chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Injection site erythema, Injection site inflammation, Injection site warmth, Pain in extremity
Clinical narrative: 8 days later big red area; raised; warm to the touch; tender; COVID arm; only sore arm first; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only sore arm first), INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch) and TENDERNESS (tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: ARTHRITIS BAYER TIMED RELEASE ASPIRIN and PROLIA. Concomitant products included SIMVASTATIN, CELECOXIB (CELEXA [CELECOXIB]) and DENOSUMAB (PROLIA) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (only sore arm first). On 30-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch), TENDERNESS (tender) and DERMATITIS ALLERGIC (COVID arm). At the time of the report, PAIN IN EXTREMITY (only sore arm first), INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch), TENDERNESS (tender) and DERMATITIS ALLERGIC (COVID arm) 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: 8 days later big red area; raised; warm to the touch; tender; COVID arm; only sore arm first; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only sore arm first), INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch) and TENDERNESS (tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: ARTHRITIS BAYER TIMED RELEASE ASPIRIN and PROLIA. Concomitant products included SIMVASTATIN, CELECOXIB (CELEXA [CELECOXIB]) and DENOSUMAB (PROLIA) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (only sore arm first). On 30-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch), TENDERNESS (tender) and DERMATITIS ALLERGIC (COVID arm). At the time of the report, PAIN IN EXTREMITY (only sore arm first), INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch), TENDERNESS (tender) and DERMATITIS ALLERGIC (COVID arm) 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Feeling hot, Pain, Pruritus, Urticaria
Clinical narrative: itchiness; hot; sore; welt uncomfortable; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot), PAIN (sore) and URTICARIA (welt uncomfortable) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolaemia (Medical history reported as high cholesterol) and Arrhythmia (Medical history reported as heart arrhythmia.). Concomitant products included CORTISONE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot), PAIN (sore) and URTICARIA (welt uncomfortable). At the time of the report, FEELING HOT (hot), PAIN (sore) and URTICARIA (welt uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol increased: (High) Blood cholesterol increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pt received her 1st vax on 13feb2021 and recently develop itchiness, hot, sore, a welt uncomfortable, around injection site. She said that is hard, a good size and flatchines.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: Patient feeling fine and requested no further follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Itching; Swelling; Redness, about the size of a lemon; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE URTICARIA (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness, about the size of a lemon) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness, about the size of a lemon). At the time of the report, VACCINATION SITE URTICARIA (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness, about the size of a lemon) had not 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.   No concomitant medications reported. Treatment included Cold compresses and then warm the next day.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site swelling, vaccination site erythema and vaccination site urticaria are consistent with the known safety profile of mRNA-1273.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Vaccination site pruritus
Clinical narrative: Arm got itching; Arm had a big red lump; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Arm got itching) and INJECTION SITE MASS (Arm had a big red lump) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), PARACETAMOL (TYLENOL), CHOLESTEROL and CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES) for an unknown indication.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm got itching) and INJECTION SITE MASS (Arm had a big red lump). At the time of the report, INJECTION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Arm got itching) and INJECTION SITE MASS (Arm had a big red lump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were reported as Blood pressure meds, Cholesterol meds, Pre diabetes meds, Tylenol and Aspirin.   No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: increase in heart rate; daze; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increase in heart rate), FEELING ABNORMAL (daze) and DIZZINESS (felt dizzy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L2OA) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included METFORMIN, LEVOTHYROXINE and FLUVOXAMINE MALEATE (LUVOX) 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-Feb-2021, the patient experienced HEART RATE INCREASED (increase in heart rate), FEELING ABNORMAL (daze) and DIZZINESS (felt dizzy).   On 01-Feb-2021, HEART RATE INCREASED (increase in heart rate), FEELING ABNORMAL (daze) and DIZZINESS (felt dizzy) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Heart rate: high (High) fast Heart Beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: AE contact Info update On 08-Jul-2021: Follow-up received and event outcomes updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Dysstasia, Myalgia, Nausea
Clinical narrative: Diarrhea; Nausea; muscle pain in lower back; Can't stand up; Arm soreness; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MYALGIA (Muscle pain), BACK PAIN (muscle pain in lower back), DYSSTASIA (Can't stand up) and DIARRHOEA (Diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and MYALGIA (Muscle pain). On 07-Feb-2021, the patient experienced BACK PAIN (muscle pain in lower back) and DYSSTASIA (Can't stand up). On 08-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm soreness), MYALGIA (Muscle pain), BACK PAIN (muscle pain in lower back), DYSSTASIA (Can't stand up), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) 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.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-023037 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-023037:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Diarrhea; Nausea; muscle pain in lower back; Can't stand up; Arm soreness; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MYALGIA (Muscle pain), BACK PAIN (muscle pain in lower back), DYSSTASIA (Can't stand up) and DIARRHOEA (Diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and MYALGIA (Muscle pain). On 07-Feb-2021, the patient experienced BACK PAIN (muscle pain in lower back) and DYSSTASIA (Can't stand up). On 08-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm soreness), MYALGIA (Muscle pain), BACK PAIN (muscle pain in lower back), DYSSTASIA (Can't stand up), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) 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.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-023037 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-023037:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive for COVID) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   no concomitant medication provided no treatment given
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal
Clinical narrative: Sharp pain in my back, middle of my back; felt like there was a knife injected on it; A spontaneous report was received from a Consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sharp pain in my back, middle of my back, felt like there was a knife injected on it.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not available) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the events sharp pain in my back. middle of my back, felt like there was a knife injected on it.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of events, sharp pain in my back, On an unknown date the outcome of events, middle of my back, On an unknown date the outcome of events, felt like there was a knife injected on it was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Red circle about 2 inches in diameter; It was warm to the touch; The area was itchy; A spontaneous report was received from a health care professional concerning a 75 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed vaccination site erythema, vaccination site pruritus, and vaccination site warmth.     The patient's medical history was not provided. Concomitant medications included blood pressure and cholesterol medications.  On 14 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot#: 013L20A) in the arm for the prophylaxis of COVID-19 infection.  On 21 JAN 2021, the area was itchy (vaccination site erythema). On 22-JAN-2021, the patient developed a red circle about 2 inches in diameter (vaccination site erythema) which was warm to touch (vaccination site warmth). Treatment included doxycycline.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events,vaccination site warmth, vaccination site pruritus, and vaccination site erythema, was resolved.; Reporter'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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Trismus
Clinical narrative: sore arm; weak; problem with his jaw/muscle related and unable to open his mouth all the way; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), ASTHENIA (weak) and TRISMUS (problem with his jaw/muscle related and unable to open his mouth all the way) in a 41-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 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), ASTHENIA (weak) and TRISMUS (problem with his jaw/muscle related and unable to open his mouth all the way). At the time of the report, INJECTION SITE PAIN (sore arm), ASTHENIA (weak) and TRISMUS (problem with his jaw/muscle related and unable to open his mouth all the way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: constant pain that radiates to her neck on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (constant pain that radiates to her neck on left side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20a) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included METFORMIN and NADOLOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (constant pain that radiates to her neck on left side). The patient was treated with THERAWORX RELIEF for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (constant pain that radiates to her neck on left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow Up received contains No new information.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 82-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.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products was reported. No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Myalgia, Nausea, Pyrexia
Clinical narrative: Metallic taste in mouth; Body ache; Fever; chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 05-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth), MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 and added additional contact information. The outcome of the event (s) changed from unknown to not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Metallic taste in mouth; Body ache; Fever; chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 05-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth), MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 and added additional contact information. The outcome of the event (s) changed from unknown to not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache seems to be getting worse; Headache every day since then; A spontaneous report was received from a Healthcare Professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and three days later, she experienced headache every day since then which seem to be getting worse and tylenol does not work anymore.  The patient's medical history was not provided. Concomitant medications reported were Armour thyroid.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Lot# 022M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, she experienced headache every day since then which seem to be getting worse and tylenol does not work anymore. Treatment details included Acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  On an unknown date, the outcome of event(s) headache every day since then which seem to be getting worse and tylenol does not work anymore were unknown.; Reporter's Comments: Very limited information has been provided for the event at this time. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Eye swelling, Peripheral swelling
Clinical narrative: Black and swollen eye; Swollen, immobile left hand; Black and blue left side of the face; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Black and swollen eye), PERIPHERAL SWELLING (Swollen, immobile left hand) and CONTUSION (Black and blue left side of the face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Therapy change. Concomitant products included CELECOXIB (CELEBREX), BUPRENORPHINE (BUTRANS), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced EYE SWELLING (Black and swollen eye), PERIPHERAL SWELLING (Swollen, immobile left hand) and CONTUSION (Black and blue left side of the face). At the time of the report, EYE SWELLING (Black and swollen eye), PERIPHERAL SWELLING (Swollen, immobile left hand) and CONTUSION (Black and blue left side of the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a health care professional (subsequently medically confirmed) 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) (batch no. 043L204) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive positive (Positive) Positive.     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.   no concomitant medication and treatment provided   This case was linked to MOD-2021-018295 (Patient Link).; Reporter's Comments: COVID-19 in this patient is unlikely to be due to Moderna's mRNa-1273 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications have not been specified.  Treatment for the events was not specified.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Body aches) and CHILLS (Chills).        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-024583, MOD-2021-024588 (E2B Linked Report).   Reporter did not allow further contact.  Lab parameters were not provided .   No other reactions reported.   Action taken with mRNA-1273 in response to the event was not provided.; Sender's Comments:  MOD-2021-024583:Same reporter MOD-2021-024588:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On an unknown date, the patient experienced MYALGIA (Body aches).        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-024573, MOD-2021-024588 (E2B Linked Report).   Reporter did not allow further contact  Lab parameters were not provided .   No other reactions reported.   Action taken with mRNA-1273 in response to the event was not provided.; Sender's Comments:  MOD-2021-024573:Same reporter MOD-2021-024588:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Herpes simplex, Pyrexia, Vaccination site pain
Clinical narrative: exacerbation of the herpes simplex; localized injection site pain; localized injection site pain and swelling; low-grade fever / chills/ headache; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache) and CHILLS (chills) in a patient of an unknown age and gender 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 Herpes simplex.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache), CHILLS (chills) and HEADACHE (headache). At the time of the report, HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No Concomitant medications were provided No Treatment information provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: exacerbation of the herpes simplex; localized injection site pain; localized injection site pain and swelling; low-grade fever / chills/ headache; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache) and CHILLS (chills) in a patient of an unknown age and gender 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 Herpes simplex.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache), CHILLS (chills) and HEADACHE (headache). At the time of the report, HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No Concomitant medications were provided No Treatment information provided   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: side effects from the vaccine; Hot to toucn sensation; Fever; Chills; Itchy at injection site; Rash at injection site; Redness Near the Injection; Fatigue; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE WARMTH (Hot to toucn sensation), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 632L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to toucn sensation), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness Near the Injection). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the vaccine). On 31-Jan-2021, PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) had resolved. On 08-Feb-2021, VACCINATION SITE WARMTH (Hot to toucn sensation), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness Near the Injection) had resolved. At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: side effects from the vaccine; Hot to toucn sensation; Fever; Chills; Itchy at injection site; Rash at injection site; Redness Near the Injection; Fatigue; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE WARMTH (Hot to toucn sensation), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 632L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to toucn sensation), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness Near the Injection). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the vaccine). On 31-Jan-2021, PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) had resolved. On 08-Feb-2021, VACCINATION SITE WARMTH (Hot to toucn sensation), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness Near the Injection) had resolved. At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) 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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Lacrimation increased, Rhinorrhoea
Clinical narrative: Positive with COVID-19; Dry cough; Runny nose; Watery eye; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive with COVID-19), COUGH (Dry cough), RHINORRHOEA (Runny nose) and LACRIMATION INCREASED (Watery eye) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concomitant products included VALSARTAN, ATENOLOL, HCTZ, ATORVASTATIN, APIXABAN (ELIQUIS), FLECAINIDE, CLONAZEPAM, SILODOSIN, COLECALCIFEROL, FISH OIL (VITAMIN D WITH OMEGA 3) and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (Positive with COVID-19), COUGH (Dry cough), RHINORRHOEA (Runny nose) and LACRIMATION INCREASED (Watery eye). At the time of the report, COVID-19 (Positive with COVID-19), COUGH (Dry cough), RHINORRHOEA (Runny nose) and LACRIMATION INCREASED (Watery eye) had not 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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow up received on 04 FEB 2021 included date of birth  of the patient,additional events,.concomitant medications HCP contact details and information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Pain in extremity, Peripheral swelling
Clinical narrative: Serious Anxiety; racing heart beat; arm got sore; Arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Serious Anxiety), HEART RATE INCREASED (racing heart beat), PAIN IN EXTREMITY (arm got sore) and PERIPHERAL SWELLING (Arm swelled up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LISINOPRIL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Serious Anxiety), HEART RATE INCREASED (racing heart beat), PAIN IN EXTREMITY (arm got sore) and PERIPHERAL SWELLING (Arm swelled up). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ANXIETY (Serious Anxiety), HEART RATE INCREASED (racing heart beat), PAIN IN EXTREMITY (arm got sore) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: CHEST PAIN; short sharp pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (CHEST PAIN) and PAIN (short sharp pains) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CHEST PAIN (CHEST PAIN) and PAIN (short sharp pains). At the time of the report, CHEST PAIN (CHEST PAIN) and PAIN (short sharp pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node palpable, Swelling
Clinical narrative: lymph node swelling; on their neck by the collar bone they can feel a little hard lymph node about the size of a pea; This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING (lymph node swelling) and LYMPH NODE PALPABLE (on their neck by the collar bone they can feel a little hard lymph node about the size of a pea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 700632003 and 700632006) for COVID-19 vaccination.     Family history included Breast cancer.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced SWELLING (lymph node swelling) and LYMPH NODE PALPABLE (on their neck by the collar bone they can feel a little hard lymph node about the size of a pea). At the time of the report, SWELLING (lymph node swelling) and LYMPH NODE PALPABLE (on their neck by the collar bone they can feel a little hard lymph node about the size of a pea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Injection site pain
Clinical narrative: Limitation of movement; extreme soreness above the injection site (around the shoulder joint); soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Limitation of movement), INJECTION SITE PAIN (soreness at the injection site) and ARTHRALGIA (extreme soreness above the injection site (around the shoulder joint)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J200A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection site). In February 2021, the patient experienced HYPOKINESIA (Limitation of movement) and ARTHRALGIA (extreme soreness above the injection site (around the shoulder joint)). At the time of the report, HYPOKINESIA (Limitation of movement), INJECTION SITE PAIN (soreness at the injection site) and ARTHRALGIA (extreme soreness above the injection site (around the shoulder joint)) outcome was unknown.        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.   Reporter did not allow further contact