chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced NASAL CONGESTION (nasal congestion). At the time of the report, NASAL CONGESTION (nasal congestion) had resolved. Not Provided          No concomitant details were provided Treatment details include Nasal Saline and Unspecified nasal drops   This case was linked to US-MODERNATX, INC.-MOD-2021-062583. This case was linked to MOD-2021-062583.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: receptor: AE outcome and treatment details updated. Patient decline further follow-up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062583:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Presyncope, Pyrexia
Clinical narrative: had almost passed out; room was spinning; light headed; nauseous; threw up; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (had almost passed out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Breast cancer, Asthma, Supraventricular tachycardia and Mastectomy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (had almost passed out) (seriousness criterion medically significant), VERTIGO (room was spinning), DIZZINESS (light headed), NAUSEA (nauseous) and VOMITING (threw up). At the time of the report, LOSS OF CONSCIOUSNESS (had almost passed out), DIZZINESS (light headed), NAUSEA (nauseous) and VOMITING (threw up) outcome was unknown and VERTIGO (room was spinning), HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: had almost passed out; room was spinning; light headed; nauseous; threw up; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (had almost passed out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Breast cancer, Asthma, Supraventricular tachycardia and Mastectomy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (had almost passed out) (seriousness criterion medically significant), VERTIGO (room was spinning), DIZZINESS (light headed), NAUSEA (nauseous) and VOMITING (threw up). At the time of the report, LOSS OF CONSCIOUSNESS (had almost passed out), DIZZINESS (light headed), NAUSEA (nauseous) and VOMITING (threw up) outcome was unknown and VERTIGO (room was spinning), HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site pain, Scar, Vaccination site rash, Vaccination site vesicles
Clinical narrative: burn scar; water blisters under the injection site; Burning sensation to injected arm under skin; Developed a lumpy red rash on injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (water blisters under the injection site), SCAR (burn scar), ADMINISTRATION SITE PAIN (Burning sensation to injected arm under skin) and VACCINATION SITE RASH (Developed a lumpy red rash on injected arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included HIGH BLOOD PRESSURE MEDICATION, ANTIHYPERLIPIDEMIC MEDICATIONS and Nucynta pain medication for an unknown indication.    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 ADMINISTRATION SITE PAIN (Burning sensation to injected arm under skin) and VACCINATION SITE RASH (Developed a lumpy red rash on injected arm). On 12-Mar-2021, the patient experienced VACCINATION SITE VESICLES (water blisters under the injection site). On 25-Mar-2021, the patient experienced SCAR (burn scar). At the time of the report, VACCINATION SITE VESICLES (water blisters under the injection site), SCAR (burn scar), ADMINISTRATION SITE PAIN (Burning sensation to injected arm under skin) and VACCINATION SITE RASH (Developed a lumpy red rash on injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ice pack and Silver Sulfadiazine Cream.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Leukocytosis, Lymphocyte count, Pain
Clinical narrative: Leukocytosis; Thrombocytosis; Fatigue; feeling bad; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), PAIN (Body Aches), LEUKOCYTOSIS (Leukocytosis), THROMBOCYTOSIS (Thrombocytosis) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (DAILY VITAMINS), METFORMIN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, TAMSULOSIN and LOSARTAN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (feeling bad), PAIN (Body Aches) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced LEUKOCYTOSIS (Leukocytosis) and THROMBOCYTOSIS (Thrombocytosis). At the time of the report, FEELING ABNORMAL (feeling bad) had resolved, PAIN (Body Aches) and FATIGUE (Fatigue) was resolving and LEUKOCYTOSIS (Leukocytosis) and THROMBOCYTOSIS (Thrombocytosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Leukocytosis: high (High) High. On 23-Mar-2021, Thrombocytosis: high (High) High. On an unknown date, Lymphocyte count: low (Low) Low.         Concomitant medication included probiotics No treatment medications were provided.  Patient reported undergoing surgery and mentioned that recovery was slow.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant Follow up includes unspecified surgery
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytosis
Clinical narrative: Leukocytosis; Thrombocytosis; Fatigue; feeling bad; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), PAIN (Body Aches), LEUKOCYTOSIS (Leukocytosis), THROMBOCYTOSIS (Thrombocytosis) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (DAILY VITAMINS), METFORMIN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, TAMSULOSIN and LOSARTAN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (feeling bad), PAIN (Body Aches) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced LEUKOCYTOSIS (Leukocytosis) and THROMBOCYTOSIS (Thrombocytosis). At the time of the report, FEELING ABNORMAL (feeling bad) had resolved, PAIN (Body Aches) and FATIGUE (Fatigue) was resolving and LEUKOCYTOSIS (Leukocytosis) and THROMBOCYTOSIS (Thrombocytosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Leukocytosis: high (High) High. On 23-Mar-2021, Thrombocytosis: high (High) High. On an unknown date, Lymphocyte count: low (Low) Low.         Concomitant medication included probiotics No treatment medications were provided.  Patient reported undergoing surgery and mentioned that recovery was slow.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant Follow up includes unspecified surgery
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Scratch
Clinical narrative: Redness all over body; Scratch all over the body; Rashes all overy body; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness all over body), SCRATCH (Scratch all over the body) and RASH (Rashes all overy body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 ERYTHEMA (Redness all over body), SCRATCH (Scratch all over the body) and RASH (Rashes all overy body). At the time of the report, ERYTHEMA (Redness all over body), SCRATCH (Scratch all over the body) and RASH (Rashes all overy body) 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.   In the FU she stated the adverse effects from the first dose lasted about 3 weeks and then went away.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 05-AUG-2021 and outcome was updated.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: bad effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (bad effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Tinnitus.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (bad effects). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (bad effects) outcome was unknown. Not Provided          She stated that she is not the only person experiencing bad effects after the 2nd dose, that a lot of other people have had bad effects. Consent to follow up denied 30MAR2021   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Fatigue, Head discomfort
Clinical narrative: hard to open eyes; fatigue/extremely tired; extreme pressure in her head; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (extreme pressure in her head), EYE MOVEMENT DISORDER (hard to open eyes) and FATIGUE (fatigue/extremely tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM and DENOSUMAB (PROLIA) for an unknown indication.    On 01-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 HEAD DISCOMFORT (extreme pressure in her head). On 17-Mar-2021, the patient experienced EYE MOVEMENT DISORDER (hard to open eyes) and FATIGUE (fatigue/extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (extreme pressure in her head), EYE MOVEMENT DISORDER (hard to open eyes) and FATIGUE (fatigue/extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062621:Case for second dose
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: fatigued; feeling pain; headache; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), MYALGIA (feeling pain), HEADACHE (headache) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Shellfish allergy and Drug allergy (codeine and lipitor). Concomitant products included FENOFIBRATE, OXYBUTYNIN, AMILORIDE, AMLODIPINE, POTASSIUM CHLORIDE, LOSARTAN, OLOPATADINE, CALCIUM CITRATE, IRON, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), FLUTICASONE PROPIONATE (FLUTICASONE [FLUTICASONE PROPIONATE]) and NITROGLYCERIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued), MYALGIA (feeling pain), HEADACHE (headache) and CHILLS (chills). At the time of the report, FATIGUE (fatigued), MYALGIA (feeling pain), HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included "Nitro SR".  Patient reported that she drank water, diet coke, and cranberry juice. She wanted to know if she could take Tylenol to relieve her symptoms or not. Patient was scheduled for the second dose on 08-Apr-2021. Treatment details were not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, Peripheral swelling, Vaccination site erythema
Clinical narrative: Diagnosed with COVID; Arm was swollen; Arm was throbbing; Arm was reddish-purple; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID), PERIPHERAL SWELLING (Arm was swollen), PAIN (Arm was throbbing) and VACCINATION SITE ERYTHEMA (Arm was reddish-purple) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), PAIN (Arm was throbbing) and VACCINATION SITE ERYTHEMA (Arm was reddish-purple). On 30-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). On 08-Jan-2021, PERIPHERAL SWELLING (Arm was swollen), PAIN (Arm was throbbing) and VACCINATION SITE ERYTHEMA (Arm was reddish-purple) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on birth control medications. Treatment details included unspecified pain reliever for symptoms.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in his ear sounding like a cricket, at times very low occasionally; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in his ear sounding like a cricket, at times very low occasionally) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation.     Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (SYNTHROID) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in his ear sounding like a cricket, at times very low occasionally). At the time of the report, TINNITUS (ringing in his ear sounding like a cricket, at times very low occasionally) outcome was unknown. Not Provided      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.   As per patient, a week or 10 days after the shot was given, he heard a ringing in his ears, sounded like cricket at night. The ringing was times very low occasionally. The patient did not have any other reactions aside from this. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast oedema, Breast tenderness, Depressed mood, Fatigue, Heart rate increased
Clinical narrative: her period will not stop; breast tenderness; breast retraining water and bloated.; arm soreness; increased heart rate when trying to go to bed; sleep disturbance; mood was affected; very depressed/felt awful; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate when trying to go to bed), SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful) and FATIGUE (exhausted) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate when trying to go to bed), SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful) and FATIGUE (exhausted). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On an unknown date, the patient experienced OLIGOMENORRHOEA (her period will not stop), BREAST TENDERNESS (breast tenderness) and BREAST OEDEMA (breast retraining water and bloated.). On 21-Mar-2021, HEART RATE INCREASED (increased heart rate when trying to go to bed) had resolved. On 22-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 24-Mar-2021, FATIGUE (exhausted) had resolved. At the time of the report, SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful), OLIGOMENORRHOEA (her period will not stop), BREAST TENDERNESS (breast tenderness) and BREAST OEDEMA (breast retraining water and bloated.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Oligomenorrhoea, Pain in extremity, Sleep disorder
Clinical narrative: her period will not stop; breast tenderness; breast retraining water and bloated.; arm soreness; increased heart rate when trying to go to bed; sleep disturbance; mood was affected; very depressed/felt awful; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate when trying to go to bed), SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful) and FATIGUE (exhausted) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate when trying to go to bed), SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful) and FATIGUE (exhausted). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On an unknown date, the patient experienced OLIGOMENORRHOEA (her period will not stop), BREAST TENDERNESS (breast tenderness) and BREAST OEDEMA (breast retraining water and bloated.). On 21-Mar-2021, HEART RATE INCREASED (increased heart rate when trying to go to bed) had resolved. On 22-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 24-Mar-2021, FATIGUE (exhausted) had resolved. At the time of the report, SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful), OLIGOMENORRHOEA (her period will not stop), BREAST TENDERNESS (breast tenderness) and BREAST OEDEMA (breast retraining water and bloated.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was initially sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm was initially sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was initially sore). At the time of the report, PAIN IN EXTREMITY (My arm was initially sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-054919 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Fatigue, Head discomfort
Clinical narrative: Extreme pressure in her head; Hard to open eyes; Fatigue/extremely tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Extreme pressure in her head), EYE MOVEMENT DISORDER (Hard to open eyes) and FATIGUE (Fatigue/extremely tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN LOW), CALCIUM and DENOSUMAB (PROLIA) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEAD DISCOMFORT (Extreme pressure in her head) and EYE MOVEMENT DISORDER (Hard to open eyes). 17-Mar-2021, the patient experienced FATIGUE (Fatigue/extremely tired). The patient was treated with PARACETAMOL (TYLENOL) for Head discomfort, Fatigue and Eye movement disorder, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (Extreme pressure in her head), EYE MOVEMENT DISORDER (Hard to open eyes) and FATIGUE (Fatigue/extremely tired) outcome was unknown. Not Provided          Reportedly, the patient was asymptomatic following treatment with Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-062608 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062608:Case for first dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Rash; Red; Slightly swollen towards the injection; Tender; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), RASH (Rash), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Slightly swollen towards the injection) and VACCINATION SITE PAIN (Tender) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Slightly swollen towards the injection) and VACCINATION SITE PAIN (Tender). On an unknown date, the patient experienced RASH (Rash). At the time of the report, VACCINATION SITE REACTION (Covid arm), RASH (Rash), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Slightly swollen towards the injection) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she developed covid arm which was characterized by 2 inch circumference of red and round circle at injection site  Concomitant product use was not provided by the reporter.  Treatment information included antihistamine every night and antihistamine cream for rash.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and VACCINATION SITE INFLAMMATION (Injection site slightly inflamed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash) and VACCINATION SITE INFLAMMATION (Injection site slightly inflamed). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash) and VACCINATION SITE INFLAMMATION (Injection site slightly inflamed) outcome was unknown. No concomitant medications was reported. This case was linked to MOD21-048583 (E2B Linked Report). This case was linked to MOD-2021-039088. Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow-up information received on 09 Aug 2021 contains no new information. added dose 1 information which was missed to capture in initial version.; Sender's Comments: MOD21-048583:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Myalgia, Pain, Rhinorrhoea
Clinical narrative: positive for COVID; post nasal drops; Myalgia; cough; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), FATIGUE (tiredness), SARS-COV-2 TEST POSITIVE (positive for COVID), RHINORRHOEA (post nasal drops) and MYALGIA (Myalgia) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (sore arm) and FATIGUE (tiredness). On 30-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID), RHINORRHOEA (post nasal drops), MYALGIA (Myalgia) and COUGH (cough). On 19-Mar-2021, FATIGUE (tiredness) had resolved. On 23-Mar-2021, PAIN (sore arm) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive for COVID) had resolved and RHINORRHOEA (post nasal drops), MYALGIA (Myalgia) and COUGH (cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medicine has been reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive for COVID; post nasal drops; Myalgia; cough; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), FATIGUE (tiredness), SARS-COV-2 TEST POSITIVE (positive for COVID), RHINORRHOEA (post nasal drops) and MYALGIA (Myalgia) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (sore arm) and FATIGUE (tiredness). On 30-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID), RHINORRHOEA (post nasal drops), MYALGIA (Myalgia) and COUGH (cough). On 19-Mar-2021, FATIGUE (tiredness) had resolved. On 23-Mar-2021, PAIN (sore arm) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive for COVID) had resolved and RHINORRHOEA (post nasal drops), MYALGIA (Myalgia) and COUGH (cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medicine has been reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mental disability NOS.   On 30-Mar-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021 at 3:30 PM, 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 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient). On 30-Mar-2021, ACCIDENTAL OVERDOSE (Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment not reported.  This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Burning sensation, Chills, Headache, Heart rate
Clinical narrative: Felt so hot like his body is burning inside; BP was through the roof; Increased Heart rate; chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate), CHILLS (chills) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate) and HEADACHE (Headache). 24-Mar-2021, the patient experienced CHILLS (chills). The patient was treated with DIAZEPAM at an unspecified dose and frequency; BETA BLOCKING AGENTS at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: Positive. In January 2021, SARS-CoV-2 test: Negative. On 24-Mar-2021, Heart rate: 140 BPM.            Concomitant product use was not provided.  Treatment information included diazepam, beta blocker, Tylenol and advil. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 test
Clinical narrative: Felt so hot like his body is burning inside; BP was through the roof; Increased Heart rate; chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate), CHILLS (chills) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate) and HEADACHE (Headache). 24-Mar-2021, the patient experienced CHILLS (chills). The patient was treated with DIAZEPAM at an unspecified dose and frequency; BETA BLOCKING AGENTS at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: Positive. In January 2021, SARS-CoV-2 test: Negative. On 24-Mar-2021, Heart rate: 140 BPM.            Concomitant product use was not provided.  Treatment information included diazepam, beta blocker, Tylenol and advil. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain in arm; muscle pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and MYALGIA (muscle pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced PAIN IN EXTREMITY (Pain in arm) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and MYALGIA (muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Event occurred due to first dose vaccine administration.  No concomitant product information was reported.  No treatment information was reported.   Action taken with mRNA-1273 in response to events was not applicable.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Ear was hurting; Throat was hurting; Had a cough; Had swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN, OROPHARYNGEAL PAIN, COUGH, and LYMPHADENOPATHY in an 81-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 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 EAR PAIN, OROPHARYNGEAL PAIN, COUGH, and LYMPHADENOPATHY. The patient was treated with AZITHROMYCIN at an unspecified dose and frequency. At the time of the report, EAR PAIN, OROPHARYNGEAL PAIN, COUGH, and LYMPHADENOPATHY outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient swab test results for COVID was pending.   Most recent FOLLOW-UP information incorporated above includes  On 08-Jul-2021: Follow-up information received contains no new significant information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Vomiting
Clinical narrative: diarrhea; vomiting; tired; diarrhea recurred; felt out of it; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea recurred), FEELING ABNORMAL (felt out of it), DIARRHOEA (diarrhea), VOMITING (vomiting) and FATIGUE (tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIARRHOEA (diarrhea recurred), FEELING ABNORMAL (felt out of it), VOMITING (vomiting) and FATIGUE (tired). On 30-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 29-Mar-2021, DIARRHOEA (diarrhea recurred), FEELING ABNORMAL (felt out of it), VOMITING (vomiting) and FATIGUE (tired) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat that lasted for 6 hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat that lasted for 6 hours). On 18-Mar-2021, HEART RATE INCREASED (rapid heartbeat that lasted for 6 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were provided. Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of heart rate increased, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of heart rate increased, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) outcome was unknown. Not Provided      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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Formication, Gait disturbance, Vertigo
Clinical narrative: had to crawl on the floor; felt very tired; tried to stand then severe dizziness and crumbled to the floor; had severe dizziness; severe vertigo that night after the vaccine,room was spinning; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (severe vertigo that night after the vaccine,room was spinning), GAIT DISTURBANCE (tried to stand then severe dizziness and crumbled to the floor), DIZZINESS (had severe dizziness), FORMICATION (had to crawl on the floor) and FATIGUE (felt very tired) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history   .  The patient's past medical history included No adverse event (Past medical history was not provided). Concomitant products included ATORVASTATIN, METOPROLOL, LISINOPRIL, AMLODIPINE, LEVOTHYROXINE and FINASTERIDE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VERTIGO (severe vertigo that night after the vaccine,room was spinning). On 06-Mar-2021, the patient experienced GAIT DISTURBANCE (tried to stand then severe dizziness and crumbled to the floor), DIZZINESS (had severe dizziness) and FATIGUE (felt very tired). On an unknown date, the patient experienced FORMICATION (had to crawl on the floor). At the time of the report, VERTIGO (severe vertigo that night after the vaccine,room was spinning), GAIT DISTURBANCE (tried to stand then severe dizziness and crumbled to the floor), DIZZINESS (had severe dizziness), FORMICATION (had to crawl on the floor) and FATIGUE (felt very tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Dyspnoea
Clinical narrative: Shortness of breath upon standing or walking after 2nd dose; drop in blood pressure; Chills after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath upon standing or walking after 2nd dose), BLOOD PRESSURE DECREASED (drop in blood pressure) and CHILLS (Chills after 2nd dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010m20a and 048a21a) for an unknown indication.     The patient's past medical history included COPD.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, 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 experienced DYSPNOEA (Shortness of breath upon standing or walking after 2nd dose), BLOOD PRESSURE DECREASED (drop in blood pressure) and CHILLS (Chills after 2nd dose). At the time of the report, DYSPNOEA (Shortness of breath upon standing or walking after 2nd dose), BLOOD PRESSURE DECREASED (drop in blood pressure) and CHILLS (Chills after 2nd dose) outcome was unknown.