chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Injection site urticaria
Clinical narrative: Localized hives on arm of injection site; This is a spontaneous report from a contactable Physician. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), second dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single dose for immunisation. The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 (TRUMENBA) for immunisation and had no problems. The patient experienced localized hives on arm of injection site after 2nd dose on an unspecified date. The outcome of the event was recovered. Patient is fine now but physician wanted to report the incident.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Dizziness, Fall, Joint swelling, Movement disorder
Clinical narrative: started getting dizzy; like the world was going round and round and round and round; I fell face down on the concrete; Damaged the three front teeth's that have to be replaced; very upset; I could not move; knee was all swelled up; my face; it was all black and blue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 11Oct2021 (at age of 69 years old, Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma. The patient stated she did take other medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had a reaction from the first shot. Patient stated she had a very bad reaction from the second COVID shot. She was on the capsules three 'solid' weeks. She got up because had to get some doggy food and food for the house and whatever, whatever and she had to go to the bank and started getting dizzy, like the world was going round and round and round and round and do not have any that kind of illness ever. It was going round and round. She fell face down on the concrete and have a 6000 Dollar dental bill right now, okay 6000 dollars. Damaged the three front teeth's that had to be replaced. She was so very upset. It was not fair. She never heard of this kind of side effect and the, Pharmacy said well that was really severe. This month has been a nightmare for her. Those events occurred on 12Oct2021 (the next day after vaccination), when she woke up, she could not move. She was on the capsule three weeks. Patient stated, she went and got, she went to an urgent care, she fell and they took X-ray to make sure that she did not break anything in her face. Her knee was all swelled up. It was horrible and her face she had it was all black and blue. Just to make sure that she did not break anything. Especially face. That is 'when she went to' an urgent care. The outcome of the events was recovered on Oct2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Tooth injury, X-ray
Clinical narrative: started getting dizzy; like the world was going round and round and round and round; I fell face down on the concrete; Damaged the three front teeth's that have to be replaced; very upset; I could not move; knee was all swelled up; my face; it was all black and blue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 11Oct2021 (at age of 69 years old, Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma. The patient stated she did take other medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had a reaction from the first shot. Patient stated she had a very bad reaction from the second COVID shot. She was on the capsules three 'solid' weeks. She got up because had to get some doggy food and food for the house and whatever, whatever and she had to go to the bank and started getting dizzy, like the world was going round and round and round and round and do not have any that kind of illness ever. It was going round and round. She fell face down on the concrete and have a 6000 Dollar dental bill right now, okay 6000 dollars. Damaged the three front teeth's that had to be replaced. She was so very upset. It was not fair. She never heard of this kind of side effect and the, Pharmacy said well that was really severe. This month has been a nightmare for her. Those events occurred on 12Oct2021 (the next day after vaccination), when she woke up, she could not move. She was on the capsule three weeks. Patient stated, she went and got, she went to an urgent care, she fell and they took X-ray to make sure that she did not break anything in her face. Her knee was all swelled up. It was horrible and her face she had it was all black and blue. Just to make sure that she did not break anything. Especially face. That is 'when she went to' an urgent care. The outcome of the events was recovered on Oct2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: second dose was administered this past March/ A few weeks age we both contracted the virus; second dose was administered this past March/ A few weeks age we both contracted the virus; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for himself and his wife. This is 2nd of two reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that both reporter and his wife received the Covid vaccines. The second dose was administered this past March. It was reported that a few weeks ago on an unknown date in 2021, reporter and his wife both contracted the virus (COVID-19). The reporter was not aware he had the virus and infected one of his friends. The reporter could have infected other people. Luckily, reporter got out the alarm and they were all self-isolated. He doesn't remember ever hearing the virus could be disseminated by a vaccinated person. The event outcome was unknown at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101419659 Same reporter/vaccine/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Neoplasm malignant
Clinical narrative: Might have cancer; Inability to walk; Inability to walk or stand without a cane and great difficulty; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (after the vaccination), the patient experienced inability to walk or stand without a cane and great difficulty, might have cancer, and needs physical therapy. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain in extremity, SARS-CoV-2 test
Clinical narrative: positive Covid test; positive Covid test; arm soreness; This is a spontaneous report from a contactable physician (patient). This report was received via a Pfizer sales representative. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive covid test and arm soreness on an unspecified date after the use of the vaccine. The physician reported that first dose caused no side effects other than arm soreness, second dose happened within weeks of having positive Covid test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information , a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.,Linked Report(s) : US-PFIZER_INC-202101425759 Same reporter and patient, different dose, different AE;US-PFIZER_INC-202101425760 Same reporter and patient, different dose, different AE
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Muscle spasms, Pain
Clinical narrative: fatigue; back spasm; pain; Booster (3rd) dose; This is a spontaneous report from a contactable physician (patient). A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced arm soreness, COVID-19 and drug ineffective. The patient was also previously vaccinated with the second dose of BNT162B2 on an unspecified date (within weeks of having positive Covid test) for COVID-19 immunisation and caused similar side effects. The patient received the booster (3rd) dose on an unspecified date. On an unspecified date after the third dose, the patient experienced fatigue, back spasm and pain for about a day that later subsided. It was reported that second dose happened within weeks of having positive Covid test and caused similar side effects, but not as severe as this booster dose. Events took place after use of product. The outcome of the events fatigue, back spasm and pain was recovering. It was also reported that the patient was still happy and felt the reaction meant his body had a robust response to vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Became immunocompromised; This is a spontaneous report from a non-contactable consumer (patient reported for herself) from Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 2021 as dose 3 (booster) single for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified steroids after the Pfizer covid-19 vaccine. Patient received the dose 1 and dose 2 of BNT162B2 as covid-19 immunisation on unspecified dates. The patient became immunocompromised on an unknown date in 2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Blood glucose, Blood viscosity abnormal, Body temperature abnormal, Cough
Clinical narrative: her blood couldn't stop flowing; My blood was thin; she couldn't make her blood flow normally to take her sample for glucose test; temperature; cough; runny nose; throwing up; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on 14Oct2021 (Batch/Lot Number: EW0185) as dose 3 (booster), single (at the age of 70-years-old) for Covid-19 immunisation. Medical history included type 2 diabetic, and cancer. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Feb2021 (Batch/Lot Number: EN6200) as dose 1, single (at the age of 69-years-old) for Covid-19 immunisation and had a sore arm and tiredness. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as dose 2, single (at the age of 69-years-old) for Covid-19 immunisation and had a sore arm, tiredness and skin graft and had been hurting. The patient had no or minimal side effect on the first 2 Pfizer shots with a sore arm for a few days and tiredness. The patient recently had a skin graft (19Sep2021) and had been hurting for about a month before the doctor cleared it as the patient was concerned about being on an antibiotic during the hurting as 'it skuts down the immune system'. The patient is type 2 diabetic, controlled alcohol (ALC) in the 5's. After the third shot, in Oct2021, the patient was tested on blood and when they pricked for the dot of blood, the blood was thin, and it did not go to a dot - it ran as the blood couldn't stop flowing. They tried to pull blood in the meter and got an error 4 message over 2 days. The monitor company was contacted, and they said it was blood error to try while they were on the phone. The patient had not tested. She tested the bubble came up that time and got a reading. The incident has never happened in 20 years, probably nothing over. The patient further stated she had temperature, cough, runny nose, and throwing up on an unknown date in 2021. She is a cancer patient and had some problems with her blood after taking the 3rd vaccine. The first two days, she couldn't make her blood flow normally to take her sample for glucose test, and on the third day, her blood couldn't stop flowing. But she is fine now. With her first and second dose she only experienced fatigue. The events 'her blood couldn't stop flowing' and 'she couldn't make her blood flow normally to take her sample for glucose test' resolved in 2021 while the outcome of the rest of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Rhinorrhoea, Vomiting
Clinical narrative: her blood couldn't stop flowing; My blood was thin; she couldn't make her blood flow normally to take her sample for glucose test; temperature; cough; runny nose; throwing up; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on 14Oct2021 (Batch/Lot Number: EW0185) as dose 3 (booster), single (at the age of 70-years-old) for Covid-19 immunisation. Medical history included type 2 diabetic, and cancer. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Feb2021 (Batch/Lot Number: EN6200) as dose 1, single (at the age of 69-years-old) for Covid-19 immunisation and had a sore arm and tiredness. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as dose 2, single (at the age of 69-years-old) for Covid-19 immunisation and had a sore arm, tiredness and skin graft and had been hurting. The patient had no or minimal side effect on the first 2 Pfizer shots with a sore arm for a few days and tiredness. The patient recently had a skin graft (19Sep2021) and had been hurting for about a month before the doctor cleared it as the patient was concerned about being on an antibiotic during the hurting as 'it skuts down the immune system'. The patient is type 2 diabetic, controlled alcohol (ALC) in the 5's. After the third shot, in Oct2021, the patient was tested on blood and when they pricked for the dot of blood, the blood was thin, and it did not go to a dot - it ran as the blood couldn't stop flowing. They tried to pull blood in the meter and got an error 4 message over 2 days. The monitor company was contacted, and they said it was blood error to try while they were on the phone. The patient had not tested. She tested the bubble came up that time and got a reading. The incident has never happened in 20 years, probably nothing over. The patient further stated she had temperature, cough, runny nose, and throwing up on an unknown date in 2021. She is a cancer patient and had some problems with her blood after taking the 3rd vaccine. The first two days, she couldn't make her blood flow normally to take her sample for glucose test, and on the third day, her blood couldn't stop flowing. But she is fine now. With her first and second dose she only experienced fatigue. The events 'her blood couldn't stop flowing' and 'she couldn't make her blood flow normally to take her sample for glucose test' resolved in 2021 while the outcome of the rest of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Injection Site soreness.; General body soreness; Nausea; Headache; Fatigue; Armpit sore on Arm of injection; Elbow achiness in arm of injection; Dose 3 received; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PF8841) via an unspecified route of administration on 21Oct2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine.  The patient previously took pentothal sodium (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 01Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 11Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 22Oc2021, the patient experienced injection site soreness, general body soreness, nausea, headache, fatigue, armpit sore on arm of injection and elbow achiness in arm of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness, general body soreness, nausea, headache, fatigue, armpit sore on arm of injection and elbow achiness in arm of injection was unknown at the time of this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Injection Site soreness.; General body soreness; Nausea; Headache; Fatigue; Armpit sore on Arm of injection; Elbow achiness in arm of injection; Dose 3 received; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PF8841) via an unspecified route of administration on 21Oct2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine.  The patient previously took pentothal sodium (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 01Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 11Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 22Oc2021, the patient experienced injection site soreness, general body soreness, nausea, headache, fatigue, armpit sore on arm of injection and elbow achiness in arm of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness, general body soreness, nausea, headache, fatigue, armpit sore on arm of injection and elbow achiness in arm of injection was unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Epistaxis, Suspected COVID-19
Clinical narrative: symptoms of Covid; symptoms of Covid; excessive bleeding from nose; This is a spontaneous report from a non-contactable consumer (patient's sister) Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Calling for her sister who took the 1st dose of the Covid vaccine and was experiencing excessive bleeding from nose and symptoms of Covid. Wondering if this was side effect from the Covid vaccine. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Weight, Weight decreased
Clinical narrative: heart attack; lost 30+lbs; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. Medical history included that the patient was considered obese at time of receiving vaccine. The patient had no prior heart conditions or challenges breathing. The patient's concomitant medications were not reported. The patient experienced heart attack and lost 30+lbs on an unspecified date. The patient underwent lab tests and procedures which included weight: has since lost 30+ lbs. on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: inflammation of my left, behind my boob; had a 1.1 centimeter lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2593, Expiry date: unknown) via an unspecified route of administration on 20Oct2021 as dose 3 (booster), single for COVID-19 immunization. Medical history included pulmonary embolism from an unknown date and unknown if ongoing, patient is a cardiac patient from an unknown date and unknown if ongoing. Patient previously took first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient's concomitant medications were not reported. On unspecified date of Oct2021 the patient experienced inflammation of my left, behind my boob and had a 1.1-centimetre lymphadenopathy and on 20Oct2021 the patient had his booster dose and off-label use. Patient just got home from a visit to emergency room and one of the things that was going on and patient had these things in list as possible side effect. Patient read about it around the injection site, surrounding the injection site, maybe the arm but this in patient's boob. The outcome of events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular, Urinary tract infection
Clinical narrative: I had red blotches on lower abdomen, upper thigh, breast, underarms, a beak; Reaction to vaccine -possible body redness; UTI; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 17Mar2021 08:00 (Lot Number: EN6204) (at the age of 69-years-old) as dose 2, single for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), osteoporosis (Recast infusion), supraventricular tachycardia, arthritis, gastroparesis, cholesterol, penicillin allergy and UTI (urinary tract infection). Patient's family medical history included parkinson's, dementia, stomach cancer, colon cancer. Concomitant medications included levofloxacin taken for urinary tract infection from 16Mar2021 to 19Mar2021; atorvastatin calcium (LIPITOL) taken for blood cholesterol from an unspecified start date and ongoing; omeprazole taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; calcium taken for osteoporosis from an unspecified start date and ongoing; vitamin D3 taken for osteoporosis, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 24Feb2021 08:10 (Lot Number: EN6200) (at the age of 69-years-old) as dose 1, single for covid-19 immunisation. The patient previously took bactrim and experienced allergy. Two days after second vaccine on 19Mar2021, patient had red blotches on lower abdomen, upper thigh, breast, underarms, a beak. She also had a UTI (current condition) and thought she was having a reaction to levofloxacin. On 19Mar2021, patient had reaction to vaccine -possible body redness. The patient did not receive treatment for red blotches and body redness. Patient on unspecified date in 2021, patient had UTI. The patient received Macrobid orally for UTI from 20Sep2021 till 27Sep2021 as treatment. The outcome of red blotches and redness generalised was recovered in 2021 and outcome of urinary tract infection was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Decreased appetite, Fatigue, Headache
Clinical narrative: Headache; Fever; Body ache; Weakness; Fatigue; Severe lower back pain; Flu; Felt so ill; did not have an appetite for a week; This is a spontaneous report from a contactable consumer (patient) reported for herself in response to non-Health Care Professional letter. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8730), via intramuscular route of administration in right upper arm on 26Mar2021 at 14:10 (at the age of 61 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199), via intramuscular route of administration in right upper arm on 05Mar2021 at 02:10 PM (at the age of 61 years old) for covid-19 immunisation and patient experienced headache, fever, body aches, weakness, fatigue, severe lower back pain, flu, felt so ill. She saw her physician after her second dose because she did not have an appetite for a week after the vaccine in 2021. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understands that all these are possible side effects after receiving the vaccine on Mar2021. She felt like she had the flu after each dose. Her Symptoms began the night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. No relevant tests were performed. The events resulted in physician office visit. The patient did not received treatment due to the did not have an appetite for a week. The outcome of did not have an appetite for a week was recovered on an unspecified date in 2021, while with other events was unknown.   Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise, Pain, Pyrexia
Clinical narrative: Headache; Fever; Body ache; Weakness; Fatigue; Severe lower back pain; Flu; Felt so ill; did not have an appetite for a week; This is a spontaneous report from a contactable consumer (patient) reported for herself in response to non-Health Care Professional letter. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8730), via intramuscular route of administration in right upper arm on 26Mar2021 at 14:10 (at the age of 61 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199), via intramuscular route of administration in right upper arm on 05Mar2021 at 02:10 PM (at the age of 61 years old) for covid-19 immunisation and patient experienced headache, fever, body aches, weakness, fatigue, severe lower back pain, flu, felt so ill. She saw her physician after her second dose because she did not have an appetite for a week after the vaccine in 2021. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understands that all these are possible side effects after receiving the vaccine on Mar2021. She felt like she had the flu after each dose. Her Symptoms began the night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. No relevant tests were performed. The events resulted in physician office visit. The patient did not received treatment due to the did not have an appetite for a week. The outcome of did not have an appetite for a week was recovered on an unspecified date in 2021, while with other events was unknown.   Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Crying, Feeling abnormal, Pruritus
Clinical narrative: severe pruritis; rashes; , terrible, severe she would stand in the corner scratching her head and crying so bad.  It started at her head then escalated to her entire body- back, neck, stomach; Five months later she developed hive, terrible, severe, It started at her head then escalated to her entire body- back, neck, stomach,; UTI infections; Crying so bad; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (COVID 19 VACCINE, mRNA, solution for injection, Lot Number: EN6201, Expiry Date: Unknown, NDC Number: Unknown), dose 2 via an unspecified route of administration on 16Feb2021 (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. No PQC was present. Investigation assessment was done. Medical history included ongoing osteopetrosis, Lymph node. The patient previously took bnt162b2 (COVID 19 VACCINE, mRNA, solution for injection, Lot Number: EL9261), dose 1 via an unspecified route of administration on 26Jan2021 (at the age of 74 years old) as dose 1, single for COVID-19 immunisation. Concomitant medication(s) included Prolia taken for osteopetrosis. On Jul2021, the patient experienced five months later she developed hive, terrible, severe she would stand in the corner scratching her head and crying so bad, it started at her head then escalated to her entire body- back, neck, stomach, severe pruritis, rashes. On an unspecified date of 2021, the patient experienced UTI infections, crying so bad. The patient underwent lab tests and procedures which included biopsy resulted unknown on an unspecified date of 2021, blood test resulted unknown on an unspecified date 2021 blood was affected again (further not clarified), ultrasound scan resulted unknown on an unspecified date 2021. Therapeutic measures were taken as a result of five months later she developed hive, terrible, severe she would stand in the corner scratching her head and crying so bad, it started at her head then escalated to her entire body- back, neck, stomach, severe pruritis, rashes, UTI infections, crying so bad. Reporter stated that she was afraid to get the booster, but she was also afraid of not getting the booster and not having full coverage from Covid. She has seen every doctor and allergist about this. Reporter stated I am still going to doctor. Now I got to go to haematologist, and I am trying to figure it out why it just happened to me so I went out on the website so there was couple of cases reported of chronic idiopathic hive, so I want to make sure before I have the booster if it was safe for me to go for this booster. All those things I am not allergic (not clarified), I have never had a problem with my dentist, my endocrinologist, dermatologist radiologist everybody, neurologist to everybody. The clinical outcome of the events was reported as unknown.  Further information needed. Further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Ultrasound scan, Urinary tract infection, Urticaria
Clinical narrative: severe pruritis; rashes; , terrible, severe she would stand in the corner scratching her head and crying so bad.  It started at her head then escalated to her entire body- back, neck, stomach; Five months later she developed hive, terrible, severe, It started at her head then escalated to her entire body- back, neck, stomach,; UTI infections; Crying so bad; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (COVID 19 VACCINE, mRNA, solution for injection, Lot Number: EN6201, Expiry Date: Unknown, NDC Number: Unknown), dose 2 via an unspecified route of administration on 16Feb2021 (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. No PQC was present. Investigation assessment was done. Medical history included ongoing osteopetrosis, Lymph node. The patient previously took bnt162b2 (COVID 19 VACCINE, mRNA, solution for injection, Lot Number: EL9261), dose 1 via an unspecified route of administration on 26Jan2021 (at the age of 74 years old) as dose 1, single for COVID-19 immunisation. Concomitant medication(s) included Prolia taken for osteopetrosis. On Jul2021, the patient experienced five months later she developed hive, terrible, severe she would stand in the corner scratching her head and crying so bad, it started at her head then escalated to her entire body- back, neck, stomach, severe pruritis, rashes. On an unspecified date of 2021, the patient experienced UTI infections, crying so bad. The patient underwent lab tests and procedures which included biopsy resulted unknown on an unspecified date of 2021, blood test resulted unknown on an unspecified date 2021 blood was affected again (further not clarified), ultrasound scan resulted unknown on an unspecified date 2021. Therapeutic measures were taken as a result of five months later she developed hive, terrible, severe she would stand in the corner scratching her head and crying so bad, it started at her head then escalated to her entire body- back, neck, stomach, severe pruritis, rashes, UTI infections, crying so bad. Reporter stated that she was afraid to get the booster, but she was also afraid of not getting the booster and not having full coverage from Covid. She has seen every doctor and allergist about this. Reporter stated I am still going to doctor. Now I got to go to haematologist, and I am trying to figure it out why it just happened to me so I went out on the website so there was couple of cases reported of chronic idiopathic hive, so I want to make sure before I have the booster if it was safe for me to go for this booster. All those things I am not allergic (not clarified), I have never had a problem with my dentist, my endocrinologist, dermatologist radiologist everybody, neurologist to everybody. The clinical outcome of the events was reported as unknown.  Further information needed. Further information is expected.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: acute renal failure; This is a spontaneous report from a contactable physician. This report was received via a sales representative. Reporter is sister of patient and a physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: 301558A), via an unspecified route of administration on 29Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included zoledronic acid (RECLAST) taken for an unspecified indication from 14Oct2021.I first heard of the patient(s) condition on 24th but did not understand that COVID-19 vaccine was implicated until 25th (understood that reclast was implicated prior). The patient experienced acute renal failure on an unspecified date. Patient developed acute renal failure requiring ICU admission. Still admitted as of 25Oct2021.The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Acute kidney injury and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood clot on an unspecified date. It was reported that the event took place after use of product. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Influenza like illness, Loss of control of legs, Muscular weakness
Clinical narrative: When I tried to stand up in the morning My legs collapsed and I couldn't stand; I couldn't stand; Heart pounding, racing for 16 hrs.; My legs felt weak; worst headache for over a week .; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3151), via an unspecified route of administration, administered in right arm on 27Aug2021 at 16:00 (at the age of 58-years) as dose 1, single for covid-19 immunization. The patient medical history included Arthritis, allergies, fibromyalgia, hiatal hernia, barrettes esophagus. The patient also had known allergies to Sulfa. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks prior Covid vaccination. The patient's concomitant medications included tramadol; rabeprazole sodium (ACIPHEX); pantoprazole; anastrozole and Mov. The patient had not been diagnosed with COVID-19 prior to vaccination. After vaccination on 28Aug2021, the patient reported that she had her heart pounding, racing for 16 hrs. When she tried to stand up in the morning, her legs collapsed, and she could not stand. That happened three times then fifteen minutes later, her legs felt weak, but she was able to stand. She also had worst headache for over a week and flu like symptoms. The patient had not received any treatment for the events. The patient was tested post vaccination and the nasal swab for sars-cov-2 test showed negative result. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: When I tried to stand up in the morning My legs collapsed and I couldn't stand; I couldn't stand; Heart pounding, racing for 16 hrs.; My legs felt weak; worst headache for over a week .; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3151), via an unspecified route of administration, administered in right arm on 27Aug2021 at 16:00 (at the age of 58-years) as dose 1, single for covid-19 immunization. The patient medical history included Arthritis, allergies, fibromyalgia, hiatal hernia, barrettes esophagus. The patient also had known allergies to Sulfa. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks prior Covid vaccination. The patient's concomitant medications included tramadol; rabeprazole sodium (ACIPHEX); pantoprazole; anastrozole and Mov. The patient had not been diagnosed with COVID-19 prior to vaccination. After vaccination on 28Aug2021, the patient reported that she had her heart pounding, racing for 16 hrs. When she tried to stand up in the morning, her legs collapsed, and she could not stand. That happened three times then fifteen minutes later, her legs felt weak, but she was able to stand. She also had worst headache for over a week and flu like symptoms. The patient had not received any treatment for the events. The patient was tested post vaccination and the nasal swab for sars-cov-2 test showed negative result. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nephritis
Clinical narrative: Inflamed Kidneys; This is a spontaneous report from a contactable consumer or other non-health care professional. A adult male patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Oct2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reason for why batch/lot is unknow was reported as not available/provided to reporter at the time of report completion. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination and It was unknown if the patient had been tested for COVID-19 since the vaccination. On 25Oct2021, the patient experienced inflamed kidneys. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of inflamed kidneys. The clinical outcome of event was reported as recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pruritus, Pyrexia
Clinical narrative: itchy; migraine; fever; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 30Aug2021 11:00 (at the age of 49-year-old) (Batch/Lot Number: FC3184) as single dose for COVID-19 immunisation. Relevant medical history included hypertension, COVID-19 from 22Jun2020 to an unknown date and ongoing migraine. It was unknown if the patient was pregnant. Concomitant medications included olmesartan taken for high blood pressure from 2020 and ongoing; hydrochlorothiazide taken as water pill from 2020 to an unspecified stop date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Aug2021 (at the age of 49-year-old) (Batch/Lot number FA7484) for COVID-19 immunisation and experienced itching, migraine aggravated, eyeball soreness, fever, myalgia, sensitivity of teeth, sweating, vomiting, nauseous, blurry vision, headache, rash and foggy feeling in head. In Aug2021, after the second dose of the vaccine, the patient experienced itchy (medically significant), migraine (non-serious) and fever (non-serious). Corrective treatments taken as a result of the events included: paracetamol (TYLENOL) for fever, "EXCEDRIN" for migraine and diphenhydramine hydrochloride (BENADRYL) for itching. The patient recovered from the events in 2021. Duration of itchy and migraine was 3 days; duration of fever was 4 days.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101043898 same patient, different events after different doses of the vaccine