chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe headache, body aches (especially on her neck), soreness on the injection site, fever and.  The patient's medical history was not provided. Concomitant medications reported were Bupropion for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029l20a) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) severe headache, body aches (especially on her neck), soreness on the injection site, fever and.  Treatment details included Alka-Seltzer.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe headache, body aches (especially on her neck), soreness on the injection site, fever and was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: sore throat; internal chills; headache; feeling lousy; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore throat, internal chills, headache, and feeling lousy.  The patient's medical history was not provided. Concomitant medications reported were beclometasone for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events sore throat, internal chills, headache, and feeling lousy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sore throat, internal chills, headache, and feeling lousy was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Peripheral swelling, Pyrexia
Clinical narrative: slight headache, it turned into migraine; arm was sore; fever was 100.3; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (slight headache, it turned into migraine), PERIPHERAL SWELLING (arm was sore), PYREXIA (fever was 100.3) and FATIGUE (extremely exhausted) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced MIGRAINE (slight headache, it turned into migraine), PERIPHERAL SWELLING (arm was sore), PYREXIA (fever was 100.3) and FATIGUE (extremely exhausted). On 25-Feb-2021, MIGRAINE (slight headache, it turned into migraine) had resolved. On 26-Feb-2021, PERIPHERAL SWELLING (arm was sore), PYREXIA (fever was 100.3) and FATIGUE (extremely exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Pyrexia: (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Limb discomfort, Nausea
Clinical narrative: Nausea; felt dizzy; A lot of aches and pains; Felt weak; Arm was extremely sore; Blurred vision; Fever; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore) and VISION BLURRED (Blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore), VISION BLURRED (Blurred vision), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). On 03-Mar-2021, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, VOMITING (Throwing up) outcome was unknown. At the time of the report, DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore), VISION BLURRED (Blurred vision), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) 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.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Nausea; felt dizzy; A lot of aches and pains; Felt weak; Arm was extremely sore; Blurred vision; Fever; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore) and VISION BLURRED (Blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore), VISION BLURRED (Blurred vision), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). On 03-Mar-2021, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, VOMITING (Throwing up) outcome was unknown. At the time of the report, DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore), VISION BLURRED (Blurred vision), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) 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.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Left side body stiffness; (joint pain) all over the left side of his body; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left side body stiffness) and ARTHRALGIA ((joint pain) all over the left side of his body) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Enlarged prostate. Concomitant products included TAMSULOSIN for Enlarged prostate.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left side body stiffness) and ARTHRALGIA ((joint pain) all over the left side of his body). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Left side body stiffness) and ARTHRALGIA ((joint pain) all over the left side of his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise
Clinical narrative: not feeling well after getting the second dose of vaccine; extreme pain in shoulder high up to the neck; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well after getting the second dose of vaccine), ARTHRALGIA (extreme pain in shoulder high up to the neck) and HEADACHE (Head ache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002a21a and 032l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 27-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 27-Feb-2021, the patient experienced MALAISE (not feeling well after getting the second dose of vaccine), ARTHRALGIA (extreme pain in shoulder high up to the neck) and HEADACHE (Head ache). At the time of the report, MALAISE (not feeling well after getting the second dose of vaccine), ARTHRALGIA (extreme pain in shoulder high up to the neck) and HEADACHE (Head ache) had not resolved.            No concomitant medications were reported.  The treatment information included topical pain medication.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Warm To the touch; Itchiness; Red Spot; Swelling; Throbbing; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE WARMTH (Warm To the touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Spot) and VACCINATION SITE SWELLING (Swelling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, LOSARTAN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm To the touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Spot), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Throbbing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 03-Mar-2021, VACCINATION SITE WARMTH (Warm To the touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Throbbing) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red Spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warm To the touch; Itchiness; Red Spot; Swelling; Throbbing; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE WARMTH (Warm To the touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Spot) and VACCINATION SITE SWELLING (Swelling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, LOSARTAN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm To the touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Spot), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Throbbing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 03-Mar-2021, VACCINATION SITE WARMTH (Warm To the touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Throbbing) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red Spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspnoea, Headache, Nausea
Clinical narrative: diarrhea; upset stomach; shortness of breath; racing heart; Change in taste; nausea; headache; Tingling of Her lips; Cheeks felt fat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling of Her lips), SWELLING FACE (Cheeks felt fat), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and DYSPNOEA (shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tingling of Her lips) and SWELLING FACE (Cheeks felt fat). On 17-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (shortness of breath), PALPITATIONS (racing heart), TASTE DISORDER (Change in taste), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tingling of Her lips), SWELLING FACE (Cheeks felt fat), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (shortness of breath), PALPITATIONS (racing heart), TASTE DISORDER (Change in taste), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia oral, Swelling face, Taste disorder
Clinical narrative: diarrhea; upset stomach; shortness of breath; racing heart; Change in taste; nausea; headache; Tingling of Her lips; Cheeks felt fat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling of Her lips), SWELLING FACE (Cheeks felt fat), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and DYSPNOEA (shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tingling of Her lips) and SWELLING FACE (Cheeks felt fat). On 17-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (shortness of breath), PALPITATIONS (racing heart), TASTE DISORDER (Change in taste), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tingling of Her lips), SWELLING FACE (Cheeks felt fat), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (shortness of breath), PALPITATIONS (racing heart), TASTE DISORDER (Change in taste), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Warm Injection Site; Arm Hurts; Pain around her waist (Muscle pain); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm Injection Site), PAIN IN EXTREMITY (Arm Hurts) and MYALGIA (Pain around her waist (Muscle pain)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm Injection Site), PAIN IN EXTREMITY (Arm Hurts) and MYALGIA (Pain around her waist (Muscle pain)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm Injection Site), PAIN IN EXTREMITY (Arm Hurts) and MYALGIA (Pain around her waist (Muscle pain)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Peripheral swelling
Clinical narrative: arm was swollen; dizzy; out of air; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), DIZZINESS (dizzy), DYSPNOEA (out of air) and FATIGUE (very tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for Pulmonary fibrosis.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), DIZZINESS (dizzy), DYSPNOEA (out of air) and FATIGUE (very tired). On 28-Feb-2021, PERIPHERAL SWELLING (arm was swollen), DIZZINESS (dizzy), DYSPNOEA (out of air) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Sunburn
Clinical narrative: They feel like their face is on fire; had like a sunburn mostly their face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (They feel like their face is on fire) and SUNBURN (had like a sunburn mostly their face) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (They feel like their face is on fire) and SUNBURN (had like a sunburn mostly their face). At the time of the report, FEELING HOT (They feel like their face is on fire) and SUNBURN (had like a sunburn mostly their face) 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.   It was reported that after experiencing the events the patient applied 30 sunblock.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Left Arm) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen Left Arm) and CHILLS (Chills). On 29-Jan-2021, PERIPHERAL SWELLING (Swollen Left Arm) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-034135 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nasopharyngitis
Clinical narrative: came down with a cold; first dose 11 Jan 2021; second dose 13 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 11 Jan 2021; second dose 13 Mar 2021) and NASOPHARYNGITIS (came down with a cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 11 Jan 2021; second dose 13 Mar 2021). On an unknown date, the patient experienced NASOPHARYNGITIS (came down with a cold). On 13-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 11 Jan 2021; second dose 13 Mar 2021) had resolved. At the time of the report, NASOPHARYNGITIS (came down with a cold) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-034142 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Outcome of events and narrative updated; Patient received dose 2.; Reporter's Comments: Very limited information regarding this event (Nasopharyngitis) has been provided at this time. However, this report also refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot # unknown), with no associated AEs. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Lymphadenopathy
Clinical narrative: sleeping a ton; lymph nodes in armpit and neck were inflammed; headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSOMNIA (sleeping a ton), LYMPHADENOPATHY (lymph nodes in armpit and neck were inflammed) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 an unknown date, the patient experienced HYPERSOMNIA (sleeping a ton), LYMPHADENOPATHY (lymph nodes in armpit and neck were inflammed) and HEADACHE (headache). At the time of the report, HYPERSOMNIA (sleeping a ton), LYMPHADENOPATHY (lymph nodes in armpit and neck were inflammed) and HEADACHE (headache) 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.   Concomitant product information was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-034030 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in the arm, face and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the arm, face and shoulder) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 01-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in the arm, face and shoulder). At the time of the report, HYPOAESTHESIA (Numbness in the arm, face and shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include a thyroid medication (unspecified).  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nosebleeds), VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (itch rashy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (itch rashy). On an unknown date, the patient experienced EPISTAXIS (nosebleeds). At the time of the report, EPISTAXIS (nosebleeds) outcome was unknown and VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (itch rashy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Event information updated,
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site erythema, vaccination site swelling and vaccination site pruritis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date,  8 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  After 8 days, the patient experienced the events vaccination site erythema, vaccination site swelling and vaccination site pruritis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: swollen injection site arm; splitting headache; a goose egg at the injection site; Chills; soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE INDURATION (a goose egg at the injection site), CHILLS (Chills), INJECTION SITE PAIN (soreness at the injection site), INJECTION SITE SWELLING (swollen injection site arm) and HEADACHE (splitting headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (the patient is confident they had Covid-19 on 2 different occasions) in April 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE INDURATION (a goose egg at the injection site), CHILLS (Chills) and INJECTION SITE PAIN (soreness at the injection site). On 07-Feb-2021, the patient experienced INJECTION SITE SWELLING (swollen injection site arm) and HEADACHE (splitting headache). At the time of the report, INJECTION SITE INDURATION (a goose egg at the injection site), CHILLS (Chills), INJECTION SITE PAIN (soreness at the injection site), INJECTION SITE SWELLING (swollen injection site arm) and HEADACHE (splitting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INJECTION SITE INDURATION (a goose egg at the injection site), CHILLS (Chills), INJECTION SITE PAIN (soreness at the injection site), INJECTION SITE SWELLING (swollen injection site arm) and HEADACHE (splitting headache) to be possibly related.    Concomitant product information was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-034059, MOD-2021-059296 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up information received on 20-JUL-2021 contains no significant information.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Stomach cramps; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) and NAUSEA (nausea) outcome was unknown.            Concomitant product information was not provided by the reporter.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: diarrhoea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea) and VACCINATION SITE PAIN (pain at injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhoea) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, DIARRHOEA (diarrhoea) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD21-045219 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Taste disorder
Clinical narrative: dizzy; weak; funny taste at the back of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak) and TASTE DISORDER (funny taste at the back of her mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak) and TASTE DISORDER (funny taste at the back of her mouth). The patient was treated with IBUPROFEN on 02-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ASTHENIA (weak) and TASTE DISORDER (funny taste at the back of her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Off label use, Pain, Vaccination site pain
Clinical narrative: Body aches; Felt really sick - felt like going to die; chills; arm pain was incredibly bad; received three doses of the Moderna COVID-19 vaccine because they are overweight; A spontaneous report was received from a consumer concerning a 42- year old-male patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced extra dose administered,felt like they were going to die, felt really sick,chills, body aches and arm pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08-jan-2021,the patient received their first of two planned doses of mRNA-1273 (lot/batch 007L20A) for prophylaxis of C OVID-19 infection. On 01-Feb-2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 007L20A) for prophylaxis of COVID-19 infection. On 02 Mar 2021, a month after the second, the patient received a third dos of mRNA-1273 ( lot: 027A21A).  On an unknown date, after the second dose, the patient reports feeling "like they were going to die" and feeling really sick including chills, body aches, and incredible arm pain. They did not feel anything after the first dose or after the third dose. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, extra dose administered, was considered as resolved on 02Mar2021,T  The outcome of the events,chills,malaise,feeling abnormal,pain and pain in extremity was considered recovered/resolved on an unknown date.; 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. This report also refers to a case of Extra dose administered for mRNA-1273 (lot # 007L20A), with no associated AEs. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: Blisters; Rash that is spreading; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters) and RASH (Rash that is spreading) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included HSV infection. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for HSV infection, CALCIUM, VITAMIN D NOS and ALPRAZOLAM (XANAX) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced BLISTER (Blisters) and RASH (Rash that is spreading). At the time of the report, BLISTER (Blisters) and RASH (Rash that is spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient has been on and off of Valtrex (valacyclovir) for the past year. Every time the patient stops taking valacyclovir she develops a rash and blisters. The patient was not taking valacyclovir when the COVID-19 vaccine was administered.  Treatment information for the events was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pruritus, Rash
Clinical narrative: Patient cannot sleep; feels uncomfortable; bumps on back arms / Bumps in the legs / bumps on chest; itching everywhere / Itches in the legs / itchiness out of control; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching everywhere / Itches in the legs / itchiness out of control), INSOMNIA (Patient cannot sleep), DISCOMFORT (feels uncomfortable) and RASH (bumps on back arms / Bumps in the legs / bumps on chest) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Major depression, Hypertension and Migraine. Concomitant products included LORAZEPAM, GABAPENTIN, METOPROLOL, LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) 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 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced PRURITUS (itching everywhere / Itches in the legs / itchiness out of control) and RASH (bumps on back arms / Bumps in the legs / bumps on chest). On 22-Feb-2021, the patient experienced INSOMNIA (Patient cannot sleep) and DISCOMFORT (feels uncomfortable). At the time of the report, PRURITUS (itching everywhere / Itches in the legs / itchiness out of control), INSOMNIA (Patient cannot sleep), DISCOMFORT (feels uncomfortable) and RASH (bumps on back arms / Bumps in the legs / bumps on chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states that she doesn't know if she has chicken pox or a reaction to the vaccine. If she scratches them, they bleed.Apart from the bumps in the chest and arms, she is having itches and bumps in the legs and the itchiness is out of control, at the point that cannot sleep because feels uncomfortable.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains Significant information.Significant follow up appended to AER. Some events like discomfort, Insomnia were added
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  It was reported that the patient experienced the events overnight after receiving the COVID-19 vaccine.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: red eruption on chest/back; papular eruption on chest/back; itchy eruption on chest/back; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (red eruption on chest/back), RASH PAPULAR (papular eruption on chest/back) and PRURITUS (itchy eruption on chest/back) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (red eruption on chest/back), RASH PAPULAR (papular eruption on chest/back) and PRURITUS (itchy eruption on chest/back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red eruption on chest/back), RASH PAPULAR (papular eruption on chest/back) and PRURITUS (itchy eruption on chest/back) 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.   Concomitant product information was not provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Itchy throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A218A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (seasonal allergies to dust), Food allergy (allergic to food like apples) and Food allergy (sensitivity to raw food). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced THROAT IRRITATION (Itchy throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of UNK, as needed. At the time of the report, THROAT IRRITATION (Itchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Nasopharyngitis, Pain in extremity
Clinical narrative: Sore arm; He experienced cold (Nasopharyngitis); Past 51 days and hasn't received second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (He experienced cold (Nasopharyngitis)) and INTENTIONAL PRODUCT USE ISSUE (Past 51 days and hasn't received second vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 08-Feb-2021, the patient experienced NASOPHARYNGITIS (He experienced cold (Nasopharyngitis)) and INTENTIONAL PRODUCT USE ISSUE (Past 51 days and hasn't received second vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (Past 51 days and hasn't received second vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and NASOPHARYNGITIS (He experienced cold (Nasopharyngitis)) had resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-034120 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: Additional information received. Added second dose details, event, sore arm. Updated outcome of events experienced cold and past 51 days and hasn't received second vaccine from unknown to recovered/resolved. Updated action taken from temporarily withheld to not applicable. On 08-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of nasopharyngitis , a causal relationship cannot be excluded.  This report also refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # 037K20A with no other associated AEs.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: 8 blotches of red area/ several splotches on trunk; Pruritus like rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (8 blotches of red area/ several splotches on trunk) and RASH (Pruritus like rash) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Crohn's and Autism spectrum disorder (ASD). Concomitant products included MESALAZINE (PENTASA), LAMOTRIGINE (LAMICTAL) and RISPERIDONE (RISPERDAL) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced RASH MACULAR (8 blotches of red area/ several splotches on trunk). 03-Mar-2021, the patient experienced RASH (Pruritus like rash). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, RASH MACULAR (8 blotches of red area/ several splotches on trunk) and RASH (Pruritus like rash) had resolved.        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 13-May-2021: Additional information received: updated patient demographics, relevant medical history (Crohns, ASD), concomitant medications (Pentasa, Lamictal, Risperadal), event start date and stop date. The event outcome changed (from not resolved to resolved). Other potential cause was Insect bites.