chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transfusion, Ulcer haemorrhage
Clinical narrative: By Sunday I was so weak; I developed black diarrhea; Wednesday (day after vaccine)  I developed Gastric reflux which I never had before.; As the day  progressed I had severe abdominal pain that lasted throughout the day; Nausea set in late that evening; bleeding ulcer; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 13:00 at single dose for COVID-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility (as reported). Medical history included high blood pressure, aortic valve replacement and stent placement, 1 kidney, cancer 12 years ago (2009). Patient was not pregnant, no known allergies. No covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was yes (blood pressure medication). Concomitant medications included unspecified blood pressure medication. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on an unspecified date for COVID-19 immunisation.  Patient reported that on Wednesday (day after vaccine) (24Feb2021) she developed gastric reflux which she never had before (24Feb2021 08:00). As the day progressed she had severe abdominal pain that lasted throughout the day, also something she never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday (26Feb2021) she developed black diarrhea that continued all day. By Sunday (28Feb2021) she was so weak that a Harrogate (senior living complex) nurse came and sent her to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday (24Feb2021) when the severe pain began. After release from the 4 day (as reported) hospital stay, patient was sent to health clinic for 6 days to regain some strength. Since she never had ulcers, she firmly believed that everything was activated on Tuesday when she received the second Pfizer vaccine shot. Adverse events resulted in: Emergency room/department or urgent care, Hospitalization (as reported), Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3 (as reported). Treatment included blood transfusions and intravenous (IV). The outcome of the events was recovered.  Information of lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Blood test, Chest X-ray, Colonoscopy
Clinical narrative: By Sunday I was so weak; I developed black diarrhea; Wednesday (day after vaccine)  I developed Gastric reflux which I never had before.; As the day  progressed I had severe abdominal pain that lasted throughout the day; Nausea set in late that evening; bleeding ulcer; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 13:00 at single dose for COVID-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility (as reported). Medical history included high blood pressure, aortic valve replacement and stent placement, 1 kidney, cancer 12 years ago (2009). Patient was not pregnant, no known allergies. No covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was yes (blood pressure medication). Concomitant medications included unspecified blood pressure medication. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on an unspecified date for COVID-19 immunisation.  Patient reported that on Wednesday (day after vaccine) (24Feb2021) she developed gastric reflux which she never had before (24Feb2021 08:00). As the day progressed she had severe abdominal pain that lasted throughout the day, also something she never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday (26Feb2021) she developed black diarrhea that continued all day. By Sunday (28Feb2021) she was so weak that a Harrogate (senior living complex) nurse came and sent her to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday (24Feb2021) when the severe pain began. After release from the 4 day (as reported) hospital stay, patient was sent to health clinic for 6 days to regain some strength. Since she never had ulcers, she firmly believed that everything was activated on Tuesday when she received the second Pfizer vaccine shot. Adverse events resulted in: Emergency room/department or urgent care, Hospitalization (as reported), Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3 (as reported). Treatment included blood transfusions and intravenous (IV). The outcome of the events was recovered.  Information of lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Electrocardiogram, Endoscopy, Gastrooesophageal reflux disease, Nausea
Clinical narrative: By Sunday I was so weak; I developed black diarrhea; Wednesday (day after vaccine)  I developed Gastric reflux which I never had before.; As the day  progressed I had severe abdominal pain that lasted throughout the day; Nausea set in late that evening; bleeding ulcer; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 13:00 at single dose for COVID-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility (as reported). Medical history included high blood pressure, aortic valve replacement and stent placement, 1 kidney, cancer 12 years ago (2009). Patient was not pregnant, no known allergies. No covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was yes (blood pressure medication). Concomitant medications included unspecified blood pressure medication. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on an unspecified date for COVID-19 immunisation.  Patient reported that on Wednesday (day after vaccine) (24Feb2021) she developed gastric reflux which she never had before (24Feb2021 08:00). As the day progressed she had severe abdominal pain that lasted throughout the day, also something she never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday (26Feb2021) she developed black diarrhea that continued all day. By Sunday (28Feb2021) she was so weak that a Harrogate (senior living complex) nurse came and sent her to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday (24Feb2021) when the severe pain began. After release from the 4 day (as reported) hospital stay, patient was sent to health clinic for 6 days to regain some strength. Since she never had ulcers, she firmly believed that everything was activated on Tuesday when she received the second Pfizer vaccine shot. Adverse events resulted in: Emergency room/department or urgent care, Hospitalization (as reported), Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3 (as reported). Treatment included blood transfusions and intravenous (IV). The outcome of the events was recovered.  Information of lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ulcer haemorrhage
Clinical narrative: By Sunday I was so weak; I developed black diarrhea; Wednesday (day after vaccine)  I developed Gastric reflux which I never had before.; As the day  progressed I had severe abdominal pain that lasted throughout the day; Nausea set in late that evening; bleeding ulcer; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 13:00 at single dose for COVID-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility (as reported). Medical history included high blood pressure, aortic valve replacement and stent placement, 1 kidney, cancer 12 years ago (2009). Patient was not pregnant, no known allergies. No covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was yes (blood pressure medication). Concomitant medications included unspecified blood pressure medication. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on an unspecified date for COVID-19 immunisation.  Patient reported that on Wednesday (day after vaccine) (24Feb2021) she developed gastric reflux which she never had before (24Feb2021 08:00). As the day progressed she had severe abdominal pain that lasted throughout the day, also something she never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday (26Feb2021) she developed black diarrhea that continued all day. By Sunday (28Feb2021) she was so weak that a Harrogate (senior living complex) nurse came and sent her to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday (24Feb2021) when the severe pain began. After release from the 4 day (as reported) hospital stay, patient was sent to health clinic for 6 days to regain some strength. Since she never had ulcers, she firmly believed that everything was activated on Tuesday when she received the second Pfizer vaccine shot. Adverse events resulted in: Emergency room/department or urgent care, Hospitalization (as reported), Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3 (as reported). Treatment included blood transfusions and intravenous (IV). The outcome of the events was recovered.  Information of lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Erythema multiforme of the trunk and bilateral arms starting 18 hours post vaccination.  accompanied by mild puritis and myalgias.  no wheezing, shortness of breath, angioedema, fever.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema multiforme, Myalgia, Pruritus
Clinical narrative: Erythema multiforme of the trunk and bilateral arms starting 18 hours post vaccination.  accompanied by mild puritis and myalgias.  no wheezing, shortness of breath, angioedema, fever.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram normal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Lightheadness, racing heartbeat, Face numbness, rolling symptoms throughout body, elevated blood pressure, wrong words being spoken, lower back pain and swelling of arm at injection site.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood pressure increased, Dizziness, Heart rate increased, Injection site swelling
Clinical narrative: Lightheadness, racing heartbeat, Face numbness, rolling symptoms throughout body, elevated blood pressure, wrong words being spoken, lower back pain and swelling of arm at injection site.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Speech disorder
Clinical narrative: Lightheadness, racing heartbeat, Face numbness, rolling symptoms throughout body, elevated blood pressure, wrong words being spoken, lower back pain and swelling of arm at injection site.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Lip swelling, Pruritus, Swelling face, Swollen tongue
Clinical narrative: facial numbness, lips numb swelling, tongue swelling, nape of neck itching
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lip swelling, Pruritus, Swollen tongue
Clinical narrative: facial numbness, lips numb swelling, tongue swelling, nape of neck itching
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: rash covering their whole body; received their first dose of VAQTA, along with MMR II and VARlVAX; This spontaneous report as received from a physician refers to a 12 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T013205 expiration date 03-DEC-2021; 0.5 milliliter per intramuscular route along with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), all for prophylaxis (strength, dose, route, lot# and expiration date were not provided).      On an unknown date, the patient experienced a rash covering their whole body. The outcome of the event was not provided.  The causal relationship between the event and the suspect therapies was not provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Cough, Injection site warmth
Clinical narrative: stomach aches; wet cough; her arm was hot at the injection site; This spontaneous report was received from a patients daughter who was referring to her 84-year-old mother- female patient. Her concomitant therapies included vitamin d (unspecified) and naproxen sodium (ALEVE) taken as needed (prn). It was reported that the patient could not get the COVID-19 vaccine due to shellfish and iodine allergy, therefore a physician prescribed pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) .   On 23-FEB-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injected in arm (exact dose, frequency, lot #, expiration date and route of administration were not reported) for elderly and to prevent pneumonia.   On the same day, she experienced a reaction after administration of the vaccine, her arm was hot at the injection site and she experienced stomach aches and wet cough. The patient sought medical attention and spoke to a physician. Benzonatate was prescribed for cough. The patient stated that the stomach aches still occurred in the evening when vitamin d (unspecified) was taken. She inquired if there were any interactions between vitamin d (unspecified) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and asked about ingredients in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The outcome of the events was reported as recovering. She still had slight cough. The causality assessment was not provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; an expired dose of MMR-II was administered; diluted in sterile diluent (lot number: S005088, expiration date reported as 27-SEP-2021, but upon internal validation established as 31-DEC-2014; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-MAR-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot number: S006647, expiration date: 05-MAR-2021, also reported as 12-MAR-2021), 0.5 ml (route of administration was not provided) diluted in sterile diluent (lot number: S005088, expiration date reported as 27-SEP-2021, but upon internal validation established as 31-DEC-2014) (expired product administered). No adverse event was reported.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX was administered to a patient prior to discovering the temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a 7-year-old patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously, lot # T022314, expiration date 30-JUN-2022 (dose number and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 31.8 degrees Fahrenheit for 5 hours and 30 minutes on 14-MAR-2021. There was no previous temperature excursion. Digital Data Logger was involved.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Lower respiratory tract infection, SARS-CoV-2 antibody test positive
Clinical narrative: tested positive for Covid-19; headache; chest cold; A spontaneous report  was received from a consumer concerning a 84-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest cold, headache, and tested positive for COVID-19.  The patient's medical history was not reported by the reporter. Concomitant medication was not reported.  On 29-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) in right arm for prophylaxis of COVID-19 infection.  On 30-JAN-2021, she experienced chest cold and headache. On 02-FEB-2021, she tested positive for COVID-19.  The event chest cold was considered as serious with criteria of medically significant.  Treatment for event was unknown.  Action taken with mRNA-1273 in response to the events was reported as unknown.   The outcome of events chest cold, headache and COVID-19 were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rheumatoid arthritis, Swelling, Swelling face
Clinical narrative: Diagnosed with rheumatoid arthritis; Whole right side of body swelled up; My hands were so swollen that I could not make a fist/I had difficulty walking because my foot was swollen; Swollen from her face; A spontaneous report was received from a consumer concerning a 49 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced whole right side of body swelling/swelling, peripheral swelling, swollen from her face/swelling face and rheumatoid arthritis.   On 11 Mar 2021, an update was received providing additional information on medical history and concurrent medications.The patient's current medical conditions, as reported by her HCP, include Obesity, Asthma, Hypertension, Sleep apnea, GERD, Diabetes, Polycystic ovarian syndrome, Fibromyalgia, Debilitating anxiety, Supraventricular tachycardia, and Hyperlipidemia.   Concomitant medications were reported included  warfarin, potassium chloride, magnesium oxide, metoprolol tartrate,  hydrochlorothiazide,  amlodipine, folic acid,  metformin, Dexlansoprazole, alprazolam, Duloxetine, vitamin B complex, hydrocodone, vitamin D,  albuterol, fluticasone propionate, voltaren (Diclofenac) gel , tiotropium bromide, prednisone, methotrexate, symbicort, atorvastatin and empagliflozin.  On 15 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:024M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.    On the 5th or 6th day after receiving the vaccine, her whole right side of the body swelled from her face down to her feet. Her hands were swollen that she couldn't make a fist and she had difficulty walking due to the swelling. She had been diagnosed with Rheumatoid Arthritis which was medical significant.  On 12 Mar 2021, an update was received providing additional details of the patient's symptoms. Patient reported swelling and inflammation involving the right arm, right hand, right  knuckles, right knee, right leg and right foot. The patient reported the swelling is finally going down.  Treatment information were reported included prednisone(tapered dose) and methotrexate.  Lab details were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events- whole right side of body swelling, facial swelling, peripheral swelling were recovering. The outcome of event rheumatoid arthritis was 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 events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual, Tremor
Clinical narrative: started seeing things; shaking; A spontaneous report was received from a consumer concerning a 69-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient started seeing things and began shaking.  The patient's medical history, as provided by the reporter, included Parkinson's Disease and Dementia.  No concomitant medications were reported.   On 13-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 16-FEB-2021, after receiving mRNA-1273, patient started seeing things and began shaking. Event was considered to be medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   No treatment details were provided.  The events, patient started seeing things and shaking, were 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: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; A spontaneous report was received from a nurse concerning a patient of unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pericarditis.  No medical history was provided.  No concomitant medications were reported.   On an unknown date, one hour before the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: nor provided) intramuscularly for the prophylaxis of COVID-19 infection.  An hour after vaccination, the patient had chest pain and "decided it was pericarditis" (medically significant).   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event of pericarditis was unknown.   The reporter did not provide causality assessment for the event of pericarditis.; 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.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: His neuropathy is off the hook, really bad; Condition aggravated; Severe pain in his arm; A spontaneous report was received from a consumer concerning a 62-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced symptoms of neuropathy gone through the roof and really bad and pain in arm.  The patient's medical history states he has an autonomic nervous system problem. Concomitant medications were not reported.  On 26 Feb 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 022M20A) for prophylaxis of COVID-19 infection.   Patient received the vaccine on 26 Feb 2021 and reports that day he had severe pain in arm for around a week. His neuropathy is off the hook and really bad. Treatment for the events were not provided. Lab tests mention 2 negative COVID tests in Mar 2020, but he was not tested for antibodies he says.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, neuropathy gone through roof and really bad, was considered unknown. The outcome of the event pain in arm was considered recovered on 05 Mar 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Gastric ulcer, Headache, Histamine level increased
Clinical narrative: Stomach ulcer; A lot of histamines in the body; Headache; A spontaneous report was received from a Consumer concerning a female patient age unspecified who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a lot of histamines in the body/histamine level increased, headache/headache and stomach ulcer/gastric ulcer.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 09-MAR-2021, the patient experienced the events a lot of histamines in the body, headache and stomach ulcer.  The event stomach ulcer was considered to be serious with criteria of important medical event.  Laboratory details were not provided.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events a lot of histamines in the body, headache and stomach ulcer was 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypotension, Memory impairment, Weight decreased
Clinical narrative: he was out of it, couldn't remember anything; Had low blood pressure; Lost weight; symptoms became worse; A spontaneous report was received from a Consumer concerning her husband, a 80- year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being out of it, couldn't remember anything (memory impairment), had low blood pressure (hypotension) and lost weight (weight decreased).  The patient's medical history was not provided. Concomitant medications reported included tacrolimus, mycophenolic acid, carvedilol, clopidogrel, allopurinol, pantoprazole, prednisone, calcitriol, simvastatin and tylenol.  On 09 Feb 2021, approximately 25 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot: 025J202A) for prophylaxis of COVID-19 infection.  On 06 Mar 2021, the patient was out of it, couldn't remember anything, had low blood pressure and lost weight. Most of these symptoms started before patient received the Moderna vaccine but the symptoms became worse on 06 Mar 2021. The patient was hospitalized on 06 Mar 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, patient was out of it, couldn't remember anything, had low blood pressure and lost weight were considered 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: she passed out for 2-3 min; A spontaneous report was received from a consumer, concerning that his wife who is of age 48 years, was received Moderna's COVID-19 vaccine and experienced passed out for 2-3minutes/ loss of consciousness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 10 MAR 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (002A21A) via unknown route for COVID-19 infection prophylaxis.  On 11 MAR 2021, the patient experienced the events of passed out for 2-3min/loss of consciousness. No treatment information was provided.   The outcome of the event, passed out for 2-3minutes/ loss of consciousness, is considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Chills, Dizziness, Heart rate
Clinical narrative: Has not gotten second dose; Got really sick; Violent bed shaking chills; Pain at injection site all the way up the right and left side of neck; Was white; Minor chills; Tunnel vision; Going to pass out; Sweaty; Increased heart rate; Blood sugar dropped; Dizzy; Pain at injection site all the way up the right and left side of neck; A spontaneous report was received from a consumer concerning a 58-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tunnel vision, felt like going to pass out/ presyncope, was white/ pallor and sweaty/ hyperhidrosis, increased heart rate/ heart rate increased, blood sugar dropped/ blood glucose decreased, minor chills/ chills, dizzy/ dizziness, pain at injection site/ vaccination site pain all the way up the right and left side of neck/ neck pain, got really sick/ illness, had violent bed shaking chills/ chills and has not gotten second dose/ product dose omission issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, immediately after receiving vaccine, the patient felt like she was going to pass out, tunnel vision a medically significant event, was white and sweaty, increased heart rate, blood sugar dropped, minor chills, dizzy, pain at injection site all the way up the right and left side of neck. The patient was monitored at a doctor's office for about 3 hours before she felt good enough to drive home and felt better. Pain injections lasted a week and other symptoms ended on an unspecified date. On 26 Feb 2021, the patient got really sick and had violent bed shaking chills (ended on an unknown date). The patient has not gotten her second dose but did test negative for COVID.  Laboratory details included increased heart rate, blood sugar dropped and test negative for COVID.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tunnel vision, presyncope, pallor, hyperhidrosis, heart rate increased, blood glucose decreased, chills, dizziness and neck pain, was resolved on 31 Dec 2020. The outcome of events, vaccination site pain, illness and chills, was resolved on an unspecified 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 events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Illness, Neck pain, Pallor
Clinical narrative: Has not gotten second dose; Got really sick; Violent bed shaking chills; Pain at injection site all the way up the right and left side of neck; Was white; Minor chills; Tunnel vision; Going to pass out; Sweaty; Increased heart rate; Blood sugar dropped; Dizzy; Pain at injection site all the way up the right and left side of neck; A spontaneous report was received from a consumer concerning a 58-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tunnel vision, felt like going to pass out/ presyncope, was white/ pallor and sweaty/ hyperhidrosis, increased heart rate/ heart rate increased, blood sugar dropped/ blood glucose decreased, minor chills/ chills, dizzy/ dizziness, pain at injection site/ vaccination site pain all the way up the right and left side of neck/ neck pain, got really sick/ illness, had violent bed shaking chills/ chills and has not gotten second dose/ product dose omission issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, immediately after receiving vaccine, the patient felt like she was going to pass out, tunnel vision a medically significant event, was white and sweaty, increased heart rate, blood sugar dropped, minor chills, dizzy, pain at injection site all the way up the right and left side of neck. The patient was monitored at a doctor's office for about 3 hours before she felt good enough to drive home and felt better. Pain injections lasted a week and other symptoms ended on an unspecified date. On 26 Feb 2021, the patient got really sick and had violent bed shaking chills (ended on an unknown date). The patient has not gotten her second dose but did test negative for COVID.  Laboratory details included increased heart rate, blood sugar dropped and test negative for COVID.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tunnel vision, presyncope, pallor, hyperhidrosis, heart rate increased, blood glucose decreased, chills, dizziness and neck pain, was resolved on 31 Dec 2020. The outcome of events, vaccination site pain, illness and chills, was resolved on an unspecified 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 events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Product dose omission issue, SARS-CoV-2 test negative, Tunnel vision, Vaccination site pain
Clinical narrative: Has not gotten second dose; Got really sick; Violent bed shaking chills; Pain at injection site all the way up the right and left side of neck; Was white; Minor chills; Tunnel vision; Going to pass out; Sweaty; Increased heart rate; Blood sugar dropped; Dizzy; Pain at injection site all the way up the right and left side of neck; A spontaneous report was received from a consumer concerning a 58-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tunnel vision, felt like going to pass out/ presyncope, was white/ pallor and sweaty/ hyperhidrosis, increased heart rate/ heart rate increased, blood sugar dropped/ blood glucose decreased, minor chills/ chills, dizzy/ dizziness, pain at injection site/ vaccination site pain all the way up the right and left side of neck/ neck pain, got really sick/ illness, had violent bed shaking chills/ chills and has not gotten second dose/ product dose omission issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, immediately after receiving vaccine, the patient felt like she was going to pass out, tunnel vision a medically significant event, was white and sweaty, increased heart rate, blood sugar dropped, minor chills, dizzy, pain at injection site all the way up the right and left side of neck. The patient was monitored at a doctor's office for about 3 hours before she felt good enough to drive home and felt better. Pain injections lasted a week and other symptoms ended on an unspecified date. On 26 Feb 2021, the patient got really sick and had violent bed shaking chills (ended on an unknown date). The patient has not gotten her second dose but did test negative for COVID.  Laboratory details included increased heart rate, blood sugar dropped and test negative for COVID.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tunnel vision, presyncope, pallor, hyperhidrosis, heart rate increased, blood glucose decreased, chills, dizziness and neck pain, was resolved on 31 Dec 2020. The outcome of events, vaccination site pain, illness and chills, was resolved on an unspecified 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 events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Atrial fibrillation, Dyspnoea, Eye colour change, Insomnia
Clinical narrative: Diagnosed with Afib; Couldn't breath/Gasping for air; Eyes yellow; Asthma flairup; Couldn't sleep; Shaking; A spontaneous report was received from a consumer concerning a 73-year old female patient, who experienced asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital, diagnosed with Afib .  The patient's medical history mentions asthmatic since the age of 3 years old and Atrial fibrillation. Concomitant medications provided were steroids NOS and a zpack.  On 16 Jan 2021, one month and 6 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 0281120A) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, patient reported having an asthmatic flair up that was bad. She took medication provided by her hcp and could not sleep, could not breathe, gasping for air, eyes yellow and shaking. She was admitted to the hospital on 11 Feb 2021 and was diagnosed with Atrial fibrillation. She missed her planned dose as she was hospitalized.  The event atrial fibrillation was deemed medically significant and the patient was also hospitalized.  Treatment information mentions Xanax. Lab tests were not provided. Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, atrial fibrillation was unknown. The outcome of the events asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital was 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Diagnosed with Afib; Couldn't breath/Gasping for air; Eyes yellow; Asthma flairup; Couldn't sleep; Shaking; A spontaneous report was received from a consumer concerning a 73-year old female patient, who experienced asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital, diagnosed with Afib .  The patient's medical history mentions asthmatic since the age of 3 years old and Atrial fibrillation. Concomitant medications provided were steroids NOS and a zpack.  On 16 Jan 2021, one month and 6 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 0281120A) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, patient reported having an asthmatic flair up that was bad. She took medication provided by her hcp and could not sleep, could not breathe, gasping for air, eyes yellow and shaking. She was admitted to the hospital on 11 Feb 2021 and was diagnosed with Atrial fibrillation. She missed her planned dose as she was hospitalized.  The event atrial fibrillation was deemed medically significant and the patient was also hospitalized.  Treatment information mentions Xanax. Lab tests were not provided. Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, atrial fibrillation was unknown. The outcome of the events asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital was 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.
Sex: F
Vaccine: COVID19
Symptoms: Aspiration, Dyspnoea
Clinical narrative: shortness of breath; severe aspiration; A spontaneous report was received from a consumer who was a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe shortness of breath/dyspnea and severe aspiration/aspiration.  The patient's medical history included chronic obstructive pulmonary disease (COPD). No relevant concomitant medications were provided.  On 13 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA (Lot number:unknown ) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, patient experienced severe aspiration and called paramedics.  She received a breathing treatment when they arrived at her house but she did not go to the hospital.  Then, on 05 Mar 2021, the patient reported that her breathing got very bad again so she drove herself to the hospital.  She was given magnesium and another medication (she was unable to recall the name) as well as a five day course of prednisone.  On 10 Mar 2021, she followed up with her primary physician and he prescribed another week of prednisone with an increased dose.   No laboratory data was provided.   Treatment for the event included a breathing treatment by the paramedics,  magnesium, an unknown medication and prednisone.  On 15 Mar 2021, she was scheduled to receive second vaccine dose.   Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, severe shortness of breath and severe aspiration,  were considered recovering/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
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Herpes zoster oticus
Clinical narrative: Ramsay-Hunt syndrome; shingle in her facial nerve.; A spontaneous report was received from a consumer concerning herself, a 47-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Ramsay-Hunt syndrome (herpes zoster oticus) and shingles in her facial nerve (herpes zoster).  The patient's medical history was not provided. Concomitant medications reported included hydrochlorothiazide telmisartan, pantoprazole, metformin hydrochloride, vitamin D2, fenofibrate and eicosapentaenoic acid ethyl ester.  On 03 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch 012A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced Ramsay-Hunt syndrome. Patient stated that symptoms started in the middle of the night on 04 Mar 2021, but she noticed it on around 0300 on 05 Mar 2021.  According to the patient, it was related to shingles in her facial nerve.    Treatment for the event included valtrex.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, Ramsey-Hunt syndrome and shingles in her facial nerve, were considered not recovered/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: Anaphylactic reaction, Chills, Oropharyngeal discomfort, Rash, Swelling
Clinical narrative: Anaphylactic reaction; Throat block; RASH; SWELLING; CHILLS; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, throat block, chills, rash and swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced the events, anaphylactic reaction, throat block, chills, rash and swelling.  Treatment details included hydrocortisone shot, IV diphenhydramine as oral diphenhydramine was not working - 1st visit to emergency, IV diphenhydramine, epinephrine injection pen (had anaphylactic reaction for this drug also) and prednisone was given to, decrease itching and swelling at the 2nd visit to emergency.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, anaphylactic reaction, throat block, chills, rash, swelling was 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 events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: Experienced stroke; I'm not speaking well; A spontaneous report was received from consumer a 73 year old female patient who developed stroke/cerebrovascular accident, I'm not speaking well/aphasia.   The patient's medical history included claustrophobia. Products known to have been used by the patient, within two weeks prior to the event, included multivitamins. Laboratory test include MRI.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (Batch number: 044A21A) on 10 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. The batch number of first dose is mentioned as 00M20A.   The patient experienced stroke about a week ago, between the first and second dose. She stated she wasn't sure, but she went to the hospital over the weekend. She also stated that she was not speaking well. The medically significant event is stroke. Open magnetic resonance imaging (MRI) was performed but no results were provided. Treatment for the events was not known.   Action taken with mRNA-1273 in response to the event(s) was not applicable.   The outcome of the events stroke and I'm not speaking well was not known.; 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