chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: cough; fatigue; She's been having a hard time breathing, walking up hill, up stairs, doctor gave her an inhaler; low fever; couple days of body ache/body aches in her legs; did not feel well; This is a spontaneous report from a Pfizer- sponsored program Support from a contactable consumer (patient's husband). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient received first dose of vaccine on 24Mar2021. 1 day after vaccine she had low fever, and did not feel well, day 2 she was fine, day 3, having covid like symptoms, cough, fatigue, couple days of body ache. She's been having a hard time breathing, walking up hill, up stairs, doctor gave her an inhaler, that's continued, and no fever. Tested day 4, day 6, and day 8 with PCR tests, and were all negative. On day 3 she had body aches in her legs for a couple days but no other body aches, and she no longer has anymore. The patient underwent three Covid tests, 3-4 days later, 5-6 days later, and 7-8 days later.  The reporter added that it was thought she had Covid so they did a full screen, and she had positive antibodies. It has been three weeks since symptoms, and the worst few days. The patient experienced fatigue, hard time breathing, coughing on 26Mar2021 and not recovered, and experienced low fever, did not feel well, bodyaches in legs on unknown date in Mar2021 with outcome unknown. She was scheduled today for 2nd dose, want to know if she should get the vaccine today.  One doctor said to wait one week because of her symptoms. The patient had an EKG and full blood work - all were normal.  She also has the antibodies, but he does not know how they measure that.  Bloodwork was done approximately 10 days after the vaccine.  She had 3 Covid tests total. She was given three covid tests, all negative, and did test positive for Covid19 antibodies. It is unclear if she had Covid before or after getting the vaccine, and that the physician thought maybe she had covid before getting vaccinated which is what caused her reaction to the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Rash
Clinical narrative: rash on the neck , on the side of the injection (on the left side); sweating the whole night; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 39-years, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received vaccine on Monday and experienced rash on the neck , on the side of the injection (on the left side). Her next dose was due on 03May2021 and she wanted to know if it was ok to take it. She also stated she had been sweating the whole night from the last 2 nights. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Illness, Malaise, Nasal congestion
Clinical narrative: bad congestion; cough; really sick; felt horrible/feeling horrible; chills; nausea; throwing up; This is a spontaneous report from a contactable consumer (patient). The 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 27Mar2021 (Lot Number: EL3302) as Single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported.  The patient experienced chills and nausea, both on 28Mar2021 with outcome of recovered on 29Mar2021, and throwing up on 28Mar2021 with outcome of recovered on 28Mar2021, bad congestion and cough both on 29Mar2021 with outcome of recovering , really sick and felt horrible both on 29Mar2021 with outcome of unknown. Lab data included Covid test negative on 05Apr2021. The clinical course was reported as follows: On 27Mar2021 she got her first dose and her second dose was on Saturday 17Apr2021. She had some side effects, chills, nausea, throwing up, which she guesses was normal. 2 days after that, she got a cough, and was really congested, and felt horrible. She went to urgent care for a rapid test which came back negative. She says the doctor there, told her a lot of those test don't come back accurate.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: bad congestion; cough; really sick; felt horrible/feeling horrible; chills; nausea; throwing up; This is a spontaneous report from a contactable consumer (patient). The 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 27Mar2021 (Lot Number: EL3302) as Single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported.  The patient experienced chills and nausea, both on 28Mar2021 with outcome of recovered on 29Mar2021, and throwing up on 28Mar2021 with outcome of recovered on 28Mar2021, bad congestion and cough both on 29Mar2021 with outcome of recovering , really sick and felt horrible both on 29Mar2021 with outcome of unknown. Lab data included Covid test negative on 05Apr2021. The clinical course was reported as follows: On 27Mar2021 she got her first dose and her second dose was on Saturday 17Apr2021. She had some side effects, chills, nausea, throwing up, which she guesses was normal. 2 days after that, she got a cough, and was really congested, and felt horrible. She went to urgent care for a rapid test which came back negative. She says the doctor there, told her a lot of those test don't come back accurate.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Euphoric mood, Insomnia
Clinical narrative: felt very hyped up after the vaccine; couldn't sleep at all last night; Iam very different; This is a spontaneous report received from a contactable consumer (patient). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. Patient medical history included Thyroid condition. Concomitant medications were not reported. Patient stated that "she felt very hyped up after the vaccine. She went to work and she felt very different from what everyone was saying. She couldn't sleep at all last night". Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: severe asthma; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter wanted to check if the patient could take prednisone since she was having severe asthma on 12Apr2021. She got the 1st vaccine 29Mar2021 and the 2nd dose was on 18Apr2021. She wanted to reschedule the 2nd dose so that the vaccine won't interfere with the prednisone. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Very high pitched loud tinnitus in my right ear; This is a spontaneous report from a contactable other HCP (healthcare professional, patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 at 15:15 (at the age of 60-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included Ehlers Danlos Hypermobility, known allergies: Sulfa drugs and known allergies: narcotics, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") included levothyroxine sodium (LEVOXYL), fexofenadine hydrochloride (ALLEGRA), gabapentin and escitalopram oxalate (LEXAPRO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to receiving the COVID-19 vaccination. On 02Apr2021 at 15:15, the patient experienced very high-pitched loud tinnitus in my right ear. The event was serious for disability or permanent damage. The clinical course was reported as follows: "immediately after receiving the injection, I began experiencing very high-pitched loud tinnitus in my right ear. It has not resolved and awakens me at night. I am afraid to receive the second shot." The patient had not received treatment for the adverse event. The clinical outcome of the event very high-pitched loud tinnitus in my right ear was not recovered/not resolved. Since the vaccination, the patient was not tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Arthralgia, Blood iron normal, Blood test normal, Condition aggravated
Clinical narrative: Very high pitched loud tinnitus in my right ear; This is a spontaneous report from a contactable other HCP (healthcare professional, patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 at 15:15 (at the age of 60-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included Ehlers Danlos Hypermobility, known allergies: Sulfa drugs and known allergies: narcotics, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") included levothyroxine sodium (LEVOXYL), fexofenadine hydrochloride (ALLEGRA), gabapentin and escitalopram oxalate (LEXAPRO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to receiving the COVID-19 vaccination. On 02Apr2021 at 15:15, the patient experienced very high-pitched loud tinnitus in my right ear. The event was serious for disability or permanent damage. The clinical course was reported as follows: "immediately after receiving the injection, I began experiencing very high-pitched loud tinnitus in my right ear. It has not resolved and awakens me at night. I am afraid to receive the second shot." The patient had not received treatment for the adverse event. The clinical outcome of the event very high-pitched loud tinnitus in my right ear was not recovered/not resolved. Since the vaccination, the patient was not tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Full blood count normal, Headache, Hypotension, Influenza like illness
Clinical narrative: Very high pitched loud tinnitus in my right ear; This is a spontaneous report from a contactable other HCP (healthcare professional, patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 at 15:15 (at the age of 60-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included Ehlers Danlos Hypermobility, known allergies: Sulfa drugs and known allergies: narcotics, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") included levothyroxine sodium (LEVOXYL), fexofenadine hydrochloride (ALLEGRA), gabapentin and escitalopram oxalate (LEXAPRO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to receiving the COVID-19 vaccination. On 02Apr2021 at 15:15, the patient experienced very high-pitched loud tinnitus in my right ear. The event was serious for disability or permanent damage. The clinical course was reported as follows: "immediately after receiving the injection, I began experiencing very high-pitched loud tinnitus in my right ear. It has not resolved and awakens me at night. I am afraid to receive the second shot." The patient had not received treatment for the adverse event. The clinical outcome of the event very high-pitched loud tinnitus in my right ear was not recovered/not resolved. Since the vaccination, the patient was not tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Tinnitus
Clinical narrative: Very high pitched loud tinnitus in my right ear; This is a spontaneous report from a contactable other HCP (healthcare professional, patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 at 15:15 (at the age of 60-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included Ehlers Danlos Hypermobility, known allergies: Sulfa drugs and known allergies: narcotics, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") included levothyroxine sodium (LEVOXYL), fexofenadine hydrochloride (ALLEGRA), gabapentin and escitalopram oxalate (LEXAPRO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to receiving the COVID-19 vaccination. On 02Apr2021 at 15:15, the patient experienced very high-pitched loud tinnitus in my right ear. The event was serious for disability or permanent damage. The clinical course was reported as follows: "immediately after receiving the injection, I began experiencing very high-pitched loud tinnitus in my right ear. It has not resolved and awakens me at night. I am afraid to receive the second shot." The patient had not received treatment for the adverse event. The clinical outcome of the event very high-pitched loud tinnitus in my right ear was not recovered/not resolved. Since the vaccination, the patient was not tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid after first vaccine dose; got covid after first vaccine dose; This is a spontaneous report from a contactable consumer (reporting for neighbor) and from the same contactable consumer from a Pfizer-sponsored program . A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and got COVID, on an unspecified date. The outcome of the event was unknown.      Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Muscle spasms, SARS-CoV-2 test
Clinical narrative: very heavy bleeding (around 50 mL fluid each day over 3 days using a menstrual cup); Moderate cramping/intense cramps; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727)  via an unspecified route of administration, administered in Arm Left, at the age of 26-year-old, on 27Mar2021 15:00, as SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroidism, obesity, dysmenorrhea, moderate cramping and fatigue. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. Concomitant medications included sumatriptan and levothyroxine sodium (LEVOTHYROXIN). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6205) at left arm, at the age of 26-year-old, on 06Mar2021 13:00, for covid-19 immunisation. The morning before the vaccine, early period symptoms had begun reported as moderate cramping and fatigue. The patient waited 8 hours after vaccine to take Naproxen Sodium 540mg (a usual dosage for my usual period symptoms to be taken every 8 hours). On 28Mar2021, the day after vaccine, the patient saw some spotting but reduction in period symptoms. Three days after vaccine, the patient saw very heavy bleeding (around 50 mL fluid each day over 3 days using a menstrual cup), intense cramps even with 540mg naproxen, and fatigue that required sleeping most of the day. While this combination of symptoms is a normal occurrence for the patient, the symptoms this time is at a greater magnitude than normal, and these symptoms came in and out over five days from start of bleeding, three days longer than is normal for the patient. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Outcome of the events was recovered in 2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Drug ineffective, Fatigue, Malaise
Clinical narrative: runny nose; felt sick; colds; GI symptoms; tired/fatigued.; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021;  This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse reporting for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number E13302/expiration date: not provided), via an unspecified route of administration, on 01Feb2021 at 15:00 as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included smoker. Concomitant medication included varenicline tartrate (CHANTIX) from 25Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced runny nose, felt sick, colds, GI symptoms, and tired/fatigued. On 15Feb2021, she took a home sars-cov-2 test and tested positive. On 22Feb2021, the patient formally tested positive. The events did not require an emergency room or physician's office visit. Treatment received for the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19 included Dayquil and she was on steroids for cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive on 15Feb2021, sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive   on 22Feb2021, sars-cov-2 test: positive on an unknown date, sars-cov-2 test: negative on an unknown date. The outcome of the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19. was unknown.  The reporting nurse assessed the event "sars-cov-2 test: positive" was unrelated to BNT162B2 (COVID vaccine).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: runny nose; felt sick; colds; GI symptoms; tired/fatigued.; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021;  This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse reporting for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number E13302/expiration date: not provided), via an unspecified route of administration, on 01Feb2021 at 15:00 as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included smoker. Concomitant medication included varenicline tartrate (CHANTIX) from 25Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced runny nose, felt sick, colds, GI symptoms, and tired/fatigued. On 15Feb2021, she took a home sars-cov-2 test and tested positive. On 22Feb2021, the patient formally tested positive. The events did not require an emergency room or physician's office visit. Treatment received for the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19 included Dayquil and she was on steroids for cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive on 15Feb2021, sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive   on 22Feb2021, sars-cov-2 test: positive on an unknown date, sars-cov-2 test: negative on an unknown date. The outcome of the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19. was unknown.  The reporting nurse assessed the event "sars-cov-2 test: positive" was unrelated to BNT162B2 (COVID vaccine).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: have a low grade fever 5 days after receiving her 1st dose of the vaccine/Slight fever; arm soreness; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Right on 09Apr2021 at 16:30 (at the age of 61-years-old) at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced a low grade fever 5 days after receiving her 1st dose of the vaccine/slight fever on 15Apr2021 and arm soreness on 10Apr2021. Patient stated that she got the first Pfizer COVID-19 vaccine on 9Apr2021 at 16:30. She states she is still running a slight fever and wants to know is that normal. She states that she first noticed the fever on Saturday and it still comes and goes. She states she is taking Tylenol for it. She states her arm was sore Saturday 10Apr2021 but by Sunday 11Apr2021 she had to really press around to feel where the shot was given and it wasn't sore hardly at all. She states she is completely recovered from the arm soreness.  The patient was asking if it is normal for her to have a low grade fever 5 days after receiving her 1st dose of the vaccine. She mentioned that she has had on and off fevers ever since the day after she got vaccinated. She is also asking if this would affect her 2nd dose and should she still receive it. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines administered on same date of the Pfizer Suspect. The outcome of the event fever was not recovered, and the patient recovered from the event arm soreness on 11Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her husband got infected from Covid 19 that week she got the vaccine;She also got infected; her husband got infected from Covid 19 that week she got the vaccine;She also got infected; This is a spontaneous report from 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 28Mar2021 (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 got the first dose of the Pfizer covid vaccine on 28Mar2021 and her husband got infected from Covid 19 that week she got the vaccine. She also got infected because of living in the same place and she got fever, pain in her body and malaise but she mentioned that her symptoms were mild. She has an appointment on 18Apr2021 for the second dose and she wanted to know if she should go to get the vaccine.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: tiredness; headache; chills; nausea; musclepain; jointpain; feeling unwell; This is a spontaneous report from a Pfizer-sponsored program A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 10Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said after he got the 1st dose and until today, 12April2021, he's still experiencing side effects like tiredness, headache, chills, nausea, muscle pain, joint pain and feeling unwell. He's calling to report it and to know what he needs to do about it. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: tiredness; headache; chills; nausea; musclepain; jointpain; feeling unwell; This is a spontaneous report from a Pfizer-sponsored program A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 10Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said after he got the 1st dose and until today, 12April2021, he's still experiencing side effects like tiredness, headache, chills, nausea, muscle pain, joint pain and feeling unwell. He's calling to report it and to know what he needs to do about it. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered at inappropriate site, Rash macular
Clinical narrative: theres only a red circle; the guy put it in the wrong spot... The vaccine was administered in between her shoulder and elbow. Not at shoulder.; the guy put it in the wrong spot... The vaccine was administered in between her shoulder and elbow. Not at shoulder.; This is a spontaneous report from a Pfizer-sponsored program support a contactable consumer (patient's sister). A female patient (reporter's sister) of an unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number was not reported), via an unspecified route of administration administered in between her shoulder and elbow on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Caller sister just got second dose. she said the guy put it in the wrong spot. She didn't have any side effects. There's only a red circle. The vaccine was administered in between her shoulder and elbow. Not at shoulder. Believes it was administered wrong. Caller had really bad reception. She said she will try calling back and hung up. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Inappropriate schedule of product administration, Off label use, Pyrexia
Clinical narrative: nearly 10 weeks after 1st dose; nearly 10 weeks after 1st dose; mild headache; mild fever 99.5F; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received second dose (redo of the second dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Intramuscular on 8Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 dose 1, on 31Jan2021 for covid-19 immunisation. The patient had 2 doses of vaccine, the 2nd dose was unfortunately given in the back of her arm into subcutaneous fat on 21Feb2021. It has taken quite some time to get an appointment to have what she thought was a total redo of both doses. Yesterday was 68 days after the 1st original dose and she had an appointment. They said it was a redo of the second dose only. This was nearly 10 weeks after 1st dose.  The patient experienced mild headache, mild fever 99.5F. The outcome was unknown.  No follow up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Fatigue; Low back pain/lower back ache; Headache; Profuse cough; sore arm after the injection; throat was sore; glutes hurt; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 01Apr2021 via an unknown route for Covid-19 immunization. Medical history included cough and fatigue. She mentioned that couple of days before receiving her second dose of the Pfizer COVID-19 vaccine she felt really fatigued "wiped out". Patient inquired if it was possible she had COVID-19 before she received her second dose, and inquired "Hypothetically speaking, if I did have COVID before that second dose [of the Pfizer COVID-19 vaccine] did I not need to get that dose or should I have still gotten it?"  Concomitant drug was not provided.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 for Covid-19 immunization. She mentioned that 3-4 days after her second dose, she experienced fatigue, low back pain, headache and profuse cough. It took 3 days before she got her energy back.  She reported that she had a cough for about a year and a half (as of 12Apr2021). She had seen a cardiologist, pulmonologist, gastroenterologist and her primary care doctor about this cough and no one care figure out why she had it, however, she stated that it did seem to have gotten worse since she had taken the second dose of the Pfizer COVID-19 vaccine. She further stated that she received her second dose and had a sore arm after the injection, but then 3 days later she reported that she felt really bad. She laid on the cough all day long, had a lower back ache and glutes hurt. She also states that her throat was sore.  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: Oropharyngeal pain, Pain in extremity
Clinical narrative: Fatigue; Low back pain/lower back ache; Headache; Profuse cough; sore arm after the injection; throat was sore; glutes hurt; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 01Apr2021 via an unknown route for Covid-19 immunization. Medical history included cough and fatigue. She mentioned that couple of days before receiving her second dose of the Pfizer COVID-19 vaccine she felt really fatigued "wiped out". Patient inquired if it was possible she had COVID-19 before she received her second dose, and inquired "Hypothetically speaking, if I did have COVID before that second dose [of the Pfizer COVID-19 vaccine] did I not need to get that dose or should I have still gotten it?"  Concomitant drug was not provided.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 for Covid-19 immunization. She mentioned that 3-4 days after her second dose, she experienced fatigue, low back pain, headache and profuse cough. It took 3 days before she got her energy back.  She reported that she had a cough for about a year and a half (as of 12Apr2021). She had seen a cardiologist, pulmonologist, gastroenterologist and her primary care doctor about this cough and no one care figure out why she had it, however, she stated that it did seem to have gotten worse since she had taken the second dose of the Pfizer COVID-19 vaccine. She further stated that she received her second dose and had a sore arm after the injection, but then 3 days later she reported that she felt really bad. She laid on the cough all day long, had a lower back ache and glutes hurt. She also states that her throat was sore.  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: Pruritus, Urticaria
Clinical narrative: strange welts; itchy; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported for herself. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 on 04Feb2021 for COVID-19 immunization. 4-5 days after the second dose, she started to develop welts that were all over her body. She described them as itchy, they "come and go"/were intermittent (longest lasted for 10 minutes) and can be 6-8 inches in length. She stated they look like she's been scratched by a dog or they look like red worms. She had been taking antihistamines, which help, but she didn't want to rely on them. They go away with diphenhydramine hydrochloride (BENADRYL), but she stated she can't keep taking diphenhydramine hydrochloride. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 26Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced positive COVID-19 test with symptoms on 04Apr2021. The clinical course was reported as follows: The patient had her first vaccination 26Mar2021 and tested positive for COVID-19 on 04Apr2021, reported as 9 days after vaccination. It was reported that she was exposed to COVID-19 one to two days before vaccination. She had a low-grade fever of 99 Fahrenheit in Apr2021 for 1 day, along with feeling tired, and brain fog.  On 12Apr2021, she tested negative for COVID-19. The pharmacist was questioning if she can safely receive her second dose as scheduled or she should wait an additional week. The clinical outcome of positive COVID-19 test with symptoms was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Since the event Covid-19 occurred 9 days after the administration of first dose of vaccine BNT16B2, a temporal relation between the onset of event and administration of vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nervousness, Rash, Rash erythematous
Clinical narrative: rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders; rash has worsened in redness/rash is red; a little bit of difficulty of breathing; feels shaky/nervousness/she is nervous; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 15:00 (lot number: EW0162) on the left arm as single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL). The patient next dose was scheduled for 03May2021 at 11:40am. On 14Apr2021, patient reported to have a rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders. Patient mentioned she had a very severe rash all over her body and neck that it was pretty extreme and all over. It was the first time that something that extreme happened to her. Patient mentioned that she also had a little bit of difficulty of breathing and attributed it to her nervousness. She denied having a closing up throat. The rash all over body was reported as worsened and rash had worsened in redness. The patient's rash was red, patchy, and on her stomach it was more needle point looking. The patient wasn't feeling sick and didn't have any of the other symptoms. The patient felt shaky but it may be because she was nervous. The outcome of events "a little bit of difficulty of breathing" and "rash has worsened in redness/rash is red" was unknown, while the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Dizziness
Clinical narrative: she has been dizzy; She also has tremendous problems with depth perception/She can't tell how far away cars are from her; This is a spontaneous report from a contactable consumer (patient). This is the first report for the 2nd dose.   A 79-year-old female patient received 2nd dose of BNT162B2 (Covid 19 vaccine) on 19Mar2021 at single dose on left arm for covid-19 immunization. Medical history was ongoing Type 2 Diabetes. Concomitant drug was not reported. Historical Vaccine was the first Covid 19 vaccine on 25Feb2021 she was lightheaded for 2 days then she was great. She reported online that ever since getting her second vaccine she has been dizzy. She just got done with a neurology evaluation and the neurologist said he's never heard of this before. She can't drive, it's difficult to walk, it's awful. The neurologist is sending her for an MRI. She's never been sick or had a reaction to anything. With the second Covid 19 vaccine she was dizzy, everyone told her to take it easy, but the dizziness never went away. She's been on her couch since 21Mar2021. She also has tremendous problems with depth perception. She reports she is a psychologist. She reports she'll have routine blood work done in about a week and a half. She has routine blood work drawn every 3 months. She's doing good considering. She has not scheduled her MRI yet. When probing for additional information regarding vision problems, she reports depth perception. She can't tell how far away cars are from her. She didn't even want to get the Covid 19 vaccine. Her doctor's told her she should get the vaccine. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Visual impairment
Clinical narrative: she has been dizzy; She also has tremendous problems with depth perception/She can't tell how far away cars are from her; This is a spontaneous report from a contactable consumer (patient). This is the first report for the 2nd dose.   A 79-year-old female patient received 2nd dose of BNT162B2 (Covid 19 vaccine) on 19Mar2021 at single dose on left arm for covid-19 immunization. Medical history was ongoing Type 2 Diabetes. Concomitant drug was not reported. Historical Vaccine was the first Covid 19 vaccine on 25Feb2021 she was lightheaded for 2 days then she was great. She reported online that ever since getting her second vaccine she has been dizzy. She just got done with a neurology evaluation and the neurologist said he's never heard of this before. She can't drive, it's difficult to walk, it's awful. The neurologist is sending her for an MRI. She's never been sick or had a reaction to anything. With the second Covid 19 vaccine she was dizzy, everyone told her to take it easy, but the dizziness never went away. She's been on her couch since 21Mar2021. She also has tremendous problems with depth perception. She reports she is a psychologist. She reports she'll have routine blood work done in about a week and a half. She has routine blood work drawn every 3 months. She's doing good considering. She has not scheduled her MRI yet. When probing for additional information regarding vision problems, she reports depth perception. She can't tell how far away cars are from her. She didn't even want to get the Covid 19 vaccine. Her doctor's told her she should get the vaccine. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Fatigue, Headache, Nausea
Clinical narrative: Headache; Exhaustion; Fever; Chills; Nausea; Exposed to Covid at work; This is a Spontaneous report received from Pfizer sponsored COVAX US Support program by a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that the patient experienced headache, exhaustion, fever, chills, nausea but then the next day felt fine on an unknown date. It was also reported that patient was due for second dose today but caller said she was exposed to covid at work. The health department called her and told her to quarantine until the 18th (as reported). The patient had undergone a covid test which resulted negative on an unknown date. The outcome of the events headache, exhaustion, fever, chills, nausea was recovered on an unknown date while for other event exposed to covid at work was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Exhaustion; Fever; Chills; Nausea; Exposed to Covid at work; This is a Spontaneous report received from Pfizer sponsored COVAX US Support program by a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that the patient experienced headache, exhaustion, fever, chills, nausea but then the next day felt fine on an unknown date. It was also reported that patient was due for second dose today but caller said she was exposed to covid at work. The health department called her and told her to quarantine until the 18th (as reported). The patient had undergone a covid test which resulted negative on an unknown date. The outcome of the events headache, exhaustion, fever, chills, nausea was recovered on an unknown date while for other event exposed to covid at work was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (lot number and expiration date were not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. HCP of the reporter who received first dose, was later diagnosed with COVID-19 and was given monoclonal antibodies. The reporter asked for advice regarding second dose administration. The outcome of the events was unknown.   Information on the lot/batch number has been requested.