chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash erythematous
Clinical narrative: Fever; Body aches; Red Rash; This is a spontaneous report from a contactable female consumer.   This consumer (patient) reported for herself by Pfizer Non HCP letter that: A 65-years-old female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot Number: EW0161), dose 2 intramuscular, administered in upper arm Left on 15Apr2021 11:15 (at a age of 65-year-old) as dose 2, single for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2; solution for injection; Batch/Lot Number: ER8733), dose 1 intramuscular, administered in upper right arm on 25Mar2021 11:15 (at a age of 65-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history and prior vaccinations was reported as none. On 16Apr2021 10:30, the patient experienced fever, body aches, red rash. Patient was not received treatment for the events. On an unspecified date in 2021, the events were recovered.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site haemorrhage
Clinical narrative: had the second vaccine, the injection site bled; Sneezing a lot, after the first and second vaccine; This is a spontaneous report from a contactable consumer (mother). A 17-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0171) dose 2 via an unspecified route of administration in right arm on 12May2021 at 4 pm (At the age of 17 years old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ongoing ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE, Tablet) oral 1 mg/10 mcg monthly for birth control (started two months ago). Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) dose 1 via an unspecified route of administration in right arm on 21Apr2021 (evening) (At the age of 17 years old) as single dose for COVID-19 immunization. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Her daughter had the second vaccine, the injection site bled around 4 pm on 12May2021. When the provider stuck the needle in her daughter's arm it bled for a few seconds and they wiped the blood off with a cotton ball. Her daughter did not see any blood on the Band-Aid. She was sneezing a lot, after the first injection and then it got more intense/worsened after the second injection in 2021. Her daughter's school is making all the seniors get the shot to go back to school. Because she is her daughter's mother and told her daughter to get the vaccine. A visit to emergency room or physician office was not required. The outcome of event injection site bled was recovered on 12May2021; Sneezing was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: sick; really high fevers; This is a spontaneous report from a contactable consumer (patient). This consumer reported for 3 reports. This is 3rd of 3 reports. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, lot number: 046A21A) via unknown route of administration on 24Mar2021 as dose 1 single for COVID-19 immunisation. Medical history included COVID virus from Nov2020 (from her brother). Concomitant medication was not reported. It was reported that she was she was sick on 24Mar2021, only for the common 48-72 hours, she had really high fevers with both vaccine doses. With the first dose her fever started on 24Mar2021 and it has recovered completely at this point. She also got the COVID virus from her brother in November 2020. She says the fever with her first dose went away on the third day, so it went away 27Mar2021. The outcome of event fever was recovered on 27Mar2021, for other was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021560177 similar report from same reporter
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Psoriasis went away/disappeared; Psoriasis went away/disappeared; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot Number: EW0173; Expiration Date: Aug2021) via intramuscular route of administration, administered in Arm Right (around the shoulder area) on 05May2021 at 10:13 (at the age of 63-year-old), as dose 1, single for covid-19 immunisation. Medical history included aorta valve replacement from an unknown date and unknown if ongoing . The patient's concomitant medications were not reported. He has not been received any vaccination prior. The patient previously took Baby aspirin 81mg, Metoprolol 25mg, Glipizide 5mg, Levothyroxine 88mcg, Atorvastatin 40mg, Losartan 100mg, Hydrochlorothiazide 25mg for 20 years. On 10May2021, The patient experienced psoriasis went away/disappeared. he had psoriasis for the last 26 years. 5 days after receiving the shot, his psoriasis went away. He confirms his psoriasis disappeared. he had psoriasis on his knees, elbows and upper arms. 5 days later after receiving the vaccine, clarified as 10 May 2021, he was watching his body for symptoms like a rash, and he noticed something was strange but he couldn't figure out what it was  He then realized all of his psoriasis was completely gone. He mentions he has spoken to the pharmacists and was told its a life time sentence with psoriasis so when his psoriasis went away after the vaccine, he was blown away. He hasn't done anything out of the unusual either. He walks every day but that's it. Relevant test has not been performed. His next dose is scheduled for Wednesday, 26May2021. The outcome of the events were unknown.   Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got positive for Corona virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported about herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 06Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Apr2021 the patient experienced got positive for corona virus. Consumer reported that "I called because I asked the question, I have my 1st vaccine Pfizer April 6, I got positive for Corona virus on 15Apr, 'just to a second vaccine 27Apr' (not clarified further, if had the second vaccine or it was the due date) and I want to know how long I have to wait for that, for my vaccine after you had the virus". The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Apr2021. The outcome of event was unknown.   Further probing could not be done as consumer hung up the call abruptly. Hence, limited information available over the call.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Headache, Lumbar puncture, Nausea
Clinical narrative: Nausea; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; Severe Headache; Light sensitivity; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 10Jun2021 (at the age of 16-year-old) as single dose for Covid-19 immunization at a Hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reporter stated that patient was very limp, she was throwing up and very dizzy and with a very severe headache and light sensitivity. Patient never had any of those type symptoms before and happened four days after she got the COVID shot. Reporter stated that, the evening of the 13Jun2021. It was headache and the headache got very severe through the next day. Reporter stated that, she had no idea and do not think it was anaphylactic reactions. She thought it was a severe headache which been reported and the MRI they were looking for blood clot as patient was experiencing severe headache that need her throw up, she did not know 100 times, and that end up in the hospital. There was light sensitivity when the CT scan and lumbar puncture was done to see if there was meningitis. CT-scan and spinal patch were done and patient was given nausea and dizzy medications and reporter and patient were waiting for the MRI. The events were serious (hospitalization) on 16Jun2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown and lumbar puncture: unknown on an unspecified date in Jun2021. Therapeutic measures were taken as a result of events dizzy and nausea. Outcome of the events was unknown.  Information about lot batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vomiting
Clinical narrative: Nausea; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; Severe Headache; Light sensitivity; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 10Jun2021 (at the age of 16-year-old) as single dose for Covid-19 immunization at a Hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reporter stated that patient was very limp, she was throwing up and very dizzy and with a very severe headache and light sensitivity. Patient never had any of those type symptoms before and happened four days after she got the COVID shot. Reporter stated that, the evening of the 13Jun2021. It was headache and the headache got very severe through the next day. Reporter stated that, she had no idea and do not think it was anaphylactic reactions. She thought it was a severe headache which been reported and the MRI they were looking for blood clot as patient was experiencing severe headache that need her throw up, she did not know 100 times, and that end up in the hospital. There was light sensitivity when the CT scan and lumbar puncture was done to see if there was meningitis. CT-scan and spinal patch were done and patient was given nausea and dizzy medications and reporter and patient were waiting for the MRI. The events were serious (hospitalization) on 16Jun2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown and lumbar puncture: unknown on an unspecified date in Jun2021. Therapeutic measures were taken as a result of events dizzy and nausea. Outcome of the events was unknown.  Information about lot batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Leukopenia, White blood cell count
Clinical narrative: he got the first dose on 04 Jun 2021, he was told that today he's scheduled for the second dose, but the doctor told him on Monday that he had low white blood cells; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 04Jun2021 as dose 1, single for covid-19 immunisation in front of a hospital emergency department. Medical history included he had cancer. The patient concomitant medications were not reported. The patient stated that he got the first dose on 04Jun2021, he was told that today he was scheduled for the second dose, but the doctor told him on monday that he had low white blood cells on an unspecified date in Jun2021. The patient lab test included white blood cell count was low on an unspecified date in Jun2021. The outcome of the event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body hurting; Headache; Chills; Fever of 99.0 Fahrenheit; This is a spontaneous report from a contactable consumer. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported) via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date in 2021, patient had body hurting, headache, chills and fever of 99.0 Fahrenheit. The outcome of all events was unknown.  Information on lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Just soreness, tiredness and little bit of headache; Just soreness, tiredness and little bit of headache; Just soreness, tiredness and little bit of headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0178) via an unspecified route of administration on 15Jun2021 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Jun2021 the patient experienced just soreness, tiredness and little bit of headache. Patient asked was there any information on magnetic effects at the injection site after receiving vaccination with the Pfizer-BioNTech COVID-19 vaccine. It had actually happened, patient stated that she can place a magnet to her arm and it sticks to the injection site. Patient has pictures and witnesses. Patient was not a young kid. Patient did not receive treatment for the adverse events. Outcome of the events just soreness, tiredness and little bit of headache was unknown.  Additional information has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Computerised tomogram, Hidradenitis, Magnetic resonance imaging
Clinical narrative: Hidradenitis suppurativa; This is a solicited report based on information received by Pfizer from Manufacturer (Manufacturer Control Number: 21K-163-3939738-00) from a contactable 69-year-old female Consumer reported for herself.   A 69-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot number was not reported) and ongoing, at 40mg/0.4ml, cyclic (Citrate free,40mg 1 in 2 weeks) for Moderate to severe adult Crohn's disease. Medical history included alcohol use/beer, wine, occasionally from 1969 to 2019, tobacco use/six cigarettes per day from 1971 to 1971, hip replacement, high blood pressure, high cholesterol, thyroid disorder (unspecified thyroid medication that was part of her concomitant medications). Concomitant medications included lisinopril taken for high blood pressure; atorvastatin calcium (LIPITOR) taken for high cholesterol and unspecified thyroid medication that was part of her concomitant medications. The patient experienced hidradenitis suppurativa on 07Apr2021. On 27May2021, she had outpatient surgery for cysts on buttocks that were actually Hidradenitis suppurativa. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included colonoscopy: unknown results on 07Apr2021, computerised tomogram: unknown results on unknown date, magnetic resonance imaging: unknown results on unknown date. The action taken in response to the event for adalimumab was dose not changed. The outcome of event was recovering.  Causality about adalimumab for event Hidradenitis suppurativa as per reporter (Drug/Vaccine): Not assessable; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Causality about BNT162B2 for hidradenitis suppurativa as per reporter (Drug/Vaccine): Not Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: In agreement with the reporter, the Company deems the reported Hidradenitis suppurativa unrelated to COVID 19 vaccine, BNT162B2.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 20May2021 at 08:30 (Batch/Lot number was not reported), at the age of 17-years-old, as dose 2, single for Covid-19 immunisation. The patient has no medical history, no concomitant medications and no past drug history. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 on an unspecified date for Covid-19 immunisation with no reaction. On 20May2021 at 15:00, the patient experienced heart pain for 17 hrs. She got the injection at 08:30. Heart started hurting around 3pm and hurt for 17 hrs until next evening. Outcome of the event was recovered on 21May2021.  Since the vaccination, the patient has not been tested for COVID-19.  Information on lot number/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Bipolar disorder
Clinical narrative: bipolar disorder; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient historical vaccine includes 1ST dose of vaccination for covid-19 immunisation and had no reaction to previous exposure to vaccine. It was reported that, there are some trials for Pfizer and did psychotherapy and they gave me some pills they had me on 2 pills, and don't know nothing about them. They are supposed to be for night-time, have been doing bad, would like to try something new, got diagnosed with bipolar disorder, am barely taking my medication and want to see if you have any other trials. already got my covid shots I know you have other trials. The patient experienced bipolar disorder on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death, Headache, Loss of consciousness
Clinical narrative: death; lost consciousness; headache; This is a spontaneous report from a non-contactable consumer via a regulatory authority. A 33-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced lost consciousness, headache, and death. The event, lost consciousness, was life-threatening. The event, death, was serious for death. The clinical course was as follows: the patient was a pilot who had been vaccinated with bnt162b2. A strong headache occurred immediately after starting the flight. Two hours later, the patient almost lost consciousness and made an emergency landing. (withheld) inoculated and killed three pilots. It's been a fuss, but it doesn't stop anymore. The patient did not know when it will fall when the patient flies (as reported). The clinical outcome of the events, lost consciousness and headache, was unknown. The clinical outcome of the event, death, was fatal. The patient died on an unspecified date due to an unknown cause of death. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypotension, Lethargy, Pain
Clinical narrative: faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. 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. The patient did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain
Clinical narrative: faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. 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. The patient did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Urticaria
Clinical narrative: Pityriasis rosea/broke out everywhere/welts all over his body; Pityriasis rosea/broke out everywhere/welts all over his body; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, and expiry date was unknown), via an unspecified route of administration on 20Apr2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history included drug hypersensitivity. The patient's concomitant medications were not reported. The patient was allergic to penicillin and vancomycin and he had a lot of allergies. He stated that he had the Pfizer vaccine on 20Apr2021 and a few days later he developed a severe case of Pityriasis rosea, a skin virus (The patient stated that he broke out right after the shot, so it must be from that). The patient stated that it was not serious, but he went to the dermatologist because he broke out everywhere. He stated that it took two to three months to go away, and his doctor says that it was a coincidence, but he doubts that. The patient wants to know if he should do the report online or what he should do. The patient stated that he read online that there were a couple cases of this happening. The outcome of the events was recovered on an unknown date in 2021.  PSCC Communication: A full report and vaccine supplemental form was unable to be completed as the patient declined to complete a report and declined to provide information for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: thrombocytopenia; This is a Literature report. The full publication has been requested.  A patient of unspecified age and gender received BNT162B2 (lot number unknown), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced thrombocytopenia and eventual death on an unknown date. The patient died on an unknown date. The cause of death was thrombocytopenia. It was unknown if an autopsy was performed. The outcome of the event was fatal.  The recent report of thrombocytopenia and eventual death of a healthy person who received an mRNA-based COVID-19 vaccine has again raised concerns about whether vaccines trigger ITP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a very limited information provided in the report, lacking time to onset, history of pre-existing medical conditions, baseline laboratory data, conmeds and course of events, the Company did not consider the event, fatal thrombocytopenia, as secondary to BNT162B2.; Reported Cause(s) of Death: thrombocytopenia
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had vaccine but he got covid after it; had vaccine but he got covid after it; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), 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 medical history and concomitant medications were not reported. On an unspecified date, the patient experienced had vaccine, but he got covid after it.  During the call Reporter stated, Now with Covid 19 reporter had vaccine, reporters husband had vaccine, but he got Covid after it. The patient underwent lab tests and procedures which included covid-19: positive on an unknown date. The clinical outcome for events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Fear, Feeling abnormal, Feeling hot
Clinical narrative: Not being able to breathe/Could not catch my breath at all because of the fear; Tongue was swollen; Face was red; Feeling real hot; Pulse was slow; It is horrible; It scared me to death; Could not catch my breath at all because of the fear; I just could not move that much; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. An unspecified age female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0171), via an unspecified route of administration in Jun2021 as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took flu shot in 1991 and got deathly sick. Patient stated that, she received the first dose of her Pfizer Covid-19 vaccine about a week or two ago and she was calling because she experienced that night (Jun2021), not being able to breathe, her tongue was swollen, and her face was red, and she was enquiring if she should receive the second dose. She was feeling real hot, her pulse was slow, it is horrible and she still get by herself and it scared her to death. She was highly allergic to a lot of medications (Unspecified Medications), She haven't taken the flu shot (Unspecified Flu Shot) for probably 30 years because she got deathly sick when she got it but now, she decided to ahead and get it (Covid Vaccine) and she was scared to death and she could not catch her breath at all because of the fear. She just does not think she should take the second shot. No treatment was given for the events, because she lives by herself and the neighborhood she lives in, she did not want to call any of them and plus she did not have the money to go to the hospital, since she was not on the insurance. She just could not move that much; she just could not move. She was so sick of not getting to catch her breath (not clear, hence not captured as event). The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Movement disorder, Swollen tongue
Clinical narrative: Not being able to breathe/Could not catch my breath at all because of the fear; Tongue was swollen; Face was red; Feeling real hot; Pulse was slow; It is horrible; It scared me to death; Could not catch my breath at all because of the fear; I just could not move that much; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. An unspecified age female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0171), via an unspecified route of administration in Jun2021 as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took flu shot in 1991 and got deathly sick. Patient stated that, she received the first dose of her Pfizer Covid-19 vaccine about a week or two ago and she was calling because she experienced that night (Jun2021), not being able to breathe, her tongue was swollen, and her face was red, and she was enquiring if she should receive the second dose. She was feeling real hot, her pulse was slow, it is horrible and she still get by herself and it scared her to death. She was highly allergic to a lot of medications (Unspecified Medications), She haven't taken the flu shot (Unspecified Flu Shot) for probably 30 years because she got deathly sick when she got it but now, she decided to ahead and get it (Covid Vaccine) and she was scared to death and she could not catch her breath at all because of the fear. She just does not think she should take the second shot. No treatment was given for the events, because she lives by herself and the neighborhood she lives in, she did not want to call any of them and plus she did not have the money to go to the hospital, since she was not on the insurance. She just could not move that much; she just could not move. She was so sick of not getting to catch her breath (not clear, hence not captured as event). The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: My arm has been sore; It has just been over my neck; my arm, shoulder was swollen; my arm, shoulder was swollen; I got up and my arm, shoulder was swollen, that hurt and then it stop hurting; This is a spontaneous report from a contactable pharmacist (patient).A 81-year-old female patient received unknown dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 11Jun2021 (Lot Number: EW2178) at the age of 81-year-old as a single dose for covid-19 immunisation. Medical history included back injury from an unknown date and unknown if ongoing and patient on morphine for back injury. The patient's concomitant medications were not reported. The patient's arm has been sore which just been killing her and pain was also over her neck. patient was on morphine but that morphine did not even touch this and her neck is about to kill her. On 12Jun2021 patient's arm, shoulder was swollen and that hurts. The outcome of events pain in arm, shoulder pain was recovered and event pain neck, swollen arm, joint swelling was unknown. No treatment received for the events..
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she had second shot already today but have a headache and she was wondering if she could take Advil. The outcome of the event was unknown.   Follow up attempts are needed; Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: was exposed to a friend that was tested positive for COVID on Wednesday. It has been almost 8 days later that she was exposed and her mother in law is experiencing some symptoms; This is a spontaneous report from a contactable consumer. This consumer reported for an unspecified age of female patient. A female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, after the vaccination, the patient exposed to a friend who was tested positive for COVID on Wednesday. It has been almost 8 days later that the patient was exposed and the patient was experiencing some symptoms. Caller was wondering if the patient needs to get tested for COVID. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Head discomfort, Headache, Ocular discomfort
Clinical narrative: headache; painful throat; back pain; weak eyes; At times I feel so weak and my head seem heavy on me; head seem heavy on me; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWO180),  via an unspecified route of administration on 01Jun2021, as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had received the first doses of the vaccine (batch number: EWO163) in 16May2021. In Jun2021, the patient stated that, took 2 doses of the covid-19 vaccine 1st dose on 16May2021 Pfitzer EWO163 2nd dose 01Jun2021 Pfitzer EWO180. Since I took 2nd dose I had been having headache, painful throat, back pain & weak eyes. At times I feel so weak and my head seem heavy on me. These were symptoms and issues I never had before now. I visited my primary care doctor and he gave medication which I took for four days and there was no change, I just came back from the Emergency room and have been sent to the withheld for more. Treatment was given for the events. Outcome of the events were not recovered.    Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: headache; painful throat; back pain; weak eyes; At times I feel so weak and my head seem heavy on me; head seem heavy on me; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWO180),  via an unspecified route of administration on 01Jun2021, as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had received the first doses of the vaccine (batch number: EWO163) in 16May2021. In Jun2021, the patient stated that, took 2 doses of the covid-19 vaccine 1st dose on 16May2021 Pfitzer EWO163 2nd dose 01Jun2021 Pfitzer EWO180. Since I took 2nd dose I had been having headache, painful throat, back pain & weak eyes. At times I feel so weak and my head seem heavy on me. These were symptoms and issues I never had before now. I visited my primary care doctor and he gave medication which I took for four days and there was no change, I just came back from the Emergency room and have been sent to the withheld for more. Treatment was given for the events. Outcome of the events were not recovered.    Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration pleural cavity, Dyspnoea, Mesothelioma, Pleural effusion
Clinical narrative: Fluid subsequently tested positive for mesothelioma; Fluid was drawn from patients lungs; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (Pfizer employee). A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date in Mar2021 (age at vaccination 70-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via intramuscular route of administration on an unspecified date in Feb2021 (age at vaccination 70-year-old) at dose 1, single for covid-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021 patient experienced Shortness of breath, this led to emergency room visit and physician office visit during which fluid was drawn from patients lungs, fluid subsequently tested positive for mesothelioma. The patient underwent lab tests and procedures which included Fluid was drawn from patient lungs: positive for mesothelioma on an unspecified date in Mar2021. Patient received treatment for adverse events. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). Outcome of the event was resolved on an unspecified date in 2021.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 1 week later developed Shingles; This is a spontaneous report from a Pfizer sponsored program for contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid vaccine and 1 week later developed Shingles. Patient wanted to know can she take the Shingles vaccine before receiving the second dose of the Pfizer Covid vaccine, which should had been received on 20Jun. The clinical outcome of the events was unknown.  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet disorder
Clinical narrative: have fluctuations in his platelets about 2 months after receiving his second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as single dose for covid-19 immunization. On an unspecified date it was reported that patient started fluctuations in his platelets about 2 months after receiving his second dose of the Pfizer COVID-19 vaccine. His platelets have gone wild. He has never had this problem before they were in the 200s, then they dropped to 60 and then on repeat blood test it went to 700. Every time he goes the numbers are from 70-600 with wild variations. He has been seeing an Oncologist/ haematologist and they are running other tests as the doctors state they are not familiar with this. In response to platelets fluctuations informed that prescribing information for Pfizer COVID-19 Vaccine did not find information regarding platelet fluctuations as the prescribing Information does not include all adverse reactions that have been reported or that may occur. Hence patient was asked to consult with his doctor/healthcare provider about what he experienced/are experiencing as the doctor/healthcare provider will be most familiar with his medical condition, clinical history, how the treatment has been conducted and any relevant information to his specific case and is in the best position to advise about the appropriate action to take. It was reported that no patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. On an unspecified date, the patient underwent lab tests and procedures which included platelets resulted as he had never had this problem before they were in the 200s, now they dropped to 60 and then on repeat blood test it went to 700. Every time her goes the numbers are from 70-600, with wild variations. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I was exposed to covid the same week I was given rhe 1st vaccine; tested positive for covid on Jan. 11th and my 1st vaccine was Jan 6th; This is a spontaneous report recieved from a contactable other hcp.   A 31-years-old female patient (non pregnant) received bnt162b2 (PFIZER COVID 19 VACCINE,Solution for injection, Batch/Lot Number: EK9231) intramuscular,administered in Arm Left on 06Jan2021 12:00 (at the age of 31 years) as dose 1, single for covid-19 immunization. Medical history included varicose vein and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included buprenorphine hydrochloride and naloxone hydrochloride (SUBOXONE) and buspirone taken for an unspecified indication,start and stop date were not reported. The patient was exposed to covid the same week she was given the 1st vaccine and she tested positive for covid on jan 11th and 1st vaccine was on jan 6th. The patient underwent lab tests and procedures which included sars-cov-2 test positive positive on 11Jan2021. Therapeutic measures were taken as a result of tested positive for covid. The outcome of events were unknown.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient received the Pfizer covid vaccine, and had no symptoms but a sore arm; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 5 patients. This is 3 of 5 reports. This consumer reported for a male patient (reporter's brother). A male patient of an unspecified age received an unknown dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Lot number: unknown as caller was unwilling to complete the report), via an unspecified route of administration, on an unspecified date, as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after receiving the Pfizer covid vaccine, the patient had no symptoms but a sore arm. The patient stated while reporting about himself, and his wife, reporter mentioned that his two brothers received the Pfizer covid vaccine and had no symptoms but a sore arm. Reporter's brother number one is the patient. The reporter only knew that the patient got the Pfizer covid vaccine within the last two months and did not have any information. The outcome of event was unknown.   Information related to batch/Lot no. was requested.