chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Grip strength decreased, Hypoaesthesia, Insomnia, Joint swelling
Clinical narrative: my hands were kind of swollen and numb; my hands were kind of swollen and numb; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; Numbness is focused on my hands; don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip; don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip; This is a spontaneous report from a contactable consumer or other non hcp.  A 53-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 as dose 2, Single for covid-19 immunisation. Medical history included none. Concomitant medication included Ibuprofen ADVIL LIQUI GELS taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine first vaccine bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration, administered in Arm Left on 25Apr2021 04:15 as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. On 16Jun2021, the patient experienced my hands were kind of swollen and numb, swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief, swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief, numbness is focused on my hands, don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip. Further explained that about almost a month after she got the second shot and hands were kind of swollen and numb. As time progressed swelling and pain and numbness moved to elbows knees ankles and now hips are giving her some grief. Numbness was focused on her hands, and she couldn't make a fist, don't sleep much because she couldn't stop the buzzing her hands, and she could not do job because she cannot grip. The patient did not receive any treatment for the events. The outcome of all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: my hands were kind of swollen and numb; my hands were kind of swollen and numb; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; Numbness is focused on my hands; don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip; don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip; This is a spontaneous report from a contactable consumer or other non hcp.  A 53-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 as dose 2, Single for covid-19 immunisation. Medical history included none. Concomitant medication included Ibuprofen ADVIL LIQUI GELS taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine first vaccine bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration, administered in Arm Left on 25Apr2021 04:15 as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. On 16Jun2021, the patient experienced my hands were kind of swollen and numb, swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief, swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief, numbness is focused on my hands, don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip. Further explained that about almost a month after she got the second shot and hands were kind of swollen and numb. As time progressed swelling and pain and numbness moved to elbows knees ankles and now hips are giving her some grief. Numbness was focused on her hands, and she couldn't make a fist, don't sleep much because she couldn't stop the buzzing her hands, and she could not do job because she cannot grip. The patient did not receive any treatment for the events. The outcome of all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Migraine, Seizure
Clinical narrative: Severe migraines accompanied by mild seizure; Severe migraines accompanied by mild seizure; No appetite after dosage; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCIN), first dose, via an unspecified route of administration, administered in arm left on 11Sep2021 10:00 at the age of 24 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine which the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe migraines accompanied by mild seizure, no appetite after dosage, all on 13Sep2021. It is unknown if treatment received. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Post-traumatic stress disorder
Clinical narrative: PTSD; This is a spontaneous report from a contactable consumer (patient). A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly, administered in Arm Left on 18May2021 (Lot Number: EW0161, expiration date unknown) at age of 36 years old as a single dose for covid-19 immunisation. Medical history included ongoing celiac disease (onset date: Childhood  Patient Details: Maintains a gluten free lifestyle as much as possible). Concomitant medication included sertraline taken for antidepressant from an unspecified start date and ongoing.  The patient experienced PTSD (post-traumatic stress disorder) on 18May2021 with outcome of recovering. Therapeutic measures were taken as a result of event. The event was reported as being medically significant.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Swollen pain full arm, extremely red, hot, kept spreading down the arm; Swollen pain full arm, extremely red, hot, kept spreading down the arm; Swollen pain full arm, extremely red, hot, kept spreading down the arm; There seemed to be almost a whited head in the center and it looked like it's bruising; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2587), via an unspecified route of administration, administered in right arm on 24Sep2021 (at the age of 56 years old) as dose 1, single for COVID-19 immunization.  Medical history included being diagnosed with COVID-19 from an unknown date prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) on 13Sep2021, taken as a single dose in left arm, for immunization. In Sep2021, the patient experienced a swollen pain full arm, extremely red, hot, kept spreading down the arm, and at the time of the report, there seemed to be almost a whited head in the center, and it looked like it's bruising. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unknown date prior to vaccination. The outcome of the events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Malaise, Pain in extremity
Clinical narrative: severe hives on trunk of body; general malaise; temperature of 102.8 next day; Very sore arm; mild headache; cold/unable to get warm in middle of first night (Sun.); This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnancy female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Sep2021 14:30 (Lot Number: EW0176, at age of 71 years old) as single dose for COVID-19 immunisation. Medical history included hypo-thyroid, osteopenia, mild MGUS. Concomitant medications included levothyroxine; raloxifene; calcium; colecalciferol (D3); krill oil. The patient previously took codeine and amoxicillin and experienced drug allergy. The patient experienced very sore arm and a mild headache a few hours after (at 04:30 PM on 26Sep2021) and throughout, cold/unable to get warm in middle of first night (Sun. on 26Sep2021), general malaise and temperature of 102.8 next day (Mon. on 27Sep2021), severe hives on trunk of body (discovered on 2nd day (Tues on 28Sep2021), but did not undress on Monday (on 27Sep2021) so don't know if were there on Mon (on 27Sep2021). Temperature down to 99 on Tues. morn (on 28Sep2021). Normal later in day (on 28Sep2021). Back to 99 Wed. night (on 29Sep2021). Hives remain but less solid. Self-treating temperature with tylenol beginning Mon. (on 27Sep2021) and starting benadryl Wed. night (on 29Sep2021). The outcome of events hives and fever was recovering, the outcome of rest events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: severe hives on trunk of body; general malaise; temperature of 102.8 next day; Very sore arm; mild headache; cold/unable to get warm in middle of first night (Sun.); This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnancy female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Sep2021 14:30 (Lot Number: EW0176, at age of 71 years old) as single dose for COVID-19 immunisation. Medical history included hypo-thyroid, osteopenia, mild MGUS. Concomitant medications included levothyroxine; raloxifene; calcium; colecalciferol (D3); krill oil. The patient previously took codeine and amoxicillin and experienced drug allergy. The patient experienced very sore arm and a mild headache a few hours after (at 04:30 PM on 26Sep2021) and throughout, cold/unable to get warm in middle of first night (Sun. on 26Sep2021), general malaise and temperature of 102.8 next day (Mon. on 27Sep2021), severe hives on trunk of body (discovered on 2nd day (Tues on 28Sep2021), but did not undress on Monday (on 27Sep2021) so don't know if were there on Mon (on 27Sep2021). Temperature down to 99 on Tues. morn (on 28Sep2021). Normal later in day (on 28Sep2021). Back to 99 Wed. night (on 29Sep2021). Hives remain but less solid. Self-treating temperature with tylenol beginning Mon. (on 27Sep2021) and starting benadryl Wed. night (on 29Sep2021). The outcome of events hives and fever was recovering, the outcome of rest events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine; patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) at the age of 77-year-old as single dose; dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) in 2021 at the age of 77-year-old, as single dose for covid-19 immunisation. Patient history reported as no. There were no concomitant medications. The patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine and was currently hospitalized. He's in the hospital and he's been sick for 26 days and it's real bad. He got diagnosed 28 days before, so sometime in Aug2021, he had worsened since being in the hospital. The patient got the vaccine 3 months before he got COVID. Event reported as serious as hospitalization from 01Sep2021. The outcome of the event was not recovered (reported as worsened). The reporter's concern was why did the patient get Covid, why did it hit him so strong after having the vaccine, the vaccine was to prevent, so why did it hit him so hard.  Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: PNC13
Symptoms: Blindness, Condition aggravated, Diabetic retinopathy, Eczema
Clinical narrative: developed blindness due to worsening of diabetic retinopathy in his right eye/developed partial blindness in his other eye too; worsening of diabetic retinopathy in his right eye; worsening of diabetic retinopathy in his right eye; Eczema; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE NUMBER, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. A man reported that 13 hours after receiving PREVNAR-13 he developed blindness due to worsening of diabetic retinopathy in his right eye. After treatment by his eye doctor, (Name and address withheld) 70% of his vision returned. He developed partial blindness in his other eye too but not as bad as the right eye. He continues to have eczema as well. The outcome of blindness was recovering, outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Deep Vein Thrombosis discovered at the end of August.; Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 (Batch/Lot Number: EW1070) as DOSE 2, SINGLE for covid-19 immunisation at the age of 43-year-old. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]); clarithromycin (CLARITIN), Birth control, allergy to Ibuprofen. The patient previously took bnt162b2 dose 1 (Batch/Lot Number: ER8734) in Left arm on 01Apr2021 for covid-19 immunisation at the age of 43-year-old. The patient experienced Pulmonary Embolism and Deep Vein Thrombosis on 27Aug2021 with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 4 days. No COVID prior vaccination and COVID tested post vaccination with unknown results. Therapeutic measures taken for deep vein thrombosis and pulmonary embolism included Blood thinners.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: new diagnosis of a-fib received within 1 month of vaccine; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date in Jul2021 (at the age of 85-year-old) at single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history included Blood pressure high (HBP). The patient had no known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced new diagnosis of a-fib received within 1 month of vaccine in Aug2021. The event was considered serious due to Hospitalization, Disability or permanent damage. The patient was hospitalized for the event for 5 days. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included Eliquis and amiodarone. The patient had not been tested for COVID post vaccination. The event outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Have myocarditis from Pfizer vaccine; This is a spontaneous report from a contactable consumer.   A patient (friend's children of reporter) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOW, SINGLE for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. The patient experienced have myocarditis from pfizer vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Tremor, Vomiting
Clinical narrative: Fever of 101-102 for 24 hours; shakes for 8 hours; Throwing up twice; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in left arm on 19Sep2021 (at the age of 23-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. The patient had no known allergies. Concomitant medications were none. The patient did not received any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 29Aug2021 at 13:00 as single dose for COVID-19 immunization. The patient experienced fever of 101-102 for 24 hours, shakes for 8 hours, throwing up twice and headache on 19Sep2021 21:00. No treatment was received as a result of the events. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered in Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: just got a positive PCR result for COVID-19; just got a positive PCR result for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received bnt162b2 (at the age of 47-year-old), dose 2 on 23Mar2021 13:00 (Lot number was not reported) as single dose, dose 1 on 02Mar2021 13:00 (Lot number was not reported) as single dose; both via an unspecified route of administration, administered in Arm Left for covid-19 immunisation. There were no medical history and concomitant medications. It's that patient just got a positive PCR result for COVID-19, test taken on 28Sep2021, result 29Sep2021. No treatment received. The patient underwent lab tests and procedures which included covid test: positive (Nasal Swab, PCR) on 28Sep2021. The outcome of the events was recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Immunisation, Off label use
Clinical narrative: Blood pressure just goes through the roof, up over 200; had a really terrible reaction to a booster shot; had a really terrible reaction to a booster shot; This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), first dose on unknown date for COVID-19 immunization and second dose on unknown date (8 months ago) for COVID-19 immunization and experienced blood pressure just goes through the roof, up over 200. It was reported that the patient had a really terrible reaction to a booster shot on an unspecified date, the Pfizer booster and reported that she had the same reaction from the second shot, eight months ago and her blood pressure just goes through the roof, up over 200. It was wondered if anybody else reported that and asked for recommendation on how to neutralize it. Stated that the patient was having a 'crisis' during the report and she might have to be taken back to the emergency. The patient underwent lab tests and procedures which included blood pressure measurement: 200 on unspecified date, blood pressure just goes through the roof, up over 200. The outcome of the event blood pressure just goes through the roof, up over 200 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Blood test, Connective tissue disorder, Rash
Clinical narrative: something like a connective tissue disease or lupus.; something like a connective tissue disease; ANA titer was drawn and it came back positive; rash; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 02Mar2021, as dose 2, single, for COVID-19 immunisation. Medical history included high levels of Epstein Barr in her body. She has not seen a rheumatologist yet. The patient's concomitant medications were not reported. Patient had no prior vaccinations within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021, as dose 1, single, for COVID-19 immunisation and experienced hematoma, itchy rash and got swelled up and got huge and had a bruise. The patient experienced rash after second dose (Mar2021). But it was not bad since she took Benadryl and Advil before the second dose. After the second dose in her right arm, the rash did show up sooner, within 24 to 48 hours after the shot. The rash after the second dose did not last as long and took about 5 to 7 days to recover. On an unspecified date in Apr2021, the patient went for her yearly checkup and had bloodwork and her ANA titer came out positive, a speckled pattern, which means something like a connective tissue disease or lupus (immunocompromised). The reporter stated she might have had this before the vaccine since she had high levels of Epstein Barr in her body previously. She has not seen a rheumatologist yet. It was reported that, she heard that people who are immunocompromised might not have protection against COVID19. She went to the doctor and asked if she can get the third dose booster. The outcome for rash was recovered while for other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294311 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: something like a connective tissue disease or lupus.; something like a connective tissue disease; ANA titer was drawn and it came back positive; rash; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 02Mar2021, as dose 2, single, for COVID-19 immunisation. Medical history included high levels of Epstein Barr in her body. She has not seen a rheumatologist yet. The patient's concomitant medications were not reported. Patient had no prior vaccinations within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021, as dose 1, single, for COVID-19 immunisation and experienced hematoma, itchy rash and got swelled up and got huge and had a bruise. The patient experienced rash after second dose (Mar2021). But it was not bad since she took Benadryl and Advil before the second dose. After the second dose in her right arm, the rash did show up sooner, within 24 to 48 hours after the shot. The rash after the second dose did not last as long and took about 5 to 7 days to recover. On an unspecified date in Apr2021, the patient went for her yearly checkup and had bloodwork and her ANA titer came out positive, a speckled pattern, which means something like a connective tissue disease or lupus (immunocompromised). The reporter stated she might have had this before the vaccine since she had high levels of Epstein Barr in her body previously. She has not seen a rheumatologist yet. It was reported that, she heard that people who are immunocompromised might not have protection against COVID19. She went to the doctor and asked if she can get the third dose booster. The outcome for rash was recovered while for other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294311 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she got her first dose of covid vaccine but got covid a month ago; she got her first dose of covid vaccine but got covid a month ago; This is a spontaneous report from a contactable other health care professional and non-contactable other health care professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports no side effects to xeljanz. The patient experienced she got her first dose of covid vaccine but got covid a month ago on an unspecified date (medically significant) and was waiting 90 days until she can get second covid dose of vaccine. She reports missing a few doses. 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: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event s drug ineffective and covid19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Immunisation, Off label use
Clinical narrative: had the same reaction from the second shot/Blood pressure just goes through the roof, up over 200; received dose 3 (booster); received dose 3 (booster); This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in 2021 (lot number and expiry date: unknown) as dose 3 (booster), single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date, and second dose on unspecified date in 2021 (8 months ago), for Covid-19 immunisation. The reporter stated that the patient had a terrible reaction to the Pfizer booster. She had the same reaction from the second shot, eight months ago (not clarified further). On unspecified date in 2021, patient's blood pressure just goes through the roof, up over 200 so, they were wondering how to neutralize it. Patient experienced 'crisis' at the time of the report and reporter stated that she might be taken back to the emergency. Outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: MISCARRIAGE; This is a spontaneous report  received from a contactable consumer (patient). This is a maternal report. A 37-years-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Aug2021 10:00 (Batch/Lot number was not reported) at the age of 37-years-old as SINGLE DOSE for covid-19 immunisation. Vaccine was administered at Public Health Clinic/Military Administration facility. The patient's medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient experienced miscarriage on 08Sep2021. Event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Dilatation and Curettage (D&C). The mother reported she pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 16Apr2022. The last menstrual period (LMP) was on 10Jul2021. The outcome of the event was not recovered. Prior to vaccination,  the patient was not diagnosed with COVID-19 and Since the vaccination,  the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation irregular, Pruritus
Clinical narrative: All over body itching but no rash or swelling; Extreme fatigue; Change in menstrual cycle; This is a spontaneous report from a contactable other hcp reported for herself that. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 19Aug2021 (Batch/Lot Number: EW0183, expiry date: unknown) as dose 2, single for COVID-19 immunization (age at vaccination:41-Year-old). Medical history included anxiety, obesity, and allergy to Penicillin. Concomitant medication included sertraline hydrochloride (ZOLOFT) 150 mg daily taken for an unspecified indication, start and stop date were not reported (medications within 2 weeks prior to the vaccination). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 15Jul2021(Batch/Lot Number: EW0183, expiry date: unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with covid-19 before vaccination, and not tested post vaccination. On 20Aug2021 the patient experienced all over body itching but no rash or swelling, extreme fatigue, and change in menstrual cycle. The patient had not received treatment for the events. The outcome of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypothermia, Myalgia, Tachycardia
Clinical narrative: Hypothermia; Myalgia; Joint pain; Tachycardia; Headache; This is a spontaneous report from a non-contactable other HCP (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: FF8839, expiration date unknown) intramuscularly in the arm left on 28Sep2021 at 12:30 PM at age of 58-year-old as unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included hypothyroid, osteoporosis, known allergies to penicillin. Patient previously received influenza vaccine (reported as Flu) on 13Sep2021 within 4 weeks at age of 58-year-old for influenza immunization. Concomitant medications were not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient had hypothermia, myalgia, joint pain, tachycardia, headache; all on 29Sep2021 at 12:00 AM with outcome of recovering. Patient received naproxen as treatment for the events. The events didn't result in emergency room visit or physician office visit. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event hypothermia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Pyrexia
Clinical narrative: had a fever of 99.6; had pretty debilitating Chest pain for 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 03Sep2021 (at the age of 34 years old) (Batch/Lot Number: FE3592) as dose 1, single for covid-19 immunisation. Medical history included Grave's disease from an unknown date and unknown if ongoing. Patient has ongoing blood work, she takes blood work every 3 weeks to monitor that. Concomitant medication included thiamazole (METHIMAZOLE) taken for Grave's disease, start and stop date were not reported. Patient has no prior vaccinations. The patient experienced had a fever of 99.6 for 24 hours on 04Sep2021, had pretty debilitating chest pain for 2 weeks in Sep2021. Patient had her first dose on 03Sep and had a Fever of 99.6 for 24 hour after. As soon as the fever broke, she had pretty debilitating chest pain for 2 weeks after that and then it stopped so she wanted to call and seek any advice. The patient underwent lab tests and procedures which included blood work: none of patient's test results were indicating any cardiovascular or circulatory issue in Sep2021, pyrexia: 99.6 on 04Sep2021. Therapeutic measures were taken as a result of had a fever of 99.6 and had pretty debilitating chest pain for 2 weeks. Patient took aspirin and then she went to the emergency room (further not clarified) and the emergency room physician advised her to stop taking Aspirin because none of her blood work, none of her test results were indicating any cardiovascular or circulatory issue so he said stop taking the Aspirin and start taking Ibuprofen and so that was her treatment, so to take so she took the aspirin and then she quit the Aspirin and start taking Ibuprofen. The outcome of fever was recovering while chest pain recovered in Sep2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Drug ineffective, Gait disturbance, Joint stiffness
Clinical narrative: After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; Has been in severe flare up; Has a hard time walking; Stiffness in her ankle; This is a spontaneous report received from a contactable nurse and contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162b2 (covid-19 vaccine), first dose, via an unspecified route of administration on an unspecified date as single dose, second dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included BIOTIN, CITRACAL + D3, VITAMIN D2, PLAQUENIL, HYDROXZINE, AMLODIPINE BESYLATE, GABAPENTIN, CELEBREX, and MULTIVITAMIN. In 2021, after getting her first 2 covid vaccines she got covid back in Apr2021 or May2021 and she has been in a severe flare ever since then, has a hard time walking. Ready for a rit (uncertain what this means) was starting to get better still has stiffness in her ankle has a hard time walking. Improved but not resolved. The patient underwent lab tests and procedures which included COVID-19 Test positive, got covid in 2021. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and Covid 19 and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; Has been in severe flare up; Has a hard time walking; Stiffness in her ankle; This is a spontaneous report received from a contactable nurse and contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162b2 (covid-19 vaccine), first dose, via an unspecified route of administration on an unspecified date as single dose, second dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included BIOTIN, CITRACAL + D3, VITAMIN D2, PLAQUENIL, HYDROXZINE, AMLODIPINE BESYLATE, GABAPENTIN, CELEBREX, and MULTIVITAMIN. In 2021, after getting her first 2 covid vaccines she got covid back in Apr2021 or May2021 and she has been in a severe flare ever since then, has a hard time walking. Ready for a rit (uncertain what this means) was starting to get better still has stiffness in her ankle has a hard time walking. Improved but not resolved. The patient underwent lab tests and procedures which included COVID-19 Test positive, got covid in 2021. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and Covid 19 and suspect drug BNT162B2 cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID around 10AM EDT on 30Sep2021 via at home COVID test.; Tested positive for COVID around 10AM EDT on 30Sep2021 via at home COVID test.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscularly on 07Apr2021 (Batch/Lot number was not reported) (age at vaccination: 23 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162b2 (Batch/Lot number was not reported) on 17Mar2021 for COVID-19 immunization. No other vaccine received in four weeks. The patient was tested positive for COVID around 10 am EDT on 30Sep2021 via at home COVID test (test type unknown). No treatment was received for the event. The patient was recovering from the event.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Gait disturbance, Limb discomfort, Memory impairment
Clinical narrative: experiencing more MS relapses and hospitalized for an MS relapse; foggy brain; been forgetful; foggy brain and been forgetful, she feels it has worsened since she had the COVID vaccine; Right leg affected; walking was affected; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 21Apr2021 (at the age of 29-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included ongoing MS (multiple sclerosis) ongoing foggy brain and ongoing forgetfulness (since before Kesimpta). Concomitant medication included ofatumumab (KESIMPTA). The patient had been experiencing more MS relapses after COVID vaccine and hospitalized for an MS relapse for observation at one hospital from 08Jun2021 to 10Jun2021 and left that hospital as there was not an MS specialist overseeing her, and went to another hospital where she was hospitalized and treated for an MS relapse from 10Jun2021 to 13Jun2021. The patient right leg was affected, and her walking was affected. She received 3 days of IV steroids. The patient had foggy brain and been forgetful since before Kesimpta and the patient feels it had worsened since she had the COVID vaccine. The outcome of right leg was affected, and walking was affected was unknown while the outcome for other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Relapsing multiple sclerosis
Clinical narrative: experiencing more MS relapses and hospitalized for an MS relapse; foggy brain; been forgetful; foggy brain and been forgetful, she feels it has worsened since she had the COVID vaccine; Right leg affected; walking was affected; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 21Apr2021 (at the age of 29-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included ongoing MS (multiple sclerosis) ongoing foggy brain and ongoing forgetfulness (since before Kesimpta). Concomitant medication included ofatumumab (KESIMPTA). The patient had been experiencing more MS relapses after COVID vaccine and hospitalized for an MS relapse for observation at one hospital from 08Jun2021 to 10Jun2021 and left that hospital as there was not an MS specialist overseeing her, and went to another hospital where she was hospitalized and treated for an MS relapse from 10Jun2021 to 13Jun2021. The patient right leg was affected, and her walking was affected. She received 3 days of IV steroids. The patient had foggy brain and been forgetful since before Kesimpta and the patient feels it had worsened since she had the COVID vaccine. The outcome of right leg was affected, and walking was affected was unknown while the outcome for other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.