chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: initial symptoms started at ~ 8-12 hr post inj on FRI:  fever, chills, fatigue, muscle pain (generalized), back pain from sacrum to occiput, through cranium to behind eyes, nausea, loose stools, exhaustion, arm swelling (6" diameter) with bandaid indented becoming hard (feeling a little like cellulitis).  routinely measure pO2 and body temp--both spiked; resp rate went from normal pattern of 10-12 to 25; night time HR went from low 60's to the 100's; pO2 went from 96-98 to 89-91 (Innovo PulseOx)Treated with sleep (slept from 8PM night of shot until 48 hours after the shot), fluids, hot water bottles, arnica (I can't take NSAIDS), vit C, zinc megadoses;  by ~36 hours post injection I started wheezing and coughing deeply but non productive, both nasal passages were/are open, feels as though phlegm is stuck at bronchi.  By 48 hours, I was feeling better except chest, ribs, head, and neck and was experiencing 1-3" episodes of spasmodic coughing, wheezing, SOB; Occurred every 20-30 minutes and leaving me physically exhausted.  Sunday night slept with 4 pillows; went to see acute respiratory care clinic, evaluated, COVID-PCR was negative, temperature was normal by statistics (I tend to be colder; baseline temps between 32-33oC and over past week has ranged between 35-39oC).  Sent home with albuterol inhaler, mucinex (which I take at night), and flonase (my nostrils remain clear).  Current status:  extreme fatigue, high resting HR, minimal activity (walking) increases it to the 100s--not normal for me), and continued episodic bronchospasm (uncontrolled) with SOB and diaphragmatic, skeletal pain.  Deep diaphragmatic breaths also trigger.  Am also treating with hot water bottles to anterior and posterior chest walls, and nebulizer treatments with eucalyptus, thyme, and rosemary.  Still megadosing on C and Zinc.  Expect to return to work tomorrow (missed 2 days) as  neurologic and orthopedic physical therapist /exercise physiologist.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: 8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for  12 hrs, felt slightly better but still quite ill, tired, joint ad body aches, headache. Could not eat or get out of bed
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: 8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for  12 hrs, felt slightly better but still quite ill, tired, joint ad body aches, headache. Could not eat or get out of bed
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported.; Nurse stated 3rd dose of GARDASIL 9 was given 3 weeks too early in the series; This spontaneous report was received from a nurese refers to a 41 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. Concomitant therapies included lidocaine and lisdexamfetamine dimesylate(VYVANSE).   On 15-OCT-2020 (reported as "3 weeks too early in the series"), the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml  intramuscular in deltoid (strength was unknown) with lot # 1659422 and expiration date reported as 24-SEP-2022, but upon internal validation established as 04-SEP-2022 for prophylaxis. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose administered; No other AE or PQC  identified; This spontaneous report was received from a medical assistant referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 19-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) 0.5 ml intramuscular in the arm, lot # S006833, expiry date 02-SEP-2020 for prophylaxis. No other adverse event or PQC identidfied. No other information available.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; temperature excursion; This spontaneous report as received from an unspecified reporter and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 17-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in pre-filled syringe injection, 0.5 milliliter (ml), lot # 1602284, expiration date 26-SEP-2021, for prophylaxis (dose number, route of administration, and anatomical location were not reported).  It was reported that the dose of the product administered to the patient was stored improperly for the time frame of 30 minutes at a temperature of 31.2 Fahrenheit (F). There was no previous temperature excursion and the Digital Data Logger was involved.  No other adverse event was reported.  This is one of the several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA010448: US-009507513-2101USA009847:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; a temperature excursion involving GARDASIL 9 administered to a patient; This spontaneous report as received from a other and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 12-JAN-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (ml), lot # 1602284, expiration date 26-SEP-2021 (dose number, route of administration, anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was stored improperly for the time frame of 30 minutes in the temperature of 31.2 Fahrenheit (F). There was no previous temperature excursion. Digital Data Logger was involved.  No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: an improperly stored vaccine was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 25-JAN-2021, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (thimerosal-free)(RECOMBIVAX HB) (lot # T004378, expiration date 31-OCT-2022, 1 dosage form) for prophylaxis (product storage error). Temperature excursion was above 9 Centigrade (13.4 Centigrade) for 2 hours and 9 minutes. There was no previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired vaccine, MMR II, was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 29-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dosage form, expiration date reported as 01-NOV-2020 (route of administration and lot number were not reported) for prophylaxis. No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Blister, Chills, Cough
Clinical narrative: pneumonia; acute encephalopathy; sepsis; shingles; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles(herpes zoster). Shortly after the on an unknown date, the patient suffered weakness, altered mental status, dysarthria, hallucinations, fever, chills, cough and blíster like lesión on her hip, buttocks and leg. The patient was diagnosed with acute encephalopathy, critical illness, myopathy, pneumonia, sepsis and singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms had resulted in physical limitations not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury. The outcome of the events was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the events pneumonia, sepsis and encephalopathy were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Critical illness, Dysarthria, Emotional distress, Encephalopathy, Hallucination
Clinical narrative: pneumonia; acute encephalopathy; sepsis; shingles; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles(herpes zoster). Shortly after the on an unknown date, the patient suffered weakness, altered mental status, dysarthria, hallucinations, fever, chills, cough and blíster like lesión on her hip, buttocks and leg. The patient was diagnosed with acute encephalopathy, critical illness, myopathy, pneumonia, sepsis and singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms had resulted in physical limitations not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury. The outcome of the events was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the events pneumonia, sepsis and encephalopathy were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury, Loss of personal independence in daily activities, Mental status changes, Myopathy
Clinical narrative: pneumonia; acute encephalopathy; sepsis; shingles; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles(herpes zoster). Shortly after the on an unknown date, the patient suffered weakness, altered mental status, dysarthria, hallucinations, fever, chills, cough and blíster like lesión on her hip, buttocks and leg. The patient was diagnosed with acute encephalopathy, critical illness, myopathy, pneumonia, sepsis and singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms had resulted in physical limitations not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury. The outcome of the events was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the events pneumonia, sepsis and encephalopathy were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Physical disability, Pneumonia, Pyrexia, Sepsis
Clinical narrative: pneumonia; acute encephalopathy; sepsis; shingles; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles(herpes zoster). Shortly after the on an unknown date, the patient suffered weakness, altered mental status, dysarthria, hallucinations, fever, chills, cough and blíster like lesión on her hip, buttocks and leg. The patient was diagnosed with acute encephalopathy, critical illness, myopathy, pneumonia, sepsis and singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms had resulted in physical limitations not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury. The outcome of the events was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the events pneumonia, sepsis and encephalopathy were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: Allergy; This spontaneous report was received from a consumer via Pfizer referring to a currently 72 years old female patient. The patient's pertinent medical history and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were not reported) for prophylaxis.         The patient was allergic to the zoster vaccine live (ZOSTAVAX). The outcome of the event was unknown. Action taken with Zoster Vaccine Live (ZOSTAVAX) was not  applicable.  The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He then received his first COVID vaccine, was set to have his second 28 days later and was advised to wait 30 days for any other vaccinations. His second dose of GARDASIL 9 was scheduled within the 30 day waiting period. Patient missed his second dos; No additional AE details; This spontaneous report was received from a pharmacist via company representative regarding a male patient of unknown age. There was no information about patient's, concurrent conditions or pertinent medical history. The patient's concomitant therapy included unspecified retroviral medication.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  The patient was set to have his second vaccination of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) scheduled within the 30 day waiting period. Patient missed his second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to needing to wait from receiving a COVID-19 vaccine. The pharmacist enquired if there was an alternative dosing schedule in which the patient could receive his second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine later than 2 months and still complete the series. No additional adverse event details were reported.
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; This spontaneous report was received from a medical assistant via company representative  referring to a female patient of unknown age.  The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient ingested Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot, strength, frequency, dose and expiration date were not reported) during her grandchild's visit (Product administered to a patient of inappropriate age).   No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA001251 :  US-009507513-2102USA001245:
Sex: F
Vaccine: PPV
Symptoms: Death
Clinical narrative: her mother died in her 70's following multiple injections of PNEUMOVAX23; This spontaneous report was received from the patient's daughter, referring to a 70 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5ml, once, every 5 years, for vaccination (strength, route, lot# and expiration date were not reported).   On an unknown date, the patient died. The cause of death was not provided. It was unknown if an autopsy was performed.  The causality assessment between death with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA001947:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: Died of a heart attack; A spontaneous report was received from a consumer concerning a 56-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died due to a heart attack.  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 additional medications.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  - On an unknown date, the reporter stated the patient received Moderna's COVID-19 vaccine and sometime after he was found dead by his bedside around 02:30 am.   The patient died on an unknown date. The cause of death was due to a heart attack. Plans for autopsy were not provided.; Reporter's Comments: This case concerns a 56 year old, male patient, who experienced fatal unexpected event of myocardial infarction. The event occurred on an unspecified date after mRNA-1273 (Lot# Unknown). Treatment details not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate decreased, Hypotension, Loss of consciousness, Pain in extremity
Clinical narrative: Passed out; Hypotensive; Lightheaded; Heart rate dropped to 50; Arm  soreness; A spontaneous report was received from a consumer concerning a 43-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out, hypotensive, lightheaded, heart rate dropped to 50 and arm soreness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, approximately 0 days prior to the onset of the events, the patient received a dose of mRNA-1273 (Batch number 011L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, 6 minutes following vaccination, the patient experienced lightheadedness, became hypotensive, heart rate dropped to 50, and he passed out. Following the events, ambulance came and he was rushed to a health clinic. They gave him an Epinephrine shot and his vitals stabilized quickly. The patient also had arm soreness. Treatment for the event included epinephrine.   Action taken with mRNA-1273 in response to the events was not reported.  The events passed out, hypotensive, lightheaded, heart rate dropped to 50, were considered resolved on 23 Jan 2021. The outcome of the event arm soreness was unknown.; Reporter's Comments: Company comment: This spontaneous report concerns a 43-year old, male patient who experienced serious event of passed out and nonseries events of hypotensive, lightheaded, heart rate dropped to 50 and arm soreness.  The events occurred on the same day, 6 minutes after the administration of the first dose of mRNA 1273 (lot number 011L20A, expiration date unknown). Treatment included epinephrine and outcome of all events except arm soreness are resolved.  Based on the information provided, which indicates a temporal association of the reported events with the administration of mRNA-1273 vaccine, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: Urinary retention; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary retention.   The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient reports that two days after receiving the vaccine, she developed urinary retention. Treatment for the event included cephalexin.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, urinary retention, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced event of urinary retention. The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme; A spontaneous report was received from a physician concerning a 23-years-old male patient, who received Moderna's COVID-19 Vaccine, and who experienced erythema multiforme.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021, approximately ten days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 unknown lot number intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient started getting erythema multiforme. Treatment for the event included antihistamine and topical steroid cream.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event erythema multiforme was unknown.; Reporter's Comments: This case concerns a 23-years-old male patient, who experienced a serious unexpected event of erythema multiforme. This event occurred 11 days after first dose of mRNA-1273, lot # unknown.  Treatment details was not provided. Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Myocardial infarction, Pain in extremity
Clinical narrative: Heart attack; Short breath; Headache; Chills; A spontaneous report  was received from a 37 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, headache, chills, and short breath.    There was no medical history provided. Concomitant medications included colecalciferol and metoprolol both for unknown indications.   On 13 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # 02L20A), in in his left arm, for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the day after vaccination, the patient experienced the non-serious events of headache, chills, arm pain, and short breath. On 19 Jan 2021, six days after receiving the vaccine, the patient experienced the serious event of heart attack. Treatment included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events heart attack, headache, chills and short breath  was unknown at the time of this report.; Reporter's Comments: This case concerns a 37-year-old, male patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of myocardial infarction 7days after the first dose of mRNA-1273 (Batch # 02L20A). The patient also had non serious event of headache, chills and dyspnea the day after the first dose of mRNA-1273 (Batch # 02L20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dehydration, Dizziness, Dysphonia, Pain
Clinical narrative: Dehydration; Lost memory; Sore arm; Feels dizzy; Achy; Voice is hoarse; Fever; A spontaneous report was received from a consumer, who was a 69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dehydration, fever, lost memory, sore arm, feels dizzy, achy, and voice is hoarse.  The patient's medical history, as provided by the reporter, included some unspecified autoimmune issues. No concomitant product use was reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient felt very dehydrated and ran a fever of 101.8 degrees Fahrenheit for which she took paracetamol. The patient reported she lost all memory from Friday, 22 Jan 2021. Her husband took her to the emergency room after not being able to hold anything down. She received two bags of intravenous fluids and was discharged home the following day on 23 Jan 2021.   On 25 Jan 2021, the patient reported her arm was still sore, was dizzy and achy, and her voice was hoarse.                                                                                                                  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, dehydration, fever, and lost memory, was unknown. The events, sore arm, feels dizzy, achy, and voice is hoarse, were considered not resolved.; Reporter's Comments: This case concerns a 69 year old, female patient, with a medical history of unspecified autoimmune issues, who experienced serious unexpected event of dehydration and amnesia, non-serious unexpected event of pain in extremity, dizziness, pain, dysphonia and non-serious expected event of pyrexia. The event dehydration, amnesia and pyrexia occurred 2 days after mRNA-1273 (Lot# 030L20A), while the event of pain in extremity, dizziness, pain, dysphonia occurred on an unspecified date after mRNA-1273 (Lot# 030L20A). Treatment included Tylenol and IV fluids. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Dehydration; Lost memory; Sore arm; Feels dizzy; Achy; Voice is hoarse; Fever; A spontaneous report was received from a consumer, who was a 69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dehydration, fever, lost memory, sore arm, feels dizzy, achy, and voice is hoarse.  The patient's medical history, as provided by the reporter, included some unspecified autoimmune issues. No concomitant product use was reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient felt very dehydrated and ran a fever of 101.8 degrees Fahrenheit for which she took paracetamol. The patient reported she lost all memory from Friday, 22 Jan 2021. Her husband took her to the emergency room after not being able to hold anything down. She received two bags of intravenous fluids and was discharged home the following day on 23 Jan 2021.   On 25 Jan 2021, the patient reported her arm was still sore, was dizzy and achy, and her voice was hoarse.                                                                                                                  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, dehydration, fever, and lost memory, was unknown. The events, sore arm, feels dizzy, achy, and voice is hoarse, were considered not resolved.; Reporter's Comments: This case concerns a 69 year old, female patient, with a medical history of unspecified autoimmune issues, who experienced serious unexpected event of dehydration and amnesia, non-serious unexpected event of pain in extremity, dizziness, pain, dysphonia and non-serious expected event of pyrexia. The event dehydration, amnesia and pyrexia occurred 2 days after mRNA-1273 (Lot# 030L20A), while the event of pain in extremity, dizziness, pain, dysphonia occurred on an unspecified date after mRNA-1273 (Lot# 030L20A). Treatment included Tylenol and IV fluids. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: deviation of recommended dose- partial first dose given; syringe being a twist needle and not being securely on leding to leak; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an under dose due to "twist needle not being securely on the syringe".  The patients medical history and concomitant product use was not provided.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 27 Jan 2021, patient received a partial dose of mRNA-1273 during the immunization administration, the nurse noted the dose had leaked, "because of the syringe being a twist needle and not being securely on".  She stated she is not aware of how much mRNA-1273 leaked or how much of the dose the patient received.    Action taken with mRNA-1273 in response to the event is not reported.  The events, partial dose of mRNA-1273 received and syringe being a twist needle and not being securely on was considered resolved.; Reporter's Comments: This case concerns a patient, who, experienced a non-serious unexpected event of incorrect dose administered and device connection issue for mRNA-1273, lot # unknown. There was no AEs associated with incorrect dose administered and device connection issue.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Deep vein thrombosis; pulmonary embolism; A spontaneous report was received from a 64-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed deep vein thrombosis and pulmonary emboli.    The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Jan 2021, approximately 3 weeks prior to the onset of the events, the patient received first dose of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient reported she was hospitalized for deep vein thrombosis and pulmonary emboli. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, deep vein thrombosis and pulmonary emboli, were considered unknown.; Reporter's Comments: This case concerns a 64-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of Deep vein thrombosis and pulmonary embolism. The events occurred 22 days after the first dose of mRNA-1273 (Lot number: 037K20A) administration. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Additional information has been requested for further assessment.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: deviation from the recommended dose and some drops went out; A spontaneous report was received from a health care professional, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced in deviation from the recommended dose when some drops went out.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On unspecified date, the patient received the vaccine where some drops went out and lead to deviation from recommended dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, deviation from the recommended dose and some drops went out, was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age who received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection where some drops went out and lead to deviation from recommended dose. There were no reported adverse events after the vaccine was administered in this case of underdose.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Didnot received a full second dose of the vaccine; A spontaneous report was received from a consumer, concerning his wife, a 70-year-old female patient, who received Moderna's COVID-19 vaccine but did not received a full second dose of the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26-Jan-2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (lot number 011J20A) intramuscularly for COVID-19 infection prophylaxis.  The reporter stated that he and his wife had received the second dose of vaccine on 26-Jan-2021, and he received the full dose of vaccine, however, he believes that the syringe was not filled with any solution at the time of administration to patient, due to which the patient did not received a full dose of vaccine. Reporter denied consent to follow up. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The event, did not received a full second dose of the vaccine was considered resolved on 26-Jan-2021.; Reporter's Comments: Company comment: This case concerns a 70 year old female who experienced a nonserious event of did not received a full second dose of the vaccine (PT Incomplete dose administered).  There were no reported AEs associated with this case of incomplete dose administered. Very limited information regarding this event/s has been provided at this time. Reporter denied consent to follow-up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood glucose increased, Diabetes mellitus, Dizziness, Fatigue
Clinical narrative: diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Within 48 hours developed tachycardia. With heart rate reaching 136 at rest. Tachycardia is intermittent.; This is a spontaneous report from a contactable physician reporting for self. This 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248) on 11Jan2021 05:30 PM (vaccine location=left arm) at single dose for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medication included apremilast (OTEZLA). No other vaccine in four weeks. It was reported that within 48 hours patient developed tachycardia. With heart rate reaching 136 at rest. Tachycardia was intermittent. Using propranolol currently to keep heart rate down, propranolol 10 mg, and titrated to 20 mg. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination, and did not test COVID post vaccination.  The outcome of event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: lost the taste and smell; lost the taste and smell; tested positive for the COVID-19 infection; tested positive for the COVID-19 infection; This is a Spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program .   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on  13Jan2021 for Covid-19 immunisation, as being a dental hygienist.  The patient medical history and concomitant medications were not reported.  on 15Jan2021 the patient lost the taste and smell and then in Jan2021 she was tested positive for the covid-19 infection. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive in Jan2021 tested positive for the COVID-19 infection.  The outcome of events was unknown.  Patient wanted to know if she should receive the second dose of the vaccine if she tested positive for the COVID-19 infection. She already consulted her physician and was instructed to receive the second dose. Patient wanted to know for how long would she be protected after receiving the second dose of the vaccine.  Information on the Lot/Batch Number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dysarthria, Hallucination, Injection site pain
Clinical narrative: muscle weakness; fever; oxygen level of less than 90; blurred vision; his legs are still kind of weak; his arm still aches on the left side where he got the shot; slurred speech; had no balance; frozen fingers; had no strength in his legs or arms; hallucinations; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left in Jan2021 at single dose for COVID-19 immunization. The patient medical history included a minor hearing impairment from an unknown date and ongoing. The patient's concomitant medication included vitamin C from Jan2021 and ongoing. On 20Jan2021, the patient experienced hallucinations (the first day or two), slurred speech, he had had no balance, frozen fingers (2 fingers on each hand and his thumb), he had no strength in his legs or arms. On an unspecified date also experienced blurred vision, slurred speech, muscle weakness, fever, oxygen level of less than 90, his arm still aches on the left side where he got the shot. The patient outcome of hallucinations, slurred speech, frozen fingers was recovered, the outcome of he had no balance, he had no strength in his legs or arms was recovering, the outcome of his legs are still kind of weak and his arm still aches on the left side where he got the shot was not recovered, the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Peripheral coldness, Pyrexia, Vision blurred
Clinical narrative: muscle weakness; fever; oxygen level of less than 90; blurred vision; his legs are still kind of weak; his arm still aches on the left side where he got the shot; slurred speech; had no balance; frozen fingers; had no strength in his legs or arms; hallucinations; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left in Jan2021 at single dose for COVID-19 immunization. The patient medical history included a minor hearing impairment from an unknown date and ongoing. The patient's concomitant medication included vitamin C from Jan2021 and ongoing. On 20Jan2021, the patient experienced hallucinations (the first day or two), slurred speech, he had had no balance, frozen fingers (2 fingers on each hand and his thumb), he had no strength in his legs or arms. On an unspecified date also experienced blurred vision, slurred speech, muscle weakness, fever, oxygen level of less than 90, his arm still aches on the left side where he got the shot. The patient outcome of hallucinations, slurred speech, frozen fingers was recovered, the outcome of he had no balance, he had no strength in his legs or arms was recovering, the outcome of his legs are still kind of weak and his arm still aches on the left side where he got the shot was not recovered, the outcome of the other events was unknown.  Information on the lot/batch number has been requested.