chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Choking, Decreased appetite, Dizziness, Dysphagia
Clinical narrative: Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts to close in I couldn't breathe; I have a lot of trouble in breathing; I couldn't eat; I couldn't sleep; I was very dizzy; I had a lot of vomiting; I couldn't even swallow; My neck was really getting swollen; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 5EW0182), via an unspecified route of administration on 03May2021 (at the age of 22-years-old) as a single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her shot right in, "my breaths starts to close in I couldn't breathe", "I couldn't eat", "I couldn't sleep", "I was very dizzy", "I had a lot of vomiting" and it was basically not good. Then she went to the urgent care because "I couldn't even swallow", "my neck was really getting swollen" and "neck was chocking I feel like that I have taken a pill and it stuck in a throat" and then "I had fever", chills and a lot of hard time. When paraphrased the above concern, the patient stated, and then "I have a lot of trouble in breathing". She received the second dose on 24May2021. The patient stated, the only thing that they gave her was Ibuprofen because they say, that's the only thing that they could give her. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Pyrexia, Swelling, Vomiting
Clinical narrative: Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts to close in I couldn't breathe; I have a lot of trouble in breathing; I couldn't eat; I couldn't sleep; I was very dizzy; I had a lot of vomiting; I couldn't even swallow; My neck was really getting swollen; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 5EW0182), via an unspecified route of administration on 03May2021 (at the age of 22-years-old) as a single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her shot right in, "my breaths starts to close in I couldn't breathe", "I couldn't eat", "I couldn't sleep", "I was very dizzy", "I had a lot of vomiting" and it was basically not good. Then she went to the urgent care because "I couldn't even swallow", "my neck was really getting swollen" and "neck was chocking I feel like that I have taken a pill and it stuck in a throat" and then "I had fever", chills and a lot of hard time. When paraphrased the above concern, the patient stated, and then "I have a lot of trouble in breathing". She received the second dose on 24May2021. The patient stated, the only thing that they gave her was Ibuprofen because they say, that's the only thing that they could give her. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: He had a bad flare up; This is a spontaneous report from a contactable nurse. A 63-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 26Apr2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 2019 to an unspecified stop date. It was unknown, whether the patient was pregnant at the time of event. On an unspecified date, in April 2021, patient stated "I had to hold my xeljanz when I received my covid vaccines per my doctor. She had to stop Xeljanz a week Before, the week of and the week after both vaccines. Last vaccine was 26Apr2021". She had a bad flare up and Had to go to doctor to get a shot to help. She has appointment to go back and see doctor next week." doctor aware. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of rheumatoid arthritis flare up. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Completed suicide, Fatigue, Tinnitus
Clinical narrative: Tinnitus; Committed suicide; Fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 05Mar2021 11:15 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 26Mar2021 10:30; both via an intramuscular route of administration, administered in Arm left (left shoulder), as single dose, for covid-19 immunization. Medical history included multiple sclerosis (MS) from 07Jul2002 and ongoing. Patient's prior vaccination was none. The patient's concomitant medications were not reported. Caller reported the side effects after the administration of the Covid-19 vaccine. On unknown date in Mar2021, after the first shot his tinnitus started and he was also fatigued; and he committed suicide eventually. The caller went to a specialist and was told that he had heard about that symptom before from 6 patients who reported the same thing. Later the reporter mentioned he didn't know the guy other than he was a founder of one organization (name no provided) and he committed suicide. Had spoken with one of his friends who knew of a friend who also had tinnitus shortly after getting Covid and it was serious because the guy committed suicide. The guy was about his age and he ended up committing suicide and he had similar symptoms. This all happened around the same time in March when he had his vaccine and it's kind of eerie. It stated on the guy's obituary he had covid and tinnitus, but caller unable to clarify if guy had covid virus or vaccine. He didn't know the guy, but his other friend who have friends that were doctors said that you could go crazy. No further details provided for this person or other persons. This was the report two of three. Upon receipt of the follow up, it was stated that approximately 1-2 days after just vaccine, the patient started with hissing second on both ears which stated was diagnosed as tinnitus. As of today, 12Jun2021, the "hissins" was consistent or worse than the start and it fall day and night. On an unspecified date in Mar2021, the patient died, and the autopsy was not performed. The outcome of the events committed suicide and tinnitus was fatal while the outcome of the event fatigue was unknown.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Tinnitus; committed suicide
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abnormal behaviour, Blood test, Constipation, Dizziness, Malaise
Clinical narrative: feeling light headed; sinus pressure; reports nausea; has slowed down & still constipated".; still constipated; bending down; weak and tired; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program  Pharmacy Sutent and assistance Program. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation; palbociclib (IBRANCE), via oral route from 04Mar2021 (Batch/Lot number was not reported) and was ongoing, at 75 mg every other day (21 days on/7 days off) for breast cancer. The recommended dose was 125mg daily, 21 days on/7 days off as per the prescribing information. The patient's medical history included breast cancer and had problems with sinuses in the past. Concomitant medication(s) included fulvestrant (FULVESTRANT). On an unknown date, the patient was feeling lightheaded, a little dizzy when position changes, sinus pressure, nausea, has slowed down, still constipated, bending down. All the events were considered to be medically significant. Patient reports about a month ago, feeling very exhausted, real weak and tired. The patient went to the emergency room and was given 1pint of blood. Doctor instructed patient to restart current ibrance cycle 04Mar2021, 75mg every other day (ten tablets) + one week off to see if it improves red counts. Patient reports feeling "improved energy levels. The doctor was aware of dosing history of ibrance: 100mg dose on 18Nov2020-Jan2021; 75mg dose 21 days on/7 days off 04Feb2021. The patient underwent lab tests which included on an unknown date, blood test which was found to be low and oxygen saturation was low and on 22Mar2021, the results of red blood cells were pending. The outcome of all the events was unknown.  Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Oxygen saturation, Paranasal sinus discomfort, Posture abnormal
Clinical narrative: feeling light headed; sinus pressure; reports nausea; has slowed down & still constipated".; still constipated; bending down; weak and tired; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program  Pharmacy Sutent and assistance Program. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation; palbociclib (IBRANCE), via oral route from 04Mar2021 (Batch/Lot number was not reported) and was ongoing, at 75 mg every other day (21 days on/7 days off) for breast cancer. The recommended dose was 125mg daily, 21 days on/7 days off as per the prescribing information. The patient's medical history included breast cancer and had problems with sinuses in the past. Concomitant medication(s) included fulvestrant (FULVESTRANT). On an unknown date, the patient was feeling lightheaded, a little dizzy when position changes, sinus pressure, nausea, has slowed down, still constipated, bending down. All the events were considered to be medically significant. Patient reports about a month ago, feeling very exhausted, real weak and tired. The patient went to the emergency room and was given 1pint of blood. Doctor instructed patient to restart current ibrance cycle 04Mar2021, 75mg every other day (ten tablets) + one week off to see if it improves red counts. Patient reports feeling "improved energy levels. The doctor was aware of dosing history of ibrance: 100mg dose on 18Nov2020-Jan2021; 75mg dose 21 days on/7 days off 04Feb2021. The patient underwent lab tests which included on an unknown date, blood test which was found to be low and oxygen saturation was low and on 22Mar2021, the results of red blood cells were pending. The outcome of all the events was unknown.  Information about batch/ lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Culture, Haemorrhage, Illness
Clinical narrative: bleeding; sore throat; sickness; raw blisters; joint pain early morning; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a 37-year-old male patient in response to Non-HCP letter sent in cross referenced case that included:  A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration in Arm left on 10Mar2021 at 11:13 (Batch/lot number: EN6207) and second dose administered in Arm right on 30Mar2021 at 10:45 AM (Batch/lot number: EP7533) both doses as a single dose for Covid-19 immunisation. Patient's medical history included, a traumatic brain injury on 18Jun1995 at age 11-17 years old treated (4 mo), and at the age of 37 now he has short term memory issues left side spasticity from brain injury and handicapped from an unspecified date and unknown if ongoing. Concomitant medications included ibuprofen, multiple vitamin 1day gummies, Cinnamomum spp. oil, citrus aurantium essential oil, commiphora myrrha oil, eucalyptus spp. essential oil, rosmarinus officinalis essential oil, syzygium aromaticum essential oil (DOTERRA ON GUARD), and Peppermint on guard for unknown indication. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as A6E37. After vaccination, on an unspecified date in 2021, patient experienced joint pain early morning and was hardly ever sick, was shocked at severity of sore throat in evening and actually bleeding. He went to doctor next morning and they though it could be Scarlet fever. After 2 days, it was reported that the symptom does not show the actual bleedings lower back of throat not shown also raw blisters punch like marks. The patient underwent lab test which included culture results as negative on an unspecified date and strep investigation test, results as negative on 02Apr2021 (did strep test looked like scarlet fever; Had no fever). The outcome of events was unknown.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Oropharyngeal pain
Clinical narrative: bleeding; sore throat; sickness; raw blisters; joint pain early morning; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a 37-year-old male patient in response to Non-HCP letter sent in cross referenced case that included:  A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration in Arm left on 10Mar2021 at 11:13 (Batch/lot number: EN6207) and second dose administered in Arm right on 30Mar2021 at 10:45 AM (Batch/lot number: EP7533) both doses as a single dose for Covid-19 immunisation. Patient's medical history included, a traumatic brain injury on 18Jun1995 at age 11-17 years old treated (4 mo), and at the age of 37 now he has short term memory issues left side spasticity from brain injury and handicapped from an unspecified date and unknown if ongoing. Concomitant medications included ibuprofen, multiple vitamin 1day gummies, Cinnamomum spp. oil, citrus aurantium essential oil, commiphora myrrha oil, eucalyptus spp. essential oil, rosmarinus officinalis essential oil, syzygium aromaticum essential oil (DOTERRA ON GUARD), and Peppermint on guard for unknown indication. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as A6E37. After vaccination, on an unspecified date in 2021, patient experienced joint pain early morning and was hardly ever sick, was shocked at severity of sore throat in evening and actually bleeding. He went to doctor next morning and they though it could be Scarlet fever. After 2 days, it was reported that the symptom does not show the actual bleedings lower back of throat not shown also raw blisters punch like marks. The patient underwent lab test which included culture results as negative on an unspecified date and strep investigation test, results as negative on 02Apr2021 (did strep test looked like scarlet fever; Had no fever). The outcome of events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone density abnormal, Cellulitis, X-ray of pelvis and hip
Clinical narrative: cellulitis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8733, expiration date unspecified), intramuscularly, administered in Arm Left on 03Apr2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient medical history included type 2 diabetes mellitus (ongoing) Pertinent Details: 2018 Oct-Stomach gastric sleeve, sleep apnoea syndrome from 1999 and ongoing Pertinent Details: BI PAP Machine, spinal stenosis for 9 years (ongoing) Pertinent Details: Cortisone ingestions knees, brain and neck. The patient family history included cardiac failure congestive in 2002 to her mom, emphysema in 1988 to her Dad, which cause his death. The patient had x-ray of pelvis and hip on an unknown date in Nov2020 and results indicated lumber tailbone, fractured tailbone. The patient's concomitant medications were not reported. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6207, expiration date unspecified), intramuscularly, administered in Arm right on 13Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. On 06Apr2021, the patient experienced cellulitis. On 20May2021, the patient had her bone density checked and results are unknown at the time of report. The patient was treated with immediate care and received antibiotic shots for 7days. The outcome of the event cellulitis was reported as recovered on 21May2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: still contracted the corona virus; still contracted the corona virus; This is a spontaneous report from a contactable consumer or other non hcp(patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 on an unknown date for COVID-19 immunization. The patient experienced still contracted the corona virus on an unspecified date. Outcome of the events were unknown.  Follow up(04Jun2021): This is a follow up spontaneous report from a consumer.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Course of the anaphylactic reaction: broke out in hives all over; Course of the anaphylactic reaction: broke out in hives all over; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK8982; Expiration date was not reported), intramuscular on the right arm on 01Feb2021 (10:00) as a 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 08Jan2021 (10:00) as a single dose, intramuscular on the right arm for COVID-19 immunization. On 01Feb2021, after the second dose of vaccination, the patient had described the course of anaphylactic reaction as broke out in hives all over. The events were reported to be severe (assessed as medically significant). The patient had received treatment with adrenaline, corticosteroids and steroid creams for the events. The outcome of the events was recovered on an unspecified date in 2021. The reporter did not consider BNT162B2 to have a causal effect to the reported events (unrelated).; Sender's Comments: There is a reasonable possibility that the event "anaphylactic reaction as broke out in hives" was related to BNT162b2 based on known drug safety profile and close temporal relationship.  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: Asthenia, Chest pain, Disability, Dyspnoea, Electrocardiogram
Clinical narrative: She reports her daughter has to use braces and a wheelchair and is unable to work; patient received the Pfizer covid-19 injection on 14Apr2021 and was paralyzed 13 hours later; has to use braces and a wheelchair and is unable to work; her daughter has to use braces and a wheelchair and is unable to work; Does not have full strength in her legs; Left arm goes numb cannot feel hot or cold; Has shortness of breath; Always feels cold; Chest pain; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 14Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the patient has to use braces and a wheelchair and is unable to work, reporter stated here have been other people she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), patient received the Pfizer covid-19 injection on 14apr2021 and was paralyzed 13 hours later, does not have full strength in her legs, left arm goes numb cannot feel hot or cold, has shortness of breath, always feels cold, chest pain on Apr2021. Patient had been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection and had been on the local news about her reaction. It was reported that a cardiologist saw "something" on an EKG and patient has also seen a neurologist and several other doctors. The patient underwent lab tests and procedures which included electrocardiogram: unknown in 2021. Clinical outcome of the events was not recovered.  Response: A review of the Prescribing Information (LAB-1457-9.0 Revised: 19May2021) for Pfizer-BioNTech covid-19 vaccine did not find information regarding leg paralysis. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your daughter's doctor/healthcare provider.  Information about lot/batch no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Hypokinesia, Paralysis
Clinical narrative: She reports her daughter has to use braces and a wheelchair and is unable to work; patient received the Pfizer covid-19 injection on 14Apr2021 and was paralyzed 13 hours later; has to use braces and a wheelchair and is unable to work; her daughter has to use braces and a wheelchair and is unable to work; Does not have full strength in her legs; Left arm goes numb cannot feel hot or cold; Has shortness of breath; Always feels cold; Chest pain; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 14Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the patient has to use braces and a wheelchair and is unable to work, reporter stated here have been other people she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), patient received the Pfizer covid-19 injection on 14apr2021 and was paralyzed 13 hours later, does not have full strength in her legs, left arm goes numb cannot feel hot or cold, has shortness of breath, always feels cold, chest pain on Apr2021. Patient had been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection and had been on the local news about her reaction. It was reported that a cardiologist saw "something" on an EKG and patient has also seen a neurologist and several other doctors. The patient underwent lab tests and procedures which included electrocardiogram: unknown in 2021. Clinical outcome of the events was not recovered.  Response: A review of the Prescribing Information (LAB-1457-9.0 Revised: 19May2021) for Pfizer-BioNTech covid-19 vaccine did not find information regarding leg paralysis. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your daughter's doctor/healthcare provider.  Information about lot/batch no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate increased, Pyrexia
Clinical narrative: fever; headache; felt like she even might cough a little due to the heartbeat increase; fast heart beating/ heartbeat increase in a short period of time; This is a spontaneous report from a contactable consumer (patient's father) via Medical Information Team. A 12-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 10Jun2021 as single for covid-19 immunisation. Previously received first dose of BNT162B2 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, her daughter is just 12 years old and she who received the second dose of the Pfizer-BioNTech COVID-19 Vaccine on 10Jun2021. Now she's suffering, there are some normal side-effects like fever, headache but she also experiencing like a heartbeat increase in a short period of time say two third of the time will be okay but it is one third of the time, she felt the heartbeat is going fast, faster than normal and then she felt like she even might cough a little due to the heartbeat increase. He mentioned that 24 hours after the shot (11Jun2021), his daughter has experienced a side effect listed in the pamphlet: the fast heart beating. So, he like to find out specifically, first of all if that is normal the heart beat thing, 2nd should we be concerned and worried and go to the hospital ER because of this. Pfizer Response to Reported Cases of Myocarditis in Recipients of COVID-19 Vaccine. Pfizer is aware of the Israeli observations of myocarditis that occurred predominantly in a population of young men who received the Pfizer-BioNTech COVID-19 vaccine. Adverse events are regularly and thoroughly reviewed and we have not observed a higher rate of myocarditis than what would be expected in the general population. A causal link to the vaccine has not been established. There is no evidence at this time to conclude that myocarditis is a risk associated with the use of Pfizer/BioNTech COVID-19 vaccine. [for non-HCPs]: we refer you to your healthcare provider to discuss this topic. Your healthcare provider knows your medical history, can discuss the risks and benefits of the vaccine, and can provide vaccination recommendations to you. If asked about how many cases of myocarditis have you seen after administration of the Pfizer/BioNTech vaccine? Pfizer is aware of the reports of myocarditis in recipients of the Pfizer-BioNTech COVID-19 vaccine. A causal link to the vaccine has not been established. Serious adverse events unrelated to but close in timing to vaccination will likely occur at a similar rate in vaccinated individuals as they would in the overall population. With a vast number of people vaccinated to date, the benefit risk profile of our vaccine remains positive. The outcome of events was unknown.  Information on the batch/lot number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Tremor, Urine analysis
Clinical narrative: Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head; This is a Spontaneous case report a contactable consumer(patient). A 17-years-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0196), via an unspecified route of administration on 05Jun2021 at 18:30 into left arm as a single dose for COVID-19 immunization (at the age of 17 years). The patient medical history and concomitant medications were not reported. The historical vaccine includes the patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration on 04May2021 at 19:00 pm into left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.On 05Jun2021 at 20:30, patient had Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head. The patient underwent lab tests and procedures which included blood test, computerised tomogram, electroencephalogram, urine analysis was unknown on an unspecified date.  The patient was visited to Emergency room/department or urgent care for the events. The patient had received Benadryl as a treatment for the adverse event. The outcome of the events was recovering.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood disorder, Computerised tomogram, Echocardiogram, Musculoskeletal chest pain
Clinical narrative: he received an  infusion at a hospital ' to purify' the blood; pain in back; pain in back then  his ribs and then  travelled to his chest; pain in back then  his ribs and then  travelled to his chest; virus in his system from the virus as a result of the pfizer covid vaccine.; he was in a lot of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 77-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), (at the age of 77-years-old) via an unspecified route of administration on 06Apr2021 as dose 2 single for COVID-19 immunisation. The patient historical vaccine included received first dose of bnt162b2(Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 16Mar2021 as dose 1 single informed that no reaction on previous exposure to drug. The patient's medical history includes liver transplant about 10years ago. Patient concomitant medications were not reported. On an unspecified date, 3 days after the second shot he developed pain in back then his ribs and then travelled to his chest. He has been to Emergency twice, seen 6 or 7 different doctors; doing testing, had a CAT scan and an echogram. He told this morning that the doctor suspects he has a ' virus in his system from the virus' as a result of the pfizer covid vaccine. Caller asking if we know anything about this and wanting treatment recommendations. Caller unable to clarify what the hcp means. States before he received the vaccine, he was healthy other than a liver transplant about 10 years ago. States he was in a lot of pain-prescribed morphine but did not want to take it. Also states he received an infusion at a hospital to purify' the blood. He felt better after the infusion then 2 hours later it came right back (unclear if caller referring to pain). He was told by his hcp that everything was normal, and they can't find anything wrong. He said he read on the news that people were reporting aches and pains from the pfizer covid vaccine, but he was surprised how long it took for pfizer to acknowledge it. The outcome of the adverse events was unknown.  Information about lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Non-cardiac chest pain, Pain, Viral infection
Clinical narrative: he received an  infusion at a hospital ' to purify' the blood; pain in back; pain in back then  his ribs and then  travelled to his chest; pain in back then  his ribs and then  travelled to his chest; virus in his system from the virus as a result of the pfizer covid vaccine.; he was in a lot of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 77-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), (at the age of 77-years-old) via an unspecified route of administration on 06Apr2021 as dose 2 single for COVID-19 immunisation. The patient historical vaccine included received first dose of bnt162b2(Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 16Mar2021 as dose 1 single informed that no reaction on previous exposure to drug. The patient's medical history includes liver transplant about 10years ago. Patient concomitant medications were not reported. On an unspecified date, 3 days after the second shot he developed pain in back then his ribs and then travelled to his chest. He has been to Emergency twice, seen 6 or 7 different doctors; doing testing, had a CAT scan and an echogram. He told this morning that the doctor suspects he has a ' virus in his system from the virus' as a result of the pfizer covid vaccine. Caller asking if we know anything about this and wanting treatment recommendations. Caller unable to clarify what the hcp means. States before he received the vaccine, he was healthy other than a liver transplant about 10 years ago. States he was in a lot of pain-prescribed morphine but did not want to take it. Also states he received an infusion at a hospital to purify' the blood. He felt better after the infusion then 2 hours later it came right back (unclear if caller referring to pain). He was told by his hcp that everything was normal, and they can't find anything wrong. He said he read on the news that people were reporting aches and pains from the pfizer covid vaccine, but he was surprised how long it took for pfizer to acknowledge it. The outcome of the adverse events was unknown.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient contracted COVID-19 on 17Jun21 and went for testing on 20Jun2021 which was positive.; Patient contracted COVID-19 on 17Jun21 and went for testing on 20Jun2021 which was positive.; This is a spontaneous report received from a contactable Other HCP (other health professional). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) via intramuscular at single dose at age of 35-year-old in left arm for COVID-19 immunization, the first dose was on 03Feb2021 (Lot#: EL3247), the second dose of on 24Feb2021 11:15 AM (Lot#: EL3247). Medical history and concomitant medication received within 2 weeks of vaccination were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient contracted COVID-19 on 17Jun2021 and went for testing on 20Jun2021 which was positive. Covid test on 20Jun2021 was positive. The event resulted in doctor or other healthcare professional office/clinic visit. The events was assessed serious due to medically significant, not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Nausea, Ovarian cyst ruptured
Clinical narrative: They said it was an ovarian cyst rupture; Around 8 pm she started screaming in pain; feeling nauseous; feeling nauseous and dizzy; This is a spontaneous report from a contactable consumer (patient).   A 15-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jun2021 12:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 2, SINGLE for covid-19 immunisation. Administered is Pharmacy or Drug Store. Medical history included asthma and no known allergies. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 1, SINGLE for covid-19 immunisation. After her 1st covid shot on 30May2021 and then had her period on 02Jun2021. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps. It maybe a coincidence. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported.  After her 2nd covid shot on 20Jun2021 around 12 noon. Around 8 pm she started screaming in pain, hunched over, feeling nauseous and dizzy. Patient had clinic visit, ended up taking to ER where they gave her morphine for pain. They started IV, did bloodwork, ultrasound and ct scan with contrast all on 20Jun2021. They said it was an ovarian cyst rupture. Patient was only 15 years old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun21 and pray it's not as bad as last month after the shot. They do believe in science, but also think should study menstrual cycles with this shot. They pray this was just a fluke, but patient has never experienced pain or severe periods like this until shot. Treatment received for all events. The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Ultrasound scan
Clinical narrative: They said it was an ovarian cyst rupture; Around 8 pm she started screaming in pain; feeling nauseous; feeling nauseous and dizzy; This is a spontaneous report from a contactable consumer (patient).   A 15-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jun2021 12:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 2, SINGLE for covid-19 immunisation. Administered is Pharmacy or Drug Store. Medical history included asthma and no known allergies. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 1, SINGLE for covid-19 immunisation. After her 1st covid shot on 30May2021 and then had her period on 02Jun2021. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps. It maybe a coincidence. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported.  After her 2nd covid shot on 20Jun2021 around 12 noon. Around 8 pm she started screaming in pain, hunched over, feeling nauseous and dizzy. Patient had clinic visit, ended up taking to ER where they gave her morphine for pain. They started IV, did bloodwork, ultrasound and ct scan with contrast all on 20Jun2021. They said it was an ovarian cyst rupture. Patient was only 15 years old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun21 and pray it's not as bad as last month after the shot. They do believe in science, but also think should study menstrual cycles with this shot. They pray this was just a fluke, but patient has never experienced pain or severe periods like this until shot. Treatment received for all events. The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy test
Clinical narrative: Early Miscarriage the week following the second vaccine- following 2 previous positive pregnancy tests; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 31 years on 10Jun2021 11:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included diagnosed with COVID-19 Prior to vaccination. The patient's concomitant medications were none, no any other vaccines within 4 weeks prior to the COVID vaccine; no any other medications the patient received within 2 weeks of vaccination. The patient previously took BNT162B2 dose 1 in left arm at age of 31 years on 21May2021 13:00. The patient experienced early miscarriage on 18Jun2021 17:00 the week following the second vaccine- following 2 previous positive pregnancy tests (Seriousness criteria reported as congenital anomaly/birth defect). Last menstrual date was 19May2021 and due to deliver on 22Feb2022. Since the vaccination, patient has not been tested for COVID-19. No treatment was received. The outcome of the event was recovered with sequelae in Jun2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, Cerebrovascular accident, Haemoglobin, Haemoglobin decreased, Infection
Clinical narrative: stroke; hemoglobin won't stay above 7; anemia; muscle atrophy; persistent fevers; inflammation; infectious disease; white blood cells are low; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports which corresponds to the second person the reporter knew who experienced the same events as her father.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer was reporting for her father and mentioned that she personally knew two people who had the same situation in the blood as her father. It was reported that the patient experienced stroke, hemoglobin won't stay above 7, anemia, muscle atrophy, persistent fevers with signs of inflammation and infectious disease, and low white blood cells. The patient had been in the hospital for three months (90 days). Therapeutic measures were taken as a result of the events. The consumer mentioned that Pfizer has reached out to them and gave them some sort of medicine that helped regulate the blood. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021751102 same reporter and drug, similar events, different patients;US-PFIZER INC-2021748630 same reporter and drug, similar events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Muscle atrophy, Pyrexia, White blood cell count, White blood cell count decreased
Clinical narrative: stroke; hemoglobin won't stay above 7; anemia; muscle atrophy; persistent fevers; inflammation; infectious disease; white blood cells are low; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports which corresponds to the second person the reporter knew who experienced the same events as her father.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer was reporting for her father and mentioned that she personally knew two people who had the same situation in the blood as her father. It was reported that the patient experienced stroke, hemoglobin won't stay above 7, anemia, muscle atrophy, persistent fevers with signs of inflammation and infectious disease, and low white blood cells. The patient had been in the hospital for three months (90 days). Therapeutic measures were taken as a result of the events. The consumer mentioned that Pfizer has reached out to them and gave them some sort of medicine that helped regulate the blood. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021751102 same reporter and drug, similar events, different patients;US-PFIZER INC-2021748630 same reporter and drug, similar events, different patients