chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Pain in extremity
Clinical narrative: Has scheduled epidural with steroids for bad back; Little sore arm for a day or two; This is a spontaneous report from a contactable physician received from a Pfizer sponsored program.  A 76-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on an unspecified date and the first dose of BNT162B2 (lot number: unknown) on an unspecified date, both via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received both doses of BNT162B2 and was due for a booster shot. The patient also had an epidural with steroids scheduled and the caller was asking if they need to postpone her booster. Caller came onto the line and verified information received from the transferring agent. Stated the epidural was for the patient's very bad back and it won't get postponed. Caller stated that the patient had all kinds of other problems. Stated her epidural was for next week. Caller stated that his gut told him they ought to postpone the booster shot. He was questioning if they should or should not and asked if there any information on how long it can be postponed for. Caller stated that he doesn't want to do the whole report thing.  Stated there was nothing wrong with the patient involving the previous 2 vaccines. Stated the patient just had a little sore arm for a day or two, nothing unexpected. Caller stated that if she got the epidural and then the booster and anything occurred he would be willing to provide more information. Caller then stated he felt the vaccine was a grand experiment. He then discussed his own experiences and declined to complete a safety report for himself. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Back disorder and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EC31W1 and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 23Aug2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included breast cancer and lymph node removed 10 years ago when patient had breast cancer. The patient experienced headache and regular symptoms after words the entire forearm pain on an unspecified date. By the 3rd day afterword patient was fine. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-4111476-00).A contactable consumer (patient) reported for herself. Solicited report from a consumer of an adult female with an event of non-serious Rheumatoid Arthritis flare up with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Rheumatoid Arthritis flare up. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient received 1st dose Covid-19 Vaccine manufactured by Pfizer via intramuscular on an unspecified date at single dose for COVID-immunization. The outcome of event was not recovered. Causality between event Rheumatoid Arthritis flare up and bnt162b2 per reporter was possible. Causality between event Rheumatoid Arthritis flare up and Adalimumab per reporter was not reported.  No follow-up attempts possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported event..  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: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Rash
Clinical narrative: feeling clouded; Rash; Not feel well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient have now broken out with a rash as well so not feel well. If this gets worse patient will go to ER. As patient was also feeling clouded and not clear headed. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Off label use, Pain, Pyrexia
Clinical narrative: week later still hurt like being run over by a truck; Off label use; booster; Fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified dates as 1st dose and 2nd dose both for covid-19 immunisation. On an unspecified date in Oct2021, the patient experienced week later still hurt like being run over by a truck. On an unspecified date in 2021, the patient experienced fever. It was reported that the patient received the booster last Monday and a week later still hurt like being run over by a truck. Her fever finally broke overnight, thankfully. It sat for days at 103 F. Her question was that with the first two shots she received messages asking how she was doing, her side effects, etc. She would like to know if Pfizer was doing this for the booster also. She would like to report on her side effects because it was one of the worst things she had ever dealt with in her lifetime. On an unspecified date in 2021, the patient underwent lab tests and procedures which included body temperature: 103 fahrenheit (It sat for days at 103 F). The outcome of the events week later still hurt like being run over by a truck was not recovered. The outcome of the event fever was recovered on an unspecified date in 2021.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches  whenever she's around someone who is fully vaccinated; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored Program  Support. A female patient of an unspecified age received 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 number unknown, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient experienced headaches whenever she was around someone who was fully vaccinated. The outcome of event was unknown.  Follow-up attempts were completed. Information about lot/batch number cannot be obtained. No further information was expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a Solicited report based on information received by Pfizer from (Manufacturer Control Number#: 21K-163-4111738-00). A contactable consumer (patient) reported that a 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 in Mar2021 and dose 1 in Feb2021 (Batch/Lot number was not reported), both via intramuscular as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date at unspecified dose for hidradenitis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient experienced tested positive for Covid. The action taken in response to the event for adalimumab was unknown. The outcome of event was not recovered. The reporter's causality for the event of tested positive for Covid with adalimumab was not provided. The reporter's causality for the event of tested positive for Covid with bnt162b2 was not provided  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective and COVID-19 and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blister, Facial paralysis, Rash
Clinical narrative: Facial paralysis; Rash; Blisters; Pimples; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced adverse effects from the vaccine which included facial paralysis, rash, blisters and pimples on an unspecified date. The patient went to get a second dose but they didn't want the liability and said no (dose might be missed) and still experiencing the side effects from the first shot. The patient wasn't able to get the second shot. They felt that they didn't got the satisfactory results when reported to nurse. They also spoke with a nurse at the Pfizer and reached out to them to see if they could help to get an appointment for them. The patient wanted to know if the Pfizer can connect them to somebody regarding this issue who can help her. The outcome of all these events was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Rash
Clinical narrative: she had a rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) dose 1 and dose 2 (lot number, expiration date was not reported); both via an unspecified route of administration, on an unspecified date for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient had a rash on an unspecified date after both doses of vaccination. The patient underwent lab tests and procedures which included mammogram appointment and the imaging technician informed that she had a rash with both doses. The patient was still intended to get a booster dose. Therapeutic measures taken included Benadryl. The outcome of the events was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, Taste disorder
Clinical narrative: Chicken cooked a certain way does not taste right; was told that he had Covid four months ago after the second shot; was told that he had Covid four months ago after the second shot; This is a spontaneous report from a contactable nurse (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 (lot number was not reported) as single dose, dose 2 via an unspecified route of administration in 2021 (Lot Number: EWO175) as single dose, both at the age of 62-year-old for covid-19 immunization. There were no medical history and concomitant medications. It was reported that on an unspecified date in 2021, the patient went to get an antibody and was told that he had Covid four months ago after the second shot. The patient reported that in Jul2021, chicken cooked a certain way did not taste right. Stated that if it was broiled that he could taste it. Stated that he ate different vegetables. Stated that he is a homecare nurse for his better half who has cancer. Stated that they were into smoothies and eating good. Stated that he had not had smoothies in 3 months because he had not had the desire. Stated that he was back into the habit of eating bananas, grapes and strawberries. This was after the second shot. Stated that he tells himself every morning that he would make a smoothie but he did not had desire. Stated that when he gets hard he gets hard. Outcome of the event covid was recovered in 2021; did not taste was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events.  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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder, Respiratory disorder, Sleep disorder
Clinical narrative: it obviously effected my brain system and causing damages and symptoms and stuff which obviously resulting in me not perform in a regular basis,; sleep disorder; breathing thing; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 02Aug2021 (pending clarification) (Lot Number: FA7485) as single dose for covid-19 immunisation at the age of 44-year-old. There were no medical history and concomitant medications. Patient didn't have other medical condition other than Pfizer vaccine have given him. Patient got some side effect through the COVID vaccine shot from Pfizer and very serious side effect to the point when he first got the vaccine. He had a sleep disorder from taking 1st vaccine in 2021. He never had sleeping problem before and he never had any issue before with breathing thing and ever since I took the vaccine 1 and 2, he had been having all of these problems and health issues in 2021. He had never had issues with any of this with sleeping pattern with having a weird motion it obviously effected his brain system and causing damages and symptoms and stuff which obviously resulting in him not perform in a regular basis in 2021, need someone to contact him right away this was going on for a week. Outcome of events was unknown.  Follow-Up (25Oct2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101358597 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Full blood count abnormal, Myalgia, White blood cell count decreased
Clinical narrative: low blood counts; muscle pain; low WBCs; hip pain; This is a spontaneous report from a contactable other hcp and consumer. A 62-year-old female patient received 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 at dose number unknown, single for covid-19 immunisation; palbociclib (IBRANCE) TAB 100MG, via an unspecified route of administration from 07May2021 (Batch/Lot number was not reported) to an unspecified date, at 100 mg for an unspecified indication. Medical history and concomitant medications were not reported. Verbatim and Event Description: Patient reports adverse events of low blood counts, muscle pain, pain in hip. Duration: hip pain started 09Jul2021 after getting COVID19 injection. Patient saw provider and was prescribed anti-flammation medication (patient does not recall name of medication) which gives relief. Patient also administers Zarxio for low WBCs. Outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: PCR, covid test result - Positive, date 12Oct2021; PCR, covid test result - Positive, date 12Oct2021; Patient received 1st dose and 2nd dose on same day (09Apr2021); This is a spontaneous report from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ep6955) via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 09:00 (Age at vaccination was 47-years-old) DOSE 2, SINGLE and DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. On 09Apr2021, patient received 1st dose and 2nd dose on same day (09apr2021) (inappropriate schedule of product administration). on 08Oct2021, the patient experianced loss of smell and taste and eye irritation. on 12oct2021, the patient experienced pcr, covid test result - positive (drug ineffective) and Covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: result was positive on 12Oct2021 (Nasal Swab). Patient did not received any treatment. The outcome of loss of smell and taste and eye irritation was recovering and for remaining events unknown.
Sex: M
Vaccine: UNK
Symptoms: Laboratory test, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Did not develop antibodies against covid-19 virus after vaccination; wondered if Venclexta had caused this to happen; This is a spontaneous report received from a contactable consumer (patient). (Mfr. Control No.: 21K-163-4110551-00). A 77-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1, dose 2 and dose 3, all via intramuscular on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization and venetoclax, orally from Aug2020 to Sep2021, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Spontaneous report by a consumer of an elderly male with an event of non-serious did not develop antibodies against covid-19 virus after vaccination with VENCLEXTA (VENETOCLAX). There was no reported medical history. On an unknown date, the patient experienced did not develop antibodies against covid-19 virus after vaccination. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient completed his Covid-19 vaccines from Pfizer and already received the booster shot too but when he had his biologics, he did not develop antibodies for Covid-19 virus. He wondered if Venclexta had caused this to happen. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. He received COVID-19 Vaccine manufactured by Pfizer.  The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on an unknown date.  The action taken in response to the events for venetoclax was permanently withdrawn on an unspecified date. The outcome of the events was unknown. The reporter's causality for the events of did not develop antibodies against covid-19 virus after vaccination with VENCLEXTA (VENETOCLAX) was a reasonable possibility.  No follow-up attempts are needed. information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Renal function test, Renal impairment, SARS-CoV-2 test
Clinical narrative: just diagnosed with covid, breakthrough cases; covid pneumonia; kidney function was elevated a little bit; just diagnosed with covid, breakthrough cases; This is a spontaneous report from a contactable consumer or other non-health professional (wife reporting for her husband). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration in arm on 10Feb2021 in the morning as DOSE 2, single for COVID-19 immunisation (age at vaccination: 71-years-old). The patient medical history included: High blood pressure. The patient was also taking other products. The reporter mentioned that the patient was diagnosed with other unspecified conditions most of his life. No additional vaccine was administered on same date of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not report any AE (s) prior vaccination. The concomitant medications include Enalapril for blood pressure from an unspecified date at an unknown dose once a day by mouth. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration in upper left arm on 20Jan2021 in the morning as DOSE 1, single for COVID-19 immunisation. The symptoms started on 01Oct2021, and he was tested for covid on 06Oct2021, which came back positive and just got diagnosed with covid, breakthrough cases. On 01Oct2021 the patient had covid pneumonia and the patient was in hospital due to that since 12Oct2021 till the date of the report. Patient treatment included: He was on oxygen, steroids and antibiotics. He does not qualify for Remdesivir since his kidney function was elevated a little bit but has now returned to normal. The outcome of the events covid pneumonia and just diagnosed with covid, breakthrough cases (COVID-19)) was not resolved. The oxygen intake was improved but he was still on oxygen. The outcome of the event kidney function was elevated a little bit was resolved on an unspecified date. The outcome of the event just diagnosed with covid, breakthrough cases (Vaccination failure) was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: just diagnosed with covid, breakthrough cases; covid pneumonia; kidney function was elevated a little bit; just diagnosed with covid, breakthrough cases; This is a spontaneous report from a contactable consumer or other non-health professional (wife reporting for her husband). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration in arm on 10Feb2021 in the morning as DOSE 2, single for COVID-19 immunisation (age at vaccination: 71-years-old). The patient medical history included: High blood pressure. The patient was also taking other products. The reporter mentioned that the patient was diagnosed with other unspecified conditions most of his life. No additional vaccine was administered on same date of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not report any AE (s) prior vaccination. The concomitant medications include Enalapril for blood pressure from an unspecified date at an unknown dose once a day by mouth. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration in upper left arm on 20Jan2021 in the morning as DOSE 1, single for COVID-19 immunisation. The symptoms started on 01Oct2021, and he was tested for covid on 06Oct2021, which came back positive and just got diagnosed with covid, breakthrough cases. On 01Oct2021 the patient had covid pneumonia and the patient was in hospital due to that since 12Oct2021 till the date of the report. Patient treatment included: He was on oxygen, steroids and antibiotics. He does not qualify for Remdesivir since his kidney function was elevated a little bit but has now returned to normal. The outcome of the events covid pneumonia and just diagnosed with covid, breakthrough cases (COVID-19)) was not resolved. The oxygen intake was improved but he was still on oxygen. The outcome of the event kidney function was elevated a little bit was resolved on an unspecified date. The outcome of the event just diagnosed with covid, breakthrough cases (Vaccination failure) was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Anxiety, Blood pressure increased, Condition aggravated, Fibromyalgia, Mobility decreased
Clinical narrative: worsening pre-existing conditions due to stressful events; worsening pre-existing conditions due to stressful events; decreased mobility (surgery); increase anxiety; flares-ups of fibromyalgia/osteoarthritis.; flares-ups of fibromyalgia/osteoarthritis.; blood pressure elevated; foot pain; Low vitamin D (before therapy) improved for the first time; This is a spontaneous report from contactable other health professional and consumer (patient) via a Pfizer-sponsored program. A 51-year-old female patient started to receive tofacitinib citrate (XELJANZ XR; strength 11mg), oral from Mar2021 (Batch/Lot number was not reported) to 21Jun2021, at 11 mg once daily and via oral from Sep2021 (Batch/Lot number was not reported) and ongoing, at 11 mg once daily for rheumatoid arthritis; 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; and influenza vaccine (Manufacturer unknown) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date at dose number unknown, single for immunisation. Medical history included low vitamin D. The patient has unspecified concomitant medication. The patient initially started therapy with XELJANZ XR from Mar2021 to 21Jun2021 and restarted at the end of Sep2021. Most recent shipment was on 07Oct2021 due to right ankle reconstruction/tibial bone graft from 06Jul2021 to 07Jul2021 (2 days hospitalization), COVID-19 vaccine (Pfizer), and flu shot.  In 2021, the patient experienced worsening pre-existing conditions due to stressful events, out of work, disability, decreased mobility (surgery)/increase anxiety after being off therapy resulting in flares-ups of fibromyalgia/osteoarthritis. The patient is coping and taking unspecified medication for the events. MD was aware. The patient also experienced blood pressure elevated (onset eight months ago) could be due to foot pain. Low vitamin D (before therapy) improved for the first time. The action taken of tofacitinib citrate in response to the events was dose not changed. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events are likely intercurrent conditions and are not related to the suspect drugs.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Osteoarthritis, Pain in extremity, Stress, Therapeutic response unexpected
Clinical narrative: worsening pre-existing conditions due to stressful events; worsening pre-existing conditions due to stressful events; decreased mobility (surgery); increase anxiety; flares-ups of fibromyalgia/osteoarthritis.; flares-ups of fibromyalgia/osteoarthritis.; blood pressure elevated; foot pain; Low vitamin D (before therapy) improved for the first time; This is a spontaneous report from contactable other health professional and consumer (patient) via a Pfizer-sponsored program. A 51-year-old female patient started to receive tofacitinib citrate (XELJANZ XR; strength 11mg), oral from Mar2021 (Batch/Lot number was not reported) to 21Jun2021, at 11 mg once daily and via oral from Sep2021 (Batch/Lot number was not reported) and ongoing, at 11 mg once daily for rheumatoid arthritis; 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; and influenza vaccine (Manufacturer unknown) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date at dose number unknown, single for immunisation. Medical history included low vitamin D. The patient has unspecified concomitant medication. The patient initially started therapy with XELJANZ XR from Mar2021 to 21Jun2021 and restarted at the end of Sep2021. Most recent shipment was on 07Oct2021 due to right ankle reconstruction/tibial bone graft from 06Jul2021 to 07Jul2021 (2 days hospitalization), COVID-19 vaccine (Pfizer), and flu shot.  In 2021, the patient experienced worsening pre-existing conditions due to stressful events, out of work, disability, decreased mobility (surgery)/increase anxiety after being off therapy resulting in flares-ups of fibromyalgia/osteoarthritis. The patient is coping and taking unspecified medication for the events. MD was aware. The patient also experienced blood pressure elevated (onset eight months ago) could be due to foot pain. Low vitamin D (before therapy) improved for the first time. The action taken of tofacitinib citrate in response to the events was dose not changed. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events are likely intercurrent conditions and are not related to the suspect drugs.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: sister has had 2 shots of the covid vaccine by pfizer and diagnosed with Covid; sister has had 2 shots of the covid vaccine by pfizer and diagnosed with Covid; This is a spontaneous report based on information received by Pfizer/Merck and Co., Inc. from a contactable consumer or other non-health care professional reported for her sister. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administer at an unspecified anatomical location on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administer at an unspecified anatomical location on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sister has had 2 shots of the covid vaccine by Pfizer and diagnosed with covid. The patient underwent lab tests and procedures which included sars-cov-2 test diagnosed with covid on diagnosed with COVID. The outcome of the event was unknown.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Diagnosis 15Oct2021; Covid Diagnosis 15Oct2021; This is a spontaneous report from a contactable other hcp. A 14-Year-old male patient received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 09Jun2021 16:00 (Batch/Lot Number: EW0185) (age at vaccination 13 years) as dose 2, single and via an unspecified route of administration on 19May2021 (Batch/Lot Number: EW0187) (age at vaccination 13 years) as dose 1, single both doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior vaccination, the patient has not been diagnosed with COVID-19 and Since the vaccination, patient has been tested for COVID-19. On 15Oct2021, patient experienced Covid Diagnosis 15Oct2021. Seriousness of the event was medically significant. Adverse event resulted in physician office visit. The patient underwent lab tests and procedures which included PCR: positive on 15Oct2021 (Nasal Swab). The patient did not receive any treatment for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID after fully vaccinated; Tested positive for COVID after fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old (non-pregnant) female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EP6955, expiration date: not reported), via intramuscular route, administered in right arm on 12Apr2021 as dose 2, single and patient had earlier received dose 1 of bnt162b2 (COMIRNATY, formulation: intramuscular, lot number was EP6955 expiration date was not reported), via intramuscular route administered in right arm on 22Mar2021 as dose 1, single for COVID-19 immunisation. Age at vaccination was 47 years. Medical history included dry eye, Chronic pain in hands from an unknown date and unknown if ongoing. Known allergies were none. Patient was not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within 2 weeks of vaccination) included pregabalin (LYRICA) 25mg (2 per day), probiotics, colecalciferol (VITAMIN D [COLECALCIFEROL]), omega 3 (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. On 15Oct2021 at 20:00 the patient was tested positive for covid after fully vaccinated. The most recent COVID-19 vaccine was administered in workplace clinic. On 15Oct2021 the patient underwent lab tests and procedures which included PCR (polymerase chain reaction) with result positive and Covid test (SARS-CoV-2 test) with result positive (nasal Swab). No hospitalization. Therapeutic measures were not taken. The outcome of events was recovering.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed Blood clot in right leg; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. This is the 1st case out of 2 cases.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 13Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On 14Sep2021, the patient developed blood clot in right leg. The outcome of the event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383187 same reporter/drug/AE, different patient
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Feeling abnormal, Feeling drunk, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: his legs were weak; his arms felt like they were floating; seemed to move like he was drunk and uncoordinated; seemed to move like he was drunk and uncoordinated; got his second dose of the covid vaccine 2 weeks after his first dose; It is like a spinal cord myelitis; numbness in his hands and feet; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 46-year-old male patient (reporter's son) that: A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 2, single on 13Oct2021 (at the age of 46-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccina included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on unspecified date in Sep2021 for covid-19 immunisation and experienced sore arm. Patient got his second dose of the Covid vaccine (on 13Oct2021) 2 weeks after his first dose (inappropriate schedule of product administration). He had nothing but a sore arm after the first dose but within 8 hours after the second shot he began to experience numbness in his hands and feet on unspecified date in Oct2021 and the next day his legs were weak, and his arms felt like they were floating on 14Oct2021. Patient had to work very hard when walk to keep from falling he seemed to move like he was drunk and uncoordinated on 14Oct2021. This is the second day after his shot and his condition was unchanged. Has anyone reported any reactions similar to this. It was like a spinal cord myletitus on unspecified date in Oct2021. If he was no better by tomorrow 48 hours after the shot, we will get medical attention. Reporter's hope that others have had a reaction like this and that it was just a temporary condition. At the time of this report, the outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myelitis
Clinical narrative: his legs were weak; his arms felt like they were floating; seemed to move like he was drunk and uncoordinated; seemed to move like he was drunk and uncoordinated; got his second dose of the covid vaccine 2 weeks after his first dose; It is like a spinal cord myelitis; numbness in his hands and feet; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 46-year-old male patient (reporter's son) that: A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 2, single on 13Oct2021 (at the age of 46-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccina included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on unspecified date in Sep2021 for covid-19 immunisation and experienced sore arm. Patient got his second dose of the Covid vaccine (on 13Oct2021) 2 weeks after his first dose (inappropriate schedule of product administration). He had nothing but a sore arm after the first dose but within 8 hours after the second shot he began to experience numbness in his hands and feet on unspecified date in Oct2021 and the next day his legs were weak, and his arms felt like they were floating on 14Oct2021. Patient had to work very hard when walk to keep from falling he seemed to move like he was drunk and uncoordinated on 14Oct2021. This is the second day after his shot and his condition was unchanged. Has anyone reported any reactions similar to this. It was like a spinal cord myletitus on unspecified date in Oct2021. If he was no better by tomorrow 48 hours after the shot, we will get medical attention. Reporter's hope that others have had a reaction like this and that it was just a temporary condition. At the time of this report, the outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for Covid-19; Covid-19; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EP6955), dose 1 intramuscular, administered in left arm on 26Mar2021 09:00 (at age of 24-year-old) as dose 1, single and then second dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EP6955), intramuscular, administered in left arm on 17Apr2021 10:30 (at age of 24-year-old) as dose 2, single for covid-19 immunization at clinic. The patient medical history was not reported. Concomitant medications included Vita Fusion multivitamin gummies within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient TL tested positive for Covid-19 on Saturday 16Oct2021 at 08:30 AM (PCR test via nasal swab administered on Friday 15Oct2021). Patient was experiencing minor fever, cough, and nasal congestion. Patient had no known exposure prior to testing positive. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): positive on 15Oct2021. The outcome of event covid-19 was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest pain, Colon cancer, Scan
Clinical narrative: She had colon cancer and they took out half her colon; Chest pain; She had a large heart; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot/NDC number and Expiry date was not reported) via an unspecified route and date in Jan2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, she had colon cancer and they took out half her colon (medically significant), chest pain and she had a large heart. On an unspecified date in 2021, the patient underwent lab tests and procedures which included a scan and found that she had a large heart. Other information included, patient received the vaccine in Jan2021 and 3 weeks later she was having chest pains. She went to her doctor who did a scan which showed she had a large heart. She had to get a stent placed and while they were in there they found out she had colon cancer and they took out half her colon. Now she has stage 4 colon cancer and she isn't going to make it. Reporter does not know the date of her procedure, but thinks it was probably sometime in Feb2021. Healthcare Professional postal address was reported. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: his best friend died; This is a spontaneous report from a contactable consumer or other non-HCP. A 56-years-old patient of an unspecified gender received unknown dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that his best friend died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: his best friend died
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling hot, Hypoaesthesia oral, Pruritus
Clinical narrative: My mouth was little numbness -upper level and tongue; dizziness; hot; My face was red and itchy; My face was red and itchy; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm left on 18Oct2021 at 15:15 as dose 1, single (age at vaccination 50 years) for covid-19 immunisation. Medical history included allergy to penicillin since an unknown date. The patient was allergic to pneumonia 23 vaccine. The patient's concomitant medications were not reported. The patient after 5 minutes of vaccination got dizziness and hot, her face was red and itchy and her mouth had little numbness -upper level and tongue an 18Oct2021 at 15:30. Therapeutic measures were taken as a result of the events that included taking twice loratadine at same day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for covid post vaccination. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.