chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dyspnoea, Fatigue, Loss of consciousness
Clinical narrative: collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded.  Case will be re-assessed upon the additional information provided. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: son received first shot of the vaccine but tested positive; son received first shot of the vaccine but tested positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (parent) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The son received first shot of the vaccine but tested positive on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She reports having an allergic reaction to a supplement; This is a spontaneous report from Pfizer Sponsored Program.  A contactable female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had an allergic reaction to a supplement. She wanted to know if she can take prednisone to treat that reaction, she was concerned by the possible effect of prednisone on her vaccine doses. she scheduled for her second dose of the Pfizer-Biontech Covid19 vaccine on 02May2021. The Outcome of the event was unknown.     No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Dizziness, Headache
Clinical narrative: felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Nausea, Palpitations
Clinical narrative: felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor
Clinical narrative: felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: first dose on 22Mar2021, tested positive for SARS-Cov-2 on 31Mar2021/tested positive for CoVid March 31st; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 22Mar2021 (Lot number: unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On 31Mar2021, the patient experienced first dose on 22mar2021, tested positive for sars-cov-2 on 31mar2021/tested positive for COVID march 31st. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 31Mar2021. The patient was scheduled for second dose for on 12Apr2021 (day if reporting) and was looking for recommendation. The patient also asked about the interval for second dose, how it is given and whether the patient should have 2nd dose of vaccine or not. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A Fib; This is a spontaneous report from a contactable consumer received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient went into A Fib after receiving the vaccine. The patient was treated in the hospital and received a blood transfusion. The outcome of the event was unknown.  Information on lot/batch number should be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Loss of personal independence in daily activities, Pain
Clinical narrative: flu like symptoms; extremely fatigued; headache; I could do nothing; ached all over/aching; This is a spontaneous report from a consumer (patient). An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown; expiry date: not known), first dose via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. After the 2nd shot of the Pfizer covid 19 vaccine, she had 48 hours of flu like symptoms, aching, extremely fatigued, headache that went away, just like someone opened the blinds, very quickly, 5 weeks from last shot, and got the same symptoms and they lasted for 7 days. she could do nothing, went from the couch to the bed, ached all over. The patient had went to urgent care, had two swabs in 48 hours, negative for covid, swabs one done at drugstore on Thursday and Saturday went to urgent care and both were negative. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: flu like symptoms; extremely fatigued; headache; I could do nothing; ached all over/aching; This is a spontaneous report from a consumer (patient). An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown; expiry date: not known), first dose via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. After the 2nd shot of the Pfizer covid 19 vaccine, she had 48 hours of flu like symptoms, aching, extremely fatigued, headache that went away, just like someone opened the blinds, very quickly, 5 weeks from last shot, and got the same symptoms and they lasted for 7 days. she could do nothing, went from the couch to the bed, ached all over. The patient had went to urgent care, had two swabs in 48 hours, negative for covid, swabs one done at drugstore on Thursday and Saturday went to urgent care and both were negative. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer. A contactable consumer (wife) reported for an 83-year-old male patient (husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 11Mar2021 through unspecified route of administration single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. he patient historical vaccine included first dose BNT162B2 through unspecified route of administration single dose for COVID-19 immunization. Immediately after the shot he developed reddish/blue like color around injection site on 11Mar2021. The reporter stated that "Soon after the second dose," he developed a rash on his arm and legs, described as itchy in Mar2021. He had no side effects after the first dose. The reporter also stated that he has not taken blood thinners in 2 years. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiac flutter, Dyspnoea, Heart rate, Heart rate irregular, Oropharyngeal discomfort
Clinical narrative: Patient could feel it in her throat for a couple of days; heart flutter; shortness of breath; heartbeat was irregular; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Mar2021 (Lot Number: EN6207; Expiration Date: 31Jul2021) as single dose for COVID-19 immunization and Glatiramer acetate, via an unspecified route of administration from 22Mar2021 at 40 mg, unknown frequency for an unspecified indication. Medical history included multiple sclerosis (MS), diagnosed on 25Feb2021. The patient's concomitant medications were not reported. On 22Mar2021, with the first dose of Glatiramer Acetate, patient experienced shortness of breath and heart flutter, like her heartbeat was irregular. Patient could feel it in her throat for a couple of days since on an unspecified date. The action taken in response to the events for Glatiramer acetate was unknown. Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had the first dose on 22Mar2021 and tested positive with Covid-19; had the first dose on 22Mar2021 and tested positive with Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose and tested positive with Covid-19 in Mar2021. His second dose was due on 12Apr2021 and he would like to know if he still needs to take the second dose. Outcome of event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 15:00 (Lot Number: Er8737) as single dose (at the age of 44-years-old) for covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. There were no concomitant medications in two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 08Apr2021 06:00 patient experienced bells palsy. Event resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures taken as a result of bells palsy included antibiotics and steroids. Patient had not recovered from the event, at the time of the report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Pain at base of left thumb inflammation.; Pain at base of left thumb inflammation.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EN6199), via an unspecified route of administration in right arm on 18Feb2021 at 10:30 AM (at the age of 61-year-old) at a single dose, for COVID-19 immunization. Medical history included high blood pressure, hypothyroidism and psoriasis. The patient had no allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ). The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced pain at base of left thumb inflammation on 22Feb2021 at 12:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. The outcome of the events was not recovered. The second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6199) was administered, via an unspecified route of administration, in left arm on 11Mar2021 at 11:00 AM at a single dose for COVID-19 immunization.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: dizziness/dizzy spells; it is like a vasovagal response; This is a spontaneous case is received from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (Batch/Lot number was not reported) as SINGLE DOSE on 08Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On 10Apr2021 the patient experienced dizziness/dizzy spells (dizziness) and also reported it is like a vasovagal response (presyncope). The patient reported it is like a vasovagal response that happens 24 hours a day, 7 days a week. The patient was upset when informed that dizziness was not reported in the clinical trials as a side effect of the vaccine. Caller states he regrets taking the vaccine. "I am going to proceed legal action against you." "See you in court". The outcome of the events was unknown.  Follow-up (12Apr2021): New information received from the same contactable consumer (patient).  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms on side of injection in neck and face; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 30-years-old) at 14.15 at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient had no known allergies including allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior and was not pregnant. The patient had not been tested for COVID-19 since the vaccination. The patient experienced muscle spasms on side of injection in neck and face on 11Apr2021. The event was reported as non-serious. No treatment was received for the event. The patient was recovering the event.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive for Covid-19 even though fully vaccinated; tested positive for Covid-19 even though fully vaccinated; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 28Jan2021 (Batch/Lot number and expiry was not reported) as single dose, and second dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered in arm left on 18Feb2021 (Batch/Lot number and expiry was not reported) as single dose, both for covid-19 immunisation at clinic (at the age of 29years and was not pregnant). There was no other vaccine in four weeks and no covid and covid test prior vaccination was done. No Medical history was none and there were no known allergies. The patient's concomitant medications were not reported. On 08Apr2021, the patient tested positive for Covid-19 even though fully vaccinated and Covid-19 was confirmed on 10Apr2021 with lab tests SARS-COV-2 antibody test (via nasal swab with PCR test). The patient went to doctor or other healthcare professional office/clinic and however no therapeutic measures were taken. The outcome of the event tested positive for Covid-19 even though fully vaccinated was recovering. Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first dose on 19Mar2021 and was scheduled to have 2nd dose on 09Apr2021/tested positive for Covid19 on 07Apr2021; received first dose on 19Mar2021 and was scheduled to have 2nd dose on 09Apr2021/tested positive for Covid19 on 07Apr2021; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received her first dose on 19Mar2021 and was scheduled to have her second dose on 09Apr2021. Patient tested positive for COVID-19 on 07Apr2021 and missed her second dose. She wanted to know how soon should she be able to receive her second dose of vaccine. The outcome was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lower limb fracture
Clinical narrative: he recently broke his leg; This is a spontaneous report from a contactable consumer (reported as caregiver) via Medical Information Team and Pfizer-sponsored program COVAX US support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient recently broke his leg on an unspecified date after the first dose. He had a leg surgery last week in Apr2021 and was prescribed a blood thinner. Patient wanted to know if it was okay for him to take the medication before or after the second dose of vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got a COVID test today now I am positive for COVID /I got really sick; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration at an unknown anatomical location on an unknown date (age at vaccination was unknown) at a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient had Pfizer shot on Thursday and the patient got really sick after that next day Friday, Saturday and Sunday and is still sick, the patient went and got a COVID test today and now and is positive for COVID. The patient was asking whether the test was good or not. The patient still got to get the second one yet but just the patient didn't know if got, is that ruling out after his first shot or (the sentence was incomplete). The outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain in extremity, Pruritus
Clinical narrative: Her other arm started hurting as if she had gotten the shot in the other arm; spasms; she started having itchy hands/arms/face; headache; The is a spontaneous report received from contactable consumer. This 43-year-old female consumer (patient) reported that she had first dose BNT162B2 (Pfizer BIONTECH COVID19 vaccine) via unknown route of administration on 25Mar2021 at single for COVID-19 immunization. The patient medical history included of muscle spasms and nerve issues. She did not have an immediate allergic reaction. After she took the vaccine, it seemed to have set off these symptoms that she had before. She mentions that by evening time it started to spread. Her other arm started hurting as if she had gotten the shot in the other arm. She reached a peak a week later for the spasms and she started having itchy hands/arms/face in 2021. She had a headache after leaving the site that persisted for 1.5 weeks in 2021. She spoke to her doctor/doctor's office and they said to take Claritin and muscle relaxants before her next shot. She read online (CDC) that people should not pre-medicate before the vaccine. It's been 2.5 weeks now; her second appointment is scheduled on Friday. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer-Sponsored-Program. A contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 then the second dose was admministered  via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid-19 vaccine (both rapid test and pcr test) on 16Mar2021. COVID-19 confirmed by positive COVID-19 test. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: 8 days after vaccination, a rash-type reaction on skin started at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8734), via an unspecified route of administration, in left arm on 02Apr2021 at 17:00 (at the age of 34-year-old) at single dose for COVID-19 immunization. The patient did not have medical history and did not receive concomitant medications. The patient doesn't have any known allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. Eight days after vaccination, the patient experienced a rash-type reaction on skin started at injection site, on 10Apr2021 at 12:00. The patient was not treated for the event. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: right leg started hurting; have a rash on the right leg; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 09Apr2021, as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 09Apr2021, the patient right leg started hurting, it was the same side where patient took the vaccine. It was reported that patient took shower and had a rash on the right leg. The HCP advised the patient to take Benadryl through phone and a cortisone cream and if that doesn't help in 2 days to call her back again for follow up. Therapeutic measures were taken as result of events. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: I'm feeling really exhausted all of the sudden; experience a fever up to 101.9; he experienced soreness in his arm; This is a spontaneous report received from a contactable consumer (parent). An 18-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8737) via unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 21Mar2021 for COVID-19 immunization. On 11Apr2021, the patient experienced soreness in his arm (last night) and at 20:30 the patient felt really exhausted all of the sudden and experienced a fever up to 101.9. The patient wanted to know whether fevers go that high after getting the vaccine. The outcome of the events was unknown.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got the first dose; however they have tested positive for COVID 19 Virus; got the first dose; however they have tested positive for COVID 19 Virus; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer Sponsored Program . A 55-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206, expiry: not reported (vaccination card did not show the expiration date), age of vaccination: 55 years), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. He said that he and his wife got the first dose; however, they have tested positive for Covid 19 virus on 01Apr2021 (after 16 days latency, we tested positive last week) with lab tests Covid 19 virus (SARS-COV-2 test). His wife was in same condition also. Now they want to know if they can take the second dose tomorrow or reschedule it. Second due date of vaccine was confirmed. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021395968 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site swelling
Clinical narrative: swelling in her arm pit/ swelling between her shoulder and her neck that was visible; It hurts and is very uncomfortable; off the injection site was higher up on her arm than normal; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via an unspecified route of administration on 09Apr2021 (lot number: EW0162) as single dose for COVID-19 immunisation. The patient medical history included receiving prior flu and shingles vaccine. The patient's concomitant medications were not reported. As reported, the patient received the vaccine of the Pfizer Covid 19 vaccine on Friday. She stated she had swelling in her arm pit and it was uneasy to put her arm by her side. It hurt and was very uncomfortable. She kind of had to keep her arm away from her body. She also reported swelling between her shoulder and her neck that was visible. When she took the band aid, off the injection site was higher up on her arm than normal. The report was reported as non-serious. The outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got sick with COVID 5 days later with mild symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 12Mar2021 (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked when was best time to get second dose of COVID-19 vaccine, after the patient got the first dose on 12Mar2021, then got sick with COVID 5 days later with mild symptoms on 17Mar2021. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: He is tested positive for Covid; He is tested positive for Covid.; This is a spontaneous report received from Pfizer sponsored Program. A contactable male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 07Apr2021 as Single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient went to the clinic because he had bad allergies and get tested, found that he tested positive for COVID-19. The outcome for events were unknown,  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm near injection site; This is a spontaneous report received from a contactable consumer (patient herself). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247, Expiry date: Unknown) administered intramuscularly in arm left on 21Jan2021 09:00 as single dose for COVID-19 immunisation. Patient was not pregnant. Family history included Kidney-related health issues and patient's medical history was none. There were no concomitant medications and no prior vaccination within 4 weeks. On 21Jan2021 09:00, the patient experienced sore arm rear injection site. Therapeutic measures were taken with Advil. The outcome of sore arm rear injection site was recovered on 24Jan2021.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Vaccination site erythema
Clinical narrative: cold sweats; a red hot spot the size of a golf ball appeared over the injection site; This is a spontaneous report from a contactable consumer (the patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 31Mar2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. It was stated that (tonight, as reported) on 08Apr2021, the patient experienced a red hot spot the size of a golf ball appeared over the injection site and cold sweats. The outcome of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I've had horrible hot flashes from menopause for 4 years. Since 2nd dose I've had only 1 or 2 minor flashes; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program .  A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had both doses of covid vaccine. One great side effect has lasted more than 2 weeks. On an unspecified date the patient experienced i've had horrible hot flashes from menopause for 4 years. Since 2nd dose i've had only 1 or 2 minor flashes. Patient wanted to know could the vaccine have done that. The outcome of the event was unknown.   Follow-up (12Apr2021): This Follow-up report contains no new safety information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid 19 today; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not reported), via intramuscular on 08Apr2021 (at the age of 36-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Apr2021, patient was tested positive for Covid 19 today. Patient underwent Covid test on 12Apr2021 and result was positive. As reported, there was unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Pain in extremity, Pyrexia
Clinical narrative: had some pain in his arm; fever of 101 degrees Fahrenheit; felt sick all night; felt some chills; This is a initial spontaneous report received from a contactable consumer. A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. Medical history included some heart problem ongoing (underlying condition). The patient's concomitant medications were not reported. After receiving the immunisation, the patient experienced fever of 101 degrees Fahrenheit (Body temperature), felt sick all night, felt some chills, no nausea, also had some pain in his arm. Patient had some underlying condition like heart problem. The outcome for all the events were unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives/broke out in hives; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer Sponsored Program COVAX US Support. A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date not reported), via an unspecified route of administration on Mar2021, as single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that patient received first dose of the Covid vaccine two weeks ago (on Mar2021). And reports 3 days after administration of the first dose, he had hives/broke out in hives, They went away quickly, gone after 1.5-2 days. Patient asked if he can get the second dose. He wants to know if this was part of the normal reaction to the vaccine and was asking what is the difference between immediate reactions and adverse reactions. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: he recently tested positive for the virus; he recently tested positive for the virus; he has is a head cold; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received series , last one was on 08Feb2021 and he recently (unspecified date) tested positive for the virus. The patient was asking how can that happen with the series on board. He stated all he has is a head cold. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Had hives and rash; Had hives and rash; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives and rash. The events were assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.