chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: + covid hospital admission; + covid hospital admission; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An elderly male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 05Feb2021 (Lot number: EL3247) as dose 1, single and administration date 25Feb2021 (Lot number: EL3247) 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 (hospitalization, medically significant) with onset 09Nov2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 06Jan2022, outcome "not recovered" and all described as "+ covid hospital admission". The patient was hospitalized for immunisation, vaccination failure, covid-19 (start date: 06Jan2022). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Covid test type post vaccination: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she got sx 29Dec22 and tested positive 05Jan22; she got sx 29Dec22 and tested positive 05Jan22; cough; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  A 33 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 04Nov2021 (Lot number: FF2589) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 02Mar2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 23Mar2021, when the patient was 33 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "she got sx 29Dec22 and tested positive 05Jan22"; COUGH (non-serious) with onset 29Dec2021, outcome "recovering", described as "cough". The event "cough" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of cough.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event covid19, vaccination failure and immunization cannot be totally excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Ischemic Stroke 21Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Oct2021 13:00 (Lot number: FF2589) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn''s Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy_Doxycycline". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2589, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 26Sep2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant) with onset 21Nov2021 11:30, outcome "recovering", described as "Ischemic Stroke 21Nov2021". The event "ischemic stroke 21nov2021" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of ischaemic stroke.  Clinical Course: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had tested since the vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: congestion; runny nose; cough; left-side headache; PCR test: positive; PCR test: positive; laryngitis; chills; aches; significant fatigue; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 13:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) received within 2 weeks of vaccination included: ALLEGRA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "PCR test: positive"; IMMUNISATION (non-serious) with onset 12Oct2021 13:00, outcome "unknown", described as "dose number=3"; CHILLS (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "significant fatigue"; LARYNGITIS (non-serious) with onset 04Jan2022, outcome "recovering", described as "laryngitis"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 05Jan2022, outcome "recovering", described as "left-side headache"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, chills, pain, fatigue, laryngitis, cough, headache, nasal congestion, rhinorrhoea.  Clinical course: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Awareness Date : 06Jan2022. The report was considered as serious.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Laryngitis, Nasal congestion, Pain, Rhinorrhoea
Clinical narrative: congestion; runny nose; cough; left-side headache; PCR test: positive; PCR test: positive; laryngitis; chills; aches; significant fatigue; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 13:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) received within 2 weeks of vaccination included: ALLEGRA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "PCR test: positive"; IMMUNISATION (non-serious) with onset 12Oct2021 13:00, outcome "unknown", described as "dose number=3"; CHILLS (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "significant fatigue"; LARYNGITIS (non-serious) with onset 04Jan2022, outcome "recovering", described as "laryngitis"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 05Jan2022, outcome "recovering", described as "left-side headache"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, chills, pain, fatigue, laryngitis, cough, headache, nasal congestion, rhinorrhoea.  Clinical course: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Awareness Date : 06Jan2022. The report was considered as serious.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: congestion; runny nose; cough; left-side headache; PCR test: positive; PCR test: positive; laryngitis; chills; aches; significant fatigue; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 13:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) received within 2 weeks of vaccination included: ALLEGRA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "PCR test: positive"; IMMUNISATION (non-serious) with onset 12Oct2021 13:00, outcome "unknown", described as "dose number=3"; CHILLS (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "significant fatigue"; LARYNGITIS (non-serious) with onset 04Jan2022, outcome "recovering", described as "laryngitis"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 05Jan2022, outcome "recovering", described as "left-side headache"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, chills, pain, fatigue, laryngitis, cough, headache, nasal congestion, rhinorrhoea.  Clinical course: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Awareness Date : 06Jan2022. The report was considered as serious.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid/AG 1/3 positive; covid/AG 1/3 positive; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) at the age of 34 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 25Feb2021 (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 05Nov2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION FAILURE (medically significant) with onset 03Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jan2022, outcome "recovering" and all described as "covid/AG 1/3 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  cannot be ruled out
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Groin pain, Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 14:30 (Lot number: FD8448) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing), notes: Known allergies: sulfa medications; "Known allergies: Antibiotics" (unspecified if ongoing), notes: Known allergies: Antibiotics. Concomitant medication(s) included: LEVOTHYROXINE; GABAPENTIN; FOLIC ACID; METHOTREXATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL882, Location of injection: Left arm), administration date: 04Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Left arm), administration date: 14Jan2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Aug2021 14:30, outcome "unknown", described as "Dose Number: 3"; LYMPHADENOPATHY (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Swollen lymph nodes"; NECK PAIN (non-serious), BREAST PAIN (non-serious), GROIN PAIN (non-serious), ABDOMINAL PAIN (non-serious) all with onset 23Aug2021, outcome "not recovered" and all described as "stinging pain in neck, breasts, groin, abdomen". The events "swollen lymph nodes", "stinging pain in neck, breasts, groin, abdomen", "stinging pain in neck, breasts, groin, abdomen", "stinging pain in neck, breasts, groin, abdomen" and "stinging pain in neck, breasts, groin, abdomen" were evaluated at the physician office visit.  Additional information: This case assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Swollen lymph nodes; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 14:30 (Lot number: FD8448) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing), notes: Known allergies: sulfa medications; "Known allergies: Antibiotics" (unspecified if ongoing), notes: Known allergies: Antibiotics. Concomitant medication(s) included: LEVOTHYROXINE; GABAPENTIN; FOLIC ACID; METHOTREXATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL882, Location of injection: Left arm), administration date: 04Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Left arm), administration date: 14Jan2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Aug2021 14:30, outcome "unknown", described as "Dose Number: 3"; LYMPHADENOPATHY (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Swollen lymph nodes"; NECK PAIN (non-serious), BREAST PAIN (non-serious), GROIN PAIN (non-serious), ABDOMINAL PAIN (non-serious) all with onset 23Aug2021, outcome "not recovered" and all described as "stinging pain in neck, breasts, groin, abdomen". The events "swollen lymph nodes", "stinging pain in neck, breasts, groin, abdomen", "stinging pain in neck, breasts, groin, abdomen", "stinging pain in neck, breasts, groin, abdomen" and "stinging pain in neck, breasts, groin, abdomen" were evaluated at the physician office visit.  Additional information: This case assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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 Oct2021, outcome "unknown", described as "booster shot"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Clinical Course: The reporter stated that, her husband had COVID, and thankfully his was a mild case of COVID which they credit to the total of 3 Pfizer Covid Vaccine doses including the booster shot that he was adminsitered prior to being diagnosed with COVID. Tested positive for COVID about 2-2.5 weeks ago, before time of this call. He has been out of isolation for about a week now. She stayed in isolation with him just to follow guidelines even though she did not have COVID.Pfizer Covid Vaccine:First dose: Date administered: A week or two after 25Feb2021 or 26Feb2021, so around Mar2021 reporter thinks.Second dose: Date administered: A week or two after 19Mar2021, so around Apr2021 reporter thinks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Nasal congestion, Pain, SARS-CoV-2 test
Clinical narrative: PCR positive 01Jan2022; PCR positive 01Jan2022; Congestion and body aches; Congestion and body aches; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter Other Health professional from product quality group.  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FF2589; Expiration Date: Unknown) via an unknown route of administration, on 22Oct2021 (at the age of 41 years), as dose 3 (booster), single, received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL3247; Expiration Date: Unknown) via an unknown route of administration, on 25Feb2021, as dose 2, single also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL3247; Expiration Date: Unknown) via an unknown route of administration, on 05Feb2021, as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19. The patient Since the vaccination, had been tested for COVID-19. On 22Oct2021, the patient had Dose Number: 3. On 31Dec2021, the patient experienced Congestion and body aches. On 01Jan2022, the patient had PCR positive, which were considered serious due to medical significance. The events were evaluated at the physician office visit. On 01Jan2022, the patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Nasal Swab. The clinical outcome of the event PCR positive 01Jan2022 and Congestion and body aches was recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: PCR positive 01Jan2022; PCR positive 01Jan2022; Congestion and body aches; Congestion and body aches; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter Other Health professional from product quality group.  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FF2589; Expiration Date: Unknown) via an unknown route of administration, on 22Oct2021 (at the age of 41 years), as dose 3 (booster), single, received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL3247; Expiration Date: Unknown) via an unknown route of administration, on 25Feb2021, as dose 2, single also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL3247; Expiration Date: Unknown) via an unknown route of administration, on 05Feb2021, as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19. The patient Since the vaccination, had been tested for COVID-19. On 22Oct2021, the patient had Dose Number: 3. On 31Dec2021, the patient experienced Congestion and body aches. On 01Jan2022, the patient had PCR positive, which were considered serious due to medical significance. The events were evaluated at the physician office visit. On 01Jan2022, the patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Nasal Swab. The clinical outcome of the event PCR positive 01Jan2022 and Congestion and body aches was recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Vaccination site pain
Clinical narrative: Mild Injection site pain; chills; body aches; Dose number=3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jan2022 17:00 (Lot number: FE3594) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin family of antibiotics" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207), administration date: 26Apr2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318), administration date: 05Apr2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 17:00, outcome "unknown", described as "Dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 06Jan2022 07:00, outcome "not recovered", described as "Mild Injection site pain"; CHILLS (non-serious) with onset 06Jan2022 07:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 06Jan2022 07:00, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of vaccination site pain, chills, pain.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstrual disorder
Clinical narrative: having menstrual periods; booster; 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 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 11:15 (Lot number: D7248) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, around midday, in left arm, Lot: EP6955, Expiration: unknown), administration date: 16Mar2021, when the patient was 66 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number:02, around midday, in left arm, Lot: EWD162, states she cannot read it on the vaccination card, Expiration: unknown), administration date: 13Apr2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "having menstrual periods". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 11:15, outcome "unknown", described as "booster"; MENSTRUAL DISORDER (non-serious) with onset 20Dec2021, outcome "unknown", described as "having menstrual periods".  Additional information: It was reported that after receiving the booster dose on 17Dec2021, she had a period 3 days ago. Patient took the vaccine for the prevention of serious disease, age and since she was overweight, and lives in a packed community. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vomiting
Clinical narrative: vomiting with in 24 hours; dose_received: 03; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 17:00 (Lot number: FL3197) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178), administration date: 18May2021, when the patient was 21 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168), administration date: 09Jun2021, when the patient was 21 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 17:00, outcome "unknown", described as "dose_received: 03"; VOMITING (non-serious) with onset 06Jan2022 11:30, outcome "not recovered", described as "vomiting with in 24 hours". Therapeutic measures were not taken as a result of vomiting.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Joint swelling, Tendonitis
Clinical narrative: one of my joints swelled on right hand/After the booster, the same thing happened but it didn't resolve/My other joint was also swollen.; I had tendinitis  in thumb joint; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 (Lot number: FL3197) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=EN6199, prev dose administration date=06Mar2021, prev dose dose number=1), administration date: 06Mar2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=ER8734,, prev dose administration date=03Apr2021, prev dose dose number=2), administration date: 03Apr2021, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "Joints swelled on right hand". The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "booster dose"; JOINT SWELLING (medically significant) with onset 23Dec2021, outcome "not recovered", described as "one of my joints swelled on right hand/After the booster, the same thing happened but it didn't resolve/My other joint was also swollen."; TENDONITIS (non-serious) with onset 23Dec2021, outcome "not recovered", described as "I had tendinitis  in thumb joint". The events "one of my joints swelled on right hand/after the booster, the same thing happened but it didn't resolve/my other joint was also swollen." and "i had tendinitis  in thumb joint" were evaluated at the physician office visit. Therapeutic measures were taken as a result of joint swelling, tendonitis included steroid injection to thumb. The patient had no other vaccine in 4 weeks. The patient reported that after her second vaccine, one of her joints swelled on right hand. It was probably a week or a few days after the vaccine but couldn't be sure it was related. After the booster, the same thing happened but it didn't resolved and she got a steroid injection. Her doctor said she had tendinitis in thumb joint and her other joint was also swollen. The patient stated that she don't know if it's because of the vaccine but it seemed very coincidental and she never had flare ups like this before. The patient did not had covid prior vaccination and was not tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dysphagia, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; dysarthria; severe dysphagia; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional).  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Nov2021 11:30 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Myasthenia gravis", start date: 2013 (unspecified if ongoing); "known_allergies:Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021 11:30, outcome "unknown", described as "booster"; DYSARTHRIA (non-serious) with onset Nov2021, outcome "recovering", described as "dysarthria"; DYSPHAGIA (non-serious) with onset Nov2021, outcome "recovering", described as "severe dysphagia". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysarthria, dysphagia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Immunisation, Pain, Pyrexia
Clinical narrative: I am putting 3 times the vaccine; feel like burn my head/burn in my brain; headache; fever; pain in all my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/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, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I am putting 3 times the vaccine"; BURNING SENSATION (non-serious), outcome "unknown", described as "feel like burn my head/burn in my brain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "pain in all my body".  Additional Information: Patient states that he had putting 3 times the vaccine and he felt like burn my head, headache, fever, pain in all my body, but the most is like burn in his  brain, he is worried about this burn in her brain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 09:00 (Lot number: 30155BA) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 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. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18May2021, when the patient was 19 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 27Apr2021, when the patient was 19 years old, for Covid-19 Immunization.The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 09:00, outcome "unknown", described as "Dose number:3"; VACCINATION SITE PAIN (non-serious) with onset 05Jan2022 18:00, outcome "recovered" (Jan2022), described as "injection site pain"; FATIGUE (non-serious) with onset 05Jan2022 18:00, outcome "recovered" (Jan2022), described as "fatigue"; CHILLS (non-serious) with onset 05Jan2022 18:00, outcome "recovered" (Jan2022), described as "chill". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills.No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Immunisation, Menstruation delayed
Clinical narrative: Menstruation delayed by two weeks and lighter than normal; Menstruation lighter than normal; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 16:45 (Lot number: 330268d) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient did not receive any other vaccines within 4 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. Concomitant medication(s) included: CITRAZINE, multivitamin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8727, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 21Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6198, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 27Feb2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 16:45, outcome "unknown", described as "booster"; MENSTRUATION DELAYED (non-serious) with onset 03Jan2022 11:00, outcome "unknown", described as "Menstruation delayed by two weeks and lighter than normal"; OLIGOMENORRHOEA (non-serious) with onset 03Jan2022 11:00, outcome "unknown", described as "Menstruation lighter than normal". Therapeutic measures were not taken as a result of menstruation delayed, oligomenorrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 1.17
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, 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 a contactable reporter(s) (Consumer or other non HCP).  A 15 month-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 07:00 (Lot number: FK5127) at the age of 14 months as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovering" and all described as "Tested positive for COVID-19"; PYREXIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "fever of 101.2"; COUGH (non-serious) with onset 26Dec2021, outcome "recovering", described as "coughing". The patient underwent the following laboratory tests and procedures: body temperature: (26Dec2021) 101.2; sars-cov-2 test: (31Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia, cough.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: COVID test nasal swab positive; COVID test nasal swab positive; patient's cycle has changed since the vaccine/came on a few days after shot 1 and 2 which was not it's scheduled dates/since the vaccines it has made it unpredictable and sporadic; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single and administered in arm left, administration date 01Feb2021 (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 "COVID test nasal swab positive"; MENSTRUAL DISORDER (non-serious) with onset 07Jan2022, outcome "not recovered", described as "patient's cycle has changed since the vaccine/came on a few days after shot 1 and 2 which was not it's scheduled dates/since the vaccines it has made it unpredictable and sporadic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: nasal swab. Therapeutic measures were not taken as a result of menstrual disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoantibody test, Blood glucose, Investigation, Magnetic resonance imaging
Clinical narrative: TM (LETM); This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cervical cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Restless leg syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "recovering", described as "TM (LETM)". The patient underwent the following laboratory tests and procedures: antibody test: negative; autoantibody test: negative; blood glucose: normal; investigation: negative; negative; normal; negative; normal; normal; magnetic resonance imaging: extensive t2 signal abnormalities seen, notes: particularly in the anterior aspect, as well as the midcord extending from C3- 4 down to T2-3; magnetic resonance imaging head: normal; plasma cell count: normal; protein total: normal; treponema test: negative; viral test: negative. Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate