chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Severe fatigue; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 at 11:00 (Lot number: FH8072) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications included: AMLODIPINE; LOSARTIN; PROZAC and TYLENOL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EF6955; Administration Location: Arm Left; Route of Administration: Unspecified), administration date: 30Mar2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8730; Administration Location: Arm Left; Route of Administration: Unspecified), administration date: 21Apr2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Nov2021 at 11:00, outcome "unknown", described as "Dose number: 3"; PAIN (non-serious) with onset 05Nov2021 at 16:00, outcome "recovered", described as "Body aches"; FATIGUE (non-serious) with onset 05Nov2021 at 16:00, outcome "recovered", described as "Severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain and fatigue.  Additional information: Therapeutic measures included treatment with TYLENOL. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 17.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Exposure to COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4216771-00 (Agency).  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 17 years as dose 2, single and intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 28Dec2021, outcome "not recovered" and all described as "COVID-19"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Dec2021, outcome "not recovered", described as "Exposure to COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. The action taken for adalimumab was unknown.The reporter considered "covid-19" and "exposure to covid-19" related to bnt162b2.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of exposed to Covid 19 was not provided. The reporter's causality for the event(s) of COVID 19 with Humira(adalimumab) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 vaccine (TOZINAMERAN): The reporter's causality for the event(s) of exposed to Covid 19 was possible. The reporter's causality for the event(s) of COVID 19 with TOZINAMERAN was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events COVID-19, Vaccination Failure, Exposure to SARS-CoV-2, cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of COVID-19, Vaccination Failure, Exposure to SARS-CoV-2 is : expected. The case will be reassessed further upon receipt of additional information.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Autoimmune disorder, Drug hypersensitivity
Clinical narrative: Autoimmune disorder; Drug allergy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4216087-00 (Abbvie).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single and intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disorder"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Drug allergy". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unspecified date, the patient experienced non-serious severe allergic reaction to the medication and thought humira gave another auto immune disease with humira (adalimumab). Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect.   The reporter's causality for the event(s) of severe allergic reaction to the medication and thought humira gave another auto immune disease with humira (adalimumab) was a reasonable possibility.  Causality for Humira (Adalimumab):  Drug allergy (Drug hypersensitivity) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A  Autoimmune disorder (Autoimmune disorder) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  Causality for Pfizer BioNTech COVID-19 Vaccine (Tozinameran):  Drug allergy (Drug hypersensitivity) Causality as per reporter (Drug/Vaccine): Possible  Autoimmune disorder (Autoimmune disorder) Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Drug hypersensitivity, Autoimmune disorder  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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pain, Pyrexia
Clinical narrative: Dose number: 3; Nausea; Fever; Body aches; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.   An 18-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: unknown) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing) and "Anxiety" (unspecified if ongoing). Concomitant medications included: FAMOTIDINE; NEXPLANON; SERTRALINE and WELLBUTRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: Unspecified), administration date: an unknown date in May2021, when the patient was 18 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: Unspecified), administration date: an unknown date in Jun2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; NAUSEA (non-serious) with onset 12Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Nausea"; PYREXIA (non-serious) with onset 12Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Fever"; PAIN (non-serious) with onset 12Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Body aches".  Additional Information: It was unknown if any therapeutic measures were taken as a result of the events. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth immediately following vaccination; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 at 11:00 (Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Type II diabetes mellitus" (unspecified if ongoing), notes: DMII; "Hypertension" (unspecified if ongoing), notes: HTN; "Celiac disease" (unspecified if ongoing) and "Gluten intolerance" (unspecified if ongoing), notes: Known allergies: Gluten. Concomitant medications included: ATENOLOL taken for Hypertension; LISINOPRIL taken for Hypertension; METFORMIN taken for Type II diabetes mellitus and LANTUS taken for Type II diabetes mellitus. Past drug history included: Levaquin, reaction: "Drug allergy", notes: Known allergies: Levaquin.  The following information was reported: DYSGEUSIA (non-serious) with onset 13Jan2022 at 11:00, outcome "not recovered", described as "Metallic taste in mouth immediately following vaccination". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: Positive case of COVID; Positive case of COVID; strong fever; headaches; bodychills; body aches; fatigue; coughing; congestion; 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 30 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EL3247) at the age of 29 years as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "recovering" and all described as "Positive case of COVID"; PYREXIA (non-serious) with onset Jan2022, outcome "recovering", described as "strong fever"; HEADACHE (non-serious) with onset Jan2022, outcome "recovering", described as "headaches"; CHILLS (non-serious) with onset Jan2022, outcome "recovering", described as "bodychills"; PAIN (non-serious) with onset Jan2022, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset Jan2022, outcome "recovering", described as "fatigue"; COUGH (non-serious) with onset Jan2022, outcome "recovering", described as "coughing"; NASAL CONGESTION (non-serious) with onset Jan2022, outcome "recovering", described as "congestion". The patient had strong fever, headaches, bodychills, body aches, fatigue, coughing and congestion for a week. Post vaccination, the patient was tested covid-19 positive. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (07Jan2022) negative, notes: Nasal Swab; sars-cov-2 test: (08Jul2021) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, headache, chills, pain, fatigue, cough, nasal congestion.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Positive case of COVID; Positive case of COVID; strong fever; headaches; bodychills; body aches; fatigue; coughing; congestion; 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 30 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EL3247) at the age of 29 years as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "recovering" and all described as "Positive case of COVID"; PYREXIA (non-serious) with onset Jan2022, outcome "recovering", described as "strong fever"; HEADACHE (non-serious) with onset Jan2022, outcome "recovering", described as "headaches"; CHILLS (non-serious) with onset Jan2022, outcome "recovering", described as "bodychills"; PAIN (non-serious) with onset Jan2022, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset Jan2022, outcome "recovering", described as "fatigue"; COUGH (non-serious) with onset Jan2022, outcome "recovering", described as "coughing"; NASAL CONGESTION (non-serious) with onset Jan2022, outcome "recovering", described as "congestion". The patient had strong fever, headaches, bodychills, body aches, fatigue, coughing and congestion for a week. Post vaccination, the patient was tested covid-19 positive. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (07Jan2022) negative, notes: Nasal Swab; sars-cov-2 test: (08Jul2021) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, headache, chills, pain, fatigue, cough, nasal congestion.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Positive case of COVID; Positive case of COVID; strong fever; headaches; bodychills; body aches; fatigue; coughing; congestion; 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 30 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EL3247) at the age of 29 years as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "recovering" and all described as "Positive case of COVID"; PYREXIA (non-serious) with onset Jan2022, outcome "recovering", described as "strong fever"; HEADACHE (non-serious) with onset Jan2022, outcome "recovering", described as "headaches"; CHILLS (non-serious) with onset Jan2022, outcome "recovering", described as "bodychills"; PAIN (non-serious) with onset Jan2022, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset Jan2022, outcome "recovering", described as "fatigue"; COUGH (non-serious) with onset Jan2022, outcome "recovering", described as "coughing"; NASAL CONGESTION (non-serious) with onset Jan2022, outcome "recovering", described as "congestion". The patient had strong fever, headaches, bodychills, body aches, fatigue, coughing and congestion for a week. Post vaccination, the patient was tested covid-19 positive. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (07Jan2022) negative, notes: Nasal Swab; sars-cov-2 test: (08Jul2021) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, headache, chills, pain, fatigue, cough, nasal congestion.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she didn't die but she knows 2 people that did; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: DEATH (death, medically significant), outcome "fatal", described as "she didn't die but she knows 2 people that did". The patient date of death was unknown. The reported cause of death was "she didn't die but she knows 2 people that did". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between  Death and the vaccine (BNT162B2 )cannot be excluded. The case will be reassessed once new information is available.; Reported Cause(s) of Death: she didn't die but she knows 2 people that did
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Asthenia, Diarrhoea, Dyspnoea, Ear disorder
Clinical narrative: covid; covid; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: covid; covid; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vision blurred
Clinical narrative: covid; covid; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Polymerase chain reaction, Vaccination failure
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; Dose received:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200065177 (Pfizer).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 (Lot number: FF2587) at the age of 24 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 24Apr2021 (Lot number: EW0171) as dose 2, single and intramuscular, administered in arm left, administration date 04Apr2021 (Lot number: EW0150) 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 15Dec2021, outcome "unknown", described as "Dose received:3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "covid_test_result=Positive"; OROPHARYNGEAL PAIN (non-serious) with onset 06Jan2022, outcome "recovering", described as "sore throat"; RHINORRHOEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "runny nose"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "recovering", described as "congestions"; HEADACHE (non-serious) with onset 06Jan2022, outcome "recovering", described as "minor headaches". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of oropharyngeal pain, rhinorrhoea, nasal congestion, headache.  Additional Information: Treatment received for the adverse event are Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19.  Follow-Up (17Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Dose number: 3; Sore arm; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   An adolescent male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date 12Jan2022 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious) with onset 12Jan2022, outcome "unknown", described as "Sore arm". It was unknown whether any therapeutic measures were taken as a result of pain in extremity.   Additional information: It was unknown whether the patient received other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: My tinnitus, that I have had for at least 10 years and which had not had any noticeable change in intensity or sound, became louder and included new pitches; BNT162B2 was administered before 19 days of primary dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 (Lot number: EW0167) at the age of 70 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes and "Tinnitus" (ongoing), notes: My tinnitus, that I have had for at least 10 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0164; Anatomical site: Right arm; Route of administration: unspecified), administration date: 29Apr2021, when the patient was 70 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15May2021, outcome "unknown", described as "BNT162B2 was administered before 19 days of primary dose"; TINNITUS (non-serious) with onset 01Jun2021, outcome "not recovered", described as "My tinnitus, that I have had for at least 10 years and which had not had any noticeable change in intensity or sound, became louder and included new pitches". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that the change persisted to the present day. The patient was nervous about getting the booster shot as a result. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has had covid 3 times; has had covid 3 times; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2) (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), outcome "unknown" and all described as "has had covid 3 times". Seriousness reported as: No. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID; Breakthrough COVID; Booster; This is a spontaneous report received from a contactable reporter (consumer).  An 88-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 88-years as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) at the age of 88-years as dose 1, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 88-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 Oct2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) all with onset 08Jan2022, outcome "not recovered" and all described as "Breakthrough COVID". The event "Breakthrough COVID" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and included treatment with vitamin supplement, cough medicine, and paracetamol.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Breakthrough Covid; Breakthrough Covid; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (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) with onset Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) with onset 06Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 06Jan2022, outcome "recovered" (2022) and all described as "Breakthrough Covid". The event "breakthrough covid" and "breakthrough covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. Therapeutic measures were taken as a result of covid-19 included Herbal supplements treatment. No other vaccine in four weeks. No COVID prior to vaccination. Patient tested COVID positive post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200085835 mother/fetus
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Investigation, Resuscitation
Clinical narrative: she experienced cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 17:00 (Lot number: FC3181) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: FC3182, Anatomical Location: Left arm), administration date: 04Sep2021, when the patient was 47 years old, for COVID-19 Immunization. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. The following information was reported: CARDIAC ARREST (hospitalization, medically significant) with onset 11Oct2021, outcome "recovering", described as "she experienced cardiac arrest". The patient was hospitalized for cardiac arrest (start date: 11Oct2021, discharge date: 19Oct2021, hospitalization duration: 8 day(s)). The event "she experienced cardiac arrest" was evaluated at the emergency room visit and Physician Office: Unknown. She was admitted on 11Oct2021 and was in the ICU for 4 days and they had some therapies. They put her into sedation and put her in hypothermia for 24 hours and then spent the next 24 hours bringing her out of that. They did not know if she was going to have any side effects from that or if she would even make it. But she came through and then they inserted a defibrillator because they do not know why her heart stopped. They said she has strong heart and healthy, there was no blockage or nothing. On 18Oct2021 she had the AICD implanted and then on 19Oct2021 she was discharged. They do not suspect her to be fully recovered until probably 6 months or so because it was a major event. Investigation Assessment: No. Patient was advised to inform Pfizer, as there was no reason for her going into cardiac arrest and it was roughly 2 weeks after she had that 2nd dose so the doctor's advised them to inform Pfizer. The patient underwent the following laboratory tests and procedures: investigation: (Oct2021) it was clear, notes: They tested to see if it was a widow maker heart attacked and it was clear. there was no blockage to suggest heart attack; resuscitation: (Oct2021) performed cpr for an hour. Therapeutic measures were taken as a result of cardiac arrest.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: On the 6th i notice a increase of my vertigo, it is still occurring even now its minor and manageable. Its mainly on the left side or left ear area. this does not change my feelings about the shot more as a service.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 54 year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 04Oct2021 (Lot number: FF2593)at the age of 54 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rosacea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergy to chemicals" (unspecified if ongoing), notes: Known allergies: Sulfates and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications were not reported. Past drug history included: Robitussin, reaction: "Drug allergy", notes: Known allergies: robitussin.  The following information was reported: VERTIGO (non-serious) with onset 06Oct2021, outcome "not recovered", described as "On the 6th i notice a increase of my vertigo, it is still occurring even now its minor and manageable. Its mainly on the left side or left ear area. this does not change my feelings about the shot more as a service". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient also received bnt162b2 (BNT162B2), administered in right arm , administration date 25Oct2021 (Lot number: FF8839) at the age of 55 years as dose 2, single for COVID-19 immunisation.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal oedema, Vaccination site pain
Clinical narrative: Sore muscle at injection point; Slightly swollen throat; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2022 at 10:00 (Lot number: unknown) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: DULOXETINE; NAPROXEN and TEMAZEPAM.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Jan2022 at 20:00, outcome "recovered" (an unknown date in Jan2022), described as "Sore muscle at injection point"; PHARYNGEAL OEDEMA (non-serious) with onset 13Jan2022 at 20:00, outcome "recovered" (an unknown date in Jan2022), described as "Slightly swollen throat". Therapeutic measures were not taken as a result of vaccination site pain and pharyngeal oedema.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Immunisation, Nausea
Clinical narrative: Body Aches; Diarrhea; Nausea; Chills; Injection Site soreness; General arm soreness; Fatigue; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 15Jan2022 at 15:00 (Lot number: F31614) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraines; "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish and "Allergy to nuts" (unspecified if ongoing), notes: known allergies: Tree Nuts. Concomitant medications included: ADVIL and SUMATRIPTAN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3246, Anatomical location: Left arm, Administration time: 12:00, Route of administration: Intramuscular), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Anatomical location: Left arm, Administration time: 12:00, Route of administration: Intramuscular), administration date: 03Feb2021, when the patient was 34 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022 at 15:00, outcome "unknown", described as "Dose received: 3"; PAIN (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Body Aches"; DIARRHOEA (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Nausea"; CHILLS (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Injection Site soreness"; PAIN IN EXTREMITY (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "General arm soreness"; FATIGUE (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Fatigue". Therapeutic measures were not taken as a result of pain, diarrhoea, nausea, chills, vaccination site pain, pain in extremity and fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Body Aches; Diarrhea; Nausea; Chills; Injection Site soreness; General arm soreness; Fatigue; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 15Jan2022 at 15:00 (Lot number: F31614) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraines; "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish and "Allergy to nuts" (unspecified if ongoing), notes: known allergies: Tree Nuts. Concomitant medications included: ADVIL and SUMATRIPTAN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3246, Anatomical location: Left arm, Administration time: 12:00, Route of administration: Intramuscular), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Anatomical location: Left arm, Administration time: 12:00, Route of administration: Intramuscular), administration date: 03Feb2021, when the patient was 34 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022 at 15:00, outcome "unknown", described as "Dose received: 3"; PAIN (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Body Aches"; DIARRHOEA (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Nausea"; CHILLS (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Injection Site soreness"; PAIN IN EXTREMITY (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "General arm soreness"; FATIGUE (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Fatigue". Therapeutic measures were not taken as a result of pain, diarrhoea, nausea, chills, vaccination site pain, pain in extremity and fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 3 people died.; 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 (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DEATH (death, medically significant), outcome "fatal", described as "3 people died.". The patient date of death was unknown. The reported cause of death was "3 people died.".  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-202200071657 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: 3 people died.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 3 people died.; 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 (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DEATH (death, medically significant), outcome "fatal", described as "3 people died.". The patient date of death was unknown. The reported cause of death was "3 people died.". It was not reported if an autopsy was performed.  Clinical Information: A 77-years-old caller stated that she was not interested in getting the vaccine because many of her friends died because of the side effects. Caller reported that, 14 people she knows have side effects and 3 people died. She is seeking information on if the vaccine is fully FDA approved or under EUA, when did this approval take place, how did it get approved since it has not been years.  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-202200071657 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: 3 people died.