chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm; felt so bad; fever; achiness; felt tired that lasted all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt so bad), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (felt tired that lasted all day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt so bad), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (felt tired that lasted all day). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt so bad), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (felt tired that lasted all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Tylenol. concomitant medications are not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: second dose was not administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (second dose was not administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (second dose was not administered). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (second dose was not administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR form received in which gives information about second dose .
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Hives (red spots) on right arm; Hives on neck (two spots); Itchy hives; Sore arm; Headache; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives (red spots) on right arm), URTICARIA (Hives on neck (two spots)), PAIN (Body Aches), PRURITUS (Itchy hives) and PAIN IN EXTREMITY (Sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Body Aches), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On an unknown date, the patient experienced URTICARIA (Hives (red spots) on right arm), URTICARIA (Hives on neck (two spots)) and PRURITUS (Itchy hives). On 24-Mar-2021, PAIN (Body Aches), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (Hives (red spots) on right arm), URTICARIA (Hives on neck (two spots)) and PRURITUS (Itchy hives) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided. concomitant drug information does not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: chills; fever of 101.1F; sore arm after second dose; arm feels a little warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose), FEELING HOT (arm feels a little warm), CHILLS (chills) and PYREXIA (fever of 101.1F) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm after second dose) and FEELING HOT (arm feels a little warm). On 06-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever of 101.1F). At the time of the report, PAIN IN EXTREMITY (sore arm after second dose), FEELING HOT (arm feels a little warm), CHILLS (chills) and PYREXIA (fever of 101.1F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 101.1 Farenheit.         Treatment details were not provided. the patient took blood pressure medications and Thyroid medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-068621 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068621:1st Dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 0030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included METOPROLOL, AMLODIPINE and POTASSIUM for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) outcome was unknown. Not Provided          relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Pruritus, Rash
Clinical narrative: did not receive second dose of Moderna Covid-19 vaccine; intense itching for about six weeks/A little bit itchy/Whole body itchy at times; minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (did not receive second dose of Moderna Covid-19 vaccine), PRURITUS (intense itching for about six weeks/A little bit itchy/Whole body itchy at times) and RASH (minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (intense itching for about six weeks/A little bit itchy/Whole body itchy at times) and RASH (minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (did not receive second dose of Moderna Covid-19 vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (did not receive second dose of Moderna Covid-19 vaccine), PRURITUS (intense itching for about six weeks/A little bit itchy/Whole body itchy at times) and RASH (minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided. No treatment information given.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nodule
Clinical narrative: Right arm pulling; bump in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm pulling) and NODULE (bump in arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LIMB DISCOMFORT (Right arm pulling) and NODULE (bump in arm). At the time of the report, LIMB DISCOMFORT (Right arm pulling) and NODULE (bump in arm) outcome was unknown. Not Provided          Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient received the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the first dose of Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the first dose of Moderna COVID-19 vaccine). In March 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the first dose of Moderna COVID-19 vaccine) 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.   Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Coordination abnormal, Dizziness
Clinical narrative: joint pain; pain on her nails.; weak; without coordination; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; body ache; pain at the site of injection on the R arm; pain above the ribs; legs and feet chained; dizziness, she felt she was going to faint; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.) and MUSCULOSKELETAL CHEST PAIN (pain above the ribs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL and TORSEMIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2002, the patient experienced DIZZINESS (dizziness, she felt she was going to faint). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (legs and feet chained), MUSCULOSKELETAL CHEST PAIN (pain above the ribs) and VACCINATION SITE PAIN (pain at the site of injection on the R arm). On 02-Apr-2021, the patient experienced PAIN (body ache), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache). On 03-Apr-2021, the patient experienced ONYCHALGIA (pain on her nails.). On an unknown date, the patient experienced ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.), MUSCULOSKELETAL CHEST PAIN (pain above the ribs), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (pain at the site of injection on the R arm), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient second shot was on 29-APR-2021, and was hesitating to receive or not. The patient took Onglaze 2,5 mg drug.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Musculoskeletal chest pain, Nausea, Onychalgia
Clinical narrative: joint pain; pain on her nails.; weak; without coordination; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; body ache; pain at the site of injection on the R arm; pain above the ribs; legs and feet chained; dizziness, she felt she was going to faint; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.) and MUSCULOSKELETAL CHEST PAIN (pain above the ribs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL and TORSEMIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2002, the patient experienced DIZZINESS (dizziness, she felt she was going to faint). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (legs and feet chained), MUSCULOSKELETAL CHEST PAIN (pain above the ribs) and VACCINATION SITE PAIN (pain at the site of injection on the R arm). On 02-Apr-2021, the patient experienced PAIN (body ache), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache). On 03-Apr-2021, the patient experienced ONYCHALGIA (pain on her nails.). On an unknown date, the patient experienced ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.), MUSCULOSKELETAL CHEST PAIN (pain above the ribs), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (pain at the site of injection on the R arm), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient second shot was on 29-APR-2021, and was hesitating to receive or not. The patient took Onglaze 2,5 mg drug.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: joint pain; pain on her nails.; weak; without coordination; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; body ache; pain at the site of injection on the R arm; pain above the ribs; legs and feet chained; dizziness, she felt she was going to faint; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.) and MUSCULOSKELETAL CHEST PAIN (pain above the ribs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL and TORSEMIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2002, the patient experienced DIZZINESS (dizziness, she felt she was going to faint). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (legs and feet chained), MUSCULOSKELETAL CHEST PAIN (pain above the ribs) and VACCINATION SITE PAIN (pain at the site of injection on the R arm). On 02-Apr-2021, the patient experienced PAIN (body ache), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache). On 03-Apr-2021, the patient experienced ONYCHALGIA (pain on her nails.). On an unknown date, the patient experienced ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.), MUSCULOSKELETAL CHEST PAIN (pain above the ribs), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (pain at the site of injection on the R arm), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient second shot was on 29-APR-2021, and was hesitating to receive or not. The patient took Onglaze 2,5 mg drug.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; Injection hurt more than last time; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN and VACCINATION SITE PAIN in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN and VACCINATION SITE PAIN. At the time of the report, OROPHARYNGEAL PAIN and VACCINATION SITE PAIN outcome was unknown. Not Provided          Treatment information was not provided. The action taken with the drug was Not applicable. Concomitant drugs are not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse Event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver cirrhosis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ADVERSE EVENT (Adverse Event). At the time of the report, ADVERSE EVENT (Adverse Event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided  Upon in internal review on 21 May 2021, the age was corrected to an unknown age.   This case was linked to US-MODERNATX, INC.-MOD-2021-068430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068430:Relative case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: arm pain; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and NAUSEA (nauseous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm pain) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant drugs are not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (slight fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038A21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5 milliliter. On Mar 6, 2021, patient experienced pyrexia (slight fever). At the time of the report, pyrexia (slight fever) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Upon internal review on Aug 4, 2021, the age corrected to 38 years.
Age: 40.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Cough, Pyrexia
Clinical narrative: Coughing; Low energy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), ASTHENIA (Low energy) and PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    Concomitant products included PREGABALIN (PREP C) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MULTIVITAMINS [VITAMINS NOS] (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced COUGH (Coughing), ASTHENIA (Low energy) and PYREXIA (Fever). At the time of the report, COUGH (Coughing), ASTHENIA (Low energy) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided The action taken with the drug was Not applicable.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Burning sensation, Chills, Fatigue, Feeling cold
Clinical narrative: Weird feeling when he urinated; Went to the bathroom twice; Arm on fire; Body feels cold; Chills; Woke up fatigue; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, and CHILLS in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, CHILLS, FATIGUE, and MYALGIA. At the time of the report, MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, CHILLS, FATIGUE, and MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ice. Concomitant drugs are not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Micturition disorder, Myalgia
Clinical narrative: Weird feeling when he urinated; Went to the bathroom twice; Arm on fire; Body feels cold; Chills; Woke up fatigue; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, and CHILLS in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, CHILLS, FATIGUE, and MYALGIA. At the time of the report, MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, CHILLS, FATIGUE, and MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ice. Concomitant drugs are not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Swelling, Vaccination site pruritus
Clinical narrative: Red; Next day it was more swollen; little itchy at injection site; Patient's arm was swollen 8 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Patient's arm was swollen 8 days after receiving 1st dose), ERYTHEMA (Red), SWELLING (Next day it was more swollen) and VACCINATION SITE PRURITUS (little itchy at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021, the patient experienced PERIPHERAL SWELLING (Patient's arm was swollen 8 days after receiving 1st dose). On 06-Apr-2021, the patient experienced ERYTHEMA (Red), SWELLING (Next day it was more swollen) and VACCINATION SITE PRURITUS (little itchy at injection site). At the time of the report, PERIPHERAL SWELLING (Patient's arm was swollen 8 days after receiving 1st dose), ERYTHEMA (Red), SWELLING (Next day it was more swollen) and VACCINATION SITE PRURITUS (little itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 35 years and event onset dates were updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Myalgia
Clinical narrative: Couldn't get warm; Chills/shaking; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Couldn't get warm), CHILLS (Chills/shaking) and MYALGIA (Body Aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING COLD (Couldn't get warm), CHILLS (Chills/shaking) and MYALGIA (Body Aches). At the time of the report, FEELING COLD (Couldn't get warm), CHILLS (Chills/shaking) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-068226, MOD-2021-068239 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-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 URTICARIA (Hives all over her body). At the time of the report, URTICARIA (Hives all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medication information were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Vaccination site erythema
Clinical narrative: belly pain; diarrhea; redness and swelling at the site of injection; redness and swelling at the site of injection; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (belly pain), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for Diabetes, FLUOXETINE HYDROCHLORIDE (PROZAC) and LISINOPRIL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ABDOMINAL PAIN (belly pain), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection), HEADACHE (headache) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN (belly pain) had not resolved and DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant product use was provided by the reporter as allergies pill OTC. Treatment information was not provided. The action taken with the drug was Not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: belly pain; diarrhea; redness and swelling at the site of injection; redness and swelling at the site of injection; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (belly pain), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for Diabetes, FLUOXETINE HYDROCHLORIDE (PROZAC) and LISINOPRIL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ABDOMINAL PAIN (belly pain), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection), HEADACHE (headache) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN (belly pain) had not resolved and DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant product use was provided by the reporter as allergies pill OTC. Treatment information was not provided. The action taken with the drug was Not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Freezing phenomenon, Pain, Pruritus, Rash, Swelling
Clinical narrative: Swelling around the neck; Itching all over the head and arms; Excruciating pain all the body; Freezing; Rash; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING, PRURITUS, PAIN, FREEZING PHENOMENON, and RASH in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING, PRURITUS, PAIN, FREEZING PHENOMENON, and RASH. At the time of the report, SWELLING, PRURITUS, PAIN, FREEZING PHENOMENON, and RASH had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she decided not to take the second shot. Concomitant medication reported as thyroid medication.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Dry mouth, Headache, Heart rate increased
Clinical narrative: did not get the second shot in 42 day window; Rapid heartbeat; Dry mouth; aches; really bad reaction; unbelievable aches; fever; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window), HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches) and ADVERSE EVENT (really bad reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had a history of covid on early December and  was on oxygen was noted.).    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 HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches), ADVERSE EVENT (really bad reaction), PAIN (unbelievable aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window) had resolved and HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches), ADVERSE EVENT (really bad reaction), PAIN (unbelievable aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported. Treatment was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product dose omission issue, Pyrexia
Clinical narrative: did not get the second shot in 42 day window; Rapid heartbeat; Dry mouth; aches; really bad reaction; unbelievable aches; fever; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window), HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches) and ADVERSE EVENT (really bad reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had a history of covid on early December and  was on oxygen was noted.).    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 HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches), ADVERSE EVENT (really bad reaction), PAIN (unbelievable aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window) had resolved and HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches), ADVERSE EVENT (really bad reaction), PAIN (unbelievable aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported. Treatment was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: feel dizzy; heart rate is up quite a bit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy) and HEART RATE INCREASED (heart rate is up quite a bit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (feel dizzy) and HEART RATE INCREASED (heart rate is up quite a bit). At the time of the report, DIZZINESS (feel dizzy) and HEART RATE INCREASED (heart rate is up quite a bit) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Tinnitus, Vaccination site pain
Clinical narrative: Increased Tinnitus in both ears; Injected arm was sore; Nausea; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Increased Tinnitus in both ears), VACCINATION SITE PAIN (Injected arm was sore), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus in 2019 and COVID-19 in August 2020.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 29-Mar-2021, the patient experienced TINNITUS (Increased Tinnitus in both ears), VACCINATION SITE PAIN (Injected arm was sore), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, TINNITUS (Increased Tinnitus in both ears), VACCINATION SITE PAIN (Injected arm was sore), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eczema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Eczema on hand Flared up; Excruciating pain in arm/sore arm; Pain extending to neck, back and chest; Pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema on hand Flared up), PAIN IN EXTREMITY (Excruciating pain in arm/sore arm), PAIN (Pain extending to neck, back and chest), INJECTION SITE PAIN (Pain at injection site) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema on hand Flared up), PAIN IN EXTREMITY (Excruciating pain in arm/sore arm), PAIN (Pain extending to neck, back and chest), INJECTION SITE PAIN (Pain at injection site) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ECZEMA (Eczema on hand Flared up), PAIN IN EXTREMITY (Excruciating pain in arm/sore arm), PAIN (Pain extending to neck, back and chest), INJECTION SITE PAIN (Pain at injection site) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 68-year-old female patient 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: symptoms of numbness in lips and face; feels weird; numbness in lips and face 40 mins after the first dose; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (numbness in lips and face 40 mins after the first dose), HYPOAESTHESIA (symptoms of numbness in lips and face) and FEELING ABNORMAL (feels weird) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (numbness in lips and face 40 mins after the first dose) and FEELING ABNORMAL (feels weird). On an unknown date, the patient experienced HYPOAESTHESIA (symptoms of numbness in lips and face). At the time of the report, HYPOAESTHESIA ORAL (numbness in lips and face 40 mins after the first dose), HYPOAESTHESIA (symptoms of numbness in lips and face) and FEELING ABNORMAL (feels weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No concomitant medications reported by investigator
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash. He described it to be like a poison ivy-like rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash. He described it to be like a poison ivy-like rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 RASH PRURITIC (itchy rash. He described it to be like a poison ivy-like rash). At the time of the report, RASH PRURITIC (itchy rash. He described it to be like a poison ivy-like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-068340 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068340: