chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Laboratory test, Pain in extremity
Clinical narrative: Only sore arm for a few days; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported in response to Non-HCP letter sent. A 49-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration, administered in arm left (Left shoulder) on 23Apr2021 10:30 (at the age of 49-year-old) at dose 2, single for covid-19 immunisation. Medical history included Knee surgery from 28Dec2018 to an unknown date (Knee Surgery Meniscus), anxiety from an unknown date and unknown if ongoing. Concomitant medication included buspirone hydrochloride (BUSPAR) taken for anxiety orally from 06Apr2021 to 12Apr2021. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm left (Left shoulder) on 25Mar2021 13:25 at dose 1, single for covid-19 immunisation and experience extremely rapid heart rate/heart rate of approx 200bpm/after 25 mins heart rate was still above 150 bpm, Elevated blood pressure/blood pressure was also high, Dry mouth, Lightheaded/dizziness, Shakes/ shaking uncontrollably, Extremely Lethargic, Significant fatigue/tired, Tachycardia. On an unspecified date in Apr2021 the patient experienced only sore arm for a few days. The patient underwent lab tests and procedures which included on an unspecified date EKG, several test were run over with normal result, on 25Mar2021 BPM was approx. 200 bpm, 150bpm. Comments/Narrative: Approx. 5 mins after first shot received, experienced dizziness, dry mouth and tachycardia with a heart rate of approx. 200 bpm. Was shaking uncontrollably. Blood pressure was also high. After 25 mins heart rate was still above 150 bpm, sent to ER for evaluation. Heart rate stabilized and was released from hospital. I was extremely tired/lethargic for 5+ days. Two evening later, woke up in the middle of the night with same symptoms as above. After heart rate didn't stabilize, went to ER for evaluation. EKG came back normal and was sent home. Was later evaluated by cardiologist (approx. two weeks later). Several test were run over the next few weeks and all appeared to be normal. No adverse effects from second vaccine shot. Only sore arm for a few days. Outcome of the event was resolved on an unspecified date in 2021.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a Solicited report from a non-contactable consumer (patient) based on information received by Pfizer from AbbVie, Inc. (Manufacturer Control No: 21K-163-4055854-00).  Solicited report from the USA by a consumer of an adult female (58-year-old) with an event of non-serious rheumatoid arthritis flare up with upadacitinib (RINVOQ). The route of administration for upadacitinib was oral. There was no reported medical history and concomitant medications. On an unknown date, the patient experienced rheumatoid arthritis flare up. Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) was also considered suspect. The patient was having rheumatoid arthritis flare up a little due to not taking upadacitinib. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech lot number and expiration date were unknown. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number and expiration date were unknown. The route of administration for COVID-19 Vaccine manufactured by Pfizer/BioNTech was intramuscular, both for COVID-19 immunization. The action taken in response to the event for upadacitinib was not applicable. The outcome of the event was unknow.    The reporter considered there was a reasonable possibility that the event was related to upadacitinib, there was a possible causal relationship for the event with tozinameran.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event Rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Infectious mononucleosis, SARS-CoV-2 test
Clinical narrative: Mononucleosis Flare up; Mononucleosis Flare up; This is a spontaneous report from contactable consumers (primary reporter was the patient). A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiry date unknown), via an unspecified route of administration administered in arm left on 10Aug2021 as dose 2, single for covid-19 immunisation. Medical history included autism, mononucleosis, and allergies. There was no other medication (concomitant medications) in two weeks. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered in the left arm on 20Jul2021 for covid-19 immunisation at the age of 16-years-old. There were no other vaccines received in four weeks. The patient had no covid-19 prior vaccination. The patient was not pregnant at the time of event and time of vaccination. The patient experienced mononucleosis flare up on Aug2021 caused by the vaccine after the 2nd dose which was administered at same location on 10Aug2021. By 23Aug2021 symptoms of flare up of prior mono diagnosis flared up and continued to this day 02Sep2021. Negative covid-19 tests post-vaccination included rapid test (reported type nasal swab) on 01Sep2021 and; PCR test (reported type nasal swab) on 29Aug2021. The patient missed school and still ongoing. It was further reported that the patient was allowed to receive the vaccine at age 16 without her parent's permission and; now was extremely ill from prior mono diagnosis. The patient was autistic and should not have been allowed to take the vaccine without parental permission. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care - 3 Telehealth visits and one urgent care visit. Seriousness criterion was reported as disability or permanent damage. The patient has received treatment for the event and reported as "symptoms treatment for mononucleosis". The patient had not recovered from the event. Seriousness criterion was reported as disability or permanent damage.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic pain, Initial insomnia, Liver disorder, Urticaria
Clinical narrative: little spots, almost hives, they don't itch, around her abdomen; woke up and couldn't go back to sleep; liver swelling/liver is bumping out; Liver pain; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left deltoid on 31Aug2021 at 17:00 (Lot Number: FC3183, unknown expiration; at the age of 45 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing tick bite, allergic to meat (ongoing), and ongoing alpha one complications since she was about 9 or 10 years old; ongoing seizures; immunocompromised; and penicillin allergy. Family medical history included her father has severe cardiac condition. Concomitant medication included topiramate (TOPAMAX) taken for seizures from 2006 and ongoing. The patient previously took morphine and experienced drug hypersensitivity; and influenza vaccine for immunisation and experienced pneumonia (years ago as a teenager). The patient reported that she is having reactions that are not listed. She has been trying to get an appointment with the emergency room or her PCP but couldn't get through, so she decided to call Pfizer. She wanted to report in case others are having the same thing. The patient mentioned that she is having liver swelling. Her side effect developed yesterday (on 01Sep2021). She was recommended the Johnson one, but it is not available. The patient further described the event as liver is bumping out, and it was very painful (liver pain); it started as a light pain. Then about 03:00 am on 01Sep2021, she woke up and couldn't go back to sleep. The pain was unbearable last night. Today (02Sep2021), she noticed little spots, almost hives, they don't itch, around her abdomen. She thinks her liver swelling and pain started about seven hours after the vaccination. All of her symptoms are getting worse. When ask for seriousness she states all her events are medically significant; when ask for causality she states yes, related to the product. She has been unable to get a hold of the ER or the health department, she has not had any treatment yet. No history of previous immunization with the Pfizer vaccine considered as suspect. The patient asked if anyone else had this side effect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient did not receive treatment for the events. No relevant tests. The patient has not yet recovered from the events. The events were assessed as serious (medically significant).   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Inappropriate schedule of product administration, Muscular weakness, Pain in extremity
Clinical narrative: vaginal bleeding; Blurred vision; sharp, stabbing pain in right leg; muscle weakness; numbness in limbs and right side of my face; brain fog; administration date=19Aug2021 dose number=2/administration date=06Aug2021 dose number=1; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a contactable consumer (patient). This 36-year-old not pregnant female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 19Aug2021 (Batch/Lot Number: FC3182) (at the age of 36-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of bnt162b2 in left arm on 06Aug2021 with Lot# FA7484. Medical history and patient's concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Aug2021 patient experienced vaginal bleeding, blurred vision, sharp, stabbing pain in right leg, muscle weakness, numbness in limbs and right side of face, brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The outcome of events was not recovered. Patient has not been tested for COVID-19 since the vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vision blurred
Clinical narrative: vaginal bleeding; Blurred vision; sharp, stabbing pain in right leg; muscle weakness; numbness in limbs and right side of my face; brain fog; administration date=19Aug2021 dose number=2/administration date=06Aug2021 dose number=1; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a contactable consumer (patient). This 36-year-old not pregnant female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 19Aug2021 (Batch/Lot Number: FC3182) (at the age of 36-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of bnt162b2 in left arm on 06Aug2021 with Lot# FA7484. Medical history and patient's concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Aug2021 patient experienced vaginal bleeding, blurred vision, sharp, stabbing pain in right leg, muscle weakness, numbness in limbs and right side of face, brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The outcome of events was not recovered. Patient has not been tested for COVID-19 since the vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Vaccination site pain
Clinical narrative: Ulcerative colitis; Vaccination site pain; This is a solicited report based on the information received by Pfizer from a company (MFR Control No. # 21K-163-4054866-00). A contactable consumer (patient) reported for himself that a 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 vaccination at age of 65 years old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at 'CF' for moderate to severe ulcerative colitis. There was no reported medical history. Concomitant medication included prednisone taken for an unspecified indication, start and stop date were not reported. The patient experienced ulcerative colitis and vaccination site pain in Feb2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was resolved in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 13Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.  Causality for Adalimumab: The reporter's causality for the events of issues with ulcerative colitis and vaccination site pain with Humira (Adalimumab) was no reasonable possibility.  Causality for bnt162b2: The reporter's causality for the event of vaccination site pain with bnt162b2 was possible, for event of ulcerative colitis with bnt162b2 was not provided.   The reporter's assessment of the causal relationship of the event ulcerative colitis with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and events Ulcerative colitis and vaccination site pain cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Investigation, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3184) via intramuscular route in the right arm on 27Aug2021 at about 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. There were no vaccinations received prior to the COVID-19 vaccine. There was no family medical history. The patient had the COVID vaccine first dose on Friday morning about 9:30. On Friday night (27Aug2021), she got sick really bad. She had chill, fever, ache, and couldn't sleep well. On 30Aug2021, Monday morning, she woke up and noticed rash, red, itchy, burning rash appeared on patient's arm, leg and little on stomach. On 30Aug2021 in the afternoon, patient experienced nausea. Patient states, today rash and red nowand still itchy and burning  Itching. The patient wanted to know if this is a known issue and how long it usually lasts. She inquired if she needs to go and see a doctor about it. Patient was taking diphenhydramine hcl (BENADRYL) 47.5 mg each dose as treatment. She stated, "Perhaps I did not do anything." Lab test included P & J on 28Jul2021, procedure on her job; not further specified. The outcome of the events 'Rash, Red, Itchy, Burning rash' was not recovered, while of the other events was unknown. Follow-up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3184) via intramuscular route in the right arm on 27Aug2021 at about 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. There were no vaccinations received prior to the COVID-19 vaccine. There was no family medical history. The patient had the COVID vaccine first dose on Friday morning about 9:30. On Friday night (27Aug2021), she got sick really bad. She had chill, fever, ache, and couldn't sleep well. On 30Aug2021, Monday morning, she woke up and noticed rash, red, itchy, burning rash appeared on patient's arm, leg and little on stomach. On 30Aug2021 in the afternoon, patient experienced nausea. Patient states, today rash and red nowand still itchy and burning  Itching. The patient wanted to know if this is a known issue and how long it usually lasts. She inquired if she needs to go and see a doctor about it. Patient was taking diphenhydramine hcl (BENADRYL) 47.5 mg each dose as treatment. She stated, "Perhaps I did not do anything." Lab test included P & J on 28Jul2021, procedure on her job; not further specified. The outcome of the events 'Rash, Red, Itchy, Burning rash' was not recovered, while of the other events was unknown. Follow-up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He was vaccinated with 1st and 2nd dose of the vaccine and tested positive; He was vaccinated with 1st and 2nd dose of the vaccine and tested positive.; This is a spontaneous report from Pfizer-sponsored program. This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he was vaccinated with 1st and 2nd dose of the vaccine and tested positive on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date (he was vaccinated with 1st and 2nd dose of the vaccine and tested positive). Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Laboratory test
Clinical narrative: my voice has changed from a clear voice to a hoarse voice; This is a spontaneous report from a contactable consumer (patient). An unspecified gender 84-year-old patient received the second dose of BNT162B2 via an unspecified route of administration in Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration in Feb2021 as single dose for COVID-19 immunization. On an unspeicified date, the patient's voice has changed from a clear voice to a hoarse voice that people have a hard time understanding. Patient's vocal cords have been examined and have been found to be cancer free. The patient's family doctor had tried antibiotics and antihistamines to no avail. The patient wondered whether had recorded anyone else with him problem. For the record the patient was 84 year-old. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer or other non healthcare professional via medical information team. A male patient of an unspecified age received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller states two colleagues right now who had the Pfizer COVID vaccine are sick and they have been put in ICU since 30Jul; This is a spontaneous report from a contactable consumer.  This consumer reported that a patient (colleague) of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), on an unknown date at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The consumer states the colleague right now who had the Pfizer COVID vaccine is sick and  has been put in ICU since 30Jul. The outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101133823 same reporter and drug, different patient and event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: There was a coworker who got COVID after receiving the Pfizer COVID vaccine; There was a coworker who got COVID after receiving the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer.  This consumer reported that a female patient (coworker) of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The caller reported there was a coworker who got COVID after receiving the Pfizer COVID vaccine. Caller states she is suppose to work with her again this week and she may not be there to show up to work again. Caller states it will be two months that she is out. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101133823 same reporter and drug, different patient and event
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Eye irritation
Clinical narrative: eye burning; ear burning; This is a spontaneous report from a contactable consumer (Patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 31Aug2021 10:00 (at the age of 23-year-old) as unknown single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. No additional vaccines was administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was reported as none. On 31Aug2021. the patient experienced eye burning and ear burning. Patient did not visit to emergency Room or physician office due to adverse event. No test was performed. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: vision problems/Had problems in both eyes after the second vaccine shot.; This is a spontaneous report from a contactable consumer (patient). A male patient unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 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 were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Lot number not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced vision problems/had problems in both eyes after the second vaccine shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a solicited report based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-4054062-00).   This is a solicited report from the USA by a contactable consumer (patient) of an adult female with an event of non-serious COVID-19 with upadacitinib. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 vaccination; upadacitinib (RINVOQ), orally from an unspecified date (batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. On unknown date, she received COVID-19 Vaccine manufactured by Pfizer. On an unknown date, the patient experienced COVID-19. Pfizer Biontech Covid-19 Vaccine  was also considered suspect. The action taken in response to the event for upadacitinib was unknown. Outcome of COVID-19 was unknown.   Causality for upadacitinib: the reporter's causality for the event of COVID-19 was not provided. Causality for bnt162b2: the reporter's causality for the event of COVID-19 was possible.  The lot number for 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, a possible causal relationship between the events DI and Covid 19 and suspect drug BNT162B2 cannot be excluded
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Feb2021 (at the age of 45-year-old) (Batch/Lot Number: EM9810) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. There was no family medical history relevant to the event. On 18Feb2021, the patient experienced sore arm. She reported that she had the first vaccine on 18Feb2021 and it was fine. She just had a sore arm and it was kind of expected. That night of the vaccine and her arm hurt really bad, more than a flu vaccine or anything she ever had. She heard people complain of sore arms. It was very sore for about 3 days. She took Motrin and Tylenol and was fine after that. She had her 2nd dose of bnt162b2 on 16Mar2021 and she had some muscle twitching in her extremities and sharp, shooting nerve pain everywhere, from her knees, toes, and legs. She has been going to the doctors and has had lots and lots of tests since that point. They found myasthenia gravis and small fiber neuropathy, all induced by the vaccine. Prior vaccinations (within 4 weeks) was none and events following prior vaccinations was also none. Causality for sore arm was 100 percent yes. Outcome of event was recovered on an unspecified date. Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event Pain in extremity cannot be excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the drug is evaluated as part of 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, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Crohn's disease, Drug ineffective, Pharyngitis streptococcal
Clinical narrative: COVID-19; COVID-19; Crohn's aggravated; Streptococcal sore throat; This is a solicited report based on information received by Pfizer from a company (Manufacturer Control Number#: 21K-163-3939945-00). A 34-year-old female consumer (patient) reported that:  Solicited report by a consumer of an adult female with events of non-serious CROHN'S FLARES, STREP THROAT and COVID-19 with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced Crohn's Flares, Strep Throat and COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 07Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for HUMIRA(ADALIMUMAB). The reporter's causality for the event(s) of Crohn's Flares, Strep Throat and COVID-19 was not provided.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of Crohn's Flares, Strep Throat and COVID-19 was not provided.  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) Causality for events 1)Crohn's aggravated, 2)Streptococcal sore throat, 3) COVID-19 Causality as per reporter was Possible  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.; Sender's Comments: As per the information in the case provided, the causal association between the events Drug Ineffective, COVID-19, Crohn's disease, Pharyngitis streptococcal and the suspect drug COVID-19 Vaccine 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: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: fully vaccinated to Cominarty but contracted COVID; fully vaccinated to Cominarty but contracted COVID; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), on an unspecified date, dose 1, single and on an unspecified date, dose 2, single; both via an unspecified route of administration for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was fully vaccinated to Comirnaty but contracted COVID and was hospitalized and has had a long recovery period. The outcome of the events was recovered.  No follow-up attempts are possible, No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Back pain, Dyspnoea, Loss of consciousness, Tremor
Clinical narrative: miscarry her baby; vaginal bleeding; back pain; difficulty breathing; body began to shake; felt like passing out; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Aug2021 (Lot Number: FF2588, at the age of 37-year-old) as single dose for covid-19 immunisation. Medical history included pregnant at time of vaccination, non smoker and non-alcoholic. The concomitant product included prenatal vitamins. There were no other vaccine in four weeks. There were no covid prior vaccination. There were no covid tested post vaccination. Within one to two hours after the vaccine on 29Aug2021 patient felt like passing out, difficulty breathing and her body began to shake. Patient was pregnant at the time. She was previously healthy with no existing health conditions. She did not smoke, drink, or use drugs. At 24 hours post vaccine on 30Aug2021 she began to miscarry her baby. She had severe back pain with vaginal bleeding. This continues as of today. Treatment for events included blood work, intravenous (IV) fluids, and monitoring. The events resulted in emergency room/department or urgent care. Last menstrual date was on 23Jul2021. The mother was due to deliver on 29Apr2022. Gestational period was 5 weeks. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: miscarry her baby; vaginal bleeding; back pain; difficulty breathing; body began to shake; felt like passing out; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Aug2021 (Lot Number: FF2588, at the age of 37-year-old) as single dose for covid-19 immunisation. Medical history included pregnant at time of vaccination, non smoker and non-alcoholic. The concomitant product included prenatal vitamins. There were no other vaccine in four weeks. There were no covid prior vaccination. There were no covid tested post vaccination. Within one to two hours after the vaccine on 29Aug2021 patient felt like passing out, difficulty breathing and her body began to shake. Patient was pregnant at the time. She was previously healthy with no existing health conditions. She did not smoke, drink, or use drugs. At 24 hours post vaccine on 30Aug2021 she began to miscarry her baby. She had severe back pain with vaginal bleeding. This continues as of today. Treatment for events included blood work, intravenous (IV) fluids, and monitoring. The events resulted in emergency room/department or urgent care. Last menstrual date was on 23Jul2021. The mother was due to deliver on 29Apr2022. Gestational period was 5 weeks. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Thrombosis
Clinical narrative: Patient also had a severe COVID case previous to having clots; Patient also had a severe COVID case previous to having clots; Patient also had a severe COVID case previous to having clots; This is a spontaneous report received from a contactable consumer via sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration at Arm on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that About 2 weeks before the clots re-appeared received the Pfizer COVID vaccine in the same arm about 2 weeks before the first occurrence of clots in May. Patient also had a severe COVID case previous to having clots on 2021. Event took place after use of product. The patient underwent lab tests and procedures which included investigation: blood clots on 2021. Therapeutic measures were taken as a result of patient also had a severe covid case previous to having clots. The outcome for the event covid-19, drug ineffective was unknown and outcome for thrombosis was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: lost a little bit of action in the limbs of my legs; This is a spontaneous report from a contactable consumer. This consumer (patient) that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter was just calling discuss side effects of the shot. Patient got a little bit of confusion going on and patient have lost a little bit of action in the limbs of his legs. Consumer asking is that possible? Is it actually FDA approved?" Consumer also added, "I had it back 5 days ago. "Consumer was informed about Pfizer Medical Information Department. Consumer stated, "It is FDA approved you say? So, who do I talk to about the side effects of the shot that I have so this not FDA approved?". The outcome of event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. On an unknown date, the patient experienced chest pain after took the second Pfizer Covid shot and wants to know if the patient can be a candidate for trials C4591009 NCT or C4591021 or C4591036. The patient found these studies and want to make sure patient was supervised in a trial environment instead of just taking the third Covid booster shot. The outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis
Clinical narrative: Ankylosing Spondylitis Flare; This is a solicited report based on the information received by Pfizer from a company (MFR Control No. # 21K-163-4057384-00). A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (Batch/Lot number was not reported), first dose intramuscular on 01Apr2021 at the age of 63-year-old as single dose, second dose intramuscular on 01May2021 at the age of 63-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at citrate free for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced ankylosing spondylitis flare in 2021, patient paused a week dose of humira to take covid-19 vaccine in 2021. Solicited report by a consumer of a 63 years old female with events of non-serious patient paused a week dose of Humira to take covid-19 vaccine and Ankylosing spondylitis flare with Humira (adalimumab). There was no reported Medical history. In 2021, the patient experienced patient paused a week dose of Humira to take Covid-19 vaccine and ankylosing spondylitis flare. Pfizer BioNTech covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01Apr2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/BioNTech. On 01May2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer/BioNTech. The action taken in response to the event for adalimumab was unknown. The outcome of event was unknown.  The reporter's causality for the events of patient paused a week dose of Humira to take covid-19 vaccine and Ankylosing spondylitis flare with adalimumab was not provided. Causality as per reporter (drug/vaccine) between bnt162b2 and events was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event ankylosing spondylitis flare  and the suspect drug BNT162B2  cannot be ruled out. 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 31Aug2021; Tested positive for Covid 31Aug2021; This is a spontaneous report from a contactable consumer or other non-health care professional. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 19Feb2021 (Age at vaccination 41 years old) (Lot Number: EN6201) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Aug2021 the patient experienced tested positive for covid 31Aug2021. On 31Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test positive. The outcome of the event covid-19 was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3246) via an unspecified route of administration in Arm Left on 05Jan2021 (age at vaccination 85years old) as single dose and Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3246) via an unspecified route of administration in Arm Left on 26Jan2021 (age at vaccination 85years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Aug2021 the patient experienced covid-19 virus test positive. She is concerned about getting the booster vaccine. After getting the two doses of the Pfizer COVID 19 vaccine; 05Aug2021 she tested positive for COVID. She received the first dose 05Jan2021 and second dose 26Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Aug2021 She went to place where they were giving tests and she had a swab in the throat. she had seen a doctor or gone to the emergency room or received any kind of treatment she reported no. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 01Sep2021 16:45 (Batch/Lot Number: EWO191) (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. The patient was not pregnant at the time of vaccination. 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. Medical history included pineapple (reported as Relevant past drug history: Name of Drug as Reported: Pineapple), seizure from an unknown date to an unspecified date (seizure disorder as a young child. Medication and seizure free 8 plus years. Current Anxiety/ depression), ongoing anxiety/depression. Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously received the first dose of BNT162B2, administered in the left arm on 11Aug2021 at 13:00 (Batch/Lot Number: EWO183) (at the age of 17-year-old) for COVID-19 immunization. On 02Sep2021 at 01:45 AM, the patient experienced seizure. The event was reported as non-serious. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 02Sep2021. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.