chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flatulence, Headache, Insomnia, Nausea
Clinical narrative: Couldn't sleep; twisting stomach in knots; Feel like I gotta poop and gassy; Severe headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), ABDOMINAL DISCOMFORT (twisting stomach in knots), FLATULENCE (Feel like I gotta poop and gassy), HEADACHE (Severe headache) and NAUSEA (nausea) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022321A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced INSOMNIA (Couldn't sleep), ABDOMINAL DISCOMFORT (twisting stomach in knots), FLATULENCE (Feel like I gotta poop and gassy), HEADACHE (Severe headache) and NAUSEA (nausea). At the time of the report, INSOMNIA (Couldn't sleep), ABDOMINAL DISCOMFORT (twisting stomach in knots), FLATULENCE (Feel like I gotta poop and gassy), HEADACHE (Severe headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Non-significant Follow up appended on 16-MAY-2021,Initial receive date updated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: reddened area the size of a baseball (left arm; lump like an extra muscle ( left arm); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (reddened area the size of a baseball (left arm) and PERIPHERAL SWELLING (lump like an extra muscle ( left arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 046B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ATENOLOL, SPIRONOLACTONE, LEVOTHYROXINE, OMEPRAZOLE and FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for an unknown indication, LISINOPRIL.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-May-2021, the patient experienced ERYTHEMA (reddened area the size of a baseball (left arm) and PERIPHERAL SWELLING (lump like an extra muscle ( left arm)). At the time of the report, ERYTHEMA (reddened area the size of a baseball (left arm) and PERIPHERAL SWELLING (lump like an extra muscle ( left arm)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information not reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got kinda sick a little bit; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got kinda sick a little bit) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got kinda sick a little bit). At the time of the report, ILLNESS (got kinda sick a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) in a male 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 PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he missed second dose because he was in the hospital. No concomitant medications were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue
Clinical narrative: stomach pain; fatique; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and FATIGUE (fatique) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and FATIGUE (fatique). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and FATIGUE (fatique) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant  medications were not reported Treatment medication were not reported
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: the first one hit me hard; normal pain; high fever; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the first one hit me hard), PAIN (normal pain), PYREXIA (high fever), HEADACHE (headache) and MYALGIA (body ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     The patient's past medical history included Surgery (had surgery a few years ago).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (the first one hit me hard), PAIN (normal pain), PYREXIA (high fever), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (the first one hit me hard), PAIN (normal pain), PYREXIA (high fever), HEADACHE (headache) and MYALGIA (body ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   This case was linked to MOD-2021-132606 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered from a vial that was at room temperature for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered from a vial that was at room temperature for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered from a vial that was at room temperature for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered from a vial that was at room temperature for more than 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling
Clinical narrative: Swollen lips; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen lips) and HEADACHE (headache). At the time of the report, LIP SWELLING (Swollen lips) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received: Added new event swollen lips
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Malaise; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (Malaise) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (Fever). At the time of the report, MALAISE (Malaise) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication was provided.   This case was linked to MOD21-090768 (E2B Linked Report).; Sender's Comments:  MOD21-090768:invalid document
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product dose omission issue (vaccine first administered Jan 18, 2021; patient is yet to receive second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included surgery (patient had a surgery after the first dose of vaccine). On Jan 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 18, 2021, patient experienced product dose omission issue (vaccine first administered Jan 18, 2021; patient is yet to receive second dose). At the time of the report, product dose omission issue (vaccine first administered Jan 18, 2021; patient is yet to receive second dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant products or treatment information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test
Clinical narrative: 4 days later had a real diminishment in sense of smells; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ANOSMIA (4 days later had a real diminishment in sense of smells) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Recovered within 2-3 days) in January 2021. Concomitant products included ALFUZOSIN and DOXYCYCLINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (4 days later had a real diminishment in sense of smells). At the time of the report, ANOSMIA (4 days later had a real diminishment in sense of smells) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included steroid for 12 days   This case was linked to MOD-2021-132540 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced NASOPHARYNGITIS (cold symptoms). At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; Mild arm pain; Fatigue/tired; This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MYALGIA (Mild arm pain) and FATIGUE (Fatigue/tired) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). 01-Apr-2021, the patient experienced MYALGIA (Mild arm pain) and FATIGUE (Fatigue/tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and MYALGIA (Mild arm pain) had resolved and FATIGUE (Fatigue/tired) had not resolved.            No concomitant medication details was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pruritus, Pyrexia, Swelling
Clinical narrative: Red face; Itchy arm; Swelling; Headache; Low grade fever (99.8); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red face), PRURITUS (Itchy arm), SWELLING (Swelling), HEADACHE (Headache) and PYREXIA (Low grade fever (99.8)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced ERYTHEMA (Red face), PRURITUS (Itchy arm), SWELLING (Swelling), HEADACHE (Headache) and PYREXIA (Low grade fever (99.8)). At the time of the report, ERYTHEMA (Red face), PRURITUS (Itchy arm), SWELLING (Swelling), HEADACHE (Headache) and PYREXIA (Low grade fever (99.8)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Deafness, Depression, Effusion, Nasal congestion
Clinical narrative: Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.; Fluid behind ears - had sense of hearing loss; I am depressed and furious; physical blockage in both nostrils; Fluid in sinuses and nasal cavity; Fluid behind ears - had sense of hearing loss; Fluid in nasal cavity; I am depressed and furious; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils) and SINUSITIS (Fluid in sinuses and nasal cavity) in a 55-year-old male 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.     The patient's past medical history included COVID-19 ("recovered within 2-3 days") in January 2021 and Loss of smell ("took 7 weeks to recover from") in January 2021. Concomitant products included ALFUZOSIN and DOXYCYCLINE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils), SINUSITIS (Fluid in sinuses and nasal cavity), DEAFNESS (Fluid behind ears - had sense of hearing loss), RHINORRHOEA (Fluid in nasal cavity) and ANGER (I am depressed and furious). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils), SINUSITIS (Fluid in sinuses and nasal cavity), DEAFNESS (Fluid behind ears - had sense of hearing loss), RHINORRHOEA (Fluid in nasal cavity) and ANGER (I am depressed and furious) outcome was unknown.            Consent was given for safety follow up.  Patient reported that the was going to the hospital and would talk later.   This case was linked to MOD-2021-132479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Narrative updated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal turbinate hypertrophy, Rhinorrhoea, Sinusitis
Clinical narrative: Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.; Fluid behind ears - had sense of hearing loss; I am depressed and furious; physical blockage in both nostrils; Fluid in sinuses and nasal cavity; Fluid behind ears - had sense of hearing loss; Fluid in nasal cavity; I am depressed and furious; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils) and SINUSITIS (Fluid in sinuses and nasal cavity) in a 55-year-old male 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.     The patient's past medical history included COVID-19 ("recovered within 2-3 days") in January 2021 and Loss of smell ("took 7 weeks to recover from") in January 2021. Concomitant products included ALFUZOSIN and DOXYCYCLINE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils), SINUSITIS (Fluid in sinuses and nasal cavity), DEAFNESS (Fluid behind ears - had sense of hearing loss), RHINORRHOEA (Fluid in nasal cavity) and ANGER (I am depressed and furious). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils), SINUSITIS (Fluid in sinuses and nasal cavity), DEAFNESS (Fluid behind ears - had sense of hearing loss), RHINORRHOEA (Fluid in nasal cavity) and ANGER (I am depressed and furious) outcome was unknown.            Consent was given for safety follow up.  Patient reported that the was going to the hospital and would talk later.   This case was linked to MOD-2021-132479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Narrative updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Malaise, Product dose omission issue, Pulmonary pain
Clinical narrative: "felt uncomfortable"; "tight chest"; "chest pain as lung pain when deep breath''; only first dose received; This spontaneous case was reported by a patient and describes the occurrence of MALAISE ("felt uncomfortable"), CHEST DISCOMFORT ("tight chest"), PULMONARY PAIN ("chest pain as lung pain when deep breath'') and PRODUCT DOSE OMISSION ISSUE (only first dose received) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 MALAISE ("felt uncomfortable"), CHEST DISCOMFORT ("tight chest"), PULMONARY PAIN ("chest pain as lung pain when deep breath'') and PRODUCT DOSE OMISSION ISSUE (only first dose received). On 14-Apr-2021, MALAISE ("felt uncomfortable"), CHEST DISCOMFORT ("tight chest") and PULMONARY PAIN ("chest pain as lung pain when deep breath'') had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose received) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  No treatment information was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Headache. Concurrent medical conditions included Hypertension.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). The patient was treated with TOPIRAMATE for Headache, at a dose of 25 mg once a day; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Migraine, at an unspecified dose and frequency and ATENOLOL, CHLORTALIDONE (TENORETIC) for Hypertension, at a dose of 100 mg once a day. At the time of the report, HEADACHE (Headaches) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Pain, Scratch, Wound
Clinical narrative: Blood running down in places; Fell up the steps/down the steps; Scratched in places; Bruised in places; Hurt from head to toe; This spontaneous case was reported by a patient and describes the occurrence of WOUND (Blood running down in places), FALL (Fell up the steps/down the steps), SCRATCH (Scratched in places), CONTUSION (Bruised in places) and PAIN (Hurt from head to toe) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknwn) for COVID-19 vaccination.     The patient's past medical history included Difficulty in walking (trouble in her legs in the past). Concurrent medical conditions included Stomach discomfort. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.   On 05-May-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 05-May-2021, the patient experienced WOUND (Blood running down in places), FALL (Fell up the steps/down the steps), SCRATCH (Scratched in places), CONTUSION (Bruised in places) and PAIN (Hurt from head to toe). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, WOUND (Blood running down in places), FALL (Fell up the steps/down the steps), SCRATCH (Scratched in places), CONTUSION (Bruised in places) and PAIN (Hurt from head to toe) outcome was unknown.            Additional concomitant medications included a stomach tablet for stomach discomfort and Pemprol.  Patient stated she did not believe the fall was from  the Moderna vaccine because she moved the steps.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Erythema, Fatigue
Clinical narrative: whole body is itching like crazy; burning; red; felt so sick; chills that come and go; really bad fever; whole body was sore/muscle pain; fatigue; headache; joint pain; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning), ERYTHEMA (red), MALAISE (felt so sick) and CHILLS (chills that come and go) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MALAISE (felt so sick), CHILLS (chills that come and go), PYREXIA (really bad fever), MYALGIA (whole body was sore/muscle pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). On 15-May-2021, the patient experienced PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning) and ERYTHEMA (red). On 15-May-2021, MALAISE (felt so sick), PYREXIA (really bad fever), MYALGIA (whole body was sore/muscle pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning), ERYTHEMA (red) and CHILLS (chills that come and go) outcome was unknown.            No concomitant medication use was provided by the reporter. No treatment of events was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pruritus
Clinical narrative: whole body is itching like crazy; burning; red; felt so sick; chills that come and go; really bad fever; whole body was sore/muscle pain; fatigue; headache; joint pain; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning), ERYTHEMA (red), MALAISE (felt so sick) and CHILLS (chills that come and go) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MALAISE (felt so sick), CHILLS (chills that come and go), PYREXIA (really bad fever), MYALGIA (whole body was sore/muscle pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). On 15-May-2021, the patient experienced PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning) and ERYTHEMA (red). On 15-May-2021, MALAISE (felt so sick), PYREXIA (really bad fever), MYALGIA (whole body was sore/muscle pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning), ERYTHEMA (red) and CHILLS (chills that come and go) outcome was unknown.            No concomitant medication use was provided by the reporter. No treatment of events was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: whole body is itching like crazy; burning; red; felt so sick; chills that come and go; really bad fever; whole body was sore/muscle pain; fatigue; headache; joint pain; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning), ERYTHEMA (red), MALAISE (felt so sick) and CHILLS (chills that come and go) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MALAISE (felt so sick), CHILLS (chills that come and go), PYREXIA (really bad fever), MYALGIA (whole body was sore/muscle pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). On 15-May-2021, the patient experienced PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning) and ERYTHEMA (red). On 15-May-2021, MALAISE (felt so sick), PYREXIA (really bad fever), MYALGIA (whole body was sore/muscle pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, PRURITUS (whole body is itching like crazy), BURNING SENSATION (burning), ERYTHEMA (red) and CHILLS (chills that come and go) outcome was unknown.            No concomitant medication use was provided by the reporter. No treatment of events was reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Axillary pain, Myalgia, Rash, Vaccination site pain
Clinical narrative: feels like she might have had less than the required second dose; the caller still has pain at the injection site until now occasionally in the arm pit; rash; the caller still has pain at the injection site until now occasionally in the arm pit; pain; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (feels like she might have had less than the required second dose), AXILLARY PAIN (the caller still has pain at the injection site until now occasionally in the arm pit), RASH (rash), VACCINATION SITE PAIN (the caller still has pain at the injection site until now occasionally in the arm pit) and MYALGIA (pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Small lymphocyte B lymphoma (Lukes-Collins Classification) (B cell lymphoma).   In January 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) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ACCIDENTAL UNDERDOSE (feels like she might have had less than the required second dose), AXILLARY PAIN (the caller still has pain at the injection site until now occasionally in the arm pit), RASH (rash), VACCINATION SITE PAIN (the caller still has pain at the injection site until now occasionally in the arm pit) and MYALGIA (pain). At the time of the report, ACCIDENTAL UNDERDOSE (feels like she might have had less than the required second dose), AXILLARY PAIN (the caller still has pain at the injection site until now occasionally in the arm pit), RASH (rash), VACCINATION SITE PAIN (the caller still has pain at the injection site until now occasionally in the arm pit) and MYALGIA (pain) outcome was unknown.            No concomitant medications were reported.  On an unknown date, the patient had semi-qualitative-IgG antibody testing which reportedly came back negative.
Sex: M
Vaccine: COVID19
Symptoms: Gingival bleeding
Clinical narrative: Bleeding from our gums, a lot of blood coming from my mouth; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (Bleeding from our gums, a lot of blood coming from my mouth) in a male patient of an unknown age 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) (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 14-May-2021, the patient experienced GINGIVAL BLEEDING (Bleeding from our gums, a lot of blood coming from my mouth). At the time of the report, GINGIVAL BLEEDING (Bleeding from our gums, a lot of blood coming from my mouth) had not resolved.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: lost the ability to see well.; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (lost the ability to see well.), DIZZINESS (dizziness) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VISUAL IMPAIRMENT (lost the ability to see well.), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, VISUAL IMPAIRMENT (lost the ability to see well.) had not resolved and DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Dyspnoea
Clinical narrative: could not breath through nose; slowed movement; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (could not breath through nose) and BRADYKINESIA (slowed movement) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DYSPNOEA (could not breath through nose) and BRADYKINESIA (slowed movement). At the time of the report, DYSPNOEA (could not breath through nose) and BRADYKINESIA (slowed movement) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included acetaminophen and nasal spray.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-132703 (E2B Linked Report). This case was linked to MOD-2021-132703 (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. US-MODERNATX, INC.-MOD-2021-132703:Case for second dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Chest discomfort, Dyspnoea, Hypertension
Clinical narrative: vascular problems; high blood pressure; chest pressure; difficulty breathing; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (chest pressure), DYSPNOEA (difficulty breathing), ANGIOPATHY (vascular problems) and HYPERTENSION (high blood pressure) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CHEST DISCOMFORT (chest pressure) and DYSPNOEA (difficulty breathing). On 11-Apr-2021, the patient experienced ANGIOPATHY (vascular problems) and HYPERTENSION (high blood pressure). At the time of the report, CHEST DISCOMFORT (chest pressure), DYSPNOEA (difficulty breathing), ANGIOPATHY (vascular problems) and HYPERTENSION (high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Treatment medication not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pollakiuria
Clinical narrative: Frequent urination; Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) and INJECTION SITE PAIN (Sore arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced POLLAKIURIA (Frequent urination) and INJECTION SITE PAIN (Sore arms). At the time of the report, POLLAKIURIA (Frequent urination) and INJECTION SITE PAIN (Sore arms) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna COVID-19 Vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, received third 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) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna COVID-19 Vaccine). On 13-May-2021, EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. Concomitant medications were not reported.  The patient mentioned that he received a letter stating that one of his doses may have been invalid due to temperature and would need another dose.  Patient had no symptoms afterwards.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Dizziness, Fall
Clinical narrative: Brutal after second dose; She is dizzy; Diarrhea; Her back hurts from the middle down towards her legs; Has palpitations at times she can feel her heart; She fell and was lying on the floor for a while until she managed to get up; Sweating; Vomiting; Headache; High fever; Shivering; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs) and PALPITATIONS (Has palpitations at times she can feel her heart) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044821A and 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 14-May-2021, the patient experienced FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering). At the time of the report, FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering) outcome was unknown.            No concomitant medications provided.  Treatment information mentioned Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-132469 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: Brutal after second dose; She is dizzy; Diarrhea; Her back hurts from the middle down towards her legs; Has palpitations at times she can feel her heart; She fell and was lying on the floor for a while until she managed to get up; Sweating; Vomiting; Headache; High fever; Shivering; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs) and PALPITATIONS (Has palpitations at times she can feel her heart) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044821A and 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 14-May-2021, the patient experienced FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering). At the time of the report, FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering) outcome was unknown.            No concomitant medications provided.  Treatment information mentioned Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-132469 (Patient Link).