chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Stomach is "different", suddenly has to go to the bathroom; Fatigue; Appendicitis; Stomach pain / Stomach upset; Indigestion; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy on 20-Apr-2021. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain / Stomach upset), DYSPEPSIA (Indigestion), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). On 13-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach is "different", suddenly has to go to the bathroom). The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis), ABDOMINAL PAIN UPPER (Stomach pain / Stomach upset), DYSPEPSIA (Indigestion), PAIN IN EXTREMITY (Pain in arm), ABDOMINAL DISCOMFORT (Stomach is "different", suddenly has to go to the bathroom) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Computerised tomogram: revealed appendicitis Revealed appendicitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took Pepto-Bismol (bismuth subsalicylate) and laxatives for stomach pain and indigestion.   She had appendectomy on 20-Apr-2021. She now reports that her stomach feels 'different' and she has sudden urges to go to the bathroom.  Treatment information was not provided.  Company Comment : 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.; Sender'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: Dizziness, Dyspnoea, Influenza like illness, Loss of consciousness, Oral herpes
Clinical narrative: 'Passing out' at their doorstep; Shortness of breath; Fever blisters on upper lip; Flu-like symptoms; Dizziness; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461321A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, MONTELUKAST SODIUM (SINGULAIR), CLOPIDOGREL BISULFATE (PLAVIX) and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ORAL HERPES (Fever blisters on upper lip), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DIZZINESS (Dizziness) and PYREXIA (Fever). On 13-May-2021, DYSPNOEA (Shortness of breath), ORAL HERPES (Fever blisters on upper lip), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included valaciclovir (Valtrex), meclizine (only once for dizziness) and docosanol (Abreva) (for some improvement of fever blisters).  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.   This case was linked to MOD-2021-127691 (Patient Link).; Sender'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: Pyrexia
Clinical narrative: 'Passing out' at their doorstep; Shortness of breath; Fever blisters on upper lip; Flu-like symptoms; Dizziness; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461321A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, MONTELUKAST SODIUM (SINGULAIR), CLOPIDOGREL BISULFATE (PLAVIX) and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ORAL HERPES (Fever blisters on upper lip), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DIZZINESS (Dizziness) and PYREXIA (Fever). On 13-May-2021, DYSPNOEA (Shortness of breath), ORAL HERPES (Fever blisters on upper lip), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included valaciclovir (Valtrex), meclizine (only once for dizziness) and docosanol (Abreva) (for some improvement of fever blisters).  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.   This case was linked to MOD-2021-127691 (Patient Link).; Sender'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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (very tired) (seriousness criterion hospitalization). At the time of the report, FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  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.   This case was linked to MOD-2021-127637 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Loss of consciousness, Product dose omission issue, Speech disorder
Clinical narrative: Passed out; Does not want to get 2nd dose; Head was hurting; Mini stroke; Speech difficulties; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and CEREBROVASCULAR ACCIDENT (Mini stroke) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.  Concomitant products included LOSARTAN, LEVOCETIRIZINE, TEMAZEPAM, ATORVASTATIN CALCIUM (LIPITOR), BISOPROLOL and BUSPIRONE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On 01-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mini stroke) (seriousness criteria hospitalization and medically significant), SPEECH DISORDER (Speech difficulties) and HEADACHE (Head was hurting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Does not want to get 2nd dose). The patient was hospitalized from 01-Apr-2021 to 04-Apr-2021 due to CEREBROVASCULAR ACCIDENT and LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CEREBROVASCULAR ACCIDENT (Mini stroke), SPEECH DISORDER (Speech difficulties) and HEADACHE (Head was hurting) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Does not want to get 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included generic Plavix and blood thinner.  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.; Sender'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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Difficulty breathing; Covid-19 symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced COVID-19 (Covid-19 symptoms). On 06-May-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Difficulty breathing) and COVID-19 (Covid-19 symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On 06-May-2021, started with breathing issues, and although being negative for covid-19 since 02-May-2021, had to go to hospital to receive treatment.  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. The mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of the COVID-19 event is assessed as not applicable.; Sender'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. The mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of the COVID-19 event is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died in the car on the way home after receiving the second dose of the Moderna COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died in the car on the way home after receiving the second dose of the Moderna COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA in response to the event/s was not applicable. A  patient called on 13MAY2021 to report adverse effects she experienced after receiving the Moderna COVID-19 vaccine. During the call, she reported a serious adverse effect for "another lady" who "died in the car on the way home" after receiving the second dose of the Moderna COVID-19 vaccine. The caller reported that the individual received the second dose of the vaccine.  No additional information was provided. The Serious Adverse Event Reporting form has been completed.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-128107, MOD21-090166, US-MODERNATX, INC.-MOD-2021-128999 (E2B Linked Report).; Sender'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. US-MODERNATX, INC.-MOD-2021-128107: MOD21-090166: US-MODERNATX, INC.-MOD-2021-128999:; Reported Cause(s) of Death: unknown cause of death
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), DECREASED APPETITE (poor appettie) and FATIGUE (extreme fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN (OPSUMIT) for Pulmonary hypertension.    Concurrent medical conditions included Pulmonary hypertension (secondary Pulmonary hypertension). Concomitant products included RIOCIGUAT (ADEMPAS) and APIXABAN (ELIQUIS) for an unknown indication.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MACITENTAN (OPSUMIT) (Oral) at an unspecified dose. On 12-Apr-2021, the patient experienced PYREXIA (fever) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (poor appettie) (seriousness criterion hospitalization prolonged) and FATIGUE (extreme fatigue) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 12-Apr-2021 to 19-Apr-2021 due to DECREASED APPETITE, FATIGUE and PYREXIA. At the time of the report, PYREXIA (fever), DECREASED APPETITE (poor appettie) and FATIGUE (extreme fatigue) outcome was unknown.            No treatment medications provided by the reporter.  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.; Sender'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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gait inability, Guillain-Barre syndrome, Nerve conduction studies, Physical examination
Clinical narrative: Guillain Barre syndrome; she can hardly walk without any assistance; Condition worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced GAIT INABILITY (she can hardly walk without any assistance) and CONDITION AGGRAVATED (Condition worsened). On 04-May-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), GAIT INABILITY (she can hardly walk without any assistance) and CONDITION AGGRAVATED (Condition worsened) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Nerve conduction studies: inconclusive (Inconclusive) Inconclusive. On 11-May-2021, Physical examination: inconclusive (Inconclusive) Inconclusive.         The concomitant medications were not reported.  After the 2nd Moderna vaccine the patient reported that her condition had worsened. She can hardly walk without any assistance.  On 04-May-2021, she went in to see her doctor and was told she could possibly have Guillain Barre Syndrome from  the Moderna Covid-19 Vaccine.  She had a Nerve Conduction Test and full physical examination done on 11-May2021,  but is to undergo additional tests yet to rule out other conditions and to confirm Gillian Barre Syndrome coming from the Moderna Vaccine.  She will be having her Next Office Visit on Tuesday and yet had to schedule a Magnetic resonance imaging (MRI,) unspecified spinal test and an electroencephalogram  (EEG).  The doctor wants to get all tests done yet before starting treatments or drawing up a conclusion.  The treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  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.   This case was linked to MOD-2021-128666 (Patient Link).; Sender'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: very hot; indurated; itched; Red; huge, great big, rash; Saw an HCP 2 days ago who attributed her vision changes to optical neuritis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eyes. Concomitant products included POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS) for Dry eyes.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) (seriousness criteria disability and medically significant). On 30-Apr-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (indurated), VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (huge, great big, rash). At the time of the report, OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) had not resolved and VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (indurated), VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (huge, great big, rash) outcome was unknown.            Treatment information was not provided.  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.   This case was linked to MOD-2021-128857 (Patient Link).; Sender'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: very hot; indurated; itched; Red; huge, great big, rash; Saw an HCP 2 days ago who attributed her vision changes to optical neuritis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eyes. Concomitant products included POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS) for Dry eyes.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) (seriousness criteria disability and medically significant). On 30-Apr-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (indurated), VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (huge, great big, rash). At the time of the report, OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) had not resolved and VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (indurated), VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (huge, great big, rash) outcome was unknown.            Treatment information was not provided.  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.   This case was linked to MOD-2021-128857 (Patient Link).; Sender'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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Inflammation, SARS-CoV-2 test positive
Clinical narrative: inflammation around the heart; Hot then cold; Brain fog; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation around the heart) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A TCP#4 and 008B212A TCP#4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive. Nasal swabaf) on 05-Jan-2021, Vitamin D deficiency and Anxiety. Concurrent medical conditions included Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin), Perfume sensitivity (allergy to stromg smells like perfume) and Seasonal allergy. Concomitant products included HYDROXYZINE for Anxiety, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Eye disorder prophylaxis, CETIRIZINE HYDROCHLORIDE (ZYRTEK) for Seasonal allergy, VITAMIN D3 for Vitamin D decreased, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 23-Mar-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot then cold), FEELING ABNORMAL (Brain fog) and CHILLS (chills). On 09-May-2021, the patient experienced INFLAMMATION (inflammation around the heart) (seriousness criterion hospitalization). The patient was hospitalized on 10-May-2021 due to INFLAMMATION. At the time of the report, INFLAMMATION (inflammation around the heart), FEELING OF BODY TEMPERATURE CHANGE (Hot then cold), FEELING ABNORMAL (Brain fog) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test positive: positive (Positive) nasal swab.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient spent a day and a half in the hospital, many tests were done and the patient is being treated for inflammation around the heart. More tests are coming up in two weeks.  Very limited information regarding this event has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-057833 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Reaction to the Moderna COVID-19 Vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the Moderna COVID-19 Vaccine) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (Reaction to the Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No treatment information was provided.; Sender'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: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Decreased appetite, Discomfort, Muscular weakness, Myocardial infarction
Clinical narrative: Stroke; Heart Attack; loss of appetite; weak in the legs; felt achy; felt yucky; felt queasy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MYOCARDIAL INFARCTION (Heart Attack) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy). On 12-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening) and MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 12-May-2021 due to CEREBROVASCULAR ACCIDENT and MYOCARDIAL INFARCTION. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), MYOCARDIAL INFARCTION (Heart Attack), DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy) outcome was unknown.            Treatment information was not provided. The reporter reported that the patient did not have any medical conditions to cause the events.   This case was linked to MOD-2021-132255 (Patient Link).; Sender's Comments: This case concerns a 92-year-old male with serious unexpected events of cerebrovascular accident and myocardial infarction, and nonserious unexpected decreased appetite, muscular weakness, pain, discomfort and nausea. Latency 1 day after second dose mRNA-1273. Based on 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: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Stroke; Heart Attack; loss of appetite; weak in the legs; felt achy; felt yucky; felt queasy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MYOCARDIAL INFARCTION (Heart Attack) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy). On 12-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening) and MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 12-May-2021 due to CEREBROVASCULAR ACCIDENT and MYOCARDIAL INFARCTION. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), MYOCARDIAL INFARCTION (Heart Attack), DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy) outcome was unknown.            Treatment information was not provided. The reporter reported that the patient did not have any medical conditions to cause the events.   This case was linked to MOD-2021-132255 (Patient Link).; Sender's Comments: This case concerns a 92-year-old male with serious unexpected events of cerebrovascular accident and myocardial infarction, and nonserious unexpected decreased appetite, muscular weakness, pain, discomfort and nausea. Latency 1 day after second dose mRNA-1273. Based on 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, Rash, Swelling face
Clinical narrative: fever of 101.3; face puffy; Rash on his throat; body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face puffy), RASH (Rash on his throat), MYALGIA (body aches) and PYREXIA (fever of 101.3) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 008C21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced SWELLING FACE (face puffy), RASH (Rash on his throat) and MYALGIA (body aches). On 14-May-2021, the patient experienced PYREXIA (fever of 101.3). On 14-May-2021, RASH (Rash on his throat) had resolved. At the time of the report, SWELLING FACE (face puffy) and MYALGIA (body aches) had not resolved and PYREXIA (fever of 101.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 100.3 degree fahrenheit High.         Treatment information was not provided.  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.; Sender'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: Hospitalisation
Clinical narrative: Hospitalization nos; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization nos) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization nos) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization nos) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039B21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal).   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). On 07-Apr-2021, VACCINATION SITE PAIN (Injection arm soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included acid reflux medication. No treatment information was provided.   This case was linked to MOD-2021-133391 (Patient Link).; Sender'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: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Spasms-had 28 episodes until 4:12 pm today; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Spasms-had 28 episodes until 4:12 pm today) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced MUSCLE SPASMS (Spasms-had 28 episodes until 4:12 pm today) (seriousness criterion hospitalization). The patient was hospitalized from 14-May-2021 to 15-May-2021 due to MUSCLE SPASMS. At the time of the report, MUSCLE SPASMS (Spasms-had 28 episodes until 4:12 pm today) outcome was unknown.            No concomitant medication information was provided. Additional information received included that the patient had 28 episodes till now from the first dose vaccination. Treatment information was not provided.  Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-076263 (Patient Link).; Sender'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.  Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Diplopia, Dysstasia, Eyelid ptosis
Clinical narrative: Myasthenia gravis; Eye dropping just for a little bit; Double vision; Felt weak; Unable to stand up; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia gravis) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included PYRIDOSTIGMINE BROMIDE (MESTINON) and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia gravis) (seriousness criterion medically significant), EYELID PTOSIS (Eye dropping just for a little bit), DIPLOPIA (Double vision), ASTHENIA (Felt weak) and DYSSTASIA (Unable to stand up). At the time of the report, MYASTHENIA GRAVIS (Myasthenia gravis), EYELID PTOSIS (Eye dropping just for a little bit), DIPLOPIA (Double vision), ASTHENIA (Felt weak) and DYSSTASIA (Unable to stand up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: myasthenia gravis myasthenia gravis.         After a week of vaccination, the patient experience double vision. Patient also said he got eye dropping just for a little bit and he felt weak. The patient went to hospital for eye exam and blood work. After the blood work, the team of doctor said he had myasthenia gravis, a autoimmune disease that affects the neuromuscular system and explained that his eye dropping was caused by muscle weakened. The physician advised him to have a surgery by removing his thymus gland and advised he might experience a myasthenia gravis crisis which could put his life in danger. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided.  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.; Sender'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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Myasthenia gravis; Eye dropping just for a little bit; Double vision; Felt weak; Unable to stand up; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia gravis) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included PYRIDOSTIGMINE BROMIDE (MESTINON) and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia gravis) (seriousness criterion medically significant), EYELID PTOSIS (Eye dropping just for a little bit), DIPLOPIA (Double vision), ASTHENIA (Felt weak) and DYSSTASIA (Unable to stand up). At the time of the report, MYASTHENIA GRAVIS (Myasthenia gravis), EYELID PTOSIS (Eye dropping just for a little bit), DIPLOPIA (Double vision), ASTHENIA (Felt weak) and DYSSTASIA (Unable to stand up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: myasthenia gravis myasthenia gravis.         After a week of vaccination, the patient experience double vision. Patient also said he got eye dropping just for a little bit and he felt weak. The patient went to hospital for eye exam and blood work. After the blood work, the team of doctor said he had myasthenia gravis, a autoimmune disease that affects the neuromuscular system and explained that his eye dropping was caused by muscle weakened. The physician advised him to have a surgery by removing his thymus gland and advised he might experience a myasthenia gravis crisis which could put his life in danger. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided.  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.; Sender'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: Syncope
Clinical narrative: fainted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The reporter stated that patient fainted and was taken to the hospital emergency room. No treatment information was provided  Company comment: 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.   This case was linked to MOD-2021-089124, MOD-2021-089511 (E2B Linked Report).; Sender'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. MOD-2021-089124:Reporter's husband MOD-2021-089511:Same Reporter_Invalid Case_No patient identifier