chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 RNA, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough case of COVID-19; Breakthrough case of COVID-19; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Lot number: ER8732) at the age of 36 years as dose 3 (booster), single, administered in arm left, administration date 19Apr2021 (Lot number: ER8731) as dose 2, single and administered in arm left, administration date 29Mar2021 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy-Allergic to Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. It was reported that patient not received other vaccine in four weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 20Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Breakthrough case of COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 rna: (31Dec2021) positive, notes: Nasal Swab; sars-cov-2 test: (31Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Dose Number 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 12Oct2021 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single, administered in arm left, administration date 02Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 09Feb2021 (Lot number: EL3247) as dose 1, single for COVID-19 immunization. Relevant medical history included: "endometriosis" (unspecified if ongoing); "ichthyosis" (unspecified if ongoing). Concomitant medications included: MIRALAX; RESTASIS; VIVELLE [ESTRADIOL]; CAL SUP; MG [MAGNESIUM SULFATE]; PROBIOTICS. The following information was reported: IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "Dose Number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "positive COVID-19 test with symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab; (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Sore throat started on 03Jan2022, sore throat and chills on 04Jan2022, took home test kit for Covid from pharmacy on 04Jan2022, result came up positive. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Reporter assessed case as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Fever as high as 103.7; coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 13:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 05Jan2022 23:45, outcome "not recovered", described as "Fever as high as 103.7"; COUGH (non-serious) with onset 05Jan2022 23:45, outcome "not recovered", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, cough.  Additional information: No other vaccine in four weeks. Not tested for covid post vaccination. No known allergies. Other medical history was None.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Hip arthroplasty
Clinical narrative: I had total hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 02Apr2021 (Lot number: ER8730) at the age of 73 years as dose 2, single and intramuscular, administered in arm, administration date 12Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 28Sep2021, outcome "unknown", described as "I had total hip replacement".  Clinical course: I called Pfizer because I had some headache after 3rd booster shot. No problems with the first 2 shots. With the 3rd shot. I had a headache an hour or so later. It eased, but had a headache most of the next day. The headaches continued on off for about 3 weeks. They other perstiant information was, I had total hip replacement 28Sep2021. So when I got the booster. It had been 5 and half weeks from that surgery.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID-19 (PCR test). His symptoms are mild (headache, sore throat, fatigue); positive for COVID-19 (PCR test). His symptoms are mild (headache, sore throat, fatigue); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A "15 (units not provided)" male patient received bnt162b2 (COMIRNATY), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 04Jan2022, outcome "unknown" and all described as "positive for COVID-19 (PCR test). His symptoms are mild (headache, sore throat, fatigue)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Injected limb mobility decreased, Vaccination site mass, Vaccination site pain
Clinical narrative: Pain in arm clarified that it was on the injection site; Her arm still has a round, red, knot. It's like a circle on arm and stuff clarified that it was on the injection site; could not lift the injected arm as good as she once was; Pfizer Booster shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 58 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 30Dec2021 13:15 (Lot number: FJ8757) at the age of 58 years as dose 3, (booster) single for Covid-19 Immunization. Relevant medical history included: "Blood pressure abnormal" (ongoing). Concomitant medication included: LOSARTAN HCTZ taken for Blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot- ER8734), administration date: 01Apr2021, when the patient was 58 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Lot- EN0164), administration date: 23Apr2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 13:15, outcome "not recovered", described as "Pfizer Booster shot"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Pain in arm clarified that it was on the injection site"; VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "Her arm still has a round, red, knot. It's like a circle on arm and stuff clarified that it was on the injection site"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "not recovered", described as "could not lift the injected arm as good as she once was". Therapeutic measures were taken as a result of vaccination site pain, vaccination site mass, injected limb mobility decreased. Clinical course: Patient called to report that she had Pfizer Booster shot. After she took the shot, on unknown date, she felt pain in the arm and stuff. Her arm still has a round, red, knot. It's like a circle on arm and stuff. Patient later on clarified that these were on the injection site. Patient also could not lift the injected arm as good as she once was. She called her doctor and was told to apply a heating pad. In addition, she was taking Tylenol and Benadryl and started doing a soft massage to help it out.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: ended up getting COVID; ended up getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0151, Expiration Date: 30Jul2021) at the age of 56 years as dose 2, single and administered in arm left, administration date 16Mar2021 (Lot number: EP7534, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: VALSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "ended up getting COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) getting covid, notes: I ended up getting COVID. Therapeutic measures were taken as a result of covid-19 with Azithromycin 250mg, that was for 5 days and it actually did help.The patient did not receive any other vaccines within four weeks prior to the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have gotten Covid; have gotten Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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 2021, outcome "unknown" and all described as "have gotten Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID PCR test on 30Dec21 reporting breakthrough infections; Positive COVID PCR test on 30Dec21 reporting breakthrough infections; Dose number: 3; This is a spontaneous report received from a non-contactable reporter (nurse).  A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 07Dec2021 (lot number: FF2589) at the age of 52-years as dose 3 (booster), single, administration date 27Mar2021 (lot number: EL3247) at the age of 52-years as dose 1, single and administration date 17Apr2021 (lot number: EP6955) at the age of 52-years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, described as "Dose number: 3"; VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Positive COVID PCR test on 30Dec21 reporting breakthrough infections". The event "Positive COVID PCR test on 30Dec21 reporting breakthrough infections" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure and COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: 03Jan2022 PCR positive for COVID after exposure to sister on 24Dec2021 NO SYMPTOMS; 03Jan2022 PCR positive for COVID after exposure to sister on 24Dec2021 NO SYMPTOMS; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP(nurse)) from product quality group.  An adult male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "positive for COVID after exposure to sister", start date: 24Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" and all described as "03Jan2022 PCR positive for COVID after exposure to sister on 24Dec2021 NO SYMPTOMS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and asymptomatic COVID-19 cannot be ruled out.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: exposure to covid positive roomie 25Dec then tested + Ag on 31Dec after work mild fatigue ST mild sx; exposure to covid positive roomie 25Dec then tested + Ag on 31Dec after work mild fatigue ST mild sx; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single, administration date 27Jan2021 (Lot number: EL3247) as dose 2, single and administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "exposure to covid positive roomie", start date: 25Dec2021, stop date: 25Dec2021. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 31Dec2021, outcome "recovering" and all described as "exposure to covid positive roomie 25Dec then tested + Ag on 31Dec after work mild fatigue ST mild sx". The patient underwent the following laboratory tests and procedures: home Ag: (31Dec2021) positive; (02Jan2022) positive; (03Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: after getting 3 vaccines the patient had symptoms on 01Jan2022 and tested positive for Rapid Ag COVID 1/2 awaiting PCR results presumend positive; after getting 3 vaccines the patient had symptoms on 01Jan2022 and tested positive for Rapid Ag COVID 1/2 awaiting PCR results presumend positive; Booster; This is a spontaneous report received from a non-contactable reporter (Other HCP) from product quality group.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 02Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 02Jan2022, outcome "recovering" and all described as "after getting 3 vaccines the patient had symptoms on 01Jan2022 and tested positive for Rapid Ag COVID 1/2 awaiting PCR results presumend positive". The event "after getting 3 vaccines the patient had symptoms on 01jan2022 and tested positive for rapid ag covid 1/2 awaiting pcr results presumend positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive; (02Jan2022) awaiting results presumend positive. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event after getting 3 vaccines the patient had symptoms on 01Jan2022 and tested positive for Rapid Ag COVID 1/2 awaiting PCR results presumend positive cannot be excluded based on temporal association and available information. 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive by PCR/Symptoms include fever, headache, chill, cough, sore throat, little runny nose, nasal congestion; COVID positive by PCR/Symptoms include fever, headache, chill, cough, sore throat, little runny nose, nasal congestion; Third dose administered; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Oct2021 (Lot number: FF8841) at the age of 29 years as dose 3 (booster), single, administered in arm left, administration date 23Feb2021 (Lot number: EN5318) at the age of 28 years as dose 2, single and administered in arm left, administration date 02Feb2021 (Lot number: EN5318) at the age of 28 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021, outcome "unknown", described as "Third dose administered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "COVID positive by PCR/Symptoms include fever, headache, chill, cough, sore throat, little runny nose, nasal congestion". The patient underwent the following laboratory tests and procedures: COVID-19 virus test test: (Mar2021) negative, notes: Nasal Swab; (24Aug2021) negative, notes: Nasal Swab; (26Dec2021) positive, notes: by PCR. Clinical course details: COVID positive by PCR. Symptoms include fever, headache, chill, cough, and sore throat. A little runny nose and nasal congestion. The patient had no COVID prior to vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Jun2021 (Lot number: EW0177) at the age of 15 years as dose 2, single and intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Jan2022, outcome "recovered", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal swab): (01Jan2022) positive, notes: QuickView at Home COVID Test. Therapeutic measures were not taken as a result of covid-19.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Dec2021 (Lot number: FD7218) at the age of 18 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 07Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm left, administration date 17Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADD" (unspecified if ongoing). No known allergies. No COVID prior to vaccination Concomitant medication(s) included: INFLUENZA VACCINE taken for immunization, received within 4 weeks of BNT162B2; ESCITALOPRAM; VYVANSE; TRI-SPRINTEC. The following information was reported: IMMUNISATION (medically significant) with onset 19Dec2021, outcome "unknown", described as "Booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: QuickVue at Home COVID Test: (01Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: boosted; Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single and administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "boosted"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID test; positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 (Lot number: EW0217) at the age of 37 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 16Mar2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm right, administration date 23Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 27Oct2021. The patient had no known allergies. The patient had no other vaccine in 4 weeks and no other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022 20:00, outcome "recovering" and all described as "positive COVID test". The event "positive covid test" and "positive covid test" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had no covid prior vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sx of covid ST fever body aches/+ rapid AG test; sx of covid ST fever body aches/+ rapid AG test; Booster; This is a spontaneous report received from a non-contactable reporter (Nurse).  A 34-year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 34 years as dose 3 (booster), single, administration date 06Apr2021 (Lot number: EL3247) as dose 2, single and administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Unknown if other vaccine in four weeks. Unknown if covid prior vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovering" and all described as "sx of covid ST fever body aches/+ rapid AG test". The patient underwent the following laboratory tests and procedures: AG home/Home Ag: (01Jan2022) positive; (03Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 with rapid antigen test; tested positive for COVID-19 with rapid antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from regulatory authority.  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Apr2021 (Lot number: EP6955) at the age of 16 years as dose 2, single and intramuscular, administered in arm left, administration date 22Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No  other medications was received within 2 weeks of vaccination. The following information was reported: On 05Jan2022 11:30, patient tested positive for COVID-19 with rapid antigen test (On/Go/Rapid antigen test, nasal swab) and also experienced fever, headache, sore throat, chills. Therapeutic measures were not taken as a result of the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Immunisation, SARS-CoV-2 test
Clinical narrative: Dose number=3; noticed no symptoms 5 days from potential exposure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "wears contact lenses" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer, dose 1), for covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, unknown manufacturer, dose 2), for covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number=3"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "noticed no symptoms 5 days from potential exposure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Other medications the patient received within 2 weeks of vaccination: unknown.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Immunisation, Laboratory test
Clinical narrative: booster injection about 6 weeks prior.; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster injection about 6 weeks prior."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) low grade fever; laboratory test: (01Jan2022) unknown result; sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient was previously fully vaccinated and had a booster injection about 6 weeks prior. COVID symptoms were low grade fever, splitting headache, cough (initially unproductive) and rather strong aches. On a scale of 0%-100% (100% being best) I felt 30%. Within 24 hours of beginning the 5 days regiment of PAXLOVID I skyrocketed to 95%. I was so very happy and relieved. Even though I still had the sense that something was not right I remained at 95% for 3 days, then on day four I jumped to 100% AND no longer had the feeling something was not right. It was as if something was purged from my body. I test again this Saturday. I completed day five of the medication and still feel great.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: booster injection about 6 weeks prior.; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster injection about 6 weeks prior."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) low grade fever; laboratory test: (01Jan2022) unknown result; sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient was previously fully vaccinated and had a booster injection about 6 weeks prior. COVID symptoms were low grade fever, splitting headache, cough (initially unproductive) and rather strong aches. On a scale of 0%-100% (100% being best) I felt 30%. Within 24 hours of beginning the 5 days regiment of PAXLOVID I skyrocketed to 95%. I was so very happy and relieved. Even though I still had the sense that something was not right I remained at 95% for 3 days, then on day four I jumped to 100% AND no longer had the feeling something was not right. It was as if something was purged from my body. I test again this Saturday. I completed day five of the medication and still feel great.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority (159558). The reporter is the patient. A 79-year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Jan2021 (Lot number: EK4176) at the age of 79 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 05Feb2021, outcome "unknown", described as "Tested positive for the covid virus". Relevant laboratory tests and procedures are available in the appropriate section. Additional information-Patient was hospitalized for a procedure, which was unrelated to this event, and they couldn't do it and said because he has covid not to get the second shot. Patient was asking whether to take second dose or not.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter (consumer) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Mar2021 (lot number: EL3247) at the age of 26-years as dose 2, single and administration date 10Feb2021 (lot number: EL3247) at the age of 26-years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset 05Jan2022, outcome "not recovered" and all described as "Tested positive for Covid." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2022) negative, notes: Nasal Swab; (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure and COVID-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Pulmonary congestion, SARS-CoV-2 test
Clinical narrative: Positive Covid; Positive Covid; pulmonary congestion developed; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: unknown, dose 1, single), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: unknown, dose 2, single), for COVID-19 immunization. The following information was reported: PULMONARY CONGESTION (medically significant) with onset 01Jan2022, outcome "not recovered", described as "pulmonary congestion developed"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Positive Covid"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Positive Covid test this morning. It was reported that, the patient experienced fever, aches, cough, congestion, wheezing, pulmonary congestion developed on 01Jan2022. Fever persisted until 02Jan2022, other symptoms continue to now, 05Jan22. Stated that, the events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 14:15 (Lot number: EW0196) at the age of 25 years as dose 3 (booster), single, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021 14:15, outcome "unknown", described as "Dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: Nasal Swab; (06Jan2022) positive, notes: Nasal Swab; (03Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had no known allergies, no other vaccine in 4 weeks and no other medications in 2 weeks. The patient had no covid prior vaccination and was tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She was due to get her second shot this week but ended up with covid instead; She was due to get her second shot this week but ended up with covid instead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 8 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single 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 "She was due to get her second shot this week but ended up with covid instead". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: My 8 yr old received her first dose of Pfizer in December. She was due to get her second shot this week but ended up with covid instead. How long before I schedule her second shot.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Meniere's disease
Clinical narrative: Meniere's disease; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient aged 61 years received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Viagra, start date: 2015, reaction(s): "problem with Viagra", notes: in 2015 he had a problem with Viagra. The following information was reported: MENIERE'S DISEASE (medically significant) with onset Mar2021, outcome "unknown", described as "Meniere's disease". The patient underwent the following laboratory tests and procedures: audiogram: (2021) significant hearing loss in the right ear, notes: diagnosed with Meniere's disease.  Clinical course: Caller states in Mar2021, the patient started experiencing a loss of hearing in the right ear. Caller states the patient saw a otolaryngologist where an audiogram saw significant hearing loss in the right ear which has persisted and the patient was diagnosed with Meniere's disease, a disease in the inner ear.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relation, the association between the event of Meniere's disease and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pruritus, Throat tightness, Urticaria
Clinical narrative: Anaphylactic reaction; her hands were itchy; developed hives on her hands; her throat was closing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Sep2021, outcome "unknown", described as "Anaphylactic reaction"; PRURITUS (non-serious) with onset Sep2021, outcome "unknown", described as "her hands were itchy"; URTICARIA (non-serious) with onset Sep2021, outcome "unknown", described as "developed hives on her hands"; THROAT TIGHTNESS (non-serious) with onset Sep2021, outcome "unknown", described as "her throat was closing". The events "anaphylactic reaction", "her hands were itchy", "developed hives on her hands" and "her throat was closing." were evaluated at the emergency room visit.The reporter asked whether the patient should not get the COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of this vaccine or if patient had a severe allergic reaction to any ingredient of this vaccine.Reporter reports that her 18 year old daughter who is also a college athlete received her first dose of the Pfizer Biontech covid 19 vaccine back in Sep2021 from which she experienced an anaphylactic reaction. It started about two and a half to 3 hours after dose, her hands were itchy, developed hives on her hands and by 4 hours her throat was closing. She had an epi pen and was rushed to the ER for treatment. On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine. Following the second dose within 35-40 min after they left the facility and got home her throat begin to close and again required an epi pen and went to the ER for treatment to open her throat. Reporter reports no residual side effects. Reporter also reports patient has history of asthma and allergies. Reporter seeking information as to why she is having these reactions, is it the mRNA spike proteins that are initially irritating her? Her allergist thinks maybe it is a combination of PEG and polysorbate together.  The lot number for bnt162b2 was not provided and will be requested during follow up.