chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Immunisation, Pyrexia, Unresponsive to stimuli
Clinical narrative: unresponsive to stimuli; flushing; high temperature; received third booster dose of Comirnaty; This is a spontaneous report from contactable pharmacists. This pharmacist reported similar events for two patients. This is the first of 2 reports. A patient of unspecified age received third dose of bnt162b2 (COMIRNATY) via unspecified route of administration on unspecified date (lot number: FD0810, Expiration Date: 30Nov2021) as DOSE 3 (BOOSTER DOSE), SINGLE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received the first and second doses of COMIRNATY on unspecified dates for COVID-19 immunisation. On unspecified date, within 24 hours of receiving the booster, the patient experienced flushing, high temperature, and unresponsive to stimuli. The patient had been transported to the hospital and are still hospitalized due to the events. The pharmacist stated, it raised a red flag for them since they have given ten to thousand doses. Outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Unresponsive to stimuli, Flushing and Pyrexia and BNT162B2.  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.,Linked Report(s) : US-PFIZER INC-202101489289 same reporter/drug/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Immunisation, Pyrexia, Unresponsive to stimuli
Clinical narrative: booster; high temperature; unresponsive to stimuli; flushing; This is a spontaneous report from contactable pharmacists. This pharmacist reported similar events for two patients. This is the second of 2 reports. A patient of unspecified age received third dose of bnt162b2 (COMIRNATY) via unspecified route of administration on unspecified date (lot number: FD0810, Expiration Date: 30Nov2021) as DOSE 3 (BOOSTER DOSE), SINGLE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received the first and second doses of COMIRNATY on unspecified dates for COVID-19 immunisation. On unspecified date, within 24 hours of receiving the booster, the patient experienced flushing, high temperature, and unresponsive to stimuli. The patient had been transported to the hospital and are still hospitalized. The pharmacist stated, it raised a red flag for them since they have given ten to thousand doses. Outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect product 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.,Linked Report(s) : PFIZER INC-202101489288 same reporter/drug/AE, different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report from a contactable consumer (Patient herself). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on unspecified date of Apr2021 (at the age of 56-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Concomitant medication(s) included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. On May2021 and Sep2021, it was reported that patient experienced COVID-19. The outcome of events was recovered on unspecified date of 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a solicited report from a contactable consumer, the patient, based on information received by Pfizer from a company (manufacturer control number: 21K-163-4135909-00). This is the second of two reports.  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 Vaccination; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot Number: 1141058) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis.  The patient medical history was not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient's concomitant medications were not reported.   The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 Vaccination and experienced spinal fusion, spinal osteoarthritis and post procedural complication. The patient experienced stroke on an unspecified date after the second COVID-19 vaccination.  The action taken in response to the event for upadacitinib was unknown. The outcome of the event stroke was unknown.  The reporter's causality for the event stroke after second COVID-19 vaccine with upadacitinib (RINVOQ), was no reasonable possibility.  The reporter considered there was a reasonable possibility that the event stroke after second COVID-19 vaccine was related to the suspect product bnt162b2.  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 information currently available,The casual association between the reported "stroke" and suspected vaccine BNT162B2 cannot be completely 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.,Linked Report(s) : PFIZER INC-202101489805 Same patient/drug, different dose/AE
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter
Clinical narrative: it has caused problems with my heart fluttering; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 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's medical history and concomitant medications were not reported.  The patient reported that they got the vaccine (both shots) and it has caused problems with their heart fluttering on an unspecified date. The patient was on meds and they have tripled the dose over several months & still not helping. Their doctor now says they may have to have an ablation to stop this. This was not one of the side affects listed. They would never have got the vaccine if it was listed. The ablation is a painful procedure and has 50% chance of not working & possibly causing more complications. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Blood pressure fluctuation, Blood pressure measurement, Cardiac flutter, Disease recurrence
Clinical narrative: it has caused problems with my heart fluttering; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 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's medical history and concomitant medications were not reported.  The patient reported that they got the vaccine (both shots) and it has caused problems with their heart fluttering on an unspecified date. The patient was on meds and they have tripled the dose over several months & still not helping. Their doctor now says they may have to have an ablation to stop this. This was not one of the side affects listed. They would never have got the vaccine if it was listed. The ablation is a painful procedure and has 50% chance of not working & possibly causing more complications. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: it has caused problems with my heart fluttering; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 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's medical history and concomitant medications were not reported.  The patient reported that they got the vaccine (both shots) and it has caused problems with their heart fluttering on an unspecified date. The patient was on meds and they have tripled the dose over several months & still not helping. Their doctor now says they may have to have an ablation to stop this. This was not one of the side affects listed. They would never have got the vaccine if it was listed. The ablation is a painful procedure and has 50% chance of not working & possibly causing more complications. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19 disease; Diagnosed with COVID-19 disease; Sore throat; This is a spontaneous report based on information received by Pfizer [Reference: MOD21-158122] from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Lot number and expiration date was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Sep2021, the patient got a sore throat and was diagnosed with COVID-19 disease with Positive PCR test post Pfizer vaccine. The outcome of the events 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) : MOD21-158122 Moderna
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diplopia, Fatigue, Headache
Clinical narrative: Exacerbation of Myasthenia Gravis (flare) drooping left eye; stomach pain; Fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours; muscle weakness; fatigue; seeing double; headache; migraine; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: FH8020), via an unspecified route of administration, administered in Arm Right on 28Oct2021 at 10:00 (at the age of 58 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included myasthenia gravis, lupus cystitis, scleroderma, raynaud's phenomenon, intervertebral disc degeneration, fructose intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included prednisone, diltiazem, pyridostigmine, bromide, hydrochlorothiazide, triamterene and ezetimibe. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ER2613) in right arm on 18March2021 at 2:30 for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) in right arm on 22Feb2021 at 11:15 for covid-19 immunisation. bnt162b2 for covid-19 immunisation, lyrica and experienced drug hypersensitivity, gabapentin and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced exacerbation of myasthenia gravis (flare) drooping left eye, stomach pain, fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours, muscle weakness, fatigue, seeing double, headache, migraine, nausea on 28Oct2021 14:00. 4 hours after vaccine -Fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours. Exacerbation of Myasthenia Gravis (flare) drooping left eye and muscle weakness, fatigue, seeing double, headache, migraine, nausea, stomach pain. The patient underwent lab tests and procedures which included body temperature result was 103.1  on 28Oct2021, body temperature result was 100.0-101.4 for 24 hours  on 28Oct2021. The patient did not receive any treatment for the events. Facility type Vaccine result was Hospital. The outcome of exacerbation of myasthenia gravis (flare) drooping left eye, stomach pain, fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours, muscle weakness, fatigue, seeing double, headache, migraine and nausea was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscular weakness, Myasthenia gravis, Nausea, Pyrexia
Clinical narrative: Exacerbation of Myasthenia Gravis (flare) drooping left eye; stomach pain; Fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours; muscle weakness; fatigue; seeing double; headache; migraine; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: FH8020), via an unspecified route of administration, administered in Arm Right on 28Oct2021 at 10:00 (at the age of 58 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included myasthenia gravis, lupus cystitis, scleroderma, raynaud's phenomenon, intervertebral disc degeneration, fructose intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included prednisone, diltiazem, pyridostigmine, bromide, hydrochlorothiazide, triamterene and ezetimibe. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ER2613) in right arm on 18March2021 at 2:30 for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) in right arm on 22Feb2021 at 11:15 for covid-19 immunisation. bnt162b2 for covid-19 immunisation, lyrica and experienced drug hypersensitivity, gabapentin and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced exacerbation of myasthenia gravis (flare) drooping left eye, stomach pain, fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours, muscle weakness, fatigue, seeing double, headache, migraine, nausea on 28Oct2021 14:00. 4 hours after vaccine -Fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours. Exacerbation of Myasthenia Gravis (flare) drooping left eye and muscle weakness, fatigue, seeing double, headache, migraine, nausea, stomach pain. The patient underwent lab tests and procedures which included body temperature result was 103.1  on 28Oct2021, body temperature result was 100.0-101.4 for 24 hours  on 28Oct2021. The patient did not receive any treatment for the events. Facility type Vaccine result was Hospital. The outcome of exacerbation of myasthenia gravis (flare) drooping left eye, stomach pain, fever 103.1 for 10 hours then fever 100.0-101.4 for 24 hours, muscle weakness, fatigue, seeing double, headache, migraine and nausea was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis viral, SARS-CoV-2 test
Clinical narrative: Viral conjunctivitis; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), intramuscularly administered in the left arm on 14Jan2021 14:45 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. Medical history included coronary vasospasm, breast cancer, adhesive allergy, and nickel allergy. The patient had no history of COVID-19 prior to vaccination. Concomitant medications included bupropion, duloxetine, metoprolol, nifedipine, spironolactone, and tamoxifen. The patient did not receive any other vaccines within four weeks of the COVID vaccine. On 30Jan2021 08:00, the patient experienced viral conjunctivitis. The event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The event was treated with steroid eye drops and saline rinse. On 03Feb2021 07:30, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL8982) intramuscularly administered in the left arm as dose 2, single for COVID-19 immunization. On 16Oct2021, the patient's nasal swab was negative. The outcome of the event was recovered with sequelae on an unspecified date.; Sender's Comments: As there is limited information in the case provided, the causal association between the event conjunctivitis viral and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Menorrhagia; This is a spontaneous report from a contactable nurse (patient). A 38 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 at 07:15, (lot number EH9899), as the first single dose, in left arm, for COVID-19 immunisation. Medical history included migraines and cephalosporins allergy. No other vaccine was administered in 4 weeks. No other medications were administered in 2 weeks. Concomitant medications were none. The patient experienced menorrhagia on an unspecified date after first dose with noticeably heavier flow that eventually stopped on its own. The event resolved on an unknown date. Then the patient received the second dose on 11Jan2021 at 07:15 (lot number EK9231) in left arm. The patient experienced menorrhagia following both doses. Flow following second dose lasted longer than 10 days and eventually required hospitalization for hemoglobin of 5.7. She received 2 blood transfusions, IV venofer infusions, oral TXA, and had to be started on birth control for the first time in her life in order to control the bleeding. She was still having abnormal bleeding to the day of report.; Sender's Comments: Linked Report(s) : PFIZER INC-202101491147 same reporter/pt/drug, different dose/event
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Fibromyalgia, Gastrooesophageal reflux disease, Muscle spasms
Clinical narrative: Sjogren''s Flare: which includes dry eyes, eyes hurt, eyes red, and eyes puffy.; Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse:; Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse:; Digestive issues: which include cramping/Muscle Cramps; Digestive issues: which include loose bowel movement; Digestive issues: which include had to increase her GERD medicine for reflux.; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.   A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 19May2021 (age at vaccination: 57 year) as dose 2, single for covid-19 immunisation. Medical history included ongoing sjogren's syndrome, fibromyalgia and GERD. The patient concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0164) as dose 1, single for covid-19 immunisation. Patient reported that the effects occurred after the second shot. Patient stated all the symptoms flared up at the same time. All symptoms probably appeared on 25May2021. On 25May2021, the patient experienced Sjogren's Flare: which includes dry eyes, eyes hurt, eyes red, eyes puffy and stated she had Sjogren's before the vaccine, she went to the doctor on 27May2021. Patient was going to an ophthalmologist. Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse and she had fibromyalgia before the vaccine. Muscle cramps, muscle cramps was reported as worsened. Patient added later in report that digestive issues: which include cramping, loose bowel movement, had to increase her GERD medicine for reflux. Patient stated that when her GERD medicine was increased by her doctor, she had some improvement of her GERD. The clinical outcome of Sjogren's Flare: which includes dry eyes, eyes hurt, eyes red, eyes puffy and Digestive issues: which include cramping, loose bowel movement, had to increase her GERD medicine for reflux was recovering and Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse, Muscle cramps was not recovered.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sjogren's syndrome
Clinical narrative: Sjogren''s Flare: which includes dry eyes, eyes hurt, eyes red, and eyes puffy.; Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse:; Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse:; Digestive issues: which include cramping/Muscle Cramps; Digestive issues: which include loose bowel movement; Digestive issues: which include had to increase her GERD medicine for reflux.; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.   A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 19May2021 (age at vaccination: 57 year) as dose 2, single for covid-19 immunisation. Medical history included ongoing sjogren's syndrome, fibromyalgia and GERD. The patient concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0164) as dose 1, single for covid-19 immunisation. Patient reported that the effects occurred after the second shot. Patient stated all the symptoms flared up at the same time. All symptoms probably appeared on 25May2021. On 25May2021, the patient experienced Sjogren's Flare: which includes dry eyes, eyes hurt, eyes red, eyes puffy and stated she had Sjogren's before the vaccine, she went to the doctor on 27May2021. Patient was going to an ophthalmologist. Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse and she had fibromyalgia before the vaccine. Muscle cramps, muscle cramps was reported as worsened. Patient added later in report that digestive issues: which include cramping, loose bowel movement, had to increase her GERD medicine for reflux. Patient stated that when her GERD medicine was increased by her doctor, she had some improvement of her GERD. The clinical outcome of Sjogren's Flare: which includes dry eyes, eyes hurt, eyes red, eyes puffy and Digestive issues: which include cramping, loose bowel movement, had to increase her GERD medicine for reflux was recovering and Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse, Muscle cramps was not recovered.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint injury, Skin fissures, Tendon rupture, Vaccination site pain
Clinical narrative: Knee arthroplasty; Skin fissures / skin cracking when it was humid; Vaccination site pain / pain right arm; Tendon rupture / torn tendons in left hand/pinky/ring finger; This is a solicited report from a contactable consumer and physician based on information received by Pfizer (Mfr. Control No. #: 21K-163-4140628-00).  A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included patient had surgery due to tore tendons in left hand two weeks before covid shot. The patient's concomitant medications were not reported. The patient experienced knee arthroplasty, skin fissures/skin cracking when it was humid, vaccination site pain/pain right arm, tendon rupture/torn tendons in left hand/pinky/ring finger, all on an unspecified date after the first dose. The events were reported as medically significant. The patient recovered from vaccination site pain, and recovering from tendon rupture. Outcome of the other events was not recovered.    Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of left knee replacement, torn tendons in left hand/pinky/ring finger, skin cracking and pain right arm after first covid vaccination with RINVOQ(UPADACITINIB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events 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 known drug safety profile, there is reasonable possibility of causal association between the events Joint injury, Skin fissure, vaccination site pain, Tendon rupture  and BNT162B2.  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: Pulmonary embolism
Clinical narrative: bilateral pulmonary emboli; This is a spontaneous report from a contactable consumer. This patient (consumer reported for self):  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 07Oct2021 as a dose 3 (booster), single for COVID-19 immunization. The patient medical history included DVT (Deep vein thrombosis) in 2019 and PE (Pulmonary embolism) in 1989. The concomitant medication of the patient was not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), both via unspecified route of administration, on an unspecified date as a dose 1 and dose 2, single for COVID-19 immunization. On 09Oct2021 the patient experienced bilateral pulmonary emboli so large the interventional radiologists were used. Patient stated that they do not have a family clotting history. The outcome of the reported event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Vaccination site pain
Clinical narrative: Injection site pain - left shoulder; Injection site pain - left shoulder; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received third booster dose of BNT162b2 (COMIRNATY; FF8841) via an unspecified route of administration in the left arm on 01Nov2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 54-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 (at the age of 54-years-old); as single dose for COVID-19 immunisation. On 01Nov2021 at 19:00, the patient experienced injection site pain-left shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events injection site pain-left shoulder were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX, UNK
Symptoms: Crohn's disease, Immunisation
Clinical narrative: Crohn's disease flare up; Booster; This is a solicited report based on the information by Pfizer, Manufacturer control number: 21K-163-4137399-00 from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 3 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK (CF) for crohn's disease; influenza vaccine (INFLUENZA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced crohn's disease flare up (medically significant). The action taken in response to the event for adalimumab, and for influenza vaccine was unknown. The outcome of the event was unknown.   The reporter's assessment of the causal relationship of the event with the suspect product 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 needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Immune thrombocytopenia, Pain, Platelet count, SARS-CoV-2 test
Clinical narrative: ended up with ITP; still dealing with pain and weakness; still dealing with pain and weakness; This is a spontaneous report from a contactable other HCP. This 39-year-old female other HCP (patient) reported for herself that a 39-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Jan2021 (Lot Number: EL0142) at the age of 39 years as dose 2, single for covid-19 immunisation. Medical history included PCOS. Patient was not pregnant. Concomitant medications included sertraline; benzylpenicillin (PENICILLIN) and birthcontrol. Historical vaccine included the first dose of bnt162b2 (Lot Number: EK5130) on 30Dec2020 at the age of 39 years in arm left for covid-19 immunisation. Patient previously took azithromycin (Z-PAK), fluoxetine hydrochloride (PROZAC), escitalopram oxalate (LEXAPRO) and clarithromycin (MACROBID) and experienced known allergies. Patient got petechiae which she first thought was a rash. Ended up going to the ED to have it checked. Patient had 1,000 platelets and was hospitalized. Patient ended up with ITP. Was on steroids till mid Jul. Got a second opinion, ended up hospitalized again. Got Cushing Syndrome from the steroids' and was now still dealing with pain and weakness. Adverse event start date was 21Jan2021. AE resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Hospitalization days: 4. AE treatment: platlet transfusion, IVIG and steroids. Nasal Swab for covid-19 was negative on 12Apr2021. Outcome of events were recovering.; Sender's Comments: Based on the available information in the case, the causal association between the events ITP, pain, asthenia 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Inflammation, Limb discomfort, Magnetic resonance imaging
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; Right elbow/forearm inflammation,left knee inflammation; Right elbow/forearm inflammation,left knee inflammation; quality of life is a struggle with daily activities; Prevents me from fully straightening my arm out going on 6 months; Been in extreme pain; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiry date was not reported), via an unspecified route of administration on 30May2021 (at the age of 42-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The Patient Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included metformin taken for an unspecified indication, start and stop date were not reported; semaglutide (RYBELSUS) taken for an unspecified indication, start and stop date were not reported; glimepiride taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient previously took amoxicillin, erythromycin and experienced drug hypersensitivity. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0182 and Expiry date was not reported), via an unspecified route of administration on 09May2021(at the age of 41-years-old) in Arm Right as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The Patient did not received other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination. The Patient was tested COVID post vaccination and COVID test post vaccination was yes. On 05Jun2021, the patient experienced COVID test result=positive (medically significant), right elbow/forearm inflammation/left knee inflammation (inflammation), right elbow/forearm inflammation/left knee inflammation (arthritis) no injury no previous history of inflammation or joint issues no autoimmune issues, quality of life is a struggle with daily activities, prevents me from fully straightening my arm out going on 6 months now, did PT with no success, been in extreme pain. The patient underwent lab tests and procedures which included magnetic resonance imaging: no injuries to the joint or arm, polymerase chain reaction: positive on 09Oct2021 COVID test name post vaccination=PCR, sars-cov-2 test: positive on 09Oct2021, x-ray: no injuries to the joint or arm. The Patient visited physician office visit. A lot of doctors appointments with nothing helping the inflammation. The Patient received treatment for the events with prednisone, Naproxen, Hydroxychloroquin. The outcome for the events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymerase chain reaction, Quality of life decreased, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; Right elbow/forearm inflammation,left knee inflammation; Right elbow/forearm inflammation,left knee inflammation; quality of life is a struggle with daily activities; Prevents me from fully straightening my arm out going on 6 months; Been in extreme pain; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiry date was not reported), via an unspecified route of administration on 30May2021 (at the age of 42-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The Patient Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included metformin taken for an unspecified indication, start and stop date were not reported; semaglutide (RYBELSUS) taken for an unspecified indication, start and stop date were not reported; glimepiride taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient previously took amoxicillin, erythromycin and experienced drug hypersensitivity. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0182 and Expiry date was not reported), via an unspecified route of administration on 09May2021(at the age of 41-years-old) in Arm Right as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The Patient did not received other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination. The Patient was tested COVID post vaccination and COVID test post vaccination was yes. On 05Jun2021, the patient experienced COVID test result=positive (medically significant), right elbow/forearm inflammation/left knee inflammation (inflammation), right elbow/forearm inflammation/left knee inflammation (arthritis) no injury no previous history of inflammation or joint issues no autoimmune issues, quality of life is a struggle with daily activities, prevents me from fully straightening my arm out going on 6 months now, did PT with no success, been in extreme pain. The patient underwent lab tests and procedures which included magnetic resonance imaging: no injuries to the joint or arm, polymerase chain reaction: positive on 09Oct2021 COVID test name post vaccination=PCR, sars-cov-2 test: positive on 09Oct2021, x-ray: no injuries to the joint or arm. The Patient visited physician office visit. A lot of doctors appointments with nothing helping the inflammation. The Patient received treatment for the events with prednisone, Naproxen, Hydroxychloroquin. The outcome for the events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; Right elbow/forearm inflammation,left knee inflammation; Right elbow/forearm inflammation,left knee inflammation; quality of life is a struggle with daily activities; Prevents me from fully straightening my arm out going on 6 months; Been in extreme pain; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiry date was not reported), via an unspecified route of administration on 30May2021 (at the age of 42-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The Patient Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included metformin taken for an unspecified indication, start and stop date were not reported; semaglutide (RYBELSUS) taken for an unspecified indication, start and stop date were not reported; glimepiride taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient previously took amoxicillin, erythromycin and experienced drug hypersensitivity. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0182 and Expiry date was not reported), via an unspecified route of administration on 09May2021(at the age of 41-years-old) in Arm Right as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The Patient did not received other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination. The Patient was tested COVID post vaccination and COVID test post vaccination was yes. On 05Jun2021, the patient experienced COVID test result=positive (medically significant), right elbow/forearm inflammation/left knee inflammation (inflammation), right elbow/forearm inflammation/left knee inflammation (arthritis) no injury no previous history of inflammation or joint issues no autoimmune issues, quality of life is a struggle with daily activities, prevents me from fully straightening my arm out going on 6 months now, did PT with no success, been in extreme pain. The patient underwent lab tests and procedures which included magnetic resonance imaging: no injuries to the joint or arm, polymerase chain reaction: positive on 09Oct2021 COVID test name post vaccination=PCR, sars-cov-2 test: positive on 09Oct2021, x-ray: no injuries to the joint or arm. The Patient visited physician office visit. A lot of doctors appointments with nothing helping the inflammation. The Patient received treatment for the events with prednisone, Naproxen, Hydroxychloroquin. The outcome for the events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Chills, Erythema, Fall
Clinical narrative: My face became red with tiny bumps; My face became red with tiny bumps; Hard chills; Headache; Body aches; I got up to bathroom & had to hold on to the wall because I was wobbly. On the way back to bed, when I let go of the wall, I fell backwards into the floor.; Temperature was 101.2 F; My arm where I had the injection is still sore to touch with itching.; My arm where I had the injection is still sore to touch with itching.; fell backwards into the floor; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female (not pregnant) patient received the third dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration on the left arm on 27Oct2021 at 09: 15 (Batch/Lot Number: FH8027) at the age of 69-year-old as single dose for COVID-19 immunization. Medical history included hypertension, hypercholesterolemia, low thyroid, tachycardia, right knee replacement from Apr2021 and hysterectomy. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, vitamin c [ascorbic acid] and vitamin d3. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 08Mar2021 at 09:30 AM (Batch/Lot No: EN6201), the first dose on 15Feb2021 at 09:15 AM (Batch/Lot Number: EN6201), both via an unspecified route of administration on the left arm at the age of 69-year-old as single dose for COVID-19 immunization. On 27Oct2021 at 09:15 AM, 2 hours after the vaccine, the patient's face became red with tiny bumps. That evening the patient started having hard chills, headache and body aches. During the night, the patient got up to bathroom and had to hold on to the wall because he was wobbly. On the way back to bed, when he let go of the wall, he fell backwards into the floor. The next day the temperature was 101.2 F. Continued with headache & body aches the next day. Her arm where he had the injection was still sore to touch with itching. Treatment was not received. The outcome of events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.