chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: neck/shoulder pain; Extreme pain in left arm for over 3 months now; neck/shoulder pain; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program and medical information team. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number En6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation. Medical history included coronary artery disease and COVID. Concomitant medications included metoprolol tartrate; metoprolol tartrate (LOPRESSOR); acetylsalicylic acid (ASPIRIN) and niacin taken in two weeks prior vaccination. It was unknown if patient received any other vaccine in four weeks. The patient was not tested COVID post vaccination On 01Mar2021, patient experienced neck/shoulder pain, extreme pain in left arm for over 3 months now. The patient went to Physician Office due to the events. No treatment was given for the events. The outcome for the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Blood pressure increased, Blood pressure measurement, Product administered at inappropriate site, Tremor
Clinical narrative: Hashimotos; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; blood pressure being up; shaking; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 03May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism. The concomitant medications were not reported. On an unspecified date, she received the vaccine in her butt and whenever she took the band aid off it was full of blood. On 06Jun2021, she had her blood pressure being up for no reason and she was shaking for 1.5 hours. On an unspecified date, she was diagnosed with Hashimoto's. On 06Jun2021, the patient went emergency room (ER) for blood pressure being up for no reason and shaking. The reporter reported that, took the band aid off it was full of blood. On 06Jun2021 Patient reported she had to call 911 due to her blood pressure being up for no reason and she was shaking for 1.5 hours. She was taken to the ER. She has now been diagnosed with Hashimoto's. Patient seeking information if others have reported this symptom. The lab data included blood pressure was increased on 06Jun2021. Outcome of the events was unknown.; Sender's Comments: The event of Hashimoto's thyroiditis is assessed as possibly related to the suspect drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Hashimotos; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; blood pressure being up; shaking; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 03May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism. The concomitant medications were not reported. On an unspecified date, she received the vaccine in her butt and whenever she took the band aid off it was full of blood. On 06Jun2021, she had her blood pressure being up for no reason and she was shaking for 1.5 hours. On an unspecified date, she was diagnosed with Hashimoto's. On 06Jun2021, the patient went emergency room (ER) for blood pressure being up for no reason and shaking. The reporter reported that, took the band aid off it was full of blood. On 06Jun2021 Patient reported she had to call 911 due to her blood pressure being up for no reason and she was shaking for 1.5 hours. She was taken to the ER. She has now been diagnosed with Hashimoto's. Patient seeking information if others have reported this symptom. The lab data included blood pressure was increased on 06Jun2021. Outcome of the events was unknown.; Sender's Comments: The event of Hashimoto's thyroiditis is assessed as possibly related to the suspect drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy
Clinical narrative: Swollen lymph nodes but it's swollen to the extent that she can't put her arm down without a great deal discomfort; Swollen lymph nodes but it's swollen to the extent that she can't put her arm down without a great deal discomfort; This is a spontaneous report received from a contactable consumer. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0191 and expiration date: not reported), via intramuscular, on Right arm, on 06Jul2021 (at the age of 35-year-old),  as DOSE 1, SINGLE for covid-19 immunization. The patient had no medical history and concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 08Jul2021, the patient experienced swollen lymph nodes, but it's swollen to the extent that patient can't put her arm down without a great deal discomfort. The patient wants to report it and ask if patient need to seek additional medical advice from Healthcare provider or vaccine distribution site. Further reported that, patient still having the problems and it was worsened and currently in a worsened state. The second dose of the vaccine was scheduled on 27Jul2021. The patient did not receive any treatment for the event. The outcome of the events was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Headache, Lip swelling, Pain in extremity
Clinical narrative: a tingling feeling on her top lip that was also puffy; a tingling feeling on her top lip that was also puffy; headache; eye itching; 2 hives on her arm; sore arm; cheeks were a lot of color; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 06Jun2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jun2021, the patient experienced a tingling feeling on her top lip that was also puffy, headache, eye itching, 2 hives on her arm, sore arm and cheeks were a lot of color. It was reported that the patient had the first dose of the Pfizer COVID-19 vaccine last Tuesday (06Jun2021) and 48 minutes after, she had a tingling feeling on her top lip that was also puffy. She also had headache (in which she took Tylenol afterwards), eye itching, 2 hives on her arm (in which she thought were mosquito bites but she said they were not because the shape looked like hives instead of the circular mosquito bites), sore arm, and her cheeks were a lot of color. She was primarily concerned about her upper lip. It has been 2 days and she was still feeling the tingling sensation until today. She wanted to know how long it would last. She also wanted to know if she should be worried about taking the second dose of the vaccine . In response it was mentioned that as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. She was suggested to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as healthcare provider knows her health situation and has access to information that can better help inform this decision. She also wanted to know if she should take something for her adverse event like a Benadryl. In response it was suggested that Pfizer was unable to make treatment recommendations and referred her to HCP. Therapeutic measures were taken as a result of headache. The clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: a tingling feeling on her top lip that was also puffy; a tingling feeling on her top lip that was also puffy; headache; eye itching; 2 hives on her arm; sore arm; cheeks were a lot of color; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 06Jun2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jun2021, the patient experienced a tingling feeling on her top lip that was also puffy, headache, eye itching, 2 hives on her arm, sore arm and cheeks were a lot of color. It was reported that the patient had the first dose of the Pfizer COVID-19 vaccine last Tuesday (06Jun2021) and 48 minutes after, she had a tingling feeling on her top lip that was also puffy. She also had headache (in which she took Tylenol afterwards), eye itching, 2 hives on her arm (in which she thought were mosquito bites but she said they were not because the shape looked like hives instead of the circular mosquito bites), sore arm, and her cheeks were a lot of color. She was primarily concerned about her upper lip. It has been 2 days and she was still feeling the tingling sensation until today. She wanted to know how long it would last. She also wanted to know if she should be worried about taking the second dose of the vaccine . In response it was mentioned that as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. She was suggested to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as healthcare provider knows her health situation and has access to information that can better help inform this decision. She also wanted to know if she should take something for her adverse event like a Benadryl. In response it was suggested that Pfizer was unable to make treatment recommendations and referred her to HCP. Therapeutic measures were taken as a result of headache. The clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Incomplete course of vaccination
Clinical narrative: Caller stated that her family member got hospitalized for 2 months at some point after getting the first dose of the Pfizer BioNTech Covid-19 vaccine and missed the 2nd dose until now; This is a spontaneous report from a contactable consumer or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 23Dec2020 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her family member got hospitalized for 2 months at some point after getting the first dose of the Pfizer BioNTech Covid-19 vaccine and missed the 2nd dose until now. It was stated that she was frustrated that Pfizer cannot provide recommendation whether to restart the vaccination series for a patient who still hasn't received the 2nd dose after 42 days. Reporter wanted to know if there will be a need to start over the Pfizer BioNTech Covid-19 vaccination series for one of her family members who got the first dose on 23Dec2020. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: dizzy; Just extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Jul2021 11:00 (Lot Number: Unknown) as dose number unknown, single at the age of 34-year-old for covid-19 immunisation.  Medical history included MS multiple sclerosis, migraines, seizures and known allergies to Ibuprofen, naproxen. Concomitant medications included gabapentin, glatiramer acetate (GLATOPA) and oxybutynin all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced just extremely tired and dizzy on 08Jul2021 11:00. The outcome of the events was recovering with no treatment.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral herpes
Clinical narrative: Developing a cold sore due to sun exposure/broke out with fever blister; Swelling in her armpit that was pretty big; This is a spontaneous report received from Pfizer Sponsored Program. A contactable 50-year-old female consumer (patient) reported for herself.  A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. On an unspecified date The patient experienced developing a cold sore due to sun exposure/broke out with fever blister and swelling in her armpit that was pretty big. The patient asked developing a cold sore due to sun exposure. She is scheduled to receive her second dose of the Pfizer-Biontech Covid19 vaccine today. Will the vaccine interact with the cold sore and make it worse. The reporter stated that about 2 days after her first dose, she developed swelling in her armpit that was "pretty big, but went away". The reporter asked she was out in the sun and broke out with fever blister and is asking if she should still get the covax or wait. Reviewed fact sheet for information regarding cold sores with no results. Discussed lymphadenopathy as found in the attached Cons doc, which states, "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days." Referred to HCP for additional guidance. As Per FAQ: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.  Information about batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: a moderate fever (99.9), a mild fever that came and went; fatigue, fatigue but not as bad; a headache, a headache that was mild but had not gone away; swelling at the injection site; muscle pain; This is a spontaneous report from a contactable consumer (patient) received. A 34-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 08Jul2021 01:15 PM (Batch/Lot Number: Unknown Unable to locate or read the details) as dose 1, single at the age of 34-year-old for covid-19 immunisation. Medical history included panic disorder, autism spectrum disorder, ADHD (attention deficit hyperactivity disorder), and PTSD (post-traumatic stress disorder), all from an unknown date. Concomitant medications included multivitamin; aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX); ascorbic acid (VITAMIN C), all taken for an unspecified indication. The event onset date was 08Jul2021 03:30 PM. The patient had a moderate fever (99.9), fatigue, and a headache the first day. She was on the second day (as reported) and had a mild fever that came and went, fatigue but not as bad, and a headache that was mild but had not gone away. She also had swelling at the injection site and muscle pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Lab test included a moderate fever (99.9) on 08Jul2021. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: a moderate fever (99.9), a mild fever that came and went; fatigue, fatigue but not as bad; a headache, a headache that was mild but had not gone away; swelling at the injection site; muscle pain; This is a spontaneous report from a contactable consumer (patient) received. A 34-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 08Jul2021 01:15 PM (Batch/Lot Number: Unknown Unable to locate or read the details) as dose 1, single at the age of 34-year-old for covid-19 immunisation. Medical history included panic disorder, autism spectrum disorder, ADHD (attention deficit hyperactivity disorder), and PTSD (post-traumatic stress disorder), all from an unknown date. Concomitant medications included multivitamin; aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX); ascorbic acid (VITAMIN C), all taken for an unspecified indication. The event onset date was 08Jul2021 03:30 PM. The patient had a moderate fever (99.9), fatigue, and a headache the first day. She was on the second day (as reported) and had a mild fever that came and went, fatigue but not as bad, and a headache that was mild but had not gone away. She also had swelling at the injection site and muscle pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Lab test included a moderate fever (99.9) on 08Jul2021. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid; Received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid; This is a spontaneous report from a contactable Nurse. A 59-years-old female patient received first dose of 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 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid and was given monoclonal antibody -Bamlanivimab on an unspecified date. She was directed by her physician and the manufacturer of bamlanivimab (monoclonal antibody) to wait 90 days to get 2nd dose of the covid vaccine. The patient underwent lab tests and procedures which included Covid which was positive (received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid) on an unspecified date. The outcome of the events was unknown.  Information about batch/Lot number has been requested. ; 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 serious events drug ineffective and COVID-19  cannot be totally excluded
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Musculoskeletal stiffness
Clinical narrative: Caller received first dose yesterday and noticed "baseball" bruise on right calf after shower.; arm was stiff/average weight in his arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included Hepatitis C shot on an unknown date and had stiffness in arm. The patient's concomitant medications were not reported. On 08Jul2021, post vaccination the patient reported that when he woke up this morning and had average weight in his arm. He clarified as stiffness. About an hour after he woke up, he went in the shower and there was a baseball size bruise on his calf, on his right calf. Not at the injection site. The outcome of the events was reported as unknown at the time of report.  Information about batch/lot number has been requested.
Sex: F
Vaccine: UNK
Symptoms: Back pain, Blood creatinine increased, Contraception, Laboratory test, Peripheral swelling
Clinical narrative: beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; lower back pain; fever up to 103.7 degrees; This is a spontaneous report from a contactable consumer. A 19-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 in mid May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. It was reported that the patient was generally healthy. The patient received her second dose of Pfizer COVID vaccine on mid-May. The patient was hospitalized with 5 blood clots and lower back pain. The patient was initially given Aleve and a muscle relaxant thinking it was a back strain. The patient woke up three hours later with a severely swollen leg and immediately went to ER and the ultrasound confirmed blood clots with 4 clots reaching the lungs. The patient had fever up to 103.7 degrees. The patient was told at the hospital that she was in the beginning of kidney failure due to high creatinine levels. Doctors told her that it was most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots. The events took place after the use of vaccine. The patient underwent lab tests and procedures which included body temperature: 103.7 degrees (Fever), ultrasound scan: blood clots on ultrasound confirmed blood clots with 4 clots reaching the lungs, blood creatinine: high. The outcome for the events was unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: UNK
Symptoms: Pulmonary thrombosis, Pyrexia, Renal failure, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; lower back pain; fever up to 103.7 degrees; This is a spontaneous report from a contactable consumer. A 19-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 in mid May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. It was reported that the patient was generally healthy. The patient received her second dose of Pfizer COVID vaccine on mid-May. The patient was hospitalized with 5 blood clots and lower back pain. The patient was initially given Aleve and a muscle relaxant thinking it was a back strain. The patient woke up three hours later with a severely swollen leg and immediately went to ER and the ultrasound confirmed blood clots with 4 clots reaching the lungs. The patient had fever up to 103.7 degrees. The patient was told at the hospital that she was in the beginning of kidney failure due to high creatinine levels. Doctors told her that it was most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots. The events took place after the use of vaccine. The patient underwent lab tests and procedures which included body temperature: 103.7 degrees (Fever), ultrasound scan: blood clots on ultrasound confirmed blood clots with 4 clots reaching the lungs, blood creatinine: high. The outcome for the events was unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: Cannot walk right; Her balance was horrible; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in 2021 as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient stated she was having second side effects from the Pfizer covid vaccine that she got. She said that she had a reaction to the first COVID shot. Her balance was horrible and could not walk right in 2021. She stated that the first time she called in about at the end of Feb or beginning of Mar. Patient confirmed that she was experiencing the same symptoms that she was experiencing when she called in Feb or Mar and she just wanted to walk normally again. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Both of them then contracted COVID19; Both of them then contracted COVID19; This is a spontaneous report received from a contactable consumer. This consumer reported for a 78-year-old male patient (husband) that:   A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 2 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EL9262) (at the age of 78-year-old) and dose 1 via an unspecified route of administration in Arm Right on 10Jan2021 12:50 (Batch/Lot Number: EL3246) (at the age of 78-year-old) as single dose  for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. The patient concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer suspect was none. Patient did not received any other vaccine within 4 weeks of COVID vaccine. No adverse event prior to vaccination. The patient experienced as, both of them then contracted COVID-19 on 09Jun2021, and mild cold on an unspecified date. Reported as, they received the COVID-19 Vaccine, both doses, 1st: 10Jan2021 and the 2nd dose: 31Jan2021. Both of them then contracted COVID19 09Jun2021. One question being how could she and or her husband become part of a clinical study or trial that may help with the data for a needed booster dose. Her husband went to (withheld) and on the way back, both tested positive. They were both over the age of 70 and are concerned. The short and long tests were before the trip, on 02Jun2021, and both were negative. On 09Jun2021 they did the nasal swab and had immediate results, this was while in (withheld).  After testing positive, the department of health came and did another test, they did the longer one they had to wait 24 hours for and it was still positive. They then had 14 days of quarantine. No treatments reported. It was explained that all the information is the same for her and her husband, they had the same product details, same positive results, and the same symptoms after testing positive. Once testing positive they had 3 days of a mild cold, it was very mild. They thought it was just a cold, they couldn't believe they had COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Jun2021, sars-cov-2 test: positive on 09Jun2021(nasal swab). Outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: a little out of it the day after the second shot; but she got really exhausted; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional via Medical Staff. This consumer reported similar events for daughter and lot of people. This is the 2nd of 2 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced a little out of it the day after the second shot and got really exhausted. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021726880 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: Bleeding under the skin since the covid vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a female patient (reporter's mother) via telephonic follow-up activity. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown, Expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bleeding under the skin since the covid vaccine. The event outcome was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I contracted Covid-19 two months after getting my second dose with symptoms; I contracted Covid-19 two months after getting my second dose with symptoms; This is a spontaneous report from a contactable consumer (patient). A 29-yeas-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in left arm on an unspecified date, as single dose and dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 (Lot Number: ER8730), as single dose for COVID-19 immunisation. The patient had no other medical history and no known allergies. The patient had no any other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient contracted COVID-19 (01Jul2021 at 10:00) two months after got her second dose with loss of taste and smell, body aches, nausea, vomiting and chills and fever while on vacation. The patient underwent lab tests and procedures which included rapid test (nasal swab): positive on 01Jul2021. Event occurred in a location different from that of the reporter. The patient did not receive treatment in response to the events. Outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest discomfort, Electrocardiogram, Illness, Influenza like illness
Clinical narrative: Severely sick; Flu like symptoms; Chest discomfort-a heavy feeling in my heart; Chest discomfort-a heavy feeling in my heart; palpitations; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Jun2021 10:30 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any concomitant medications (within 2 weeks of vaccination). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19May2021 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine with 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After receiving the second dose on 17Jun2021,  the patient got severely sick (felt like the flu 4 days after receiving the vaccine). The patient started to experience chest discomfort--a heavy feeling in heart and palpitations. The flu like symptoms lasted a full week. The patient still felt chest discomfort presently. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent echocardiogram (EKG), results were unknown on an unspecified date. The patient received unspecified treatment for the events. The outcome of flu-like symptoms was recovered after 7 days (24Jun2021). The outcome of other events was not recovered. The events were assessed as non-serious by the reporter. On 26Jun2021, the patient had PCR COVID test (nasal swab) with negative results. On 04Jul2021, the patient had Rapid Antigen COVID test (nasal swab) with negative results.  Information about lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Severely sick; Flu like symptoms; Chest discomfort-a heavy feeling in my heart; Chest discomfort-a heavy feeling in my heart; palpitations; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Jun2021 10:30 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any concomitant medications (within 2 weeks of vaccination). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19May2021 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine with 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After receiving the second dose on 17Jun2021,  the patient got severely sick (felt like the flu 4 days after receiving the vaccine). The patient started to experience chest discomfort--a heavy feeling in heart and palpitations. The flu like symptoms lasted a full week. The patient still felt chest discomfort presently. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent echocardiogram (EKG), results were unknown on an unspecified date. The patient received unspecified treatment for the events. The outcome of flu-like symptoms was recovered after 7 days (24Jun2021). The outcome of other events was not recovered. The events were assessed as non-serious by the reporter. On 26Jun2021, the patient had PCR COVID test (nasal swab) with negative results. On 04Jul2021, the patient had Rapid Antigen COVID test (nasal swab) with negative results.  Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Does not feel well; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 16-year-old female patient (reporter's daughter) that: A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration on 09Jul2021 (at the age of 16-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated I have a question I got a new information about Pfizer that their vaccine is not as effective now because of the new variant. My daughter is 16, so the Pfizer vaccine is the only one she qualified for right now, yesterday she got her first vaccine. Reporter stated she does not feel well today on 10Jul2021, but she said she doesn't eat any Tylenol or anything, she also had a headache on unknown date in Jul2021 that's the only thing. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptomatic Positive COVID test after vaccination; Symptomatic Positive COVID test after vaccination; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported for herself.  A patient with unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On an unspecified date, after the vaccination, the patient experienced symptomatic positive COVID test after vaccination with congestion and loss of smell. Event took place after use of product. Lab data include SARS-CoV-2 test which showed positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Leg amputation, Pain in extremity, Thrombosis
Clinical narrative: I was having some foot pain; amputated to my lower right leg/chopped my leg; blood clot; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8730, expiry date: unknown), via an unspecified route of administration, administered in right arm on 12Apr2021 (at the age of 56 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included cervical cancer stage IV from Jun2019 and thyroid disorder unknown if ongoing. The patient had no prior vaccination. Historical vaccine includes first dose of BNT162B2 (lot: EN6208/expiration: unknown) via an unspecified route of administration administered in left arm on an unspecified date for covid-19 immunisation. The concomitant medications included levothyroxine and pembrolizumab (KEYTRUDA) on an unspecified date. April about three weeks after the second shot; i didn't know I thought it was just a foot ache and it didn't get bad until i went into the hospital and they couldn't save my leg and they amputated my right leg. I had blood clot and caused chopped my leg. Consumer stated, I started in April, but i can't remember the exact date, I start having foot pain until 10May2021 and I realize that it was something serious and went to the hospital. I am trying to report that I had Pfizer second vaccine and after that I had a blood clot, and I lost my leg. I am trying to report it to let you guys know because I know you keep record on that, but I had a blood clot that amputated my right leg. The patient was caused/prolonged hospitalization in ICU for the events from May2021 to an unspecified date. The patient had several unspecified lab tests on an unspecified date for which results were unknown. On 10May2021, the patient was treated with blood thinner and a bunch of things for events. Outcome of the events was unknown.  Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Pain, Swelling
Clinical narrative: Swelling near the ribs; Resulting in pain; Experienced neurological symptoms; This is a spontaneous report from two contactable consumers via a Pfizer colleague. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included comorbidity of celiac disease. The patient's concomitant medications were not reported. Patient had experienced neurological symptoms and swelling near the ribs, resulting in pain since the administration of the vaccine in Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Urticaria
Clinical narrative: Hives all over my body; Chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Jul2021 (at the age of 38-year-old) (Lot Number: EWO196) as dose 2, single for COVID-19 immunization. Medical history was none. The patient's concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Jun2021 11:30 (at the age of 38-year-old) (Lot Number: EWO217) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hives all over her body and started getting chills with the hives on 08Jul2021 23:00. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.