chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Thirst, Vaccination site erythema, Vaccination site swelling
Clinical narrative: sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient).  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation.   The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot.   Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s.     The patient's concomitant medications were not reported.  The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6.  Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site.  Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for fever and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient).  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation.   The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot.   Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s.     The patient's concomitant medications were not reported.  The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6.  Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site.  Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for fever and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23Mar2021 at 08:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and Tourette's syndrome from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on 23Feb2021 at 10:30 A.M. (at the age of 41-years-old), administered in right arm for COVID-19 immunisation. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine and birth control pills, all taken for an unspecified indication, start and stop date were not reported. The patient experienced grand mal seizure on 07Apr2021. The patient was hospitalized for grand mal seizure for 2 days. Therapeutic measures were taken as a result of grand mal seizure (anti-seizure medication). The outcome of the event was recovered with sequelae on an unspecified date.    Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: very sore arm; experienced fever; headache; chills; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received BNT162B2, dose 2, via intramuscular on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history included type 2 diabetes. Concomitant medications included trilobite, metformin, and insulin glargine (LANTUS) taken for type 2 diabetes. The patient received her second covid vaccine on 06Apr2021. On 07Apr2021 experienced fever, headache, chills, very sore arm. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Injection Site Discomfort; This is a spontaneous report received to Pfizer from Novartis (Reference no: NUS2021US048284). A contactable consumer or other non-health professional reported for female patient. A 89-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: unknown Expiry date: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced injection site discomfort on an unspecified date. The outcome of all events was unknown.   No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm soreness on the injection site; This is a spontaneous report received from a contactable female consumer from a Pfizer sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 10Mar2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose on 07Apr2021. Medical history and concomitant medication was not reported. Caller, on behalf of her Boss asking if it was okay not having any side effects after getting the second dose of the vaccine today, 07Apr2021 and if receiving the second dose of the vaccine 4 weeks later from the first dose given on 10Mar2021 instead of getting it in 3 weeks and which was not as expected based from what they heard about the second dose side effects, considering also her Boss had some side effects after the first dose of the vaccine. She mentioned the side effects of her Boss felt after the first dose of the vaccine which was arm soreness on the injection site on unspecified date in 2021. 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: patient who recieved first dose 3/20 and tested positive for covid 2 days later; This is a spontaneous report received from a contactable Other HCP (nurse) via Pfizer sponsored program. A unspecified age and gender of a patient received first dose of BNT162B2(BNT162B2,Covid-19 Vaccine, formulation solution for injection lot number and expired date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Lab test included covid positive after 2 days later, the patient tested positive for covid. nurse calling for patient who recieved first dose 3/20 and tested positive for covid 2 days later, would like to know if ok to administer second dose read ISI, cold transfer due to hold time to PMI,The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous report from a contactable consumer (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration in the right arm, on 24Mar2021 15:45, as single dose, for COVID-19 immunisation. Medical history included DCIS stage 0 in left breast in 2017 and known allergies to sulfa based medications. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 26Mar2021, the patient began to experience rapid heart rate and heaviness in her chest. She went to the hospital and was admitted for 1 day on an unspecified date. It was reported that after so many tests (unspecified) in Mar2021, they found nothing. The patient felt light-headed and felt like she needed to catch her breath. Her heartbeat was prominent at times. At the time of the report, the patient was wearing a heart holster for 48 hours. The events resulted to emergency room and physician's office visits. Treatment for the events was reported as unknown. The patient had COVID-19 Nasal Swab in 31Mar2021 and was negative. The outcome of light-headed and need to catch breath was not resolved; and the outcome of rapid heart rate and heaviness in chest was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, SARS-CoV-2 test
Clinical narrative: rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous report from a contactable consumer (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration in the right arm, on 24Mar2021 15:45, as single dose, for COVID-19 immunisation. Medical history included DCIS stage 0 in left breast in 2017 and known allergies to sulfa based medications. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 26Mar2021, the patient began to experience rapid heart rate and heaviness in her chest. She went to the hospital and was admitted for 1 day on an unspecified date. It was reported that after so many tests (unspecified) in Mar2021, they found nothing. The patient felt light-headed and felt like she needed to catch her breath. Her heartbeat was prominent at times. At the time of the report, the patient was wearing a heart holster for 48 hours. The events resulted to emergency room and physician's office visits. Treatment for the events was reported as unknown. The patient had COVID-19 Nasal Swab in 31Mar2021 and was negative. The outcome of light-headed and need to catch breath was not resolved; and the outcome of rapid heart rate and heaviness in chest was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Oedema peripheral
Clinical narrative: edema in my right foot; broke out in these water blisters on foot; This is a spontaneous report received from a contactable consumer. This 66-year-old-female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  The medical history and concomitant medications were not reported. Historical vaccine included the first does of BNT162B2 on 06Feb2021 (66-year-old) (Batch/Lot Number: EL1264) for covid-19 immunisation. Patient didn't have any side-effects immediately for about 2 weeks later after it she felt having some edema in her right foot only and broke out in these water blisters on foot on 14Mar2021 with outcome of unknown, and she wondered if anything was connected with vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Deafness, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigue; Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration in the left arm, on 06Apr2021 15:00, as single dose, for COVID-19 immunisation. Medical history included blood clot. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, therapy dates not reported. The patient did not have COVID-19 prior to vaccination and had not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) received at age 42 years, via an unspecified route of administration in the left arm, on 12Mar2021 16:45, for COVID-19 immunization, and  within 24 hours, the patient experienced tinnitus in left ear and cannot hear out of it at all which took two weeks to return after the first dose. The patient did not receive other vaccines in for weeks. On 06Apr2021, the patient received the second dose. On 07Apr2021 at 02:30, the patient had tinnitus in his left ear and could not hear out of it at all. On 07Apr2021 at 03:00, 12 hours after the injection, the patient had a fever of 101 along with headache, muscle soreness and stiffness, and extreme fatigue. No treatment was given for the events. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigue; Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration in the left arm, on 06Apr2021 15:00, as single dose, for COVID-19 immunisation. Medical history included blood clot. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, therapy dates not reported. The patient did not have COVID-19 prior to vaccination and had not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) received at age 42 years, via an unspecified route of administration in the left arm, on 12Mar2021 16:45, for COVID-19 immunization, and  within 24 hours, the patient experienced tinnitus in left ear and cannot hear out of it at all which took two weeks to return after the first dose. The patient did not receive other vaccines in for weeks. On 06Apr2021, the patient received the second dose. On 07Apr2021 at 02:30, the patient had tinnitus in his left ear and could not hear out of it at all. On 07Apr2021 at 03:00, 12 hours after the injection, the patient had a fever of 101 along with headache, muscle soreness and stiffness, and extreme fatigue. No treatment was given for the events. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: if he got his 1st dose and then got Covid; if he got his 1st dose and then got Covid; This is a spontaneous report from a Pfizer-sponsored program from a contactable male consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient diagnosed, if he got his 1st dose and then got covid (drug ineffective). The clinical outcome of the event was unknown. 2nd dose was scheduled for 4 weeks.   Information about Batch/Lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Urine analysis
Clinical narrative: find one case of someone else experiencing a bladder problem after the vaccination; This is a spontaneous case is received reported from a contactable consumer or other non HCP. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date: UNKNOWN) via an unspecified route of administration on 04Feb2021 17:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that she looked up a report and was able to find one case of someone else experiencing a bladder problem after the vaccination on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included urine analysis: no result on.   No follow-up attempts are needed information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, Sneezing
Clinical narrative: Severe sneezing; runny nose; cough; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. When probed for concern, patient had the Pfizer Covid vaccine, last weeks, "3" (not clarified) weeks ago, and after that patient had to second one (second shot) more over 2 weeks ago. After first shot for 4 days patient had severe sneezing and a runny nose that really went away, the second shot patient really noticed that patient had a shot or anything and now with the second one and about 2 week now patient had severe sneezing again and patient got this runny nose, nothing seems to stop. Asked if these were side effects. When paraphrased the concern with Pfizer, Covid vaccine, patient got with the first one for 4 days, patient had just "cough" (not clarified) and sneezing and during the time patient had runny nose, it persisted. And with the second patient did not have the problems 2 weeks but all of sudden runny nose and sneezing again, runny nose persist. Patient stated the first shot, patient had for 4 days severe sneezing night and day and a runny nose it was for few days and the second shot patient did not have any problem until 2 weeks after and now patient developed sneezing again and patient had it for 5 days and it just does not seems to be holding, patient had got a perfused runny nose again. Patient was informed about Pfizer Medical Information Department. Reporter seriousness for events was unspecified. Outcome of events was unknown. Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunization.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report from a contactable consumer (patient). A 69-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in arm left on 01Mar2021 at 04:00 as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication(s) included methotrexate. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. On 14Mar2021, the patient experienced COVID positive. On 14Mar2021, the patient underwent lab tests and procedures which included nasal swab positive. Therapeutic measures were taken as a result of COVID positive included monoclonal infusion. The outcome of event was recovered with sequelae.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Seizure
Clinical narrative: seizures; tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age (reported as Age: 65, Unit: Unknown) and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 30Mar2021 as a single dose for COVID-19 immunisation. Medical history included cancer. Concomitant medication included unspecified pills. The patient called in to find out how they could reschedule their appointment for their second dose of Pfizer-BioNTech COVID-19 vaccine. During the call, the patient stated "I have seizures, I got a shot but I was supposed to get another today but I couldn't make it cause I have seizures. I have seizures so you have to be careful with me. You know when they shot you in your arm so you won't get sick. It's people in my building that was sick, sick from that stuff." When asked by the call agent if the patient was calling with regards to Pfizer-BioNTech COVID-19 vaccine. The patient stated "Yes, exactly I got the first shot on the 30th of March I got that shot that day, but I was supposed to come today, I should have been up there this morning but I didn't make it." The agent asked if the patient felt their seizure was brought on by the vaccine. The patient stated "No, I don't know, to be honest with you, I feel better I mean really feel better but I was scared because I know I should have got another shot. It's not because of where they shot me, it's just what I didn't do. I didn't take my pills. I got ran over my head so I have seizures if I don't take those pills then I'll have a seizure. It was not cause by the shot and it has nothing to do with where I'm at. It messed with me cause I hadn't taken my pills and that's what the problem was. I'm skinny anyway I will be for the rest of my life cause I had cancer. I'm sorry I'm just tired". The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The event "seizures" was most likely an underlying condition, unrelated to suspect vaccine BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Hepatic haemorrhage, Inappropriate schedule of product administration, Pneumonia, Product supply issue
Clinical narrative: liver bleed; pneumonia; kidney failure; Sepsis; lungs filled up with fluid; heart issues; were told they would need to wait 90 days as they were to far out of the date range; were told they would need to wait 90 days as they were to far out of the date range; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient's spouse) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 29Jan2021 and could not receive the second vaccine due to being hospitalized on an unspecified date due to gall bladder removal, sepsis, kidney failure, heart issues, lungs filled up with fluid, pneumonia, and liver bleed. The patient went to the facility to receive second vaccine and were told they would need to wait 90 days as they were to far out of the date range and was refused. The doctor refuses to administer the vaccine (other company) as they have started with the Pfizer vaccine. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema, Renal failure, Sepsis
Clinical narrative: liver bleed; pneumonia; kidney failure; Sepsis; lungs filled up with fluid; heart issues; were told they would need to wait 90 days as they were to far out of the date range; were told they would need to wait 90 days as they were to far out of the date range; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient's spouse) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 29Jan2021 and could not receive the second vaccine due to being hospitalized on an unspecified date due to gall bladder removal, sepsis, kidney failure, heart issues, lungs filled up with fluid, pneumonia, and liver bleed. The patient went to the facility to receive second vaccine and were told they would need to wait 90 days as they were to far out of the date range and was refused. The doctor refuses to administer the vaccine (other company) as they have started with the Pfizer vaccine. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She received her 1st dose last 17MAR2021 and she tested positive with Covid-Virus last 19MAR2021; This is a Spontaneous report received from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 17Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient wanted to cancel her second dose appointment because she had COVID-Virus. She was tested positive with COVID-Virus test on 19Mar2021. Outcome of the event was unknown.   No Follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Feeling sick; Having bad Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8733) on 27Mar2021 (at the age of 51-years-old) at single dose for COVID-19 immunization. Medical history included diabetes mellitus. Concomitant medications included ongoing liraglutide (VICTOZA injection) taken at 1.8 ml once a day, injected it came in needle for diabetes mellitus, ongoing metformin 500 mg taken at 500 mg twice a day for diabetes mellitus. The patient experienced feeling sick and having bad headache on 28Mar2021. She stated that she had been feeling sick every day since the day after she went, on 28Mar2021; Saturday night she stopped feeling sick, Sunday she had been sick and then this was been going on from last week until the reporting day; she still felt sick and it was more than 7 days, it was 8-9 days and she still felt sick. She just wanted to know what she could do (treatment) if she continued to feel sick. The patient had not recovered from feeling sick, the outcome of the other event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Callers son received 1st dose on Thursday 4/1 tested positive on Tuesday 4/6; This is a spontaneous report from a Pfizer sponsored program. A contactable non-healthcare professional reporter for a male of patient reported that the patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for Injection) as a single dose for COVID-19 immunization on 01Apr2021. The patient tested positive on Tuesday 06Apr2021 and would like to know more information about further process. The outcome of the event was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient didn't respond at all to the Pfizer COVID Vaccine; Patient didn't respond at all to the Pfizer COVID Vaccine; This is a spontaneous report based on the information received by Pfizer (Reference ID: NUS2021US049495). A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not respond at all to the Pfizer COVID Vaccine. He read somewhere that there is an interaction between Myfortic and COVID Vaccine. The patient stopped the medication so he can get the COVID Vaccine.  The outcome of the evets was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days; left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days; left leg weakness; low grade fever; nausea; dizziness; frontal and lt maxillary headaches for 7 weeks; This is a spontaneous report received from a contactable other HCP (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via Intramuscular in the right arm on an unspecified date 17:00 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route, in the right arm on 10Feb2021 16:15 as a single dose for COVID-19 immunization. Medical history included colon cancer (medication induced hon). The patient did not have any allergies. The patient was Covid-19 positive prior vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included amlodipine, multi vitamin, Zofran and dexamethasone all for unknown indications and from unknown dates and unknown if ongoing. No other vaccine was received in four weeks. The patient experienced left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days, left leg weakness, low grade fever, nausea, dizziness, frontal and lt maxillary headaches for 7 weeks on an unknown date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The patient did not receive any treatment for the events. Outcome of all the events were reported as recovered with sequale on an unknown date in 2021..; Sender's Comments: As there is limited information in the case provided, the causal association between the events hypoesthesia, fatigue, muscular weakness, nausea, dizziness, headache,pyrexia and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days; left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days; left leg weakness; low grade fever; nausea; dizziness; frontal and lt maxillary headaches for 7 weeks; This is a spontaneous report received from a contactable other HCP (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via Intramuscular in the right arm on an unspecified date 17:00 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route, in the right arm on 10Feb2021 16:15 as a single dose for COVID-19 immunization. Medical history included colon cancer (medication induced hon). The patient did not have any allergies. The patient was Covid-19 positive prior vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included amlodipine, multi vitamin, Zofran and dexamethasone all for unknown indications and from unknown dates and unknown if ongoing. No other vaccine was received in four weeks. The patient experienced left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days, left leg weakness, low grade fever, nausea, dizziness, frontal and lt maxillary headaches for 7 weeks on an unknown date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The patient did not receive any treatment for the events. Outcome of all the events were reported as recovered with sequale on an unknown date in 2021..; Sender's Comments: As there is limited information in the case provided, the causal association between the events hypoesthesia, fatigue, muscular weakness, nausea, dizziness, headache,pyrexia and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Headache, Hyperhidrosis, Nausea, Syncope
Clinical narrative: went to go lay back down/fainted; went to go lay back down; felt nauseous; Went to lay in bed and was sweating a lot; Before I fainted I had taken some ibuprofen for the headache; This is a spontaneous report from a contactable consumer patient(herself) reported. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown), via an unspecified route of administration in arm left on 10Apr2021 at 12:00 PM as single dose for covid-19 immunization. The patient historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EM9810, Expiration date: unknown), via an unspecified route of administration in left arm on 20Mar2021 at12:00 PM as single dose Covid-19 immunization. Patient medical history included fatty liver disease. Patient had known to allergies sulfa medication. Patient concomitant medication in two weeks included escitalopram oxalate (LEXAPRO), allergy medicine, allergy nasal spray. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the post vaccination. Patient experienced about 16 hours after the vaccine went to go lay back down, felt nauseous and fainted, got back up and fainted again. Went to lay in bed and was sweating a lot 11Apr2021 at 05:15 AM. Before fainted, patient had taken some ibuprofen for the headache. Patient not received treatment for the events. The outcome of the event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a contactable nurse. A 47-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date (received at 47-years-old) as single dose for COVID-19 immunization. The patient medical history included rheumatoid arthritis. It was unknown if patient was pregnant. Concomitant medications were not reported. The patient experienced increase in Rheumatoid arthritis pain due to being off medication for covid vaccine. She stated that MD (doctor) is aware and she was told to take aleve. Outcome of the event was not recovered.   Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information provided, the event "increase in Rheumatoid arthritis pain due to being off medication for covid vaccine" is likely to be an intercurrent event unrelated to the use of suspect product bnt162b2 (BNT162B2) in this 47-year-old female patient with underlying rheumatoid arthritis. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, SARS-CoV-2 test
Clinical narrative: Right eye ptosis that began 24 hours after vaccine administration and had not resolved 4 months later; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 06Jan2021 16:00 (at the age of 30-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history was none. No known allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; intrauterine contraceptive device (PARAGARD) taken for an unspecified indication, start and stop date were not reported. No Covid prior vaccination. No other vaccine in four weeks. It was reported that, Right eye ptosis that began 24 hours after vaccine administration (Jan2021) and had not resolved 4 months later. The patient had Planned surgery. AE resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. On 23Mar2021, the patient had Covid antigen tested post vaccination with nasal swab which was negative. Outcome of the event was not recovered.  Information about the Lot/batch number has been requested. ; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, eyelid ptosis cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Gait inability, Myalgia
Clinical narrative: Extreme Muscle pain in left leg; Can not walk; Blood work report abnormal; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 09:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Stroke 7 years ago. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 11Mar2021 10:00 AM in right arm for COVID-19 immunization at 70-years-old (lot number: 9W6205). On 02Apr2021, the patient experienced extreme muscle pain in left leg, can not walk, and blood work report abnormal. The events were assessed as serious (disability). The patient underwent lab tests and procedures which included blood test: abnormal on an unspecified date. Blood work report abnormal. The patient received treatment for the events: Ae treatment: Dr. adjusted Potassium and Diuretic Meds. The outcome of the events was not recovered.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Covid pneumonia; Covid pneumonia; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative.  A 91-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiration date was not reported) as single dose (at the age of 91-years-old) for COVID-19 immunisation. Medical history included covid-19: prior to vaccination. Concomitant medications were not reported. On an unspecified date, the patient had Covid pneumonia. The patient was tested post vaccination (unknown result). The patient was given an unspecified treatment for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: low grade, continuous ear ringing (tinnitus)/tinnitus became severe and is constant; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Mar2021 (lot number and expiry date were not reported) as a single dose (given at the age of 44 years old), and then dose 2 via an unspecified route of administration, administered in the left arm on 01Apr2021 12:30 (lot number and expiry date were not reported) as a single dose, for covid-19 immunisation. Medical history included blood pressure (abnormal), and patient had COVID over a year ago (date unspecified), and had lingering inflammatory issues since that time, but not tinnitus. The patient had no known allergies. Concomitant medications included unspecified blood pressure medications in two weeks prior to vaccination. The patient had no other vaccine in four weeks. It was reported that within a few days after the first shot, patient had low grade, continuous ear ringing (tinnitus) started (Mar2021). Patient went to the doctor, who thought it would resolve on its own and advised to get the second shot. The tinnitus did not resolve prior to the second shot (3 weeks later). Within 2 days of the second shot, the tinnitus became severe and was constant. Doctor prescribed a high dose cycle of steroids (6 days) starting that day; steroids have not improved symptoms. It's been over a week since the second shot-no relief. The patient was not tested for COVID post vaccination. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event tinnitus was not recovered.   Information on the lot/batch number has been requested.