chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Synovial cyst, Thrombosis
Clinical narrative: large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Severe side effects; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of ADVERSE DRUG REACTION (Severe side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Severe side effects) (seriousness criterion hospitalization). At the time of the report, ADVERSE DRUG REACTION (Severe side effects) outcome was unknown.            Concomitant product was not provided by the reporter.  It was reported that patient was experiencing severe side effects after her second dose of the vaccine and the patient was in Hospital. According to patient's husband, the patient had similar side effects after the 1st shot, so patient's husband was convinced that the vaccine has something to do with her condition. At the time of the report, the patient was home, but her enzymes were still up.  Company Comment : Very limited information regarding this event has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.     This case was linked to MOD-2021-190273 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07 Jun 2021 included no new information.; Sender's Comments: Very limited information regarding this event has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Blood smear test, Coombs direct test
Clinical narrative: Warm autoimmune hemolytic anemia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Warm autoimmune hemolytic anemia) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Warm autoimmune hemolytic anemia) (seriousness criterion medically significant). The patient was treated with RITUXIMAB for Autoimmune hemolytic anemia, at an unspecified dose and frequency; MYCOPHENOLATE MOFETIL for Autoimmune hemolytic anemia, at an unspecified dose and frequency and IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Autoimmune hemolytic anemia, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Warm autoimmune hemolytic anemia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood smear test: positive (Positive) Markers of hemolysis were all positive.. In April 2021, Coombs direct test: positive (Positive) Markers of hemolysis were all positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment for the event included Corticosteroids.    Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) unknown. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  No treatment information was provided.  Patient reported a family member died from a heart attack shortly after getting your vaccine.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Myocardial infarction
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Pulmonary hypertension
Clinical narrative: Pulmonary hypertension; Doing a lot worse after 2nd moderna covid shot; This spontaneous case was reported by a health care professional and describes the occurrence of PULMONARY HYPERTENSION (Pulmonary hypertension) and CONDITION AGGRAVATED (Doing a lot worse after 2nd moderna covid shot) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MACITENTAN (Oral) 10 milligram once a day. On an unknown date, the patient experienced PULMONARY HYPERTENSION (Pulmonary hypertension) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Doing a lot worse after 2nd moderna covid shot) (seriousness criterion medically significant). The patient was treated with OXYGEN for Condition aggravated, at a dose of UNK dosage form. At the time of the report, PULMONARY HYPERTENSION (Pulmonary hypertension) and CONDITION AGGRAVATED (Doing a lot worse after 2nd moderna covid shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Company causality between co-suspect product, macitentan and the event, condition aggravated was reported as not related.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (massive stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not have allergies to medications, food, or other products. Treatment information was not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: General feeling of unwell; This is a spontaneous report received from a non-contactable non-health care professional. An unspecified age of female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Not reported) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Not reported) via unspecified route of administration and anatomical site on 26Feb2021 as a single dose for COVID-19 immunization. On an unspecified date in 2021, patient experienced general feeling of unwell. The clinical outcome of the event general feeling of unwell was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient initials were updated; patient Country was added as United States; Lot unknown was removed from dosage regimens tab and BNT162B2 dose 1 was removed in product tab since captured it as historical vaccine already, event onset date added in structured field.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: post menopausal menstrual bleeding; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (Lot Number: ER8735), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 12:00 as single dose for covid-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included thyroid (ARMOUR THYROID); calcium; fish oil; vitamin b complex (VITAMIN B); vitamin C; colecalciferol (VITAMIN D). The patient previously received first dose of bnt162b2 (Lot Number: EN6204) on 25Mar2021 at 12:00 in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced post menopausal menstrual bleeding on 29Apr2021 15:00. The event did not result in emergency room/physician office visit. No treatment received. This case was reported as non-serious by reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Fall
Clinical narrative: woke up 3 days after receiving first COVID injection and tried to stand up and fell back on bed; woke up 3 days after receiving first COVID injection and tried to stand up and fell back on bed; connective tissue in both knees was excruciatingly painful; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 15:00 at the age of 44-year-old as single dose for covid-19 immunisation. Medical history included lymphoedema. No known allergies. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient woke up 3 days (28Mar2021 07:00) after receiving first COVID injection and tried to stand up and fell back on bed. The connective tissue in both knees was excruciatingly painful. Hurts the worst when he wake up and it got better as he was up on it. The events resulted in disability or permanent damage. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. The patient received second dose of bnt162b2 (Lot Number: ER8733) on 21Apr2021 16:00 in left arm.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Headache, Herpes zoster, Rash
Clinical narrative: Shingles developed I had a a ha since the 2 Nd dose and within a few weeks of the ha the rash started I have hashimotos and  have read this can be a side effect in a small number of people; Shingles developed I had a a ha since the 2 Nd dose and within a few weeks of the ha the rash started I have hashimotos and  have read this can be a side effect in a small number of people; Shingles developed I had a a ha since the 2 Nd dose and within a few weeks of the ha the rash started I have hashimotos and  have read this can be a side effect in a small number of people; Shingles developed I had a a ha since the 2 Nd dose and within a few weeks of the ha the rash started I have hashimotos and  have read this can be a side effect in a small number of people; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Apr2021 12:00 PM (Batch/Lot Number: Unknown) (at 46-year-old) at 2nd dose, single in arm left for COVID-19 immunization. The patient's medical history were not reported. Other medications the patient received within 2 weeks of vaccination included synthesis. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Mar2021 12:00 PM (Batch/Lot Number: Unknown) (at 46-year-old) at 1st dose, single in arm left for COVID-19 immunization. Prior to vaccination, the patient wasn't diagnosed with COVID-19. On 22Apr2021 12:00, shingles developed, she had a headache since the 2nd dose and within a few weeks of the headache the rash started. She had Hashimoto's and had read this can be a side effect in a small number of people. Since the vaccination, the patient hasn't been tested for COVID-19. The event resulted in emergency room visit. Therapeutic measures were taken as a result of events. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Six hours later hives. Next day like three different rashes on my body. I have been breaking out daily for 8 weeks and 3 days. I spent over a week in the hospital. I have been on steroids the whole ti; Six hours later hives. Next day like three different rashes on my body. I have been breaking out daily for 8 weeks and 3 days. I spent over a week in the hospital. I have been on steroids the whole ti; Six hours later hives. Next day like three different rashes on my body. I have been breaking out daily for 8 weeks and 3 days. I spent over a week in the hospital. I have been on steroids the whole ti; insane; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 27Mar2021 14:30 (at 48-year-old) (Batch/Lot Number: ZR8733) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included lupus (antiphospholipid antibodies), diabetes, Gilbert's disease, fibromyalgia, and thyroid. Concomitant medication included insulin; lisinopril; simvastatin; and thyroid (ARMOUR THYROID). The patient previously took penicilin and experienced drug hypersensitivity. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. On 27Mar2021 19:30, the patient experienced hives six hours later (as reported). Next day like three different rashes on her body. She had been breaking out daily for 8 weeks and 3 days. She spent over a week in the hospital. She had been on steroids the whole itching and she's going insane. The patient underwent lab tests and procedures which included SARS-COV-2 test (nasal swab): negative on 07Apr2021 02:30 PM. Therapeutic measures (Steroids and other meds. Steroid creams) were taken as a result of events except mental disorder. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not resolved.  Information on Lot/ Batch number was available. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke like symptoms 5 months after shot; This is a spontaneous report from a contactable nurse (consumer). A non-pregnant 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Feb2021 01:00 PM (at 56-year-old) (Lot Number: EN5318) at 2nd dose, single in arm right for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received via an unspecified route of administration on 27Jan2021 08:15 AM (at 56-year-old) (lot number: EN5318) at 1st dose, single in arm right for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient experienced stroke like symptoms 5 months after shot on 22May2021 08:00. The patient was hospitalized for stroke like symptoms 5 months after shot (cerebrovascular accident) for 3 days. Event resulted in emergency room/department or urgent care, and treatment was received. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab): negative on 22May2021. The outcome of the event was not resolved.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: seizure like event; Dizzy; Her head, neck, back and legs stiffened up/her entire body stiffened; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27May2021 (at 17-year-old) (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Thursday 27May2021, a few minutes after the shot she started having a very small episode of seizure that lasted for maybe 1 or 2 seconds then after that she felt a little dizzy after that and then she was fine. It's described as a very brief seizure like event. Her head, neck, back and legs stiffened up and if she would have been sitting on a stool she probably would have fallen out of her seat. She was sitting in a chair that had a back to it, though, so she did not fall out of the chair. She did not every lose consciousness and he stated that this was not a syncopal event. He reported that it happened very quickly and multiple people did not even notice that it happened. Her entire body stiffened, however, "she stayed with us throughout the entire event and it only lasted a couple of seconds before her body went back to normal position, The reporter offered to call an ambulance the day of the event but the mother of the patient declined. The mother was advised to have her daughter seen by a medical provider for follow up care given the event. The mother also told the pharmacist that the patient would not be receiving the second dose and the pharmacist encouraged her to have this conversation and make that decision with the pediatrician or medical provider. Caller stated that he personally gave about 100 doses of the Pfizer BioNTech COVID-19 vaccine on that day and this was the only serious reaction that he witness. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based from timing of occurrence, the event that occurred with the patient post vaccination which Is seizure like phenomenon cannot be totally ruled out to be not related suspected 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, IIIrd nerve paralysis, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: acute onset of nerve III palsy; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration in the arm left on 09May2021 at 16:00 at age of 25-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol (ESTROGEN, reported as low estrogen birth control prescribed for 8 yrs) which was received within 2 weeks of vaccination. Two weeks after vaccine on 24May2021 at 02:00 PM, patient had acute onset of nerve III palsy. CT and MRI was negative for aneurysm, tumor, multiple sclerosis (MS), etc. Event still has not resolved, working to neurologist. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment for the event. Event was reported as serious as disability. Outcome of the event was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 24May2021 by Nasal Swab which was negative.  Information about batch/Lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Nipple pain, Postmenopausal haemorrhage
Clinical narrative: Then I started my period, I am post menopausal and have been for 5+ years; breast hurting/first it was more my nipples but then it was the whole area/hurt to be touched, or even hurt when given a hug; breast hurting/first it was more my nipples but then it was the whole area/hurt to be touched, or even hurt when given a hug; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 19May2021 10:45 (lot number was not reported), as 1st dose, single dose, at age 44 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient has no medical history and no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported "Intense, I noticed my breast hurting, first it was more my nipples but then it was the whole area. They hurt to be touched, or even hurt when given a hug. Then I started my period, I am post-menopausal and have been for 5+ years." The onset date of the events was 22May2021. No treatment was given for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Migraine, Nausea, Pain
Clinical narrative: Bad headache; Migraines; Nausea; Vomiting; Body aches; not well.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) via an unspecified route of administration in the arm left on 03May2021 at 15:00 at age of 49-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history includes Vitamin D deficiency (managed with supplements), known allergies with penicillin. Patient previously received amoxicillin and had allergies to it. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EP7533, expiration date unknown) via an unspecified route of administration in the left arm on 12Apr2021 at 02:30 PM at age of 49-year-old for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D, multivitamin, biotin, hyaluronic acid. Patient had a very bad headache in the morning after 2nd dose of BNT162B2. Patient drank a lot of water but it only temporarily got better. Patient had been dealing with headaches and migraines ever since even though she had no history of migraines. Patient had been to the ER twice. Patient also had nausea, vomiting, body aches. She still was not well. Onset date of the events was reported as 04May2021 at 09: 00 AM. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient was hospitalized for 1 day. Seriousness criteria of the events was reported as hospitalization and disabling/incapacitating. Patient received migraine medications as treatment for the events. Outcome of the events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID Test type post vaccination by nasal swab on 27May2021 which was negative.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Bad headache; Migraines; Nausea; Vomiting; Body aches; not well.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) via an unspecified route of administration in the arm left on 03May2021 at 15:00 at age of 49-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history includes Vitamin D deficiency (managed with supplements), known allergies with penicillin. Patient previously received amoxicillin and had allergies to it. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EP7533, expiration date unknown) via an unspecified route of administration in the left arm on 12Apr2021 at 02:30 PM at age of 49-year-old for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D, multivitamin, biotin, hyaluronic acid. Patient had a very bad headache in the morning after 2nd dose of BNT162B2. Patient drank a lot of water but it only temporarily got better. Patient had been dealing with headaches and migraines ever since even though she had no history of migraines. Patient had been to the ER twice. Patient also had nausea, vomiting, body aches. She still was not well. Onset date of the events was reported as 04May2021 at 09: 00 AM. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient was hospitalized for 1 day. Seriousness criteria of the events was reported as hospitalization and disabling/incapacitating. Patient received migraine medications as treatment for the events. Outcome of the events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID Test type post vaccination by nasal swab on 27May2021 which was negative.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: Had thrombosis, Blood clots in leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (Lot Number: EN6198; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 at the age of 67-year-old as single dose for covid-19 immunisation. Medical history included diabetes. The patient's concomitant medications were not reported. Three days after vaccination, the patient had thrombosis, blood clots in her leg and had gone to the Emergency room on 21Mar2021. It started at night but she didn't know what it was, may be the same day she got vaccine (18Mar2021). The patient was taking "blood thinners" (medication name not clarified) for the Blood clots. The patient underwent lab tests and procedures which included ultrasound: unknown results on an unknown date. The outcome of event was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: after my bowel movement, there was a lot of dark red blood in my stool and in the toilet. It then turned to bright red blood my next few bowel movements.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 38-year-old administered in arm right on 13May2021 18:30 (Lot Number: ER8736) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypertension and not on meds currently. The patient's concomitant medications were not reported. It is reported the patient has a regular bowel movement between 3:30 am and 5:30 am every morning. The patient received the 1st dose on the COVID-19 vaccine on Thursday evening (13May2021) at 6:30 pm and on Saturday morning (15May2021) 05:00, after her bowel movement, there was a lot of dark red blood in her stool and in the toilet. It then turned to bright red blood of next few bowel movements. There was no pain or cramping. The bleeding during the bowel movements lasted intermittently 3-4 days and then stopped. The patient had not had blood in her stool since then, but she was due for her next vaccine tomorrow evening.  She also has a history of hypertension. After the 3rd day, she did reach out to a Telehealth physician who advised to go to an urgent care. She made an appointment for the next day, but the bleeding appeared to have stopped. No treatment received for the event. The outcome of the event was recovered on 19May2021. The patient is not pregnant.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Investigation
Clinical narrative: stroke; blood clot occurring in the brain; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in arm left on 19Feb2021 11:00 (at the age of 70-year-old) as single dose for COVID-19 immunization. The patient's medical history included 50% blockage of artery, thyroid disorder, hyperlipidemia. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included statin and thyroid. The patient experienced stroke on 22Feb2021 00:30 with blood clot occurring in the brain. On a scale of 1-10, it was a 1 or 1.5 per physician and originated in speech area. AEs resulted in emergency room/department or urgent care, and hospitalization (1 day). Patient received Clotbuster as treatment. 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 recovered in 2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Metastases to lymph nodes
Clinical narrative: Swelling and pain of left supraclavicular lymph node (Virchow node).; Swelling and pain of left supraclavicular lymph node (Virchow node).; Swelling and pain of left supraclavicular lymph node (Virchow node).; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in arm left on 23May2021 13:00 (Batch/Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced known allergies amoxicillin. Concomitant therapy included some vitamins. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications that the patient received within 2 weeks of vaccination in two weeks reported as some vitamins, nothing new. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced swelling and pain of left supraclavicular lymph node (Virchow node) on 01May2021 10:00. Event resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The treatment was unknown. The outcome of event was not recovered. The reporting patient classified the event as non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: passed out; feeling dizzy; fell out of his chair on to the ground; B/P 136/90; BGL 148; feeling nauseous; tingly feeling in arm and chest; This is a spontaneous report from a contactable Hcp. A 24-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 31May2021 11:45 (Lot Number: EW0171) at 24-years-old as 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 31May2021, the patient waiting in observation and started feeling dizzy then passed out and fell out of his chair on to the ground. Obtained baseline vitals B/P 136/90, BGL 148, O2 96% pulse 69 PT was alert immediately after falling we gave water and observed further got another set of vitals B/P 120/78 02 started feeling nauseous and called 911. overall felt nauseous and tingly feeling in arm and chest no pain, and passed out. The patient received first aid for events. The outcome of events was recovered on 31May2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Loss of consciousness, Dizziness, Fall, Blood pressure increased, Blood glucose increased, Nausea, Paraesthesia and the suspect drug BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness, Dizziness, Fall, Blood pressure increased, Blood glucose increased, Nausea and Paresthesia the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Heart rate, Loss of consciousness, Nausea, Oxygen saturation
Clinical narrative: passed out; feeling dizzy; fell out of his chair on to the ground; B/P 136/90; BGL 148; feeling nauseous; tingly feeling in arm and chest; This is a spontaneous report from a contactable Hcp. A 24-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 31May2021 11:45 (Lot Number: EW0171) at 24-years-old as 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 31May2021, the patient waiting in observation and started feeling dizzy then passed out and fell out of his chair on to the ground. Obtained baseline vitals B/P 136/90, BGL 148, O2 96% pulse 69 PT was alert immediately after falling we gave water and observed further got another set of vitals B/P 120/78 02 started feeling nauseous and called 911. overall felt nauseous and tingly feeling in arm and chest no pain, and passed out. The patient received first aid for events. The outcome of events was recovered on 31May2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Loss of consciousness, Dizziness, Fall, Blood pressure increased, Blood glucose increased, Nausea, Paraesthesia and the suspect drug BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness, Dizziness, Fall, Blood pressure increased, Blood glucose increased, Nausea and Paresthesia the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: passed out; feeling dizzy; fell out of his chair on to the ground; B/P 136/90; BGL 148; feeling nauseous; tingly feeling in arm and chest; This is a spontaneous report from a contactable Hcp. A 24-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 31May2021 11:45 (Lot Number: EW0171) at 24-years-old as 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 31May2021, the patient waiting in observation and started feeling dizzy then passed out and fell out of his chair on to the ground. Obtained baseline vitals B/P 136/90, BGL 148, O2 96% pulse 69 PT was alert immediately after falling we gave water and observed further got another set of vitals B/P 120/78 02 started feeling nauseous and called 911. overall felt nauseous and tingly feeling in arm and chest no pain, and passed out. The patient received first aid for events. The outcome of events was recovered on 31May2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Loss of consciousness, Dizziness, Fall, Blood pressure increased, Blood glucose increased, Nausea, Paraesthesia and the suspect drug BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness, Dizziness, Fall, Blood pressure increased, Blood glucose increased, Nausea and Paresthesia the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Lower respiratory tract infection, Oropharyngeal pain, Pyrexia
Clinical narrative: I haven't had a cold in years, but one month after receiving my second Covid vaccine I came down with a severe chest cold; Much chest congestion that lasted over a week; Runny nose; Sore throat; Cough; A slight fever and chills; A slight fever and chills; 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, Solution for injection), via an unspecified route of administration, administered in left arm on 18Mar2021 at 14:30 (at age of 68 years old, Lot Number: ER2613) as a single dose for covid-19 immunization. Medical history included Diabetes. No known allergies. The patient not diagnosed with COVID-19 prior to vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included empagliflozin (JARDIANCE); Propranolol; Metformin; Glipizide, etc. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 25Feb2021 at 02:30 PM (at age of 68 years old, Lot Number: EN6202) as a single dose for covid-19 immunization. The patient was haven't had a cold in years, but one month after receiving second Covid vaccine he came down with a severe chest cold. He had a runny nose, sore throat, cough and much chest congestion that lasted over a week. A month later he got it again, only this time he also experienced a slight fever and chills. The patient took a Covid test both times and they came back negative. No one else in he's household had been sick and now concerned that he may be experiencing side effects from the Covid Vaccine. The events occurred on 20Apr2021. The patient received treatment included over the counter cold medication. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 22Apr2021 and on 30May2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: I haven't had a cold in years, but one month after receiving my second Covid vaccine I came down with a severe chest cold; Much chest congestion that lasted over a week; Runny nose; Sore throat; Cough; A slight fever and chills; A slight fever and chills; 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, Solution for injection), via an unspecified route of administration, administered in left arm on 18Mar2021 at 14:30 (at age of 68 years old, Lot Number: ER2613) as a single dose for covid-19 immunization. Medical history included Diabetes. No known allergies. The patient not diagnosed with COVID-19 prior to vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included empagliflozin (JARDIANCE); Propranolol; Metformin; Glipizide, etc. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 25Feb2021 at 02:30 PM (at age of 68 years old, Lot Number: EN6202) as a single dose for covid-19 immunization. The patient was haven't had a cold in years, but one month after receiving second Covid vaccine he came down with a severe chest cold. He had a runny nose, sore throat, cough and much chest congestion that lasted over a week. A month later he got it again, only this time he also experienced a slight fever and chills. The patient took a Covid test both times and they came back negative. No one else in he's household had been sick and now concerned that he may be experiencing side effects from the Covid Vaccine. The events occurred on 20Apr2021. The patient received treatment included over the counter cold medication. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 22Apr2021 and on 30May2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.