chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, Ulcerative keratitis
Clinical narrative: patient stated recent eye exam showed corneal ulcer; This is a spontaneous report from a contactable other health professional. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, the patient stated recent eye exam showed corneal ulcer. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product information, the causal relationship between the reported ulcerative keratitis and use of BNT162B2 cannot be fully excluded. However, the medical history of rheumatoid arthritis may confound the reported drug event pair. The limited information precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information.  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  Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive after receiving the first covid vaccine.; he tested positive after receiving the first covid vaccine.; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient wanted to know if he should receive his second COVID vaccine since he tested positive after receiving the first COVID vaccine on unspecified date. The patient also experienced unspecified side effects on unspecified dates. 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: COVID-19, Drug ineffective
Clinical narrative: contracted Covid; contracted Covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), 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 wanted to know how to reschedule her second dose. The patient stated that after she got her first dose, she and her husband contracted Covid on an unknown date. The outcome of the events was unknown.   Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive to COVID-19; tested positive to COVID-19; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Apr2021, patient tested positive to COVID-19. His second dose schedule was postponed. His doctor told him that he needs to be strong first before getting the second dose. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Laboratory test, Muscle spasms, Musculoskeletal stiffness, Myalgia
Clinical narrative: muscle spasms; extreme muscle pain in his back, from his neck to his waist; a lot of stiffness; he can barely walk/ couldn't walk; This is a spontaneous report from a Pfizer-sponsored program, COVAX Support, from a contactable consumer (wife of patient). A 78-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL9262) via an unspecified route in Feb2021 (reported as both 04Feb and 09Feb) (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukemia (CLL). Concomitant medications included ibrutinib (IMBRUVICA) for CLL, finasteride, tamsulosin, metformin, and glimepiride; start and stop dates unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) in Jan2021 (reported as both 04Jan and 14Jan) as a single dose for COVID-19 immunization. About 2 weeks after the second dose (Feb2021), the patient developed extreme muscle pain in his back, from his neck to his waist. He was in the hospital twice and he was having spasms, then it happened again last week where also a lot of stiffness, he can barely walk, again he just out of blue, he got these muscle spasms and he couldn't walk again. She reported that they have led off but in the meantime, we were trying to figure out if he has done anything, which he did not. She stated the only odd thing was the vaccine. The patient was hospitalized for the events in Feb2021 for about three days, reporter estimated dates as 18Feb2021 and again on 22Feb2021. The muscle spasms ended up going away and then on 12Apr2021 they started up again. Patient had lab test done every 2 months (results not provided). Treatment for events included muscle relaxants, which didn't help. The clinical outcomes of extreme muscle pain in his back, a lot of stiffness, barely walk/couldn't walk were unknown, while of muscle spasms was not recovered.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Malaise, Tremor
Clinical narrative: Colitis ulcerative aggravated; Shaking of hands; Feeling unwell; This is a solicited report from the marketing program received from a non-contactable consumer (patient) based on information received by Pfizer  (manufacturer control number:21K-163-3860062-00).   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at (1 in 2 weeks), then subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, weekly (1 in 1wk) for moderate to severe ulcerative colitis.  Medical history included colitis ulcerative aggravated (moderate to severe ulcerative colitis) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  On unspecified date,  the patient experienced colitis ulcerative aggravated with outcome of recovering, feeling unwell in 2021 and shaking of hands on unspecified date; both with outcome of not recovered.    The reporter's causality for events feeling unwell, colitis ulcerative aggravated and shaking hands with suspect drug COVID-19 vaccine were not reported.   The reporter's causality for the event not feeling well was not provided. The reporter's causality for the events ulcerative colitis flare up and shacking hands with adalimumab (HUMIRA) was a reasonable possibility.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events were assessed as unrelated to suspected drug BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection),  Case will be reassessed once new information is reported.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a non-contactable nurse via a Pfizer-sponsored program . An 18-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was admitted into the hospital with myocarditis after taking the Covid vaccine on an unspecified date. She was wondering when Pfizer would be reaching out to patient's family as it was their vaccine that put the patient into the hospital. Also wondering if Pfizer was tracking this as a side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product information, the causal relationship between the reported myocarditis and use of BNT162B2 cannot be fully excluded. There is limited information with regards to medical history and clinical  course  thus precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chills, Pyrexia, Tremor, Vaccination site reaction
Clinical narrative: Chills; Shakes; Fever; Vomiting; Reaction to Covid-19 Vaccine; low white blood cell count; This is a solicited report from a contactable consumer, the patient, based on information received by Pfizer e (Manufacturer Control No: 21K-163-3860957-00).   Solicited report from the by a consumer of a 66 year old male with events of CHILLS, SHAKES, FEVER and vomiting and non-serious reaction to covid-19 vaccine and low white blood cell count with venclexta (venetoclax). There was no reported medical history. In 2021, the patient experienced CHILLS, shakes, fever, vomiting, reaction to covid-19 vaccine and low white blood cell count. Covid-19 vaccine was also considered suspect.  The patient had reaction to the Pfizer COVID-19 Vaccine and was hospitalized with fever of 103, chills, shakes, and vomiting. His white blood cell count went low from 4.4 to 0.9. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. In 2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer. No concomitant drugs taken. He did not agree to have physician contacted.   Causality Assessment: The reporter's causality for the event(s) of Chills, Shakes, Fever, Vomiting, Reaction To Covid-19 vaccine and low white blood cell count was not provided. opinion is that there is no reasonable possibility that the events of Chills, Shakes, Fever, Vomiting, Reaction To Covid-19 Vaccine And Low White Blood Cell Count Are Related To Venclexta(Venetoclax).   The reporter's assessment of the causal relationship of chills, shaking, fever, vomiting, vaccination adverse reaction, and white blood cell count low with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, there was a reasonable possibility that the reported events were related to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vomiting, White blood cell count, White blood cell count decreased
Clinical narrative: Chills; Shakes; Fever; Vomiting; Reaction to Covid-19 Vaccine; low white blood cell count; This is a solicited report from a contactable consumer, the patient, based on information received by Pfizer e (Manufacturer Control No: 21K-163-3860957-00).   Solicited report from the by a consumer of a 66 year old male with events of CHILLS, SHAKES, FEVER and vomiting and non-serious reaction to covid-19 vaccine and low white blood cell count with venclexta (venetoclax). There was no reported medical history. In 2021, the patient experienced CHILLS, shakes, fever, vomiting, reaction to covid-19 vaccine and low white blood cell count. Covid-19 vaccine was also considered suspect.  The patient had reaction to the Pfizer COVID-19 Vaccine and was hospitalized with fever of 103, chills, shakes, and vomiting. His white blood cell count went low from 4.4 to 0.9. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. In 2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer. No concomitant drugs taken. He did not agree to have physician contacted.   Causality Assessment: The reporter's causality for the event(s) of Chills, Shakes, Fever, Vomiting, Reaction To Covid-19 vaccine and low white blood cell count was not provided. opinion is that there is no reasonable possibility that the events of Chills, Shakes, Fever, Vomiting, Reaction To Covid-19 Vaccine And Low White Blood Cell Count Are Related To Venclexta(Venetoclax).   The reporter's assessment of the causal relationship of chills, shaking, fever, vomiting, vaccination adverse reaction, and white blood cell count low with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, there was a reasonable possibility that the reported events were related to BNT162B2 vaccine. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Neuropathy peripheral, Vitamin D
Clinical narrative: neuropathy on her left hand and foot, it never got better/got worse in her left arm and hand; had a knot came up under her arm; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on an unspecified date (batch/lot number and expiration date were not reported) and second dose on an unspecified date (batch/lot number and expiration date were not reported); both via an unspecified route of administration, administered in the left arm as a single dose for COVID-19 immunization. Relevant medical history indicated that the patient had suffered with neuropathy for years and her vitamin D levels were low; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the first dose on an unspecified date, the patient had a knot came up under her arm within the first 24 hours and neuropathy on her left hand and foot; it never got better. She received the second dose and it got worse in her left arm and hand. She also got another knot under her left arm. The events took place after use of the product. The patient was not recovered from the events.  Information on the batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Dizziness, Dysphemia, Feeling jittery
Clinical narrative: seizure; Feel woozy; felt even weaker; jittery feeling; shaky; doesn't feel well; It has left her with a stutter; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration on 02Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first shot on 02Mar2021 and the second shot 25Mar2021. She took the first shot and she wanted to say a day or so after that she got up and did some things around the house and she went to the cloth store. She clarified that she went to the fabric store and came out she had a jittery feeling. Then she began to feel woozy and stated she may need to eat. She drove up to by (withheld) and there was a cookout restaurant in the same vicinity as (withheld). When she went to turn into the lot, she was "shaky" and pulled into the parking space. She added that the best thing is for her to go home. She didn't want to take the interstate and went to the back way just in case something happened. She went home and it was approximately 10 miles away. When she got home, she felt even weaker. Her husband was outside because he fishes and was working on his boat. She told him that she doesn't feel well and was shaky. He told her to go in the house and he would come in. She went in through the basement and when she got to the step her foot wouldn't come up, so she crawled up the steps. When her husband came in, she went into a seizure and had no control. She could hear her husband speaking but couldn't speak so he called. They told him to give her four 81 mg of aspirin. So, he gave her some aspirin. She could hear them when they came in to get her, but she couldn't respond. They took her to the hospital. At the hospital they did two CAT scans and another unspecified test. The patient added that she was concerned because she is a very active person, and this is not her normal talk. Before the shot she did a lot of sewing and that's her business. But a few days after the shot she began to have a lot of seizures and went to the hospital. And when she came home it continued. Before she left the hospital, she had not spoken to anyone. When her husband came in, she couldn't get her words out. It has left her with a stutter, and she decided to go to speech therapy. She went in and a few days it seemed like it had helped. The patient further stated that she is not getting back to normal and needs a walker or cane and she's 68 and healthy. The outcome of events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Seizure, Tremor
Clinical narrative: seizure; Feel woozy; felt even weaker; jittery feeling; shaky; doesn't feel well; It has left her with a stutter; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration on 02Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first shot on 02Mar2021 and the second shot 25Mar2021. She took the first shot and she wanted to say a day or so after that she got up and did some things around the house and she went to the cloth store. She clarified that she went to the fabric store and came out she had a jittery feeling. Then she began to feel woozy and stated she may need to eat. She drove up to by (withheld) and there was a cookout restaurant in the same vicinity as (withheld). When she went to turn into the lot, she was "shaky" and pulled into the parking space. She added that the best thing is for her to go home. She didn't want to take the interstate and went to the back way just in case something happened. She went home and it was approximately 10 miles away. When she got home, she felt even weaker. Her husband was outside because he fishes and was working on his boat. She told him that she doesn't feel well and was shaky. He told her to go in the house and he would come in. She went in through the basement and when she got to the step her foot wouldn't come up, so she crawled up the steps. When her husband came in, she went into a seizure and had no control. She could hear her husband speaking but couldn't speak so he called. They told him to give her four 81 mg of aspirin. So, he gave her some aspirin. She could hear them when they came in to get her, but she couldn't respond. They took her to the hospital. At the hospital they did two CAT scans and another unspecified test. The patient added that she was concerned because she is a very active person, and this is not her normal talk. Before the shot she did a lot of sewing and that's her business. But a few days after the shot she began to have a lot of seizures and went to the hospital. And when she came home it continued. Before she left the hospital, she had not spoken to anyone. When her husband came in, she couldn't get her words out. It has left her with a stutter, and she decided to go to speech therapy. She went in and a few days it seemed like it had helped. The patient further stated that she is not getting back to normal and needs a walker or cane and she's 68 and healthy. The outcome of events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: After 2nd dose pain intensified and spread to hands wrists and shoulders.; After 2nd dose pain intensified and spread to hands wrists and shoulders.; Very limited mobility with intense pain.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 18Mar2021 at 13:00 (Batch/Lot number was not reported) (at the age of 72-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. No known allergies. The patient did no experienced COVID-19 nor tested positive pre or post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Feb2021 (at the age of 72-year-old) and experienced intense pain in right foot and knee overall joint pain.  On an unspecified date, the patient experienced after 2nd dose, pain intensified and spread to hands, wrists and shoulders. Very limited mobility with intense pain. Both shoulders very intense pain even with nonsteroidal anti-inflammatory drug (NSAIDS). Continuing with no improvement. The patient outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442973 same patient, different drug dose/event
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Nausea, Neck pain, Syncope
Clinical narrative: fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and back pain; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route in the right arm on 19Apr2021 at 14:45 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included chronic severe tension headaches and allergies to some antibiotics (unspecified products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. Concomitant medications included unspecified supplements and herbals. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) on 27Mar2021 at 14:45 in the right arm as a single dose for COVID-19 immunization. On 20Apr2021 at 02:30, the patient experienced severe head, neck and back pain, combined with nausea, vomiting and fainting. There was no treatment received for severe head, neck and back pain, combined with nausea, vomiting and fainting. The clinical outcomes of severe head, neck and back pain, nausea, vomiting and fainting was recovering. The patient was not tested for COVID post vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and back pain; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route in the right arm on 19Apr2021 at 14:45 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included chronic severe tension headaches and allergies to some antibiotics (unspecified products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. Concomitant medications included unspecified supplements and herbals. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) on 27Mar2021 at 14:45 in the right arm as a single dose for COVID-19 immunization. On 20Apr2021 at 02:30, the patient experienced severe head, neck and back pain, combined with nausea, vomiting and fainting. There was no treatment received for severe head, neck and back pain, combined with nausea, vomiting and fainting. The clinical outcomes of severe head, neck and back pain, nausea, vomiting and fainting was recovering. The patient was not tested for COVID post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: received both doses of the Pfizer Covid-19 vaccine/had contracted Covid-19; received both doses of the Pfizer Covid-19 vaccine/had contracted Covid-19; This is a spontaneous report received from agency and a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Mar2021 as SINGLE DOSE and dose 2 via an unspecified route of administration in Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received both doses of the Pfizer Covid-19 vaccine in Mar2021 and had contracted Covid-19 on an unspecified date in 2021. The patient was hospitalized for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA; A contactable nurse and pharmacist reported for a patient of unspecified age and gender who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a first responder received a vaccine too high in the shoulder from a volunteer nurse, leading to physician confirmation of SIRVA (Shoulder injury related to vaccine administration) requiring possible surgical repair. The first responder's supervisor did not report the event to FDA. Five weeks later, the patient was still in pain and had limited mobility of the arm or shoulder. Outcome of event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported shoulder injury related to vaccine administration (SIRVA) with pain and limited mobility of the arm or shoulder, was likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: His wife got the COVID-19vaccine from Pfizer she only got the first shot and she have a rash for over 10 days already.; This is a spontaneous report from a contactable consumer (patient's husband). 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 an unspecified date (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 stated that his wife got the covid-19vaccine from pfizer she only got the first shot and she have a rash for over 10 days already on an unspecified date. The patient was hospitalized for the event on an unspecified date. She has been to the hospital many times and has tried about 6 creams as treatment, none of which are working. The reporter also stated that they have been to 2 hospital's 4 times and she took 6 prescriptions and nothing is happening and were trying over the counter stuff and this rash keeps growing. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Body temperature, Chills
Clinical narrative: back pain upper and lower back; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Severe body pain, joint pain; Severe body pain, joint pain; This is a spontaneous report from a contactable consumer. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:30 (Lot Number: EW0158) as SINGLE DOSE (at the age of 47 years old) for covid-19 immunisation. Medical history included High cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin (ROSUVASTATIN) 20 mg taken for an unspecified indication, start and stop date were not reported.  The patient previously took Penicillin and experienced allergy; sulfa and experienced allergy. On 14Apr2021 16:00, the patient experienced back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. Patient had to go to emergency room (ER) on the 20Apr2021 since pain and fever was not decreasing. She tested negative for flu, COVID (rapid and pcr), blood work shows no infection and lungs were clear. On 21Apr2021 she still has headache and had to take off from work. ER physician said it is the adverse effect due to the vaccine. The patient underwent lab tests and procedures which included blood test: no infection and lungs were clear on 20Apr2021, body temperature: fever on 19Apr2021, influenza: negative on  20Apr2021 , covid rapid test: negative on 19Apr2021 , COVID (pcr): negative on 20Apr2021.  Therapeutic measures were taken as a result of back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. The events were treated with IV Pain medicine. Outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Influenza, Pain, Polymerase chain reaction
Clinical narrative: back pain upper and lower back; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Severe body pain, joint pain; Severe body pain, joint pain; This is a spontaneous report from a contactable consumer. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:30 (Lot Number: EW0158) as SINGLE DOSE (at the age of 47 years old) for covid-19 immunisation. Medical history included High cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin (ROSUVASTATIN) 20 mg taken for an unspecified indication, start and stop date were not reported.  The patient previously took Penicillin and experienced allergy; sulfa and experienced allergy. On 14Apr2021 16:00, the patient experienced back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. Patient had to go to emergency room (ER) on the 20Apr2021 since pain and fever was not decreasing. She tested negative for flu, COVID (rapid and pcr), blood work shows no infection and lungs were clear. On 21Apr2021 she still has headache and had to take off from work. ER physician said it is the adverse effect due to the vaccine. The patient underwent lab tests and procedures which included blood test: no infection and lungs were clear on 20Apr2021, body temperature: fever on 19Apr2021, influenza: negative on  20Apr2021 , covid rapid test: negative on 19Apr2021 , COVID (pcr): negative on 20Apr2021.  Therapeutic measures were taken as a result of back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. The events were treated with IV Pain medicine. Outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: back pain upper and lower back; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Severe body pain, joint pain; Severe body pain, joint pain; This is a spontaneous report from a contactable consumer. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:30 (Lot Number: EW0158) as SINGLE DOSE (at the age of 47 years old) for covid-19 immunisation. Medical history included High cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin (ROSUVASTATIN) 20 mg taken for an unspecified indication, start and stop date were not reported.  The patient previously took Penicillin and experienced allergy; sulfa and experienced allergy. On 14Apr2021 16:00, the patient experienced back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. Patient had to go to emergency room (ER) on the 20Apr2021 since pain and fever was not decreasing. She tested negative for flu, COVID (rapid and pcr), blood work shows no infection and lungs were clear. On 21Apr2021 she still has headache and had to take off from work. ER physician said it is the adverse effect due to the vaccine. The patient underwent lab tests and procedures which included blood test: no infection and lungs were clear on 20Apr2021, body temperature: fever on 19Apr2021, influenza: negative on  20Apr2021 , covid rapid test: negative on 19Apr2021 , COVID (pcr): negative on 20Apr2021.  Therapeutic measures were taken as a result of back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. The events were treated with IV Pain medicine. Outcome of the events was not recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Went and had a COVID test and we have positive COVID-19; Went and had a COVID test and we have positive COVID-19; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.   An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), the first dose on Feb2021, then the second dose on Mar2021, both via an unspecified route of administration (at the age of 84-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I just wanted to report that we had our Pfizer COVID Vaccination in Feb and Mar, my husband and I. And about a week and a half ago, 2 weeks we didn't feel well, went and had a COVID test and we have positive COVID-19. And my husband is (Name) and it 'affected' (voice feeble) both of us." When confirmed if it was the Pfizer vaccine, consumer stated, "Yes, we both have positive. It's been 2 weeks and one and a half week since he was tested and I was tested. 2 weeks ago he was tested positive and I was a week and a half positive. I want to report it and I want to know how many has there been other instances and what are some of the symptoms like I have nausea and my husband just 'doesn't, feel aches' (not clarified further), so all over he doesn't feel good he had a temperature a 102, a 101 for a couple of days. So, like we had the flu or something you know very discouraging." The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021466304 same reporter/drug, different patients, similar events; PFIZER INC-2021466304 Same reporter, drug, and events; different patient
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had their Pfizer COVID-19 vaccination (first and second doses); didn't feel well; positive COVID-19; aches; doesn't feel good; temperature at 102 and 101; like they had the flu; Had their Pfizer COVID-19 vaccination (first and second doses); didn't feel well; positive COVID-19; aches; doesn't feel good; temperature at 102 and 101; like they had the flu; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, the first dose in Feb2021, and the second dose in Mar2021, both at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and his wife had their Pfizer COVID-19 vaccination in Feb2021 and Mar2021. About a week and a half ago (Apr2021), they didn't feel well for 2 weeks. So, they went and had a COVID-19 test and they both have positive COVID-19 in Apr2021. It affected both of them. It's been 2 weeks since the patient was tested. 2 weeks ago (Apr2021), the patient was tested positive. The patient's wife wanted to report it and she wanted to know how many there has been other instances and what are some of the symptoms. The patient just doesn't have nausea (but his wife does) but feel aches (not clarified further). All over, the patient doesn't feel good, he had a temperature at 102 and 101 for a couple of days in Apr2021. So, like they had the flu or something you know very discouraging. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466214 Same reporter, drug, and events; different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Terrible cough; Little bit of headache; Fever; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patients husband) via the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Lot Number: ER8732) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that the patient tested positive for covid on 06Apr2021. On an unspecified date the patient experienced terrible cough, fever, little bit of headache. The husband clarified that his wife was tested positive for COVID on 6Apr2021 and he had symptoms and tested positive on 9Apr2021. So, both of them out of 10 days so fever is gone "and everything" (not clear nor clarified) but they still have like a cough and little bit of headache.  The patients husband reported that their second dose was scheduled for tomorrow but they both have terrible cough and they wanted to know if they should go take the second vaccine tomorrow, or should reschedule it for I don't know when after one month or whatever. The patient had lab tests which included sars-cov-2 test: positive on 06Apr2021.  The clinical outcome of fever was recovered. The clinical outcome of terrible cough and little bit of headache was not revered. The clinical outcome of tested positive for COVID was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare professional. A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0161) at the age of 43-years-old, intramuscular in left arm on 20Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. He has no COVID prior to vaccination and denied being allergic to anything. There was no other vaccine in four weeks and no other medications in two weeks. The patient received his first dose of COVID-19 vaccine in a workplace clinic on 20Apr2021 and experienced syncopal episode with mild seizure activity at 11:15, within the 15-minute period post vaccination (as reported). No treatment was given in response to the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be  reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Deafness, Drug ineffective, Fatigue, Ligament sprain
Clinical narrative: Sprain in leg; thinking I am deaf; had covid; had covid; had little chills; Tired; throat was painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 16:45 (Lot Number: EW0169) as single dose for covid-19 immunization. Medical history included Knee arthroplasty. The patient's concomitant medications were not reported. Patient received the dose1 (lot: EP7533) for Covid-19 immunisation. The patient felt a little bit tired like the symptom when had covid and throat was painful and had little chills on 20Apr2021. had a sprain in leg but patient guessed that because had a knee replacement on unknown date. Patient stated, "Sorry, I am thinking I am deaf. I am sorry, I cannot understand". The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Suspected COVID-19
Clinical narrative: Sprain in leg; thinking I am deaf; had covid; had covid; had little chills; Tired; throat was painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 16:45 (Lot Number: EW0169) as single dose for covid-19 immunization. Medical history included Knee arthroplasty. The patient's concomitant medications were not reported. Patient received the dose1 (lot: EP7533) for Covid-19 immunisation. The patient felt a little bit tired like the symptom when had covid and throat was painful and had little chills on 20Apr2021. had a sprain in leg but patient guessed that because had a knee replacement on unknown date. Patient stated, "Sorry, I am thinking I am deaf. I am sorry, I cannot understand". The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 15:05 (Lot Number: ER8734) as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient tested positive for COVID-19 on 20Apr2021. The patient's husband asked if patient should go tomorrowto get her shot? She has her appointment for the second dose on 22Apr2021 and now she wants to know if she should cancel? Adds when she got the vaccination she felt normal and she thinks that vaccine has helped. The events did not require a visit to emergency room or physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was unknown.