chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall
Clinical narrative: Dizzy; Fell; Felt weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weakness), DIZZINESS (Dizzy) and FALL (Fell) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (Felt weakness) and FALL (Fell). On 10-Mar-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, ASTHENIA (Felt weakness), DIZZINESS (Dizzy) and FALL (Fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: delayed reaction of heart palpitations/hear her heartbeat in her ear; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (delayed reaction of heart palpitations/hear her heartbeat in her ear) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PALPITATIONS (delayed reaction of heart palpitations/hear her heartbeat in her ear). At the time of the report, PALPITATIONS (delayed reaction of heart palpitations/hear her heartbeat in her ear) had resolved. Unknown          No relevant concomitant medications were reported No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23 JUN 2021, changed outcome as per obtained information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Pain in the arm of the injection; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection) and HEADACHE (Mild headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection) and HEADACHE (Mild headache). On 11-Mar-2021, HEADACHE (Mild headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain in the arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication including Blood pressure medication and Diabetic medication was reported. On 12-MAR-2021 patient reported little pain in the arm.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Localised infection, Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: Start of an infection or a reaction; Vaccination site is burning hot like hot iron that never goes away; Vaccination site was itching; The vaccination site is hard like leather; Site is red; Vaccination site is twice the size of 50c piece; Pounding headache; Pain on the arm- left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the arm- left arm), LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching) and VACCINATION SITE INDURATION (The vaccination site is hard like leather) 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.     The patient's past medical history included Swelling (Swelling the size of a large watermelon after bee sting), Swelling of tongue (Tongue swelling after bee sting) and Airway compromise (Airway was compromised due to bee sting). Concurrent medical conditions included Bee sting hypersensitivity (honey bees).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on the arm- left arm). On 09-Mar-2021, the patient experienced HEADACHE (Pounding headache). On 10-Mar-2021, the patient experienced LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching), VACCINATION SITE INDURATION (The vaccination site is hard like leather), VACCINATION SITE ERYTHEMA (Site is red) and VACCINATION SITE SWELLING (Vaccination site is twice the size of 50c piece). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency. On 02-Mar-2021, PAIN IN EXTREMITY (Pain on the arm- left arm) had resolved. At the time of the report, LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching), VACCINATION SITE INDURATION (The vaccination site is hard like leather), VACCINATION SITE ERYTHEMA (Site is red), VACCINATION SITE SWELLING (Vaccination site is twice the size of 50c piece) and HEADACHE (Pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  The patient reported an ER doctor told him to take diphenhydramine and contact his PCP because it could be the start of infection or reaction.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Start of an infection or a reaction; Vaccination site is burning hot like hot iron that never goes away; Vaccination site was itching; The vaccination site is hard like leather; Site is red; Vaccination site is twice the size of 50c piece; Pounding headache; Pain on the arm- left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the arm- left arm), LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching) and VACCINATION SITE INDURATION (The vaccination site is hard like leather) 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.     The patient's past medical history included Swelling (Swelling the size of a large watermelon after bee sting), Swelling of tongue (Tongue swelling after bee sting) and Airway compromise (Airway was compromised due to bee sting). Concurrent medical conditions included Bee sting hypersensitivity (honey bees).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on the arm- left arm). On 09-Mar-2021, the patient experienced HEADACHE (Pounding headache). On 10-Mar-2021, the patient experienced LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching), VACCINATION SITE INDURATION (The vaccination site is hard like leather), VACCINATION SITE ERYTHEMA (Site is red) and VACCINATION SITE SWELLING (Vaccination site is twice the size of 50c piece). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency. On 02-Mar-2021, PAIN IN EXTREMITY (Pain on the arm- left arm) had resolved. At the time of the report, LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching), VACCINATION SITE INDURATION (The vaccination site is hard like leather), VACCINATION SITE ERYTHEMA (Site is red), VACCINATION SITE SWELLING (Vaccination site is twice the size of 50c piece) and HEADACHE (Pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  The patient reported an ER doctor told him to take diphenhydramine and contact his PCP because it could be the start of infection or reaction.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Heart rate abnormal, Palpitations
Clinical narrative: Getting really weak to the point of passing out; Heart palpitations; Heart is fluctuating; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Getting really weak to the point of passing out), PALPITATIONS (Heart palpitations) and HEART RATE ABNORMAL (Heart is fluctuating) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Heart stents) in September 2020. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Getting really weak to the point of passing out), PALPITATIONS (Heart palpitations) and HEART RATE ABNORMAL (Heart is fluctuating). At the time of the report, ASTHENIA (Getting really weak to the point of passing out) outcome was unknown and PALPITATIONS (Heart palpitations) and HEART RATE ABNORMAL (Heart is fluctuating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was specified.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of the event updated
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Head ache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-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 HEADACHE (Head ache) and MYALGIA (Body ache). At the time of the report, HEADACHE (Head ache) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm but better.; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm but better.) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm but better.) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore arm but better.) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the concomitant medications were not provided. the treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Headache; Itching at injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness at injection site) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Tenderness at injection site). On 12-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness at injection site) and HEADACHE (Headache) 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Prickly pains through her whole body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Prickly pains through her whole body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive) on 01-Dec-2020 and Loss of smell (at the time of the report, "a couple weeks ago she lost her smell"). Concurrent medical conditions included Cramps in legs and Sleep difficult. Concomitant products included HYDROCODONE for Cramps in legs, ZOLPIDEM for Sleep difficult, GABAPENTIN, DIAZEPAM, LISINOPRIL and DICLOFENAC SODIUM (DICLOFENAC NA) for an unknown indication.    On 02-Mar-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Prickly pains through her whole body). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) for Myalgia, at an unspecified dose and frequency. On 03-Mar-2021, MYALGIA (Prickly pains through her whole body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: other (Positive) Tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Tenderness
Clinical narrative: Red hands; Back of the hands red and tender; Swollen wrists; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red hands), TENDERNESS (Back of the hands red and tender) and JOINT SWELLING (Swollen wrists) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ERYTHEMA (Red hands), TENDERNESS (Back of the hands red and tender) and JOINT SWELLING (Swollen wrists). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red hands), TENDERNESS (Back of the hands red and tender) and JOINT SWELLING (Swollen wrists) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment taken for the events included Cortisone cream however the patient reported administration did not help to relieve his symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Neck pain, Vaccination site pain
Clinical narrative: several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain; can't turn head to the right and can't look up; several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain; This spontaneous case was reported by a physician and describes the occurrence of NECK PAIN (several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain), MOVEMENT DISORDER (can't turn head to the right and can't look up) and VACCINATION SITE PAIN (several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced NECK PAIN (several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain), MOVEMENT DISORDER (can't turn head to the right and can't look up) and VACCINATION SITE PAIN (several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain). At the time of the report, NECK PAIN (several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain), MOVEMENT DISORDER (can't turn head to the right and can't look up) and VACCINATION SITE PAIN (several neck pain, in his deltoid and trapezius muscles in the side at the injection site/ can't turn head to the right/  8/10 scale pain) 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.   Patient's concomitant product include Clevis as  Blood thinners and unspecified medication for urinary tract infection.   No treatment information was reported.   This case was linked to MOD-2021-042733 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI-No new information
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Malaise, Pyrexia
Clinical narrative: diarrhea; fever; Doesn't feel good; he is so sick; vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (fever), MALAISE (Doesn't feel good), ILLNESS (he is so sick) and VOMITING (vomiting) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever), MALAISE (Doesn't feel good), ILLNESS (he is so sick), VOMITING (vomiting) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever), MALAISE (Doesn't feel good), ILLNESS (he is so sick), VOMITING (vomiting) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication details included Aleve (naproxen).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea; fever; Doesn't feel good; he is so sick; vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (fever), MALAISE (Doesn't feel good), ILLNESS (he is so sick) and VOMITING (vomiting) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever), MALAISE (Doesn't feel good), ILLNESS (he is so sick), VOMITING (vomiting) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever), MALAISE (Doesn't feel good), ILLNESS (he is so sick), VOMITING (vomiting) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication details included Aleve (naproxen).
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling hot, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: very itchy; her arm their was lump which oval shape; warm to touch; covid arm; red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on arm), PERIPHERAL SWELLING (her arm their was lump which oval shape), FEELING HOT (warm to touch) and PRURITUS (very itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced ADVERSE REACTION (covid arm) and RASH ERYTHEMATOUS (red rash on arm). On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (her arm their was lump which oval shape) and FEELING HOT (warm to touch). On an unknown date, the patient experienced PRURITUS (very itchy). On 10-Feb-2021, RASH ERYTHEMATOUS (red rash on arm) outcome was unknown. On 17-Feb-2021, PERIPHERAL SWELLING (her arm their was lump which oval shape) outcome was unknown. At the time of the report, ADVERSE REACTION (covid arm) and FEELING HOT (warm to touch) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: uncomfortable while walking; pain in knees, really bad; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (uncomfortable while walking) and ARTHRALGIA (pain in knees, really bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced GAIT DISTURBANCE (uncomfortable while walking) and ARTHRALGIA (pain in knees, really bad). On 12-Mar-2021, ARTHRALGIA (pain in knees, really bad) had resolved. At the time of the report, GAIT DISTURBANCE (uncomfortable while walking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: very hard injection site; red injection site; injection site swelled up to a very large round circle (orange sized); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (very hard injection site), VACCINATION SITE ERYTHEMA (red injection site) and VACCINATION SITE SWELLING (injection site swelled up to a very large round circle (orange sized)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02__ 21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE INDURATION (very hard injection site), VACCINATION SITE ERYTHEMA (red injection site) and VACCINATION SITE SWELLING (injection site swelled up to a very large round circle (orange sized)). At the time of the report, VACCINATION SITE INDURATION (very hard injection site), VACCINATION SITE ERYTHEMA (red injection site) and VACCINATION SITE SWELLING (injection site swelled up to a very large round circle (orange sized)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Sore; Tired / Fatigue; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), FATIGUE (Tired / Fatigue), HEADACHE (Headache) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included NAPROXEN SODIUM (ALEVE) for Migraine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Sore), FATIGUE (Tired / Fatigue), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Sore), FATIGUE (Tired / Fatigue), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Eye swelling, Pyrexia, Sensitive skin
Clinical narrative: temple and right teeth "felt like it was burning"; puffy cheeks; temple sensitive to touch; left side of her mouth had blisters in the upper palate; "felt like she had sinus infection"; left eye was swollen; aches and pain at injection site; chills; fever 100.2°F; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills), PYREXIA (fever 100.2°F), SINUSITIS ("felt like she had sinus infection") and EYE SWELLING (left eye was swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills) and PYREXIA (fever 100.2°F). On 10-Mar-2021, the patient experienced SINUSITIS ("felt like she had sinus infection"), EYE SWELLING (left eye was swollen) and BLISTER (left side of her mouth had blisters in the upper palate). On 12-Mar-2021, the patient experienced TOOTHACHE (temple and right teeth "felt like it was burning"), SWELLING FACE (puffy cheeks) and SENSITIVE SKIN (temple sensitive to touch). At the time of the report, VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills), PYREXIA (fever 100.2°F), SINUSITIS ("felt like she had sinus infection"), EYE SWELLING (left eye was swollen), TOOTHACHE (temple and right teeth "felt like it was burning"), SWELLING FACE (puffy cheeks), SENSITIVE SKIN (temple sensitive to touch) and BLISTER (left side of her mouth had blisters in the upper palate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Swelling face, Toothache, Vaccination site pain
Clinical narrative: temple and right teeth "felt like it was burning"; puffy cheeks; temple sensitive to touch; left side of her mouth had blisters in the upper palate; "felt like she had sinus infection"; left eye was swollen; aches and pain at injection site; chills; fever 100.2°F; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills), PYREXIA (fever 100.2°F), SINUSITIS ("felt like she had sinus infection") and EYE SWELLING (left eye was swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills) and PYREXIA (fever 100.2°F). On 10-Mar-2021, the patient experienced SINUSITIS ("felt like she had sinus infection"), EYE SWELLING (left eye was swollen) and BLISTER (left side of her mouth had blisters in the upper palate). On 12-Mar-2021, the patient experienced TOOTHACHE (temple and right teeth "felt like it was burning"), SWELLING FACE (puffy cheeks) and SENSITIVE SKIN (temple sensitive to touch). At the time of the report, VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills), PYREXIA (fever 100.2°F), SINUSITIS ("felt like she had sinus infection"), EYE SWELLING (left eye was swollen), TOOTHACHE (temple and right teeth "felt like it was burning"), SWELLING FACE (puffy cheeks), SENSITIVE SKIN (temple sensitive to touch) and BLISTER (left side of her mouth had blisters in the upper palate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.`   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Intention tremor, Tremor
Clinical narrative: Tremors seems to been out of control; Tremor get more violent; Weak; passed a horrible day with a lots of tremors; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (passed a horrible day with a lots of tremors), INTENTION TREMOR (Tremors seems to been out of control), TREMOR (Tremor get more violent) and ASTHENIA (Weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Neurological disorder NOS (Patient has been suffering from functional neurological disorder, for almost 2 years. She had headaches, neck aches, ringing ears and tremors but all that was under control prior to vaccination). Concomitant products included SIMVASTATIN for Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) 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 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (passed a horrible day with a lots of tremors). On 07-Mar-2021, the patient experienced INTENTION TREMOR (Tremors seems to been out of control), TREMOR (Tremor get more violent) and ASTHENIA (Weak). At the time of the report, TREMOR (passed a horrible day with a lots of tremors), INTENTION TREMOR (Tremors seems to been out of control), TREMOR (Tremor get more violent) and ASTHENIA (Weak) 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.   Treatment medication included duloxetine 30 mg.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: sore arm; joint pain all over/ knee is hurting; bheadache that is a "doozy"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint pain all over/ knee is hurting) and HEADACHE (bheadache that is a "doozy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint pain all over/ knee is hurting) and HEADACHE (bheadache that is a "doozy"). At the time of the report, PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint pain all over/ knee is hurting) and HEADACHE (bheadache that is a "doozy") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pain
Clinical narrative: Pain; Weak; Excruciating hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ASTHENIA (Weak) and ARTHRALGIA (Excruciating hip pain) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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 PAIN (Pain), ASTHENIA (Weak) and ARTHRALGIA (Excruciating hip pain). At the time of the report, PAIN (Pain), ASTHENIA (Weak) and ARTHRALGIA (Excruciating hip pain) outcome was unknown.            No concomitant medicines reported. No treatment medicines reported
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Influenza like illness, Peripheral swelling
Clinical narrative: flu-like symptoms; feet swelled up; hot flashes; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PERIPHERAL SWELLING (feet swelled up) and HOT FLUSH (hot flashes) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), PERIPHERAL SWELLING (feet swelled up) and HOT FLUSH (hot flashes). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PERIPHERAL SWELLING (feet swelled up) and HOT FLUSH (hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 6, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M208A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in November 2015, Miscarriage in June 2019 and Miscarriage in August 2020. Concomitant products included ENOXAPARIN SODIUM (LOVENOX HP), PROGESTERONE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Oct-2020 and the estimated date of delivery was 16-Jul-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound foetal: normal (normal) To view images of fetus when pregnant..     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.   The patient had taken tests relating to the pregnancy which is a genetic test. (Non invasive)
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Headache, Wheezing
Clinical narrative: slimy cough/are wheezing and coughing a lot, specially at nigh; their voice is lower; are wheezing and coughing a lot, specially at nigh; head hurts when they cough; This spontaneous case was reported by a physician and describes the occurrence of COUGH (slimy cough/are wheezing and coughing a lot, specially at nigh), DYSPHONIA (their voice is lower), WHEEZING (are wheezing and coughing a lot, specially at nigh) and HEADACHE (head hurts when they cough) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (slimy cough/are wheezing and coughing a lot, specially at nigh), DYSPHONIA (their voice is lower), WHEEZING (are wheezing and coughing a lot, specially at nigh) and HEADACHE (head hurts when they cough). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and BENZONATATE at a dose of 200 mg. At the time of the report, COUGH (slimy cough/are wheezing and coughing a lot, specially at nigh), DYSPHONIA (their voice is lower), WHEEZING (are wheezing and coughing a lot, specially at nigh) and HEADACHE (head hurts when they cough) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment medication included Mucinex, Zyrtec, benzonatate and nasal rinse with a neti pot.   This case was linked to MOD21-052130 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: It's a little bit hard; Red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (It's a little bit hard) and VACCINATION SITE ERYTHEMA (Red spot on her arm) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE INDURATION (It's a little bit hard) and VACCINATION SITE ERYTHEMA (Red spot on her arm). At the time of the report, VACCINATION SITE INDURATION (It's a little bit hard) and VACCINATION SITE ERYTHEMA (Red spot on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Whole-body hurts; Muscles hurt; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole-body hurts), MYALGIA (Muscles hurt) and HEADACHE (Headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Whole-body hurts), MYALGIA (Muscles hurt) and HEADACHE (Headache). At the time of the report, PAIN (Whole-body hurts), MYALGIA (Muscles hurt) and HEADACHE (Headache) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: headache; stomach ache; chills; body aches; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: headache; stomach ache; chills; body aches; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Ocular hyperaemia
Clinical narrative: Broken blood vessel in eye; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Broken blood vessel in eye) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history) since an unknown date.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (fatigue). On 12-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Broken blood vessel in eye). On 11-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, OCULAR HYPERAEMIA (Broken blood vessel in eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information was provided.  Based on the current available information and the temporal association of the product event and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association of the product event and the start date of the events a causal relationship cannot be excluded.