chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got Covid; I got Covid; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for two patient. This is the first of two reports.   A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunization. The patient's medical history included an auto immune deficiency, do not have a spleen, and anaemic all from an unknown date. The patient's concomitant medications were not reported. The patient was supposed to get the second dose to be somewhere between the 18Mar2021 and 21Mar2021. But she got Covid. The patient got the first dose and was supposed to go back and get it another week to take the second dose. But somehow at work like she was not in the office. Other ladies had it before she got it. But she have an auto immune deficiency, do not have a spleen and was anaemic. So her doctor said get the vaccine 'unless' she get COVID. Patient would like to know if she can still get her second dose after this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021280057 same reporter/drug/event, different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Rash papular, Rash pruritic, Rash pustular
Clinical narrative: has a rash, it is itchy; kind of like the shingles/thinks it may have caused her to have shingles; has a rash, has bumps or pustules; has a rash, has bumps or pustules; it made her sick; This is a spontaneous report from a contactable nurse (patient herself).  A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 02Mar2021 10:30 (at age of 73-year-old) (Lot Number: EL9262) at single dose for COVID-19 immunisation. Medical history (including any illness at time of vaccination) and family medical History was reported as none. There were no concomitant medications or prior vaccinations (within 4 weeks). The patient stated she got the shot on 02Mar2021 and had a rash at time of the report. Added she was going to get scheduled for the next dose but is asking if she should get it with this rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 02Mar2021 at 10: 30AM in the left arm. She didn't get the rash right away. All of the sudden a week after the shot she woke up in the night Monday (08Mar2021) with a rash; kind of like the shingles; it was itchy and had bumps or pustules. The rash was  located on her upper body; shoulders and arms. Added she could scratch her boot to hell. Stated she was an old nurse and she did a lot of things to try to stop the itching. Added it was so itchy. She treated her rash with Vicks vapor rub; Bag Balm; Greycaine powder to dry it up; and finally put diphenhydramine hydrochloride (BENADRYL) on it. She took aspirin; vitamin C; B12 and zinc. Added but this shot didn't work, it made her sick. Added she thought it may have caused her to have shingles and she had never had shingles before. She had not had the shingles vaccination. Added she was supposed to get the next dose of the Pfizer COVID 19 vaccine in three weeks. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of 'has a rash, it is itchy, has bumps or pustules'. The outcome of events was not resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion induced, Maternal exposure during pregnancy, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if 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.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Pain, Temporomandibular joint syndrome, Vomiting
Clinical narrative: Intense pain in my right side of head, face and neck; Vomited; Hasn't been able to sleep because I have been in pain for the past 48 hours; "I have been diagnosed with TMJ; This is a spontaneous report received from a contactable consumer (reporting for herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6199, expiration date: not reported), via an unspecified route of administration in Arm Right on 07Mar2021 as single dose for COVID-19 immunization; ibuprofen (formulation: unknown) via an unspecified route of administration, start and stop date, and dose were not reported for an unspecified indication. Medical history included migraine. There were no concomitant medications. Patient stated, "I have just been having a, I think a pretty bad reaction to the Pfizer Vaccine. I went to the ER yesterday, I have pretty consistent just intense pain in my right side of my head, face and neck. I mean I am not sure if you could tell me how long this is going to last. I have been in pain consistently about 48 hours. Treatment received  I have been taking Ibuprofen, Acetaminophen, Magnesium and I went to the emergency room and they administered 2 stronger NSAIDs, I only remember one of them was like Pyridol and I don't remember the other one. stated, It started on the day after the shot was administered, March 8th and it has been on and off until today except for the past 48 hours. It has been steadily present and hasn't gone away, it is persistent. in Mar2021 I just vomited and I haven't been able to sleep because I have been in the pain for the past 48 hours. Lab work: Consumer stated, did some lab work, they did a blood test when I was in the hospital yesterday and was diagnosed with TMJ in Mar2021. I am calling because I had a reaction to the Pfizer vaccine, I got the vaccine on Sunday and since Monday night I have had very intense pain in my head, face jaw and neck. For the first 2 days it was on and off and then for the last almost 48 hours it's been constant. I had to go to the emergency room for pain management but I came back home immediately. I wanted to ask about how long these side effects may continue, what can be done and whether or not I should get the second dose scheduled". The outcome of the event Pain was not recovered and for rest events outcome was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: The headache in the right eye was most troublesome; Nausea; Diarrhea; Achy; severe exhaustion; This is a spontaneous report received from a contactable consumer. This consumer reported for a 56-year-old male patient received first dose of BNT162B2 (Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Left Arm on 03Mar2021 11:00 am as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Allergies to medications, food, or other products: no. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Not sure. The patient experienced the headache in the right eye was most troublesome (non-serious), nausea (non-serious), diarrhea (non-serious), achy (non-serious), severe exhaustion (non-serious); all on 03Mar2021 12:00 pm. Treatment was not received for the adverse event.Headache on right side, nausea, diarrhea, achy, severe exhaustion. The headache in the right eye was most troublesome. The outcome of all events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Insomnia
Clinical narrative: After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion.  This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rhinorrhoea
Clinical narrative: After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion.  This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: My tongue started tingling on the opposite side from where I got my shot. It would tingle for around an hour and then would stop for about two hours.; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that her tongue started tingling on the opposite side from where she got her shot. It would tingle for around an hour and then would stop for about two hours. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: he is not feeling well earlier; This is a spontaneous report received from a Sponsored Program. A non-contactable male consumer (Patient) reported for himself that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient stated that his second dose appointment was scheduled today 09Mar2021 and he got his first dose appointment last 16Feb2021. He stated that he was not feeling well earlier that was why he decided not to take the second dose and he was trying to reschedule it on the system/online right now and during probing question he mentioned that he was feeling better now. He was looking forward in rescheduling the second dose on 11Mar2021. The outcome of the event was resolving.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive on their covid test, tested positive three days after receiving the vaccine; This is Spontaneous report from a contactable Pharmacist . This Pharmacist reported similar events for two patients. This is a 2nd of 2 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient tested positive on their covid test, tested positive three days after receiving the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276371 Same reporter/events/ drug/diff patient
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive via rapid and PCR on 13Mar for COVID even though fully vaccinated; Tested positive via rapid and PCR on 13Mar for COVID even though fully vaccinated COVID-19 PCR test; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 05Jan2021 07:00 (Batch/Lot Number: EK9231) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Batch/Lot Number: EL3Z47) as SINGLE DOSE for covid-19 immunisation. Medical history included Irritable Bowel Syndrome with constipation.  There were no concomitant medications. Received both doses of the vaccine (1st dose 05Jan2021; 2nd dose 25Jan2021). Exposed to COVID on 10Mar2021, developed symptoms on 12Mar2021, tested positive via rapid and PCR on 13Mar2021 for COVID even though fully vaccinated. Health Department and testing center unable to hold specimen for variant testing. The events were assessed as serious (medically significant). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 13Mar2021 Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=Rapid Abbott Test,. The outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for covid-19, which is considered failure of COVID-19 vaccine BNT162B2, and the administration of BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site swelling, Pain
Clinical narrative: chills; sweat; pain; redness; swelling in the injections site; fever sensation; This is a spontaneous report from a non-contactable consumer, the patient.   A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported that she was administered with the second dose of the Pfizer's COVID-19 vaccine on Thursday, 11Mar2021 and that night she had chills, sweat, pain, redness and swelling in the injections site. The consumer reported that the redness, swelling and fever sensation continues until today and it has been 4 since the administration of the vaccine. The consumer finished the interaction saying that she was going to contact her physician. The patient had not recovered from the events, redness, swelling and fever sensation. Outcome of the events, chills, sweat, and pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; sweat; pain; redness; swelling in the injections site; fever sensation; This is a spontaneous report from a non-contactable consumer, the patient.   A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported that she was administered with the second dose of the Pfizer's COVID-19 vaccine on Thursday, 11Mar2021 and that night she had chills, sweat, pain, redness and swelling in the injections site. The consumer reported that the redness, swelling and fever sensation continues until today and it has been 4 since the administration of the vaccine. The consumer finished the interaction saying that she was going to contact her physician. The patient had not recovered from the events, redness, swelling and fever sensation. Outcome of the events, chills, sweat, and pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Heart rate, Heart rate increased, Musculoskeletal chest pain
Clinical narrative: Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pulmonary pain
Clinical narrative: Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: severe pain in her shoulder/ cannot use her right arm; couldn't use the right arm in range of motion; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history included bicep tendonitis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced severe pain in her shoulder and couldn't use the right arm in range of motion. It was in her shoulder mostly and she couldn't raise her arm nor lift it. The patient had the first dose of the vaccine and experienced severe pain in her shoulder (not at the site but in her shoulder). In the range of motion, she couldn't use the right arm or work because of the pain. She could barely dress herself without screaming out in pain. In the past, in her other arm  she has had bicep tendonitis and has taken naproxen due to inflammation. Treatment included ibuprofen (ADVIL) and icing it. Clinical outcomes of severe pain in her shoulder and couldn't use the right arm in range of motion were unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: came down with the covid virus; came down with the covid virus; This is a spontaneous report received from a contactable consumer (patient). This 66-year-old-male patient reported that he received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced came down with the covid virus about 2 weeks after the vaccine in Feb2021 with outcome of unknown. MD told patient he should wait 90 days before getting the 2nd shot.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive a couple of days after 1st dose/SARS-CoV-2 antibody test: positive; tested positive a couple of days after 1st dose/SARS-CoV-2 antibody test: positive; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Mar2021 as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient tested positive a couple of days after 1st dose of the vaccine on Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive on Mar2021. Outcome of events was unknown.   Information on the lot/batch number is requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: Chest pain-radiating pain on right arm; Chest pain-radiating pain on right arm Went to the emergency room-14Mar2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng199 and expiration date not provided) via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced chest pain-radiating pain on right arm on 14Mar2021 19:30 and went to the emergency room. The event resulted in Emergency room/department or urgent care. The patient underwent EKG, Chest X-Ray, Blood work on an unspecified date with unknown results. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: A few days later Soreness and lump under arm receiving vaccine; A few days later Soreness and lump under arm receiving vaccine; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9269), via an unspecified route of administration administered in left arm on 06Feb2021 at single dose for COVID-19 Immunization. Medical history included physical urticaria past 12 years. Concomitant medications included lisinopril from an unspecified date (several years) and ongoing for high blood pressure, and sertraline from 31Dec2020 and ongoing for anxiety. The patient previously took the first dose of bnt162b2 (Lot number/Expiry Date: EL3248) administered in right arm on 16Jan2021 at single dose for COVID-19 immunization and experienced warm feeling/Getting a warm feeling and changed to cooler clothing, used cool cloth sat under fan; itching; face was really swollen/face was really swollen and red, looked like sun burnt, skin was blotchy; broke out in hives on her face, arms, and chest; a few days later Soreness and lump under arm receiving vaccine; skin was blotchy/face was really swollen and red, looked like sun burnt, skin was blotchy, took quercetin to prevent hives, and took loratadine (CLARITIN)/famotidine (PEPCID) from 17Jan2021 to an unspecified date. Patient had a history of physical urticaria and had been taken the supplement quercetin for several years to prevent hives when warm, On 17Jan2021 patient began taken loratadine (CLARITIN)/famotidine (PEPCID) again instead of quercetin. Before taking second dose on 06Feb2021 the allergist advised that 2 days before, on 04Feb2021 patient took loratadine 3 x a day and continue famotidine 2 x a day. Her vaccine was scheduled for 11:20 am. Patient took one loratadine 08:00 am and one at 11:00 am. The pharmacist there advised that patient also take one diphenhydramine hydrochloride (BENADRYL) before her vaccine. Patient had no occurrence of hives with the second dose of vaccines. A few days later (2020) soreness and lump under arm receiving vaccine same for second vaccine on alternate arm. The adverse events did not require a visit to emergency room and physician office. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051378 same patient, different events on different dose of vaccine
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened; This is a spontaneous report. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller received first dose on 31Jan2021 and, on an unspecified date in 2021, the patient had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened. Feels she was unable to get second shot because of reaction to the first. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Dysphonia, Eructation, Hypersensitivity
Clinical narrative: had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened; This is a spontaneous report. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller received first dose on 31Jan2021 and, on an unspecified date in 2021, the patient had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened. Feels she was unable to get second shot because of reaction to the first. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Oropharyngeal discomfort, Pharyngeal swelling, Throat tightness
Clinical narrative: had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened; This is a spontaneous report. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller received first dose on 31Jan2021 and, on an unspecified date in 2021, the patient had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened. Feels she was unable to get second shot because of reaction to the first. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: blood clots in his left legs and also some in his lungs.; blood clots in his left legs and also some in his lungs.; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that he had to go to the emergency room (ER) where they discovered blood clots in his left legs and also some in his lungs in Mar2021. The events were serious, the patient was hospitalized for 2 days.  Therapeutic measures were taken as a result of the events and the patient was placed on blood thinners. The patient outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain assessment, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: covid test result positive; covid test result positive on 27Jan2021; arm is still sore where he got the shot; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3264), via an unspecified route of administration at arm left on 14Jan2021 11:00 am as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); apixaban (ELIQUIS). The patient experienced arm is still sore where he got the shot on 14Jan2021. It's a low-end, 1-2 on a pain scale. No other side effects from first shot. No side effects from second shot in right arm on 08Feb2021. The patient covid test (Nasal Swab) was positive on 27Jan2021. The patient underwent lab tests and procedures which included pain assessment: 1-2 on 14Jan2021, sars-cov-2 test: positive on 27Jan2021. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Renal vein thrombosis, Retinal vein occlusion, Vision blurred
Clinical narrative: blurry vision- right eye; BRVO; A localized clot (thrombus) development in a branch retinal vein.; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) on 12Feb2021 02:15 PM in left arm at single dose for COVID-19 immunisation. Medical history included slight asthma, known allergies: sulfa, penicillin. No COVID prior vaccination. Concomitant medications included Vitamins (over-the-counter, other medications in two weeks). No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 22Jan2021 03:30 PM in left arm at single dose for COVID-19 immunisation at the age of 67-year-old. The patient was not pregnant, was not pregnant at time of vaccination. No COVID tested post vaccination. On 15Feb2021, within a few days of receiving second dose of vaccine, the patient developed blurry vision of right eye. After seeing a retina specialist, patient was diagnosed with BRVO (retinal vein branch occlusion). The cause of BRVO is a localized clot (thrombus) development in a branch retinal vein. The events resulted in disability or permanent damage. The patient received treatment as anti-VEGF drug - Avastin for the events. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Dyspnoea, Nasal congestion, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: She found out she has covid before the second dose/her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg; stuffy nose; shortness of breath; wheezing; She found out she has covid before the second dose; This is a spontaneous report from a contactable consumer. A female patient (Age: 84; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was due for her second dose on 27Feb, but she found out she has covid before the second dose. Patient did not received her second dose. Caller stated her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg. caller wanted to know when she will be able to take her second dose. Outcome was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: She found out she has covid before the second dose/her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg; stuffy nose; shortness of breath; wheezing; She found out she has covid before the second dose; This is a spontaneous report from a contactable consumer. A female patient (Age: 84; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was due for her second dose on 27Feb, but she found out she has covid before the second dose. Patient did not received her second dose. Caller stated her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg. caller wanted to know when she will be able to take her second dose. Outcome was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Came down with covid.; Came down with covid.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had received 1st dose of covid vaccine. Came down with covid. 2nd dose of vaccine due next week. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure had increased after taking the first dose of the Pfizer COVID-19 vaccine / blood pressure has been high as 178/102; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number and expiration date were not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure dropped lower. Patient went to see a doctor who's not his regular doctor because his blood pressure (BP) dropped lower than it should. The doctor lowered his BP dose. Patient was currently taking a couple of medications which may have caused this fluctuation in his blood pressure. His blood pressure had increased after taking the first dose of BNT162B2 on 25Feb2021. His blood pressure had been high as 178/102. Normally his blood pressure came back to normal within a week but it was not coming down this time around. He would go see his regular doctor now. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Rhinorrhoea
Clinical narrative: Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Vaccination site pruritus
Clinical narrative: 1 giant hive at vaccination site- itchy for about 1 week; 1 giant hive at vaccination site- itchy for about 1 week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 14Feb2021 13:15 (Lot Number: EN6201) as 0.3 mL, single for COVID-19 immunisation. Medical history Thyroid Nodules, Mild macular degeneration, postmenopausal syndrome, HBP, total hysterectomy w/ oophorectomy, gall bladder removal, appendectomy, penicillin allergies, adhesives allergies, HOH allergies, allergies: contrast dye. Concomitant medications included valsartan (DIOVAN); estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); pravastatin; colecalciferol (VIT D3); famotidine (FAMO). The patient previously took nitrofurantoin (MACRODANTIN) and experienced allergies, claritine (CLARITIN) and experienced allergies. The patient experienced 21Feb2021- 1 giant hive at vaccination site - itchy for about 1 week, started 2 days after injection (16Feb2021) - very mild - arm was not sore at all. Treatment received for the events which included self medicated with benadryl & Aleve. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fall, Generalised tonic-clonic seizure, Postictal state, SARS-CoV-2 test
Clinical narrative: Fell out of bed; tonic clonic seizure; postictal (confusion); This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 22Feb2021 10:15 (lot number: EN6203) as single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient's concomitant medications included losartan and OTC vitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 03:45PM (lot number: EL9262) for COVID-19 immunisation. On 12Mar2021 06:30, the patient fell out of bed and wife witnessed tonic clonic seizure of 5+ minutes. And when EMS arrived on 12Mar2021 06:30, the patient was postictal (confusion). The events resulted to Emergency Room visit and patient was hospitalized for 3 days. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures and included blood test and scan, both with unknown results on an unspecified date and nasal swab/NAAT: negative on 12Mar2021. Therapeutic measures were taken as a result of the events and included numerous scans, blood tests and levetiracetam. The vaccination facility type was hospital. The outcome of the events were recovered with sequel.