chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hypotension, Medical device site haemorrhage
Clinical narrative: Passed away; Severe hypotension; Hemodialysis shunt bleeding; A spontaneous report was received from other health professional concerning a 72 years old, male patient who experienced hypotension, removal and replacement of hemodialysis shunt (procedure), hemodialysis shunt bleeding and death.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    On 29-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Batch number [LOT/BATCH: 039K208] intramuscularly in the right arm for prophylaxis of COVID-19 infection.      The patient was hospitalized for severe hypotension and Removal and Replacement of hemodialysis shunt from 17-JAN-2021 to 21-Jan-2021. On 26-01-2021 the patient was sent to hospital due to his hemodialysis shunt bleeding. On 27-01-2021, the patient passed away at the hospital . Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 27 Jan 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received from a consumer who was also a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke.  The patient's medical history was not provided by the reporter.   Concomitant medications included Lisinopril, Rosuvastatin, Montelukast, Hydrochlorothiazide, Sertraline, Metoprolol, and Zyrtec.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 029L201A) on 12 Feb 2021, approximately one day prior to the onset of the symptoms in the left non-dominant arm for prophylaxis of COVID-19 infection.   The patient experienced a stroke on the night of 13 Feb 2021- 14 Feb 2021. The patient could not speak properly due to being drowsy. On unspecified date the patient was hospitalized for the event of stroke and released on 16 Feb 2021.   Treatment for the event included double cholesterol med (from 10 to 20 mg) and baby aspirin.   No relevant laboratory details were included.   Action taken with the drug in response to the event was not reported.  Outcome of the event  was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Neck mass; A spontaneous report was received from a health care professional concerning a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck mass.   The patient's medical history was not provided by the reporter. No concomitant medications were reported.   On 12 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On the 19 Jan 2021, prior to receiving mRNA-1273, the patient experienced neck mass. Patient was hospitalized from 19 Jan 2021 to 25 Jan 2021.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, neck mass, is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Human chorionic gonadotropin, Sexually transmitted disease test
Clinical narrative: Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient's medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen, Urine analysis
Clinical narrative: Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient's medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased
Clinical narrative: Very slow heart beat; A spontaneous report was received from an 85 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a very slow heartbeat.   The patient's medical history was not provided.   Concomitant medications were not reported.  On 25-FEB-2021, prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date after receiving the mRNA-1273 vaccine, the patient developed a very slow heartbeat. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: vaccine underdose; syringe connection issues; A spontaneous report received from a Healthcare Professional (pharmacist) concerning, patient of unspecified age and gender who received dose of the Moderna COVID-19 vaccine and developed syringe unscrewed itself twice and HCP do not know how much the patient received.   The patient's medical history was not included. Patient's concomitant was not included.  On unknown date, the patient received their dose of the two planned doses of mRNA-1273 in unknown arm (Batch number not provided) for prophylaxis of COVID-19 infection.   Healthcare Professional stated that the patient was given Moderna COVID-19 Vaccine. Healthcare Professional stated that the syringe unscrewed itself twice and he did not know how much vaccine the patient received.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event syringe unscrewed itself twice and HCP do not know how much the patient received was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Paralysis of entire body; A spontaneous report was received from a consumer concerning a 79-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralysis of his entire body.  The patient's medical history was not provided. Concomitant products included Evolocumab, blood pressure medication and metformin.  The patient received the first of two planned doses of mRNA-1273 (Batch number: unknown). The date of administration of first dose of vaccine was not mentioned. On 19 Feb 2021, approximately one day prior to the onset of the event, the patient received the second dose of two planned doses of mRNA-1273 (Batch number:006M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 20 Feb 2021, Patient experienced paralysis of his entire body at night and the ambulance had to come to put him back in bed.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The event paralysis of his entire body, was considered resolved on 21 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Headache, Retinal haemorrhage, Retinal migraine, Visual impairment
Clinical narrative: Retinal hemorrhage inside left eye; Impaired vision; Occular migraine; Swelling inside left eye; Severe headache; A spontaneous report was received from a reporter like consumer concerning a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like retinal haemorrhage, eye inflammation, headache, visual impairment, retinal migraine.  The patient's medication history was not provided. Concomitant medications were not provided.  On 17 Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 030M20A) intramuscularly in the anatomical location for prophylaxis  of COVID-19 infection.  On 18 Feb 2021, 28 hours following the vaccine administration, the patient experienced events like very small hemorrhage inside left eye, swelling inside the left eye, headache, impaired vision, ocular migraine with swelling inside the eye being medically significant. Laboratory details were not provided.  No treatment information was provided.  The outcome of the event was unknown.  Action taken with mRNA-1273 in response to the events were not reported.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Wasn't feeling good due to other reasons; Its past 42days of 1st shot; A spontaneous report was received from  a consumer concerning a 79 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wasn't feeling good due to other reasons and it's past 42 days of 1st shot.  The patient's medical history included chronic obstructive pulmonary disease. Relevant concomitant medications included salbutamol, budesonide, formoterol fumarate and tiotropium bromide.   On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23-Feb-2021, the patient was not feeling good due to other reasons as he has chronic obstructive pulmonary disease (COPD) and was hospitalized. The patient tested negative for COVID-19 on an unknown date.   On 25-Feb-2021, the patient was discharged. No treatment information was provided.  The outcome of the event, it's past 42 days of 1st shot, was resolved.  The outcome of the event, wasn't feeling good due to other reasons, was unknown.; Reporter's Comments: This case concerns a 79-year-old, male patient with a medical history of chronic obstructive pulmonary disease  who experienced unexpected event of past 42 days of 1st shot (inappropriate schedule of vaccine administration) and not feeling good. The event of not feeling good was attributed to the underlying COPD.as such, assessed s unlikely due to vaccine administration. Inappropriate schedule of vaccine administration is assessed as not applicable.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Syncope, Urinary tract infection
Clinical narrative: low grade UTI; collapse; been kind of weak; A spontaneous report was received from a consumer, who was the caregiver of a 94-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI), collapse (syncope), and weak (asthenia).    The patient's medical history was provided.  Concomitant product use was not provided.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The patient was hospitalized for a UTI from 10 Feb 2021 to 12 Feb 2021.  The reporter stated, "after that, he's been kind of weak and everything".  The reporter indicated it was a "low grade" UTI and the patient didn't show any symptoms but then stated "it actually had him collapse and he did that in between the two vaccines and spent two days in the hospital."   On 17 Feb 2021, the patient received his second of two planned doses of mRNA-1273 (batch number 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The patient received both planned doses of mRNA-1273; therefore, the action with mRNA-1273 in response to the events was not applicable.  Treatment for the UTI included nitrofluorine.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Chills, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Passed out; Nausea; Fever; Chills; A spontaneous report was received from an other healthcare professional for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fever, chills, nausea and passed out for a short duration.  The patient's medical history was not provided. No concomitant product use was reported.  On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient had experienced chills and fever overnight. On 27-Feb-2021, the patient developed nausea and reportedly passed out for a short duration while coming out of shower which was followed by a second episode of passing out while dressing. As per the patient this could be related to dehydration and low blood pressure in general.  The patient was feeling fine at the time of this report. Treatment information was unknown.  Action taken with mRNA-1273 was not applicable.  The outcome of the events, fever, chills, nausea and passed out for a short duration, were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-029837:Same reporter, Male patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Bell's Palsy; diarrhoea; fever between 98-99 degree Fahrenheit; several headache; nausea; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea.  The patient's medical history included: Covid-19 (start date 08-JAN-2021).  No relevant concomitant medications were reported.  On 8-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 09-FEB-2021, the patient's symptoms had started. The patient mentioned a fever between 98°F - 99°F,  headache, nausea, and diarrhea. Then on 15-FEB-2021, she had a (facial) paralysis, the left side of the mouth bent to the side and the eye fell. On 20-FEB-2021, the patient had visited the doctor's office and she was diagnosed with Bell's palsy. The patient was treated with, prednisone , valacyclovir, injection (unspecified) like a Cortisone. At the time of this report everything was coming back to normal, but it was not at 100%. The adverse event of ball's palsy was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event of bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea was 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: Anaphylactic shock, Carbon dioxide, Monocyte count, Neutrophil count, Swelling face
Clinical narrative: anaphylactic shock; facial swelling significantly increased; A spontaneous report was received from a consumer concerning a female patient(unknown age), who received Moderna's covid-19 vaccine(mRNA-1273) and experienced anaphylactic shock and facial swelling.  Patient's medical history was not provided. No relevant concomitant medications were mentioned.  On 29 Jan 2021, one day prior to the onset of events, patient received mRNA-1273 vaccine(Lot number:unknown) for prophylaxis of covid-19 infection.  On 30 Jan 2021, around 3:30pm, patient started experiencing swelling of face. By 5:00 pm, she went into complete anaphylactic shock and was hospitalized. Lab investigations included high WBC, high absolute neutrophil, high absolute monocytes and low carbon dioxide.   Treatment medications included two injections of epinephrine(Adrenalin),two injections of diphenhydramine(Benadryl),an injection of methylprednisolone(SOLU-Medrol),an injection of Famotidine(Pepcid),one litre of sodium chloride(Normal saline),and Acetaminophen(Tylenol).She was discharged with an EpiPen and another prescription of Prednisone(20mg).  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event, anaphylactic shock was not reported, whereas, the outcome of facial swelling was considered not resolved.; 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: White blood cell count
Clinical narrative: anaphylactic shock; facial swelling significantly increased; A spontaneous report was received from a consumer concerning a female patient(unknown age), who received Moderna's covid-19 vaccine(mRNA-1273) and experienced anaphylactic shock and facial swelling.  Patient's medical history was not provided. No relevant concomitant medications were mentioned.  On 29 Jan 2021, one day prior to the onset of events, patient received mRNA-1273 vaccine(Lot number:unknown) for prophylaxis of covid-19 infection.  On 30 Jan 2021, around 3:30pm, patient started experiencing swelling of face. By 5:00 pm, she went into complete anaphylactic shock and was hospitalized. Lab investigations included high WBC, high absolute neutrophil, high absolute monocytes and low carbon dioxide.   Treatment medications included two injections of epinephrine(Adrenalin),two injections of diphenhydramine(Benadryl),an injection of methylprednisolone(SOLU-Medrol),an injection of Famotidine(Pepcid),one litre of sodium chloride(Normal saline),and Acetaminophen(Tylenol).She was discharged with an EpiPen and another prescription of Prednisone(20mg).  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event, anaphylactic shock was not reported, whereas, the outcome of facial swelling was considered not resolved.; 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.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Headache, Heart rate
Clinical narrative: headache; atrial fibrillation with abnormal heart rate; A spontaneous report was received from a consumer concerning a 87 years old, male patient who experienced atrial fibrillation with abnormal heart rate/ PT: Atrial fibrillation and mild headache.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included unspecified medications.   On 03 Feb 2021 (at 2:01 pm), approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Feb 2021 (at 5:00 pm), approximately 3 hours later, the patient experienced atrial fibrillation with abnormal heart rate. The patient's heart rate was 145.  The patient went to the emergency room and the cardiologist gave him a pill to lower the heart rate.  The patient was also told to take his regular pills and was sent home.  The patient reported having atrial fibrillation for the past five days and that he had a scheduled appointment with his health care professional for an EKG on another date.  On an unknown date, the patient also reported that he experienced mild headache.  The event atrial fibrillation with abnormal heart rate was considered medically significant.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, atrial fibrillation with abnormal heart rate and mild headache, was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a consumer concerning a 28 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed anaphylactic reaction.    The patient's medical history and concomitant medications were not provided.  On an unknown date, approximately three weeks prior to the onset of the event, the patient received her first of two doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed an anaphylactic reaction. Treatment information was not provided. The patient wanted to know if the Moderna vaccine contains shellfish and shark ingredients.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylactic reaction, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Perimyocarditis post covid19 vaccine syndrome; A spontaneous report was received from a physician concerning a 19 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced perimyocarditis post covid19 vaccine syndrome.  The patient's medical history was not provided. No concomitant medications were reported.  On 16 Feb 2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) for prophylaxis of COVID-19 infection.  On 22 Feb 2021 the patient experienced the symptoms following vaccination: perimyocarditis post covid19 vaccine syndrome.  No treatment information was provided. No relevant laboratory details were included.  The seriousness criteria for the event perimyocarditis post covid19 vaccine syndrome were hospitalization and medically significant.  Action taken with the drug in response to the event was unknown.  The outcome of the event, perimyocarditis post covid19 vaccine syndrome was reported resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Echocardiogram, Pericarditis, Troponin increased
Clinical narrative: Perimyocarditis post covid19 vaccine syndrome; A spontaneous report was received from a physician concerning a 19 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced perimyocarditis post covid19 vaccine syndrome.  The patient's medical history was not provided. No concomitant medications were reported.  On 16 Feb 2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) for prophylaxis of COVID-19 infection.  On 22 Feb 2021 the patient experienced the symptoms following vaccination: perimyocarditis post covid19 vaccine syndrome.  No treatment information was provided. No relevant laboratory details were included.  The seriousness criteria for the event perimyocarditis post covid19 vaccine syndrome were hospitalization and medically significant.  Action taken with the drug in response to the event was unknown.  The outcome of the event, perimyocarditis post covid19 vaccine syndrome was reported resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Electrocardiogram, Therapeutic aspiration
Clinical narrative: blood pressure went up to 23-24 mmHg/blood pressure high; A spontaneous report was received from a 48 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his blood pressure went up to 23-24 mmHg/blood pressure increased.  The patient's medical history included bariatric surgery.  Concomitant medications included losartan.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that his blood pressure "went up to 23-24 mmHg" and he was hospitalized two times, one of the times was on 25 Jan 2021.  He reported that his blood pressure "does not go down" and that labs tests were being performed to determine the relationship with the vaccine.  AN electrocardiogram and radiography were normal.  On 25 Jan 2021, the patient was hospitalized due to high blood pressure which was 23-24 mm Hg. On 25-Jan-2021, the electrocardiogram and radiography findings were normal. The patient's blood pressure was 17-19 mm Hg at the time of this report.  The patient was worried because of the consequences of blood pressure high.  Losartan was changed to amlodipine as treatment for the event.  Action taken with mRNA-1273 in response to the event was  unknown.  The outcome of the event of blood pressure went up to 23-24 mmHg/blood pressure high was unknown; at the time of reporting, the patient said his blood pressure was "between 17-19 mmHg."; 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.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypotension
Clinical narrative: My blood pressure, which normally runs low, dipped very low (85/55); I had pretty severe brain fog.  I never blacked out, but I was concerned I might.; This is a spontaneous report from a contactable consumer reporting for himself.  A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 23Jan2021 on right arm at single dose for COVID-19 immunization. Facility type vaccine was at hospital. Medical history included small fiber neuropathy, dysautonomia/vasovagal syncope, ineffective esophageal motility disorder, migraine, GERD, allergic to preservatives in many eye drops, but never a vaccine; allergic to dust mites. Concomitant medications included nadolol, midodrine, esomeprazole magnesium (NEXIUM), amitriptyline and other unspecified medications. The patient stated "My blood pressure, which normally runs low (I have dysautonomia/vasovagal syncope) dipped very low (85/55) and I had pretty severe brain fog. I never blacked out, but I was concerned I might." The reported events happened on 25Jan2021 18:00, and resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events were resolved in 2021.
Sex: M
Vaccine: COVID19
Symptoms: HIV antibody, Hepatitis C antibody, Immune thrombocytopenia, Platelet count
Clinical narrative: ITP (platelet count 1,000); This is a spontaneous report from a contactable physician (patient).  A 31-years-old healthy male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The historical vaccine included MMR vaccine in Nov2020 (3 months before 08Feb2021) for immunization and idiopathic thrombocytopenic purpura (ITP). The patient presented with ITP (platelet count 1,000) approximately 2.5 weeks after receiving the 2nd dose of the Pfizer COVID vaccine. Hepatitis C Antibody (reported as Hep. C Ab) was negative. HIV-Ab was pending. The reporter knew there were cases reports of ITP associated with COVID-19 infection. The events outcome was unknown. The reporter asked had anyone noted COVID vaccination-related ITP? He received the MMR vaccine (which has been associated with ITP) 3 months ago. Was it too far out to attribute this case of ITP to the MMR vaccination?  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient is taking Bactrim for cellulitis and is due for the second dose of the vaccine. Outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: The association between the event cellulitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Respiratory distress, Tachycardia, Urinary tract infection
Clinical narrative: UTI; respiratory distress; elevated BP; tachycardia; This is a spontaneous report from a contactable nurse received via Medical Information Team.  A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced urinary tract infection (UTI) (hospitalization) on an unspecified date; respiratory distress, elevated blood pressure (BP) and tachycardia, all on 15Jan2021.  The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 15Jan2021. The patient outcome of the events was unknown.  Information on the lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the respiratory distress, elevated blood pressure and tachycardia due to temporal relationship. Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event UTI, which may  likely represent intercurrent medical condition.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG, arterial blood gas and physical examination, counteractive treatment measures and concomitant medications.   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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fatigue, Lymph node pain, Muscle strain, Poor quality sleep
Clinical narrative: her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a  spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number:  EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported.  There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts.  She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Illness, SARS-CoV-2 test
Clinical narrative: I am a breastfeeding mother. My daughter (3 months old) ended up hospitalized/very sick; I am a breastfeeding mother. My daughter (3 months old) ended up hospitalized/very sick; This is a spontaneous report from a contactable Other HCP. This Other HCP (Patient's mother) reported for a 3-month-old female patient that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9269) via transmammary (parent route Intramuscular at Left arm) on 08Feb2021 06:00 PM at single dose for COVID-19 immunization. Medical history was none. Concomitant drugs were not reported. Her mother was a 23 years old female and was a breastfeeding mother, her daughter (3 months old) ended up hospitalized (in Feb2021 for 6 days) and very sick a week and a half after mother received the vaccine. The event start date reported as 16Feb2021 with outcome of recovering. Treatment was unknown. No covid prior vaccination. Covid test post vaccination on 18Feb2021: (Nasal Swab) Negative.; Sender's Comments: Very limited information was provided in this report regarding the clinical course of the event.  The reported "very sick a week and a half after mother received the vaccine" is unspecified. Pending more detailed information became available, at this moment, the Company cannot completely exclude the possible causality between the reported events and COVID-19 vaccine, 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 RA, IEC, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthcare professional (patient).  A 35-year-old female patient received the 2nd dose (at the age of 35-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL8982), via an unspecified route of administration on the left arm on 05Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient had no known allergies and medical history reported as none. There were no concomitant medications. The patient was not pregnant (including the time of vaccination). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL1283), via an unspecified route of administration on the left arm on 15Jan2021 09:30 (at the age of 35-year-old) for COVID-19 immunization.  The patient developed Bell's Palsy (left side of face paralysis) on Friday afternoon 19Feb2021 (2 weeks after second dose of the vaccine). The patient went to the doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to the event (which was considered as serious disability or permanent damage). The emergency room (ER) doctor prescribed valacyclovir and prednisone. Outcome of the event was not recovered.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug cannot be excluded for the reported event Bell's Palsy.  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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 02Feb2021 at 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included ongoing systemic lupus erythematosus (Lupus), ongoing hypertension (High Blood Pressure), ongoing gout and hip arthroplasty from Dec2020 to an unknown date; all diagnosed about 20 years ago. Concomitant medications included allopurinol, atorvastatin, benzonatate, chlorthalidone, apixaban (ELIQUIS), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), hydroxychloroquine, iron, loratadine, losartan potassium, mycophenolate mofetil, omeprazole, paricalcitol, prednisone, spironolactone and valacyclovir [valaciclovir] and vitamin D NOS. The reporter's husband had a reaction to the vaccine. She was wondering if it is ok to have the second dose. He got paralysis, Bell's Palsy on 14Feb2021. She clarified vaccine as COVID19 Vaccine. She would like any information available about second dose after having Bell's Palsy with the first dose. The outcome of the event was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Auscultation, Blood glucose, Blood pressure measurement, Feeling abnormal
Clinical narrative: syncopal episode; itching; fullness; feeling funny; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscular on 19Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included manual vacuum aspiration (MVA), traumatic brain injury (TBI) from 2007 to an unknown date, vagovasal and hypotension post TBI, Celiac disease, allergy to milk products, diagnosed with COVID-19 from Aug2020 to an unknown date prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), and folic acid. The patient was previously vaccinated with the first dose of bnt162b2 (lot number: EL3246) at the age of 30-year-old, intramuscularly for COVID-19 immunisation on 19Jan2021 at 14:15 and experienced heart flutters and "fell faint" (fainted). The patient also previously took ibuprofen and experienced allergies. After approximately 5 minutes after the patient had the second dose of vaccine (19Feb2021 14:20), the patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138. Patient awakened and reported "feeling funny" on 19Feb2021, but was A &Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. At 14:20 the patient was given Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. At 15:00, EMS called for ER transport to due prolonged recovery. The events resulted in emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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.