chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, COVID-19, Exposure to SARS-CoV-2, Eye disorder, Pain
Clinical narrative: spot on top of eye; Calf pain; Pain; Hair loss; flare up; COVID-19; Exposure to SARS-CoV-2; This is a solicited report from a marketing program facilitated collect based on information received from a consumer (patient) by Pfizer from AbbVie, manufacturer control number: 21K-163-3824949-00. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 in 2-2) for moderate to severe chronic plaque psoriasis psoriatic arthritis. Medical history included ongoing psoriatic arthritis. It was unknown if patient was enrolled in a covid-19 vaccine trial. No known allergies. Concomitant medications included methotrexate; levothyroxine; duloxetine hydrochloride (CYMBALTA); montelukast sodium (SINGULAIR); biotin; and folic acid all taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient experienced spots on top of eye, flare up, hair loss, aches/pains and calf pain. On 03Mar2021, the patient experienced patient got exposed with covid-19. On 09Mar2021, the patient experienced got sick after getting covid-19 vaccine and had covid-19. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient underwent lab tests and procedures which included covid-19 test: positive on 09Mar2021. The action taken in response to the event for adalimumab was dose not changed. The outcome of Covid-19 was not recovered, outcome of other events was unknown.  Causality for HUMIRA (adalimumab): The reporter's causality for the event of patient got exposed with covid-19 was not provided. The Reporter's causality for the event(s) of spot on top of eye, flare up, got sick after getting covid-19 vaccine and had covid-19, hair loss, aches/pains and calf pain with HUMIRA (adalimumab) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events spots on top of eye, flare up, hair loss, aches/pains, exposure to covid-19, covid-19 and calf pain cannot be completely excluded based on information provided. However, concomitant adalimumab & underlying psoriatic arthritis were confounders.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Psoriatic arthropathy
Clinical narrative: spot on top of eye; Calf pain; Pain; Hair loss; flare up; COVID-19; Exposure to SARS-CoV-2; This is a solicited report from a marketing program facilitated collect based on information received from a consumer (patient) by Pfizer from AbbVie, manufacturer control number: 21K-163-3824949-00. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 in 2-2) for moderate to severe chronic plaque psoriasis psoriatic arthritis. Medical history included ongoing psoriatic arthritis. It was unknown if patient was enrolled in a covid-19 vaccine trial. No known allergies. Concomitant medications included methotrexate; levothyroxine; duloxetine hydrochloride (CYMBALTA); montelukast sodium (SINGULAIR); biotin; and folic acid all taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient experienced spots on top of eye, flare up, hair loss, aches/pains and calf pain. On 03Mar2021, the patient experienced patient got exposed with covid-19. On 09Mar2021, the patient experienced got sick after getting covid-19 vaccine and had covid-19. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient underwent lab tests and procedures which included covid-19 test: positive on 09Mar2021. The action taken in response to the event for adalimumab was dose not changed. The outcome of Covid-19 was not recovered, outcome of other events was unknown.  Causality for HUMIRA (adalimumab): The reporter's causality for the event of patient got exposed with covid-19 was not provided. The Reporter's causality for the event(s) of spot on top of eye, flare up, got sick after getting covid-19 vaccine and had covid-19, hair loss, aches/pains and calf pain with HUMIRA (adalimumab) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events spots on top of eye, flare up, hair loss, aches/pains, exposure to covid-19, covid-19 and calf pain cannot be completely excluded based on information provided. However, concomitant adalimumab & underlying psoriatic arthritis were confounders.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; right shoulder sore; This is a solicited report from a marketing program (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 20K-163-3693021-00). A non-contactable consumer (patient) reported that a 65 year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 18Feb2021 (Batch/Lot number was not reported) as single dose, intramuscular on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, age at vaccination was 66 years old; Methotrexate Sodium, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate Free for Moderate to severe rheumatoid arthritis.  Medical history and concomitant medications were not reported. On an unknown date, the patient experienced COVID-19. In 2020, the patient experienced right shoulder sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of Covid-19 and right Shoulder sore, with Humira (Adalimumab) was no reasonable possibility, with bnt162b2 was Possible (as reported). The action taken in response to the events for methotrexate was unknown, for adalimumab was permanently withdrawn on unknown date. The outcome of the events was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product Methotrexate Sodium was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on an implausible temporal association (right shoulder sore occurred in 2020 while administration of BNT162B2 vaccine was on 18Feb2021 (first dose and in Mar2021 second dose) arthralgia is considered unrelated to BNT162B2. Assuming  a plausible temporal association, the mentioned COVID-19 infection may be related to BNT162B2 as manifestation of lack of effect. Conversely, there are no elements supporting a causative role of methotrexate sodium for COVID-19 and arthralgia, being this latter a probable symptom of known rheumatoid arthritis.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: It was much heavier than usual; missed her Period in August; This is a spontaneous report from a contactable nurse via a sales representative. A 13-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient missed her period in August. She then received her period late in September and reported it was much heavier than usual and she had clotting which did not normally occur. Prior to this, the patient was receiving her periods monthly, and on time. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage, Laboratory test, Ocular hyperaemia
Clinical narrative: right eye has like a broken vessel in it; Like a just one part closes to the nose is like bloody red; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the right deltoid on 01Oct2021 (Batch/Lot Number: FF8841) (at the age of 73-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included blood pressure abnormal and he had two stents in his heart. Concomitant medications included blood pressure medicine, and he takes blood thinner because he had two stents in his heart. The patient previously received the first dose of BNT162B2 on 21Jan2021 (Lot #: EL9261) and the second dose on 13Feb2021 (Lot #: EN6201); both received by the patient at the age of 72 years old for COVID-19 immunization. It was reported that on 01Oct2021, the reporter and the patient received the third COVID vaccination shot in the morning at the (pharmacy withheld) and in the evening, his right eye has like a broken vessel in it, like a just one part closes to the nose was like bloody red (as reported). The reporter further stated, "It's white part of his right eye from the color part over towards to the nose, now if you look that the white part of his eye towards his ear. It does not have the blood, it's more saline in the coroner and right under the lower lid, he could just regular saline eye drops (Treatment) in it you know they do like refresh or something like that he 'spell' that how many time, one time and it does seem to help some so." It was reported that the patient put eye drop in his eye called Blink tears lubricating eyedrops. The patient went to his primary care physician approximately two months ago (Aug2021) and had lab work (unknown results). The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Heart Attack; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: EP7533) (at age 51-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications and no other vaccine within 4 weeks. The patient experienced heart attack on 07May2021. The event resulted in emergency room/department or urgent care, and hospitalization for 5 days. Treatment included IV blood thinners and blood thinner medications. Outcome of the event was unknown. Patient was not diagnosed with COVID prior to vaccination and had been tested post vaccination: nasal swab: negative on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Inappropriate schedule of product administration
Clinical narrative: Appendicitis; administration date 25May2021, dose 1/administration date 06Sep2021, dose 2; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 06Sep2021 14:00 (Lot number was not reported) (at the age of 17-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. Concomitant medications within two weeks of vaccination included desvenlafaxine succinate monohydrate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 25May2021 9:00 (at the age of 16-years-old) as dose 1, single for covid-19 immunisation. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced appendicitis on 17Sep2021 17:00. The patient was hospitalized for appendicitis on an unspecified date in 2021 for 2 days. The appendicitis resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient underwent appendectomy as treatment for appendicitis. The outcome of the event appendicitis was recovering.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The muscle in both of my arms where the shot was given hurts; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 09Aug2021 14:00 (Batch/Lot Number: EW0170) as DOSE 1, SINGLE (at the age of 64-years-old) and dose 2 via an unspecified route of administration, administered in arm right on 30Aug2021 14:00 (Batch/Lot Number: Ew0175) as DOSE 2, SINGLE (at the age of 64-years-old) for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant. The patient had no other vaccine in four weeks prior to COVI-19 vaccine. The patient had no known allergies. She did not have covid prior vaccination and had not been tested for covid since vaccination. It was reported that the muscle in both of the patient's arms where the shots were given hurts. She mentioned that she can hardly use her left arm. It started the day she got her first shot, it had gotten worse with time. She mentioned that her right arm was not as bad but it still hurts. The event's onset was on 09Aug2021 20:00 with outcome of not recovered, The event was reported to have resulted to disability or permanent damage. The patient did not receive treatment for the event.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Feeling abnormal, Memory impairment, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had COVID like months ago/ But she said that this was worst; had COVID like months ago/ But she said that this was worst; Shaking; Throwing up; Cannot remember conversation; she feels like horrible; This is a spontaneous report from a contactable consumer (patient's son).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, he was calling for her mom. She got the Covid-19 Vaccine and she got it at approximately 13:30. By 5 O' Clock she was shaking, throwing up and she cannot remember conversation she had around at that time. Now she doesn't remember what they spoke, and she feels like horrible. She already had COVID like months ago. But she said that this was worst. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on an unspecified date 2021. The clinical outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: had COVID like months ago/ But she said that this was worst; had COVID like months ago/ But she said that this was worst; Shaking; Throwing up; Cannot remember conversation; she feels like horrible; This is a spontaneous report from a contactable consumer (patient's son).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, he was calling for her mom. She got the Covid-19 Vaccine and she got it at approximately 13:30. By 5 O' Clock she was shaking, throwing up and she cannot remember conversation she had around at that time. Now she doesn't remember what they spoke, and she feels like horrible. She already had COVID like months ago. But she said that this was worst. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on an unspecified date 2021. The clinical outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: fever for 4 days with breakthrough COVID on Sep2021; fever for 4 days with breakthrough COVID on Sep2021; fever for 4 days with breakthrough COVID on Sep2021; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered on 28Jan2021 as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination 43 years) and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered on 06Jan2021 as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination 43 years). The patient medical history and concomitant medications was not reported. The patient did not have other vaccine in four weeks. The patient experienced fever for 4 days with breakthrough COVID on Sep2021 and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test reported result as positive on an unknown date. The outcome of the event was reported as recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: somebody else got Shingles after their second dose; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received second doe of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she knew somebody else got shingles after their second dose on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Immunisation, Off label use
Clinical narrative: received the booster dose Pfizer Covid Vaccine; received the booster dose Pfizer Covid Vaccine; the partner's blood pressure was 180/100 for 12 hours; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer reported for a 68-year-old female patient (reporters partner). A 68-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 05Mar2021 (Route of administration: Left arm, lot number: EN6206) and received second dose of BNT162B2 on 26Mar2021 (Route of administration: Left arm, lot number: ER8732) for covid-19 immunisation. On an unknown date the patient experienced received the booster dose pfizer covid vaccine. On an unknown date in 2021 the patient experienced the partners blood pressure was 180/100 for 12 hours. It was reported that the caller received the booster dose Pfizer Covid Vaccine on Monday, 27Sep2021 and is still feeling effects. When the caller received the second dose Pfizer Covid Vaccine the caller was light headed and tired for about one or two days. After the caller received the booster dose Pfizer Covid Vaccine, he has been light headed, tired, temperature reached over 100, heart rate was 120 to 130. Everything came down but the caller still feels bad now 5 days after receiving the booster dose Pfizer Covid Vaccine. The caller enquired why he was still feeling effects 5 days after receiving the booster dose Pfizer Covid Vaccine. Are the effects the caller is feeling from the booster dose Pfizer Covid Vaccine. When the callers partner received the booster dose Pfizer Covid Vaccine, the partners blood pressure went up to 200. Caller confirmed details provided by the transfer agent. The callers partner gets on the phone and clarifies the partners blood pressure was 180/100 for 12 hours. The patient states she reported her reaction after receiving second dose Pfizer Covid Vaccine online with Pfizer. The patient clarifies the blood pressure of 180/100 for 12 hours was reported on the patients initial report filed online with Pfizer. The patient underwent lab tests and procedures which included blood pressure measurement: 180/100 on an unknown date. The outcome of the event the patient experienced the partners blood pressure was 180/100 for 12 hours was resolved on 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Extra dose administered, Headache, Mental impairment
Clinical narrative: foggy mind; Fever; chills / shivering; headache; body aches; weakness; Third dose was administered; Third dose was administered; This is a spontaneous report from a non-contactable nurse (patient). A 25-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 30Sep2021 14:30 (Batch/Lot Number: FF8839) (at the age of 25 years old) as single dose for covid-19 immunisation. Medical history included asthma, and with known allergy to Penicillin. The patient was not pregnant at the time vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 29Dec2020 via unspecified route of administration, administered in left arm (lot number: EL1284) (at the age of 24 years old) as single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 21Jan2021 via unspecified route of administration, administered in left arm (lot number: EL1283) (at the age of 24 years old) as single dose; for covid-19 immunisation and experienced no adverse event. The patient's concomitant medications were not reported. After the third dose, on 01Oct2021 at 07:30am, the patient experienced foggy mind, fever, chills, shivering, headache, body aches, and weakness. The patient did not receive any treatment for the events. Patient did not have Covid prior to vaccination. Patient was not tested for Covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pyrexia
Clinical narrative: foggy mind; Fever; chills / shivering; headache; body aches; weakness; Third dose was administered; Third dose was administered; This is a spontaneous report from a non-contactable nurse (patient). A 25-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 30Sep2021 14:30 (Batch/Lot Number: FF8839) (at the age of 25 years old) as single dose for covid-19 immunisation. Medical history included asthma, and with known allergy to Penicillin. The patient was not pregnant at the time vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 29Dec2020 via unspecified route of administration, administered in left arm (lot number: EL1284) (at the age of 24 years old) as single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 21Jan2021 via unspecified route of administration, administered in left arm (lot number: EL1283) (at the age of 24 years old) as single dose; for covid-19 immunisation and experienced no adverse event. The patient's concomitant medications were not reported. After the third dose, on 01Oct2021 at 07:30am, the patient experienced foggy mind, fever, chills, shivering, headache, body aches, and weakness. The patient did not receive any treatment for the events. Patient did not have Covid prior to vaccination. Patient was not tested for Covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I vaccinated twice in early April however I was tested positive with the Covid-19 virus last Sunday; I vaccinated twice in early April however I was tested positive with the Covid-19 virus last Sunday; This is a spontaneous report from Pfizer sponsored program a contactable consumer or other non health care professional (Patient). A patient of unspecified age and gender received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on Apr2021 as dose 1, single and BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he/she got vaccinated twice in early April however patient was tested positive with the COVID-19 virus last Sunday on 26Sep2021. Patient further mentions, they were told not wear mask in public if vaccinated but this is false. Thank you and stay safe all. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021. Outcome of events was unknown.  The lot number for, the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Mental disorder, Product use issue, Suicidal behaviour
Clinical narrative: She took the influenza vaccine on the same day she took her COVID vaccine; Suicidal; Severe mental health issues worsened; Severe mental health issues worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FD8448), via an unspecified route of administration, administered in the left arm on 18Aug2021 around 12:00 or 13:00 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization; and influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, administered in the right arm on 18Aug2021 (lot number was not reported) at unspecified dose for an unspecified indication. The patient mentioned that she usually gets the influenza vaccine every year, but she gets sick after it and she usually doesn't take it because of this. Medical history included stroke, brain bleed, traumatic brain injury (TBI), severe migraines, and mental health issues (runs in her family). Concomitant medications included several daily medications (unspecified). The patient reported that she took the influenza vaccine on the same day (18Aug2021) she took her COVID vaccine. On an unspecified date (after the vaccination), the patient was suicidal and her severe mental health issues worsened. The patient wanted to report some severe mental health changes. The patient was suicidal and may need treatment for that but has not had any treatment since the event. She was thinking there was something severely wrong with her but now she was reading things and it said that this could've happen after the vaccine. This happened a week or 2 after the shot, but she didn't think it had anything to do with the shot. The patient mentioned that she's not going to get the second dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anger, Anxiety, Condition aggravated, Mental disorder, Obsessive-compulsive disorder
Clinical narrative: She took the influenza vaccine on the same day she took her COVID vaccine; Suicidal; Severe mental health issues worsened; Severe mental health issues worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FD8448), via an unspecified route of administration, administered in the left arm on 18Aug2021 around 12:00 or 13:00 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization; and influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, administered in the right arm on 18Aug2021 (lot number was not reported) at unspecified dose for an unspecified indication. The patient mentioned that she usually gets the influenza vaccine every year, but she gets sick after it and she usually doesn't take it because of this. Medical history included stroke, brain bleed, traumatic brain injury (TBI), severe migraines, and mental health issues (runs in her family). Concomitant medications included several daily medications (unspecified). The patient reported that she took the influenza vaccine on the same day (18Aug2021) she took her COVID vaccine. On an unspecified date (after the vaccination), the patient was suicidal and her severe mental health issues worsened. The patient wanted to report some severe mental health changes. The patient was suicidal and may need treatment for that but has not had any treatment since the event. She was thinking there was something severely wrong with her but now she was reading things and it said that this could've happen after the vaccine. This happened a week or 2 after the shot, but she didn't think it had anything to do with the shot. The patient mentioned that she's not going to get the second dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Suicidal ideation, Violence-related symptom
Clinical narrative: She took the influenza vaccine on the same day she took her COVID vaccine; Suicidal; Severe mental health issues worsened; Severe mental health issues worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FD8448), via an unspecified route of administration, administered in the left arm on 18Aug2021 around 12:00 or 13:00 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization; and influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, administered in the right arm on 18Aug2021 (lot number was not reported) at unspecified dose for an unspecified indication. The patient mentioned that she usually gets the influenza vaccine every year, but she gets sick after it and she usually doesn't take it because of this. Medical history included stroke, brain bleed, traumatic brain injury (TBI), severe migraines, and mental health issues (runs in her family). Concomitant medications included several daily medications (unspecified). The patient reported that she took the influenza vaccine on the same day (18Aug2021) she took her COVID vaccine. On an unspecified date (after the vaccination), the patient was suicidal and her severe mental health issues worsened. The patient wanted to report some severe mental health changes. The patient was suicidal and may need treatment for that but has not had any treatment since the event. She was thinking there was something severely wrong with her but now she was reading things and it said that this could've happen after the vaccine. This happened a week or 2 after the shot, but she didn't think it had anything to do with the shot. The patient mentioned that she's not going to get the second dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Syncope
Clinical narrative: syncope 24 hours following 3 dose (booster) COMIRNATY; syncope 24 hours following 3 dose (booster) COMIRNATY; syncope 24 hours following 3 dose (booster) COMIRNATY; This is a spontaneous report from a contactable consumer. This consumer reported that a patient of unspecified age and gender received third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. It was reported that syncope 24 hours following 3 dose (booster) COMIRNATY. Event took place after use of product. Outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Malaise
Clinical narrative: Not as sharp; feeling tired; wobbly; This is a spontaneous report based on the information received by Pfizer from Genentech. A contactable consumer (patient) reported that a 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included endometriosis (not ongoing), blocked fallopian tubes (not ongoing), hot flashes (not ongoing), sinus polyps (not ongoing), ongoing assistive device use, ongoing hypothyroidism, ongoing sinus infections, ongoing asthma, ongoing sleep apnea. Concomitant medications were not reported. On unknown date, the patient experienced feeling tired, wobbly, and not as sharp. Outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: diagnosed with COVID on 01Oct; diagnosed with COVID on 01Oct; This is a spontaneous report from a contactable consumer (patient, reported for self). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications included Methotrexate 17.5 mg QW (weekly) and abatacept (ORENCIA) Clickject QW (weekly), both for rheumatoid arthritis. On 01Oct2021, the patient got diagnosed with COVID. The patient underwent lab test and procedure included COVID (SARS-CoV-2 test): diagnosed with covid on 01Oct2021. Event took place after use of product. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and would be requested during follow-up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Flushing, Heart rate
Clinical narrative: Vasovagal Syncope; slight tunnel vision; closed eyes, reports passed out; flush; lightheaded; vomit; Is pregnant: Yes/ Pt is pregnant due on 01Nov2021; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF8841), intramuscular, administered in left arm on 28Sep2021 16:36 (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. Medical history included Mild Anemia Due to Pregnancy and near syncopal episode. No COVID prior to vaccination and no known allergies. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); fish oil (DHA FISH OIL); iron and prenatal vitamins. No other vaccines were administered in four weeks. The patient received the vaccine at 1636, 15 minutes later, she became flush, lightheaded, slight tunnel vision, closed eyes and reported passed out. Vaccination staff observed that the patient dropped her laptop and had her head down with vomit on the floor, tapped her and she was responsive but did not realize she had vomited or dropped her laptop. V/S was T 97.0, P 92, R 20, BP 121/78 and O2 sat was 97% RA at 1650. Fire department/paramedics responded and took her to hospital's ER, treated with IV fluids while in ambulance. Multiple labs done. Diagnosis was Vasovagal Syncope. The patient reported hx of near syncopal episode after recent blood drawn for current pregnancy. The patient is pregnant and id due on 01Nov2021. The events resulted in Emergency room/department or urgent care. The patient was treated with IV fluids in response to the events. The patient was tested for COVID post vaccination. The patient underwent Binex via Nasal swab on 28Sep2021 and was negative. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of consciousness, Maternal exposure during pregnancy, Oxygen saturation, Respiratory rate
Clinical narrative: Vasovagal Syncope; slight tunnel vision; closed eyes, reports passed out; flush; lightheaded; vomit; Is pregnant: Yes/ Pt is pregnant due on 01Nov2021; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF8841), intramuscular, administered in left arm on 28Sep2021 16:36 (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. Medical history included Mild Anemia Due to Pregnancy and near syncopal episode. No COVID prior to vaccination and no known allergies. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); fish oil (DHA FISH OIL); iron and prenatal vitamins. No other vaccines were administered in four weeks. The patient received the vaccine at 1636, 15 minutes later, she became flush, lightheaded, slight tunnel vision, closed eyes and reported passed out. Vaccination staff observed that the patient dropped her laptop and had her head down with vomit on the floor, tapped her and she was responsive but did not realize she had vomited or dropped her laptop. V/S was T 97.0, P 92, R 20, BP 121/78 and O2 sat was 97% RA at 1650. Fire department/paramedics responded and took her to hospital's ER, treated with IV fluids while in ambulance. Multiple labs done. Diagnosis was Vasovagal Syncope. The patient reported hx of near syncopal episode after recent blood drawn for current pregnancy. The patient is pregnant and id due on 01Nov2021. The events resulted in Emergency room/department or urgent care. The patient was treated with IV fluids in response to the events. The patient was tested for COVID post vaccination. The patient underwent Binex via Nasal swab on 28Sep2021 and was negative. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope, Tunnel vision, Vomiting
Clinical narrative: Vasovagal Syncope; slight tunnel vision; closed eyes, reports passed out; flush; lightheaded; vomit; Is pregnant: Yes/ Pt is pregnant due on 01Nov2021; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF8841), intramuscular, administered in left arm on 28Sep2021 16:36 (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. Medical history included Mild Anemia Due to Pregnancy and near syncopal episode. No COVID prior to vaccination and no known allergies. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); fish oil (DHA FISH OIL); iron and prenatal vitamins. No other vaccines were administered in four weeks. The patient received the vaccine at 1636, 15 minutes later, she became flush, lightheaded, slight tunnel vision, closed eyes and reported passed out. Vaccination staff observed that the patient dropped her laptop and had her head down with vomit on the floor, tapped her and she was responsive but did not realize she had vomited or dropped her laptop. V/S was T 97.0, P 92, R 20, BP 121/78 and O2 sat was 97% RA at 1650. Fire department/paramedics responded and took her to hospital's ER, treated with IV fluids while in ambulance. Multiple labs done. Diagnosis was Vasovagal Syncope. The patient reported hx of near syncopal episode after recent blood drawn for current pregnancy. The patient is pregnant and id due on 01Nov2021. The events resulted in Emergency room/department or urgent care. The patient was treated with IV fluids in response to the events. The patient was tested for COVID post vaccination. The patient underwent Binex via Nasal swab on 28Sep2021 and was negative. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hallucination, Headache, Pain
Clinical narrative: hallucinations; chills; Body aches; headache; dizziness; fever; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. Concomitant medications were not reported. On 29Sep2021, the patient experienced hallucinations, chills, body aches, headache, dizziness and fever. The patient did not received treatment for the events. The events resulted in physician office visit. The patient underwent lab tests and procedures which included nasal swab: negative on 01Oct2021. Outcome of events was recovering.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of hallucinations 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: hallucinations; chills; Body aches; headache; dizziness; fever; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. Concomitant medications were not reported. On 29Sep2021, the patient experienced hallucinations, chills, body aches, headache, dizziness and fever. The patient did not received treatment for the events. The events resulted in physician office visit. The patient underwent lab tests and procedures which included nasal swab: negative on 01Oct2021. Outcome of events was recovering.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of hallucinations 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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Headache, Loss of consciousness, Visual impairment
Clinical narrative: Blacking out; seeing spots; pounding headaches; memory loss; This is a spontaneous report from a contactable consumer (patient).  A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 17Sep2021 at 09:00 (Batch/Lot number was not reported) (at the age of 21-year-old) as single dose for COVID-19 immunisation.  Medical history was none. The patient did not experienced COVID-19 before vaccination. No known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 17Sep2021 at 09:15, the patient experienced blacking out, seeing spots, pounding headaches, memory loss. The events resulted in emergency room/department or urgent care. The patient outcome of the events was recovered without treatment (the event memory loss lasted for 2 weeks).  The patient underwent lab tests and procedures which included COVID-19 virus test (Nasal Swab): negative on 21Sep2021.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.