chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable consumer reported for a patient that a patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced myocarditis after mRNA vaccine. The reporter stated that they know of this one additional report of a single cardiac biopsy, but nothing particularly informative beyond the absence of cellular infiltrates. This paper mentions the recommendation to avoid excessive physical activity for several months after an episode of myocarditis. I think it was clear that we are vigorously seeking info to inform about rare risk of cardiac findings after mRNA vaccines. I will be eager to learn about any outcomes from further discussion with Doctor. Please find attached a report in follow up to our discussion about any biopsies obtained in setting of suspected myocarditis after mRNA vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia, Tinnitus
Clinical narrative: Dizziness; Bodyaches; Ringing in ears; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 28Jul2021 at 11:45 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 28Jul2021 at 22:00, the patient experienced dizziness, ringing in ears, fever, headache, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, ringing in ears, fever, headache, body aches was not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Caller had the first dose of the Pfizer vaccine today, July 28 2021 and has sinus ear infection; This is a spontaneous report from a Pfizer- sponsored program. A contactable male consumer reported for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration on 28Jul2021 as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included amoxicillin and Antibiotics (unspecified) taken for an unspecified indication, start and stop date were not reported. It was reported that, caller had the first dose of the Pfizer vaccine today, 28Jul2021 and has sinus ear infection, patient was on antibiotics for a while. Patient got a steroid shot 2-3 weeks ago (further clarification unknown). Later Transferring agent stated Caller had the first dose of the Pfizer vaccine today (28Jul2021), 28Jul2021 and has sinus ear infection and he wanted to know if he can get Amoxicillin or Steroids in between the doses because his second dose will be on 18Aug2021. It was reported that When paraphrased, consumer stated, it was not from the shot. Patient had this before patient got the shot. (Further clarification unknown). When probed since when consumer had the sinus ear infection, consumer stated, patient have been having sinus problem for a while. So, patient was on antibiotics for a while. Patient got a steroid shot 2-3 weeks ago (Further clarification unknown). Consumer stated, question was patient need to get more antibiotics for the ear infection, but the question was because patient have to take the second shot can patient take the antibiotics between the first dosage and second dosage, does it have to be out of his system like week before the shot How does it work. Therapeutic measures were taken as a result of event. The outcome of event was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Severe fatigue; Intermittent fever as high as 102 F; Chills; Muscle aches; This is a spontaneous report from a contactable healthcare professional. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E W0173) via an unspecified route of administration in the right arm on 26Jul2021 at 16:15 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Jul2021 at 04:00, the patient experienced severe fatigue, intermittent fever as high as 102 F, chills and muscle aches still occurring from 12 hours post vaccination (lasting 3 days so far). The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. On 27Jul2021 at 04:00, the patient underwent lab test and procedure which included body temperature and the result was shown as 102 F. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fatigue, intermittent fever as high as 102 F, chills and muscle aches were not resolved at the time of this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Urticaria
Clinical narrative: developed hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 86 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration on 29Jan2021 14:00 (at the age of 85 years) as SINGLE for covid-19 immunization, Followed by patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Pfizer 6198 and expiration date were not reported), second dose on deltoid left via an unspecified route of administration on 19Feb2021 14:00 as single for covid-19 immunization. Medical history included colonoscopy from an unknown date and unknown if ongoing 15 years ago, she was preparing for a colonoscopy and took MiraLax and experienced drug hypersensitivity. The patient concomitant medications were not reported. On 09Feb2021 exactly 11 days later the patient experienced developed hives. The patient underwent lab tests and procedures which included biopsy founded nothing unusual on 2021 biopsy of the hives found nothing unusual. The outcome of the event was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oral pain, Pain, Pallor
Clinical narrative: Pain all over body; Mouth pain; Very pale complexion; Headaches; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 08Jun2021 at 19:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient experienced pain all over body, exhaustion, headaches, mouth pain and very pale complexion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. On 05Jul2021, the patient underwent COVID test and the result was negative. The clinical outcome of the events pain all over body, exhaustion, headaches, mouth pain and very pale complexion was not resolved at the time of this report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pain all over body; Mouth pain; Very pale complexion; Headaches; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 08Jun2021 at 19:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient experienced pain all over body, exhaustion, headaches, mouth pain and very pale complexion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. On 05Jul2021, the patient underwent COVID test and the result was negative. The clinical outcome of the events pain all over body, exhaustion, headaches, mouth pain and very pale complexion was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, Blood immunoglobulin G decreased, Pain in jaw, Tooth fracture
Clinical narrative: her IGG area showed low; she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case; she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 17Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing pre-existing infection that went bonkers, severe emphysema, lupus, Chronic obstructive pulmonary disease and tooth extraction at the very end of Dec2020 (patients tooth broke at the gum line and they had to wiggle and bounce it and when it came out it was blackish). States it was from the gum down into the tooth and they had to fight to get it out and she had ongoing pain her in jaw and didn't pay it attention she thought about the extraction. The patient was on steroids for years and years and got into emphysema and on more steroids. She has been on steroids so long taking them and her body is falling apart and it's affecting her teeth. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9262, Expiration Date: 31May2021), via an unspecified route of administration on 28Jan2021 as dose 1, single for covid-19 immunisation and experienced face was swollen and it made her nose go crooked with pain in her mouth that was terrible, cellulitis in her face, white blood count was 20 and should have been 10, jaw pain. States she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case. She stated the 2nd shot was no big deal, you hear people complaining about being tired and chills and she didn't have that and her arm didn't hurt. She stated the worst part is the opposite side of the top of her jaw bone, the 1st time it was the right side, and right now it's the tooth on the left side, the same tooth opposite side. States it broke away from the gum and it's the exact same thing. States when she does go get it done, she is a little leery of going to get that half tooth or if it comes out and fight to get the bottom that is in the jaw and this is probably black with her staying on steroids for years and years and got into emphysema and on more steroids. After the second dose, patients Immune was low and IGG area showed low, so the patient wanted the test and was waiting for the result. She states that her immunity in general has been in a question for a while. Patient had an antibody test and no antibodies even though she got 2 shots. Patient wanted to know under the circumstances will it be in vain and get the 3rd dose. The outcome of the events was unknown.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Fainted maybe 20-30 seconds post injection; convulsive vasovagal; Fainted maybe 20-30 seconds post injection. Then had what looked like a short seizure.; This is a spontaneous report from a contactable pharmacist (patient's mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 28Jul2021 16:15 (Batch/Lot Number: FA7485), at the age of 12 years old, as dose 2, single for covid-19 immunization in a pharmacy of drug store. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen, cetirizine hydrochloride (ZYRTEC), and mupirocin, all taken for unspecified indications, start and stop date were not reported. No other vaccines were given within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 on 05Jul2021 13:00 (lot no: FA6780), at the age of 12 years old, intramuscular in left arm for COVID-19 immunisation; previously fainted once 2-3 years ago with influenza vaccination. On 28Jul2021 16:15, the patient fainted maybe 20-30 seconds post injection. Then had what looked like a short seizure. He threw himself back in his chair, went totally straight and stiff then threw himself back again. Probably convulsive vasovagal but mom will have him checked out. As treatment, patient was laid on back and was given Gatorade. The events were reported as non-serious. The patient recovered from the events on 28Jul2021.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events syncope and seizure cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: U
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Chills, Diarrhoea, Headache
Clinical narrative: Headache; Diarrhea; My headache and my eyes are killing me; Chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 22Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient stated that, got the Pfizer shot then patient had the side effects and got it on Thursday. Patient believe it was 22nd. Patient got headache, diarrhea, little bit of chills. Headache and eyes are killing patient. So, sounds like all the symptoms here, the side effects since Thursday. Patient want to report it. Patient asked that, do need to go to a doctor. Consumer was unwilling to complete the report. Hence limited information available over the call. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: AFIB episodes; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0198), via an unspecified route of administration, administered in arm right on 12Jul2021 at 10:15 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, asthma, COVID-19 and AFIB (atrial fibrillation) from an unknown date; and heart ablation from 22Jun2020 (I had a heart Ablation due to AFIB on 22Jun) to an unknown date. The patient 9 AFIB episodes and heart palpitations on 12Jul2021 at 11:15. The clinical course was as follows: The patient had a heart ablation due to AFIB on 22Jun. Approximately 1 hour after receiving her 1st dose, she begun having the same level of heart palpitations as i did prior to her surgery. She had to take additional doses of Flacenide that she uses to regulate her heart. She has had at least 9 AFIB episodes daily since then when they had all but stopped after her surgery. Therapeutic measures were taken as a result of both events. The outcome of the events was recovered with sequelae on an unspecified date.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: started losing her voice; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on 28Jul2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced that she started losing her voice on 29Jul2021.Patient was the first person at the phone but could not speak clearly as she was losing her voice.The patient didn't receive any treatment for the event.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Disorientation, Dizziness, Fall
Clinical narrative: Very weak; Very disjointed thought processes and motor function that day; Very disjointed thought processes and motor function that day; feeling like my knees were going to collapse; Passed out; I began to feel pain radiating from the center of my torso.; I became nauseated,; I fell to the floor; Dizzy and disoriented; disoriented; Began violent vomiting; Worst diarrhea I´ve ever had; Exhausted/tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 19Jul2021 at 18:15 (62-years-old at the time of vaccination) (Batch/Lot Number: FA7484) single, for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had concomitant medications (unspecified; reported as medications that the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jul2021, about 1 hour and 15 minutes after receiving the vaccine, at 19:30, the patient began to feel pain radiating from the center of his torso. The pain intensified rapidly to severe. He became nauseated and tried to walk to the bathroom but he fell to the floor. Dizzy and disoriented, he started crawling, passed out, and started again. He began violent vomiting, passed out, woke up, and dragged himself up on the commode. Stated that it was the worst diarrhea he'd ever had. Stated that everything in his digestive system left his body. He then passed out on the commode, woke up, crawled back to the living room, and went to sleep. He woke up in a few minutes feeling better but exhausted. The patient woke up the next morning, very weak, and was still somewhat disoriented. He had a very disjointed thought processes and motor function that day. He kept feeling like his knees were going to collapse. The next day, he was still weak but almost clear headed. Next day, he was tired but ok. The initial severe sequence of events lasted maybe an hour or a little more. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the events. Outcome of the events was recovered in Jul2021. The case was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Motor dysfunction, Muscular weakness, Nausea
Clinical narrative: Very weak; Very disjointed thought processes and motor function that day; Very disjointed thought processes and motor function that day; feeling like my knees were going to collapse; Passed out; I began to feel pain radiating from the center of my torso.; I became nauseated,; I fell to the floor; Dizzy and disoriented; disoriented; Began violent vomiting; Worst diarrhea I´ve ever had; Exhausted/tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 19Jul2021 at 18:15 (62-years-old at the time of vaccination) (Batch/Lot Number: FA7484) single, for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had concomitant medications (unspecified; reported as medications that the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jul2021, about 1 hour and 15 minutes after receiving the vaccine, at 19:30, the patient began to feel pain radiating from the center of his torso. The pain intensified rapidly to severe. He became nauseated and tried to walk to the bathroom but he fell to the floor. Dizzy and disoriented, he started crawling, passed out, and started again. He began violent vomiting, passed out, woke up, and dragged himself up on the commode. Stated that it was the worst diarrhea he'd ever had. Stated that everything in his digestive system left his body. He then passed out on the commode, woke up, crawled back to the living room, and went to sleep. He woke up in a few minutes feeling better but exhausted. The patient woke up the next morning, very weak, and was still somewhat disoriented. He had a very disjointed thought processes and motor function that day. He kept feeling like his knees were going to collapse. The next day, he was still weak but almost clear headed. Next day, he was tired but ok. The initial severe sequence of events lasted maybe an hour or a little more. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the events. Outcome of the events was recovered in Jul2021. The case was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Thinking abnormal, Vomiting
Clinical narrative: Very weak; Very disjointed thought processes and motor function that day; Very disjointed thought processes and motor function that day; feeling like my knees were going to collapse; Passed out; I began to feel pain radiating from the center of my torso.; I became nauseated,; I fell to the floor; Dizzy and disoriented; disoriented; Began violent vomiting; Worst diarrhea I´ve ever had; Exhausted/tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 19Jul2021 at 18:15 (62-years-old at the time of vaccination) (Batch/Lot Number: FA7484) single, for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had concomitant medications (unspecified; reported as medications that the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jul2021, about 1 hour and 15 minutes after receiving the vaccine, at 19:30, the patient began to feel pain radiating from the center of his torso. The pain intensified rapidly to severe. He became nauseated and tried to walk to the bathroom but he fell to the floor. Dizzy and disoriented, he started crawling, passed out, and started again. He began violent vomiting, passed out, woke up, and dragged himself up on the commode. Stated that it was the worst diarrhea he'd ever had. Stated that everything in his digestive system left his body. He then passed out on the commode, woke up, crawled back to the living room, and went to sleep. He woke up in a few minutes feeling better but exhausted. The patient woke up the next morning, very weak, and was still somewhat disoriented. He had a very disjointed thought processes and motor function that day. He kept feeling like his knees were going to collapse. The next day, he was still weak but almost clear headed. Next day, he was tired but ok. The initial severe sequence of events lasted maybe an hour or a little more. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the events. Outcome of the events was recovered in Jul2021. The case was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Biopsy, Haemoglobin, Laboratory test, Muscle spasms
Clinical narrative: vaginal bleeding; cramps; bloating; This is a spontaneous report from a contactable consumer (patient) in response to consumer letter sent via follow-up letter which included that a 60-years-old female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198, patient was 60-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Right on 25Feb2021 at 08:00 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included post menopause (I am 15 years post menopause, Do not need increase in oestrogen. Onset of period in my 60s), breast cancer (Concerned due to family history of breast cancer), High blood pressure. Concomitant medication(s) included ongoing metoprolol succinate (TOPROL XL, 50 mg, via oral route) taken for High blood pressure; biotin; colecalciferol (VIT D [COLECALCIFEROL]). On 02Mar2021, the patient experienced vaginal bleeding, cramps, bloating. No treatment was received for events. On 01Apr2021, the patient underwent lab tests and procedures which included biopsy polyp, Hemoglobin, Post OC-light, Thin prep which all resulted as normal. The outcomes of events were recovered on 07Mar2021.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal bleeding; cramps; bloating; This is a spontaneous report from a contactable consumer (patient) in response to consumer letter sent via follow-up letter which included that a 60-years-old female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198, patient was 60-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Right on 25Feb2021 at 08:00 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included post menopause (I am 15 years post menopause, Do not need increase in oestrogen. Onset of period in my 60s), breast cancer (Concerned due to family history of breast cancer), High blood pressure. Concomitant medication(s) included ongoing metoprolol succinate (TOPROL XL, 50 mg, via oral route) taken for High blood pressure; biotin; colecalciferol (VIT D [COLECALCIFEROL]). On 02Mar2021, the patient experienced vaginal bleeding, cramps, bloating. No treatment was received for events. On 01Apr2021, the patient underwent lab tests and procedures which included biopsy polyp, Hemoglobin, Post OC-light, Thin prep which all resulted as normal. The outcomes of events were recovered on 07Mar2021.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: 2 weeks later still have pain; Vaccine was given very high on arm - Dr. says it was too high; This is a spontaneous report from a contactable consumer (Patient).   A 69-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 14Jul2021 at 10:00 (age at vaccination 69 years) (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia and arthritis. The patient previously took steroids and experienced drug hypersensitivity. Concomitant medication included celecoxib (List of medication patient received within 2 weeks of vaccination). Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jul2021 at 06:00, patient experienced pain and it was mentioned that vaccine was given very high on arm, doctor said it was too high. Patient did not receive any treatment for adverse events. At the time of this report, the outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Migraine
Clinical narrative: Migraines; brain fog/Just felt awful on a number of fronts.; fatigue; insomnia; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo, concussion in Feb2020, and appendectomy in 2013. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not take any other medication within two weeks of taking COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 16:00, the patient experienced migraines, brain fog, fatigue, insomnia, just felt awful on a number of fronts. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with anti-migraine medication (Names unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraines, brain fog, fatigue, insomnia, just felt awful on a number of fronts was not recovered at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: low grade fever; vomiting; dull headache; exhaustion; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose2, single for Covid-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 30July2021 as dose1, single for Covid-19 immunization and experienced Sore arm. Patient was not diagnosed with Covid-19 Prior to vaccination. It was reported as after second shot had a low grade fever and vomiting. For whole next day had a dull headache and exhaustion. Since the vaccination patient was not tested for Covid-19. The patient underwent lab tests and procedures which included body temperature: low grade fever. The outcome for the events was reported as resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Husband had both doses of the vaccine and has immune issues; This is a spontaneous report from contactable consumer received from Pfizer sponsored program (patient's wife). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number, Expiry date: Unknown), via an unspecified route of administration, administered on unspecified date, dose 1 and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number, Expiry date: Unknown), via an unspecified route of administration, administered on unspecified date, dose 2, single dose for COVID-19 immunisation. The patients Medical history and Concomitant medications were not reported. On an unspecified date, reporter stated that her husband had both doses of the vaccine and had immune issues. Caller called in to know if we have a list of places that do protein antibody tests. She wanted her husband to do the test to check if the vaccine is still effective. His husband had both doses of the vaccine and has immune issues. Caller clarified that his husband is okay and was only worried because of the delta variant that is why she wanted him to do the antibody test. Escalate as NME. Referred to the health department. Created manual AE form for Precautionary as caller mentioned that her husband who got both doses of the vaccine has some immune issues and she is concerned if the vaccine works. Medical Information was not applicable, Customer's questions addressed by Program or no medical questions asked. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Cough, Dizziness, Hypertonia
Clinical narrative: Chest pain; Lightheaded and dizzy; threw-up once; whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well; couldn't move her hands due to being stiff and tense; tingling sensation as if asleep; Dry cough/the cough was on and off; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 28Jul2021 15:00 (Batch/lot number unknown), at age 36 years old, as dose 1, single, for COVID-19 immunisation, at an urgent care center. The patient was not pregnant at the time of vaccination. Relevant medical history included narcolepsy, hypothyroidism, anxiety, anemia, G.E.R.D. (gastrooesophageal reflux disease), vitamins D deficiency, and allergies to metal, soap, laundry detergent, lotions, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jul2021 15:00 (also reported as "about a minute or two after received the vaccine"), the patient became lightheaded and dizzy, threw-up once, her whole body tensed up to where she couldn't move her hands due to being stiff and tense, her legs tensed up as well and had tingling sensation as if asleep. On the same day, 28Jul2021, the patient had dry cough, the cough was on and off. The events resulted to emergency room and physician's office visits. The patient received oral BENADRYL and most of the tenseness released. The patient received more BENADRYL through an IV and sodium chloride. The patient underwent blood tests on 28Jul2021 with unknown results. "Chest drag" (as reported) was done. Most symptoms resolved except for dizziness, lightheadedness and on and off dry cough. The patient was then released home. The patient was not hospitalized. On 29Jul2021, the next day, the patient had on and off chest pain, the other events resolved. The patient recovered from the events threw-up once, whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well, couldn't move her hands due to being stiff and tense, and tingling sensation as if asleep on 28Jul2021; from lightheaded and dizzy and dry cough/the cough was on and off on 29Jul2021. The outcome of chest pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia, Vomiting
Clinical narrative: Chest pain; Lightheaded and dizzy; threw-up once; whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well; couldn't move her hands due to being stiff and tense; tingling sensation as if asleep; Dry cough/the cough was on and off; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 28Jul2021 15:00 (Batch/lot number unknown), at age 36 years old, as dose 1, single, for COVID-19 immunisation, at an urgent care center. The patient was not pregnant at the time of vaccination. Relevant medical history included narcolepsy, hypothyroidism, anxiety, anemia, G.E.R.D. (gastrooesophageal reflux disease), vitamins D deficiency, and allergies to metal, soap, laundry detergent, lotions, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jul2021 15:00 (also reported as "about a minute or two after received the vaccine"), the patient became lightheaded and dizzy, threw-up once, her whole body tensed up to where she couldn't move her hands due to being stiff and tense, her legs tensed up as well and had tingling sensation as if asleep. On the same day, 28Jul2021, the patient had dry cough, the cough was on and off. The events resulted to emergency room and physician's office visits. The patient received oral BENADRYL and most of the tenseness released. The patient received more BENADRYL through an IV and sodium chloride. The patient underwent blood tests on 28Jul2021 with unknown results. "Chest drag" (as reported) was done. Most symptoms resolved except for dizziness, lightheadedness and on and off dry cough. The patient was then released home. The patient was not hospitalized. On 29Jul2021, the next day, the patient had on and off chest pain, the other events resolved. The patient recovered from the events threw-up once, whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well, couldn't move her hands due to being stiff and tense, and tingling sensation as if asleep on 28Jul2021; from lightheaded and dizzy and dry cough/the cough was on and off on 29Jul2021. The outcome of chest pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: dry tickle type cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 30Apr2021 13:30  (at the age of 52 years old) (Lot Number: ER8737) as dose 2, single for COVID-19 immunisation. Medical history included arrhythmia and penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included esomeprazole magnesium (NEXIUM); metoprolol, Vitamin D; cyanocobalamin (VIT B12); glucosamine; all taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT2B2 on 09Apr2021, administration time: 04:00 PM, anatomical Location: Arm Right, Batch/lot number: ER8737 (at the age of 52 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, the patient experienced dry tickle type cough. Patient felt like it comes from the middle of her chest. The event was reported as non-serious. The patient was not hospitalized. No treatment was given for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.   No follow-up attempts are need. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cholecystitis, Gallbladder disorder, Pericarditis, Pericarditis constrictive
Clinical narrative: gall bladder issues/gall bladder was inflamed and it was full of sludge; pericarditis; gall bladder inflammation; extreme stomach pain; This is a spontaneous report from a contactable consumer via Medical information team. A 42 year old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included autoimmune issue and lupus from an unknown date and unknown if ongoing. The patient previously had BNT162B2 dose 1 for COVID-19 immunization. The patient's concomitant medications were not reported. The patient started experiencing some pains turned out to be gall bladder issues and she is in the hospital right now to get her gall bladder removed. The patient's husband was aware about the usual side effect, the pericarditis and also the inflammation of the gall bladder. The patient's husband concern was, is it possible that the spike protein invalidated into her gall bladder, that caused the autoimmune reaction or the inflammation to the gall bladder. He wants to know if we are doing tests on gall bladders that have been removed, and if his wife body is continuing to manufacture the spike protein and with her autoimmune condition related, will it be transmitted to another organ, or will it cause pericarditis. He is asking if we have procedure or testing spike protein concentration and other organs. The patient had gall bladder inflammation and pericarditis issue. The patient went through gall bladder surgery and had her gall bladder removed. The patient woke with extreme stomach pain and went to the emergency room that was last two days in Jul2021. The patient had CP of her heart pericarditis and they did an ultrasound of her gall bladder and told it was inflamed and it was full of sludge and then they sent her home and told her to schedule with a surgeon because he said it was a (Distorted voice). When probed if the result of test were normal: Reporter stated, No, the ultrasounds showed that her gall bladder had sludge in it and it was inflamed. It progressively got that worse over the next couple of days until the patient had surgery this morning to have her gall bladder removed. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound biliary tract
Clinical narrative: gall bladder issues/gall bladder was inflamed and it was full of sludge; pericarditis; gall bladder inflammation; extreme stomach pain; This is a spontaneous report from a contactable consumer via Medical information team. A 42 year old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included autoimmune issue and lupus from an unknown date and unknown if ongoing. The patient previously had BNT162B2 dose 1 for COVID-19 immunization. The patient's concomitant medications were not reported. The patient started experiencing some pains turned out to be gall bladder issues and she is in the hospital right now to get her gall bladder removed. The patient's husband was aware about the usual side effect, the pericarditis and also the inflammation of the gall bladder. The patient's husband concern was, is it possible that the spike protein invalidated into her gall bladder, that caused the autoimmune reaction or the inflammation to the gall bladder. He wants to know if we are doing tests on gall bladders that have been removed, and if his wife body is continuing to manufacture the spike protein and with her autoimmune condition related, will it be transmitted to another organ, or will it cause pericarditis. He is asking if we have procedure or testing spike protein concentration and other organs. The patient had gall bladder inflammation and pericarditis issue. The patient went through gall bladder surgery and had her gall bladder removed. The patient woke with extreme stomach pain and went to the emergency room that was last two days in Jul2021. The patient had CP of her heart pericarditis and they did an ultrasound of her gall bladder and told it was inflamed and it was full of sludge and then they sent her home and told her to schedule with a surgeon because he said it was a (Distorted voice). When probed if the result of test were normal: Reporter stated, No, the ultrasounds showed that her gall bladder had sludge in it and it was inflamed. It progressively got that worse over the next couple of days until the patient had surgery this morning to have her gall bladder removed. The outcome of events was unknown.  Information about lot/batch number has been requested.