office and advised him to use the Prevnar 20. Now he stated he had a 03-year-old child have a reaction to the Prevnar 20 and the parent was upset because the Prevnar 20 should be used in individuals 18 years and older. Child had increased swelling, pain, and tenderness in the arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/ Pfizer / BioNTech 12-NOV-2021; Treatment of COVID-19/ Pfizer / BioNTech 12-NOV-2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: Jan2008, stop date: Jun2022; ROSUVASTATIN, start date: Apr2021, stop date: Jun2022. The following information was reported: DRUG INEFFCETIVE ant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Pfizer / BioNTech 12-NOV-2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative, notes: Covid symptoms resolved and negative rapid antigen test on Day 6; (26May2022) Positive, notes: positive rapid antigen test on Day 8; (01Jun2022) Positive, notes: positive rapid antigen test on Day 8 thru Day 14 and continuing. Therapeutic measures were taken as a result of drug ineefctive , covid-19.  Clinical course: Patient received Covid-19 treatment from 19May2022 to 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: Took all three Covid vaccine; I just had a positive test this morning; Took all three Covid vaccine; I just had a positive test this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), in left arm, on 24Mar2021 as dose 2, single (Lot number: 3248), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). Concomitant medication(s) included: FLUVOXAMINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "Took all three Covid vaccine; I just had a positive test this morning". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive; Weight: (unspecified date) I do not know may be 145. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: This is the first case of the 2 split cases. NDC number of Covid Vaccine was unknown. The patient was taking other products. Call was from Pfizer employee and was reporting for herself. Consumer (Pfizer employee) stated, "She has a couple of adverse events to report. We just have name of things if you took the Pfizer vaccine and then experience the Covid infection, that should be reported. So, she does guess the product here would be the vaccine. So that was, that one is for her. And she was looking for to report from this morning. So that's her adverse event." When probed for another adverse event and product: Consumer stated, "The second one is for her dad (split made). So, he took Paxlovid. She didn't know if she reports it to Drug Safety or talk with the RA Drug Safety". Consumer was told about the role of Pfizer Drug Safety. Consumer stated, "The second dose said lot number 3248. That one didn't say EL, that was just LOT 3248." Consumer stated, she means she just said that, so she just diagnosed and just had a positive test this morning (at the time of reporting). So, she has taken some like over the counter like Tylenol and Mucinex. Consumer stated, those were not Pfizer drugs so, she had the container but those were not Pfizer drugs. She was looking on it. For Tylenol, there it was Lot no. BBA031. For the Mucinex, this number was long for Mucinex, NM3178901045. Consumer stated expiration dates for Tylenol was Dec2023 and Mucinex was Sep2023. The reporter was not a doctor. Consumer stated she got vaccine at the (site name withheld) site. That's first two she got at (voice not clear) office and then she got the third one at (facility name withheld). She didn't remember the dosage.  Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested COVID Positive Infected with Coronavirus; Tested COVID Positive Infected with Coronavirus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EP 6955), in left arm and on 08Apr2021 at 12:00 as dose 2, single (Lot number: EP 6955), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; TRICOR [FENOFIBRATE]; SINGULAIR; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27May2022, outcome "unknown", COVID-19 (medically significant) with onset 27May2022, outcome "not recovered" and all described as "Tested COVID Positive Infected with Coronavirus". On 23May2022 the patient also experienced generalized fatigue and cough as the symptoms of COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Lipitor, Tricor, Singulair, Protonix and Lisinopril within 2 weeks of vaccination. The patient was infected with Coronavirus, severe symptoms lasting five days, generalized fatigue and cough continued. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive with home antibody test on 02Jun2022; Tested positive with home antibody test on 02Jun2022; Patient had fever; Chills; Stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE, solution for injection), 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. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 02Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 02Jun2022, outcome "unknown", described as "Patient had fever"; NASAL CONGESTION (non-serious) with onset 02Jun2022, outcome "unknown", described as "Stuffy nose"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "Tested positive with home antibody test on 02Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative, notes: Nasal Swab; (02Jun2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, pyrexia, chills, nasal congestion. Additional information: No other vaccine in four weeks. No other medications in two weeks. Covid prior vaccination: No. Covid tested post vaccination: Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested positive with home antibody test on 02Jun2022; Tested positive with home antibody test on 02Jun2022; Patient had fever; Chills; Stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE, solution for injection), 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. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 02Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 02Jun2022, outcome "unknown", described as "Patient had fever"; NASAL CONGESTION (non-serious) with onset 02Jun2022, outcome "unknown", described as "Stuffy nose"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "Tested positive with home antibody test on 02Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative, notes: Nasal Swab; (02Jun2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, pyrexia, chills, nasal congestion. Additional information: No other vaccine in four weeks. No other medications in two weeks. Covid prior vaccination: No. Covid tested post vaccination: Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for COVID-19; testing positive for 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.  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) all with onset 26May2022, outcome "unknown" and all described as "testing positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negetive; (26May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid .  Additional information: The patient was diagnosed, tested positive for Covid-19 on 26May. He was prescribed Paxlovid for the emergency use authorization. He was 73, his symptoms he was having chills and was having uncomfortable time of it with COVID. He was fully vaccinated and fully boosted but he was immunocompromised. So he has taken the fully course of the Paxlovid and his symptoms began to improve, every day he got better for 5 days that he was taking it. He tested negative yesterday for COVID. He took both vaccines and also both boosters. Most severe side effect that he had from Paxlovid was really very, lot of diarrhea.   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, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid; she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid; 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 17Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199) and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Caller stated she tested Covid Positive last Monday or Tuesday.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Asthenia, Cataract, Eye disorder
Clinical narrative: she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid; she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid; 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 17Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199) and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Caller stated she tested Covid Positive last Monday or Tuesday.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: vaccine allergies/she experienced a reaction to the second booster of the Pfizer-BioNTech COVID-19 Vaccine gray cap; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vaccine allergies" (unspecified if ongoing); "preservative allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization, reaction(s): "I hadn't had any problem with the first 3 doses"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "I hadn't had any problem with the first 3 doses"; Bnt162b2 (Dose: 3), for COVID-19 Immunization, reaction(s): "I hadn't had any problem with the first 3 doses". The following information was reported: DRUG HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "vaccine allergies/she experienced a reaction to the second booster of the Pfizer-BioNTech COVID-19 Vaccine gray cap".  Course of the event: Caller states she is calling about the Pfizer Covid19 vaccine and had a personal reaction and ended up in the hospital and has been discharged; states the first three covid19 vaccines she got were the purple cap and the one she got last week was the grey cap and she knows she has vaccine allergies and preservative 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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 5 days at the age of 32 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 had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: COVID-19 (medically significant) with onset May2022, 9 days after the suspect product(s) administration, outcome "recovered" (May2022), described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset May2022, 9 days after the suspect product(s) administration, outcome "recovered" (May2022), described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative, notes: I began testing negative on the fourth day off Paxlovid treatment; (May2022) Positive; (May2022) Positive; (17May2022) Positive, notes: positive tests lasted 3 days. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient experienced a rebound of Covid-19 symptoms 5 days after completing a 5 day course of Paxlovid. patient began testing negative on the fourth day off Paxlovid treatment but then tested positive again 5 days after finishing Paxlovid. My rebound  symptoms and positive tests lasted 3 days.  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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had all the Pfizer COVID-19 shots except the second booster./taking Paxlovid; I had all the Pfizer COVID-19 shots except the second booster./taking Paxlovid; 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 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had all the Pfizer COVID-19 shots except the second booster./taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking Paxlovid and had problem breathing, couldn't, got choked, and couldn't get air, and was wondering if anaphylaxis is one of the side effects of this drug or it it's just due to the COVID. After taking Paxlovid patient had a problem with bladder pains and lost her voice. Patient called doctor and told to just take one pink pill and one white pill instead of all three. Yesterday took a nap, woke up choking, and couldn't breathe. Patient was gasping for breath but couldn't breathe. It was frightening but finally recovered and was fine until yesterday at 5pm. Patient was going to continue those pills today and see if they are ok. Patient have trouble swallowing them. Patient had all the Pfizer COVID-19 shots except the second booster.  The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 10Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "low back pain" (unspecified if ongoing). No known allergies reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 15May2022, outcome "not recovered", described as "Treatment of COVID-19"; VACCINATION FAILURE (medically significant) with onset 15May2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.   The patient was treated with paxlovid since 17May2022 evening, oral as covid-19 treatment. Patient completed 5 days therapy. On 25May2022 had recurrence of symptoms (congestion, rhinorrhea, fatigue, mild fever).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments:  The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: U
Vaccine: MENB
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: experienced a high fever; sore throat; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experienced a high fever"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: Patient received 1st dose of Trumenba and experienced a high fever and sore throat for about 2 days. (Name withheld) told patient these were some of the expected adverse events found in the package insert. Event took place after use of product.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: developed pneumonia a couple of weeks later; developed pneumonia a couple of weeks later; This is a spontaneous report received from contactable reporter (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "developed pneumonia a couple of weeks later". Clinical course: The patient took the vaccine and developed pneumonia a couple of weeks later. The reporter didn't know what kind of pneumonia, and this was all the information that the reporter knew. The event took place after use of product.  The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with PREVNAR 20 in this patient cannot be completely excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Thrombosis
Clinical narrative: After caller had his 2nd shot last year caller developed 2 blood clots in 1 leg; Caller's legs have been cramping since caller got the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EW0153) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (NDC number, lot number, expiration date: ER6213, Dose and route: Unknown, Dose: 1), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Cramping". The following information was reported: THROMBOSIS (medically significant) with onset 17May2021, outcome "recovered" (Nov2021), described as "After caller had his 2nd shot last year caller developed 2 blood clots in 1 leg"; MUSCLE SPASMS (non-serious) with onset 17May2021, outcome "unknown", described as "Caller's legs have been cramping since caller got the vaccine". The events "after caller had his 2nd shot last year caller developed 2 blood clots in 1 leg" and "caller's legs have been cramping since caller got the vaccine" required physician office visit. Therapeutic measures were taken as a result of thrombosis, muscle spasms.  Clinical Course : Caller is calling about the Pfizer COVID-19 vaccine. After caller had his 2nd shot last year caller developed 2 blood clots in 1 leg, which was caller's right leg. Doctor said they have never seen that before. Caller is having the same symptoms now going on in caller's left leg and caller had to go to the emergency room. Caller clarifies he did not go to the emergency room, caller went to urgent care. Just came back from urgent care and they wanted caller to go to the emergency room, but caller hasn't gone to the emergency room yet. Caller's legs have been cramping since caller got the vaccine. Caller actually went last month to urgent care and it was 7 o'clock and they sent a note for caller to go to the emergency room because the ultrasound person that checks for blood clots was gone. Caller waited a month, went back to the urgent care when the ultrasound person was supposed to be there and the ultrasound person was too busy. Don't get Healthcare. Caller has been having these symptoms for like 2 months now in both legs, now both legs are cramping and aching, but left leg is hurting more and burning more, very good burning sensation, probably where the clots are. Going to go to the emergency room later tonight. Caller is sitting up with legs in the air on pillows right now because legs are hurting so bad, has legs 4 feet up in the air, has been doing this the past 2 months, helps caller's legs. Vaccination Facility Type: Clinic set up in the mall.  No follow-up attempts are possible. No further information is expected.