chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Orbital oedema, Paraesthesia, Pruritus, Urticaria
Clinical narrative: orbital swelling; redness; itchy in her face; urticaria; prickly feeling; A spontaneous report was received from a consumer concerning a 77-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced started to feel itchy in her face (pruritis), orbital swelling (orbital oedema), urticaria (urticaria), redness (erythema) and prickly feeling (paraesthesia).  The patient's medical history was not reported. Current conditions included seasonal and environmental allergy and was allergic to ibuprofen and aspirin. Concomitant product use was not reported.  On 06 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Mar 2021, an hour after receiving vaccine, patient started to feel itchy in her face, orbital swelling,  urticaria, redness and prickly feeling. After taking diphenhydramine hydrochloride, symptoms were slowly abating.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, started to feel itchy in her face, orbital swelling, urticaria, redness and prickly feeling were considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; A spontaneous report from was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and mentioned that a patient who had received the Moderna vaccine had died, and so they were concerned about getting the second dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, The patient mentioned that a patient who had received the Moderna vaccine had died, and so they were concerned about getting the second dose.  Laboratory details are not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered Fatal.; Reporter's Comments: This is a case of death of an unknown age female subject with unknown medical history, who died on an unknown day after receiving first dose of vaccine. Very limited information has been provided at this time.  No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: severe nose bleed; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. Medical history included atrial fibrillation (afib). Concomitant medication included blood thinners. The patient received his first dose of the Pfizer Covid vaccine on 28Jan2021. He was later hospitalized for a severe nose bleed which required two blood transfusions. It was reported that the patient was on blood thinners and their house "was too dry" and cause a nose bleed. The reporter wanted to know how long he can wait to receive his second dose of the vaccine and if the patient has any protection with just one dose of the vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Meniere's disease
Clinical narrative: Meniere's disease/have noticed it has been a little worse since getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 67 years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing and ongoing Meniere's disease. The patient's concomitant medications were not reported. It was reported that the patient asked if there was anything in the vaccine that stimulates people who have Meniere's disease as she noticed that it has been a little worse since getting the vaccine. The patient received the first dose of the vaccine but already had COVID before the vaccine but read that she should not get the vaccine for 90 days after having COVID infection. As she received her vaccine last Tuesday, she was asking if she should get her second dose. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Loss of consciousness, Malaise
Clinical narrative: partial loss of consciousness approx 10 minutes after vaccination; Dizziness, faintness; General feeling of unwellness; partial loss of vision; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Mar2021 at 10:30 (batch/lot number: unknown) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient previously took ofloxacin and experienced allergy. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced dizziness, faintness. Partial loss of vision, partial loss of consciousness approx. 10 minutes after vaccination (07Mar2021 10:40). General feeling of unwellness following. The events were reported as started on an unspecified date in Mar2021 11:00. No treatment was received for the events. The outcome of the events was recovering.   Information on lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 05Mar2021 11:30 at a single dose for COVID-19 immunization. Medical history included epilepsy. Concomitant medication included levetiracetam (KEPPRA). On 07Mar2021 07:00 AM, the patient experienced seizure. The event resulted in Emergency room/department or urgent care. No treatment was received for the event. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered with lasting effects.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dyskinesia, Muscle spasms, Seizure, Tremor
Clinical narrative: started shaking and jerking like was having convulsions; started shaking and jerking like was having convulsions; started shaking and jerking like was having convulsions; gets a spasm every once in a while; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 04Mar2021 (afternoon about 01:05 or 01:15 PM) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported they got the vaccine shot (clarified as Covid-19 Vaccine by Pfizer) on 04Mar2021 afternoon about 01:05 or 01:15 and they were fine all day and all evening. On 05Mar2021, about 03:30 AM in the morning, the patient started shaking and jerking like was having convulsions. The patient was shaking so hard they couldn't get out of bed. They didn't know if that was a reaction to the vaccine or something else. It lasted about 15-20 minutes and then it subsided. The patient then gets a spasm every once in a while, for the next half hour and at the time of report it seems go stopped all together. Outcome of the events was recovered on 05Mar2021.   Information about lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: The patient has rheumatoid arthritis but he has never been so bad. He went to the hospital and an orthopedist told him that he has arthritis; his arm also hurt/pain "went down" to his left leg and got worse; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 at a single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. It was reported that on Sunday (28Feb2021), his arm also hurt. But as of Monday (01Mar2021), the pain went down to his left leg and got worse. The patient has rheumatoid arthritis but he has never been so bad. He went to the hospital and an orthopedist told him that he has arthritis, he prescribed Ibuprofen and "another pill" but it did not take away the pain. Now her husband cannot walk due to pain. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: collapsed and briefly lost consciousness; This is a spontaneous report from a contactable consumer. An 82-year-old female patient (reporter's mother) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6205, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 04Mar2021 at 14:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiration date was unknown) at the age of 82 years on 11Feb2021 at 02:00 PM administered in the left arm for COVID-19 immunization. Relevant medical history included Alzheimer's, had lost consciousness before, and she had a pacemaker; all from an unknown date. The patient had other unspecified medications in two weeks. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021, about 24 hours after the vaccine, the patient collapsed and briefly lost consciousness while taking a walk. This had happened with her before, but not for a number of months. The patient did not receive any treatment for the adverse event (AE). The patient recovered from the event on an unspecified date.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Seizure
Clinical narrative: six small seizures; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (Lot Number: EL9264) via unspecified route on left arm single dose for COVID-19 immunization on 16Feb2021, 10:15 AM, at 75-year-old. Medical history included: hypertension, dementia, Lewy body dementia; known allergies: shrimp, coconut. The patient had not had COVID prior vaccination. Concomitant medication included: atorvastatin; donepezil; fish oil; fluticasone. No other vaccine received in four weeks. The patient experienced six small seizures on 19Feb2021, 04:30 PM, emergency room/department or urgent care visited and was reported hospitalized for one day. Treatment received included: a CAT scan, levetiracetam (KEPPRA). Outcome of the event was resolved.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Pulmonary embolism
Clinical narrative: Bilateral pulmonary embolism; hypertension; shortness of breath; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 25Feb2021 at age of 75-year-old at single dose for COVID-19 immunisation. Medical history included chronic lympocytic leukemia, stem cell transplant recipient, and prostate cancer. Known allergies: possibly penicillin. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient experienced bilateral pulmonary embolism, hypertension, and shortness of breath on 02Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. It was unknown if treatment received for the events. It was unknown if COVID tested post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Acute appendicitis; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EH9899), via an unspecified route of administration in left arm on 17Dec2020 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient received the vaccine in a hospital. The patient's medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced acute appendicitis which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had appendectomy as treatment. The patient had no other vaccine in four weeks, no Covid prior vaccination and was not Covid tested post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The event appendicitis is likely an intercurrent medical condition and unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Blood clot in my bowel movement; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 05Mar2021 15:45 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that when the patient had a bowel movement, the patient had a blood clot in the bowel movement on an unspecified date. The patient was asking if it was a normal side effect or should that be something to be concerned about. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Paralysis, Tremor
Clinical narrative: I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: received his first dose and he tested positive; received his first dose and he tested positive; pneumonia; This is a spontaneous report from a contactable consumer (patient's child). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cancer. The patient's concomitant medications were not reported. The patient received his first dose and he tested positive after on an unspecified date. He actually developed pneumonia on an unspecified date which could kill him as stated by the reporter. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244030 Same reporter/drug/event, different patient.;US-PFIZER INC-2021252441 Same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: lost hearing in one ear; This is a spontaneous report from a non-contactable consumer. A 60-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the second Pfizer COVID vaccine, patient was in bed for 3 days, and lost hearing in one ear about 3-4 days after the shot. Doctor put him on steroids. ENT said that for people who had COVID the cytokine release could be very damaging to the auditory nerve. It's been about a week since the hearing loss and he has not yet recovered.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Feeling drunk, SARS-CoV-2 test, Somnolence
Clinical narrative: they said was she is COVID positive; could not wake patient up; it is like she is drunk; This is a spontaneous report from a contactable consumer reporting on mother. A 93-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9267 via unspecified route on 25Feb2021 as a single dose for COVID-19 immunisation. Reporter stated vaccine was given to her mother last Thursday, a week ago today (7 days ago).   Reporter stated that the vaccine card was handwritten, and she doesn't see NDC/EXP on it.  Medical history and concomitant medications were not reported. Reporter stated that before she was doing laundry, her mom was alert and was opening and closing her eyes, and she gave her Gatorade, and she had someone take her blood pressure and it was okay.  She says she gave her ice chips, and water and it was like pulling teeth, she can't wake her up, it was unbelievable, it was like she is drunk. They had to rush her mom to emergency room; ambulance came, and they kept her over 24 hours, she was admitted and they did observed her and released her the next day, and said she was COVID positive, and to make sure she got tested until it was negative, which she says was very surprising so she feels her mom got a false positive. Outcome of event COVID positive was unknown, could not wake patient up, was unknown and it is like she is drunk was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Limb discomfort, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; Arm Pain, Left; Can't hardly use her left arm, it is so sore; This is a spontaneous report from a contactable nurse reported for herself.    A 68-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9261, via unknown route on 12Feb2021 12:00 (at the age of 68-years-old) at left arm for COVID-19 immunization.  The patient had not medical history. Concomitant medications were not reported. Vaccination Facility Type: Hospital. On 12Feb2021 the patient experienced left arm pain, pain chest, can't hardly use her left arm, it is so sore and on 14Feb2021 Pain radiating from chest to left side of neck and Swollen Lymph Nodes. Caller stated that she was thinking needs to go to the Emergency Room because it could be her lymph nodes, a blood clot, or her heart. She stated that she has been experiencing this since day one and nobody else has had side effects but her. She stated that this was out of the ordinary and according to the list she was given, it was not listed as a side effect.  She was supposed to go tomorrow to get second shot, but she didn't think that she was going to be able to do it. No emergency room or physician office required. The outcome of the events at the time of last observation was reported as not recovered. Treatment was none. The events were assessed as serious, important medical events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Jaundice, Pallor, Vomiting
Clinical narrative: severe ulcerative colitis flare up; vomiting greater than 7 times; gray skin pallor; slightly jaundiced; This is a spontaneous report from a non-contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 81 years of age), dose 2 intramuscular, administered in arm right on 19Feb2021 17:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia. The patient's concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose at 81 years of age, intramuscular in the right arm on 28Jan2021 for COVID-19 immunisation. The patient was not pregnant. The patient had not received other vaccines in four weeks. The patient had no COVID prior to vaccination nor was she tested post vaccination. She had no known allergies. The patient experienced a severe ulcerative colitis flare up starting within 24 hours of the 2nd vaccine. Initially, as a exceptionally private and stubborn person, she did not report her progressing symptoms to her family and only after she "felt as if she was actively dying" did she reach out for help (01Mar2021). Additional symptoms included severe burning pain across her lower abdomen, vomiting greater than 7 times, persistent diarrhea, gray skin pallor and she appeared slightly jaundiced. Patient refused repeated offers from daughters to be taken to hospital. On 01Mar2021, contact was made with her gastroenterologist and in the morning of 02Mar2021, she was restarted on her UC treatment, which was oral budesonide (unsure of dose). Outcome was improving. She was now able to intake food and liquids and her UC symptoms are resolving. She was up and active again. The events started on 20Feb2021 with outcome of recovering. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as possibly related to BNT162B2. 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: Breast cancer metastatic
Clinical narrative: has metastasis breast cancer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced has metastasis breast cancer in Mar2021 with outcome of unknown.    Information about Batch/Lot number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial thrombosis, Pulmonary embolism, SARS-CoV-2 test, Splenic vein thrombosis
Clinical narrative: she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; This is a spontaneous report from a contactable Nurse. A 72-year-old female patient (Reporter's mother, not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension (HTN), hyperlipidemia and high cholesterol. The patient's concomitant medications were not reported. No other vaccine in four weeks. 2 weeks after the immunization, 06Feb2021 the patient was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots). Follow up with hematologist after discharge, MD reported unable to determine cause of clots. AE resulted in Emergency room/department or urgent care, Hospitalization. The patient hospitalized for three days. The patient received treatment blood thinners. The patient tested Covid post vaccination on 06Feb2021 with negative result. The outcome was Recovered with Sequel.   Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Lung disorder, Product dose omission issue
Clinical narrative: pre-existing lung condition; he was hospitalized due to a pre-existing lung condition.; he missed the 2nd dose; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included pre-existing lung condition. The patient's concomitant medications were not reported. The patient missed the 2nd dose (28Feb2021) because he was hospitalized due to a pre-existing lung condition.  Outcome was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric ulcer, Mouth swelling, Mouth ulceration
Clinical narrative: Developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue.; Developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue.; Developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue.; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6202), via an unspecified route of administration in right arm on 25Feb2021 (at the age of 70-years-old) as single dose for covid-19 immunisation. The vaccine facility was in a hospital. The first dose of bnt162b2 (lot: EL9265) was given on 04Feb2021 at 14:30 in right arm (at the age of 70-years-old) as single dose for Covid-19 Immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included alfuzosin. There were no other vaccine in four weeks. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue on 01Mar2021 at 09:00. There was no treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dysstasia, Gait disturbance, Pain
Clinical narrative: a little bit of hip and back pain; a little bit of hip and back pain; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk/Noticed increase in her pain; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization and for autoimmune deficient. Medical history included sjogren's syndrome, rheumatoid arthritis from 2016 (reported as about 5 years ago), hip replacement, autoimmune deficient from 2007, and hip dislocates three times a year. Concomitant medication included tofacitinib ongoing citrate (XELJANZ XR, lot number: DR2042, expiration date: 31Jan2023), hydroxychloroquine, pregabalin (LYRICA), all three for unspecified indication. On 04Mar2021, the patient noticed increase in her pain. Such pain that she couldn't stand up or walk. The patient also had a little bit of hip and back pain on an unspecified date. The patient clarified that she has oxycodone as pain medication (med). The patient stated that she has too many medications that she has to take. Stated that her brain was dying. The patient also stated that she was doing fine and hasn't had pain like this. The patient did not know if it was an adverse reaction or what. The reporter seriousness for such pain she couldn't stand up or walk was assessed as disabling. The outcome of the events was unknown.; Sender's Comments: The causal association cannot be excluded between the reported events and vaccine use based on strong temporal association. 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 AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: I developed atrial fibrillation which is ongoing several months later; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) on 22Dec2020 at single dose via an unspecified route of administration  on left arm for COVID-19 immunization. Relevant medical history included colitis ulcerative. Concomitant medications included mesalamine. On 31Jan2021 developed atrial fibrillation which is ongoing several months later. Treatment received included  metoprolol, sotalol. At the time of the reporting the patient had not yet recovered from the events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: extreme rash on both arms up to elbow; breathing problem; This is a spontaneous report from A contactable consumer (patient) reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing cancer and reported as a current cancer patient that had have both vaccines. The patient's concomitant medications were not reported. The patient experienced extreme rash on both arms up to elbow on an unspecified date with outcome of not recovered, breathing problem on an unspecified date with outcome of unknown.  Events were considered as serious with hospitalization. It is reported as the patient was rushed to hospital after first shot with extreme rash on both arms up to elbow. 3 weeks later rushed back again with extreme breathing problem and once again rash on both arms.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: spent 5 hrs in the ER due to arm having problems; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient spent 5 hrs in the ER due to arm having problems on an unspecified date with outcome of not recovered. The patient was hospitalized for event. The patient worked in Healthcare and got first shot the end of Dec2020 and the second on 19Jan2021. The patient contacted employee health at the and reported what they believe is side effects from the vaccines that happen not right after having the vaccine. Patient spent 5 hrs in the ER due to arm having problems a couple weeks after the 2nd injection and as of today 07Mar2021 still ongoing.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Head injury
Clinical narrative: severe head injury; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received the first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had first shot on 09Feb2021 and missed second dose (02Mar2021) because he had been hospitalized for severe head injury from 28Feb2021. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Macular degeneration
Clinical narrative: Macular degeneration; This is a spontaneous report from a Pfizer Sponsored contactable consumer reported for herself. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had a second dose schedule on Tuesday. The patient needed to see her eye doctor prior to her second dose because of macular degeneration and she would have an injection on her eye. Patient was asking if this would be fine to have the injection before the vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: pain is severe and disabling; severe myalgia to legs started next day after 2nd dose, then to shoulders, arms, with mild headache. Never resolved after 2 weeks.  gabapentin gave temporary relief but pain is severe and disabling.; mild headache; This is a spontaneous report. A contactable physician reported that a 37-year-old non-pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), first dose via intramuscular on 06Feb2021 as single dose for COVID-19 immunization, received (BNT162B2, solution for injection, Batch/Lot Number: EM9810) second dose via intramuscular on 27Feb2021 as single dose for COVID-19 immunization and patient was non-pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included endometriosis, and patient had allergy for meloxicam, NSAIDs, blepharospasm and angioedema. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medication included norethindrone acetate (NORETHINDRONE ACETATE) taken for an unspecified indication, botulinum toxin nos (BOTULINUM TOXIN NOS) taken for an unspecified indication on 08Jan2021 to an unspecified stop date. The patient experienced pain was severe and disabling, severe myalgia to legs started next day after the second dose, then to shoulders, arms, with mild headache on 28Feb2021. Never resolved after 2 weeks. Therapeutic measures were taken as a result of pain is severe and disabling (pain), severe myalgia to legs started next day after second dose, then to shoulders, arms, with mild headache. never resolved after 2 weeks and gabapentin gave temporary relief, but pain is severe and disabling. (myalgia), mild headache (headache). The outcomes of the events was not recovered.  Follow-up information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Peripheral swelling, Thrombophlebitis superficial, Thrombosis
Clinical narrative: Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in multiple veins & artery of left foot; several SVT &DVT in multiple veins & artery of left foot; Pain & swelling of foot; Pain & swelling of foot; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:00 AM (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation.  Medical history included known allergies: Some antibiotics cause autoimmune issues, all sulphate drugs, narcotics. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot_number=EL3249) on 22Jan2021 12:00 AM administered in Right arm. Concomitant medications included thyroid (NATURE THROID) and multiple vitamin, taken for an unspecified indication, start and stop date were not reported.  The patient experienced Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot. Pain & swelling of foot, all on 06Mar2021 01:00 AM with outcome of not recovered.  Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for events included given Eliquis to avoid further clotting. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Arthralgia, Body temperature, Chills, Headache
Clinical narrative: acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported.  4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported.  4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported.  4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.