chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Muscle Ache; Fever; extremely tired sleeping most of the day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Muscle ache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; muscle ache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In October 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). On 20-Feb-2021, CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) to be probably related.    No concomitant medications were provided.  No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the Arm for 1 day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of the Arm for 1 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the Arm for 1 day). At the time of the report, PAIN IN EXTREMITY (Soreness of the Arm for 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information about concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-032991 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Maternal exposure during pregnancy, Rash
Clinical narrative: Was pregnant; Rash; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis, Illness and Allergic rhinitis.    Concurrent medical conditions included Pollen allergy. Concomitant products included TRIAMCINOLONE ACETONIDE, FLUOCINONIDE (FLUOCINONIDE-E), TACROLIMUS MONOHYDRATE (PROTOPIC), LEVONORGESTREL (MIRENA) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for an unknown indication.   On 16-Nov-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.  She was not sure if it was due to the pollen currently, missed her dupixent dose or moderna covid vaccine. has missed 3 doses in the last 6 months due to "refill issues" with them always having to get authorization from her doctor or some other problem. It was unknown if there were lab data or results available. The reporter doesn't believe the events are related to the vaccine in any way.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received. The causality  of the event was updated.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Ear infection, Unevaluable event
Clinical narrative: Ear infection; Coughing; Unevaluable event; This spontaneous case was reported by a physician and describes the occurrence of EAR INFECTION (Ear infection), COUGH (Coughing) and UNEVALUABLE EVENT (Unevaluable event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis vulgaris.    Concurrent medical conditions included Drug allergy (No known drug allergy). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), BROMPHENIRAMINE;PSEUDOEPHEDRINE and AMOXICILLIN TRIHYDRATE (MOXICILLIN) for an unknown indication.   In March 2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EAR INFECTION (Ear infection), COUGH (Coughing) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, EAR INFECTION (Ear infection), COUGH (Coughing) and UNEVALUABLE EVENT (Unevaluable event) 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 treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Interchange of vaccine products
Clinical narrative: shingles; Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information and treatment information was provided by reporter.  Follow up : Reporter states that the shingles reaction  is believed to be  from the Pfizer vaccine and not the Moderna.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Co-suspect Pfizer Covid-19 vaccine was added.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Muscle fatigue, SARS-CoV-2 antibody test, Skin ulcer
Clinical narrative: Sores on bottom of feet after wearing shoes with hard soles; Forearm muscles felt extremely tired; This spontaneous case was reported by an other and describes the occurrence of SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia and Lymphocytic lymphoma.    The patient's past medical history included Plantar fasciitis. Concurrent medical conditions included Chronic lymphocytic leukaemia, Lymphocytic lymphoma, Joint pain since June 2020, Myalgia since July 2020, Bone pain since July 2020, Diarrhea since July 2020, Welts since 2020, Sleep disorder and Muscle pain. Concomitant products included TRAMADOL for Muscle pain, TRAZODONE for Sleep disorder.   In May 2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired). At the time of the report, SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) had not resolved and MUSCLE FATIGUE (Forearm muscles felt extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 antibody test: negative (Negative) Negative for antibodies.         Treatment information was not provided. 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. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.; 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. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction, Asthma, Therapeutic response decreased
Clinical narrative: Mild reaction to COVID-19 VACCINE; asthma consistently got worse in the springtime; asthma consistently got worse in the springtime despite of being on dupilumab; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Asthma and Illness.    Concurrent medical conditions included Drug allergy, Drug allergy and Asthma.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab). The patient was treated with PREDNISONE for Asthma aggravated, at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Very limited information regarding these events has been provided at this time. No further information is expected. Company causality for adverse drug reaction and asthma aggravated is assessed as possible, while company causality for therapeutic response decreased  is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: TCR Follow-up information contains non-significant information. Upon TCR follow-up, the initial reporter/patient denied reporting reactions experienced after vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected. Company causality for adverse drug reaction and asthma aggravated is assessed as possible, while company causality for therapeutic response decreased  is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (sick) 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 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 an unknown date, the patient experienced MALAISE (sick). At the time of the report, MALAISE (sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Product dose omission issue
Clinical narrative: received the second dose after 43 days; punching on arm lasted for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the second dose after 43 days) and LIMB DISCOMFORT (punching on arm lasted for 36 hours) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Guillain-Barre syndrome and Pacemaker insertion (cardiac). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the second dose after 43 days) and LIMB DISCOMFORT (punching on arm lasted for 36 hours). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the second dose after 43 days) and LIMB DISCOMFORT (punching on arm lasted for 36 hours) outcome was unknown.            This case was linked to MOD-2021-063990 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 antibody test
Clinical narrative: Hands had been stiffer; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Hands had been stiffer) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet, extended release for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Hands had been stiffer). At the time of the report, MUSCULOSKELETAL STIFFNESS (Hands had been stiffer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, SARS-CoV-2 antibody test: negative No Covid-19 antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.  The patient was not advised of possible need to pause Rinvoq prior to receiving the Covid-19 vaccine doses, therefore, she regularly took the medication. The patient stopped Rinvoq due to the negative Covid-19 antibodies. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Significant FU added- New event added
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Muscle spasms
Clinical narrative: Rheumatoid arthritis flare up; Burning leg; Foot/leg cramps; Swelling of legs; Lower extremities weakness of; Generalized aching; Headache; fever; fatigue; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs) and MUSCULAR WEAKNESS (Lower extremities weakness of) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown and MUSCLE SPASMS (Foot/leg cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Company Comment  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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events; 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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Peripheral swelling, Pyrexia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Burning leg; Foot/leg cramps; Swelling of legs; Lower extremities weakness of; Generalized aching; Headache; fever; fatigue; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs) and MUSCULAR WEAKNESS (Lower extremities weakness of) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown and MUSCLE SPASMS (Foot/leg cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Company Comment  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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events; 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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; nausea; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     Concomitant products included INSULIN for Diabetes mellitus, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication has been reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: hot in the injection site; Redness (2 inches ) in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for Antidepressant therapy, CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Antipsychotic drug level, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METFORMIN for Diabetes, BERBERINE for an unknown indication.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site). At the time of the report, VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site) outcome was unknown. Not Provided          No Treatment medication were provided  Action taken with the mRNA-1273 Moderna was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: SIde effect to vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (SIde effect to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced ADVERSE REACTION (SIde effect to vaccine). At the time of the report, ADVERSE REACTION (SIde effect to vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.  The patient received Moderna COVID-19 vaccine and had experienced side effects that lasted more than two months.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over the body; Progressive Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037BQ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and OMEPRAZOLE for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pains at the left side of the head/ pain location changes each time; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pains at the left side of the head/ pain location changes each time) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A. and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (Pains at the left side of the head/ pain location changes each time). The patient was treated with PARACETAMOL (TYLENOL) for Head pain, at an unspecified dose and frequency. At the time of the report, HEADACHE (Pains at the left side of the head/ pain location changes each time) outcome was unknown. 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 was not applicable.  Concomitant product use was not provided by the reporter.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; headache; temperature; feeling hot; Chills; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), HEADACHE (headache), PYREXIA (temperature) and FEELING HOT (feeling hot) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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 16-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (temperature) and FEELING HOT (feeling hot). On 17-Apr-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 pills to alleviate symptoms. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), HEADACHE (headache), PYREXIA (temperature) and FEELING HOT (feeling hot) outcome was unknown. Not Provided          No concomitant medications are provided .
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pain
Clinical narrative: hot flashes; and some pain; extreme chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills). At the time of the report, HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided No treatment medications provided
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Poor Quality drug Administered; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA AC) injection for Crohns disease aggravated.    Concurrent medical conditions included Alcohol use (Variety, once a week) since 2012, Tobacco user (one cigarette every 2 weeks) since 2014 and Autistic disorder. Concomitant products included ESTRADIOL and SPIRONOLACTONE for Gender reassignment therapy.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA AC) (Subcutaneous) 40 mg once a week. On 08-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) 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 POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) to have an unknown relationship.    No treatment information was provided by the reporter.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old daughter administered a dose of the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  No treatment medications were provided
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash
Clinical narrative: it's like holding a lot of heat; painful rashes popped up on both her knees 7  8 that were slightly risen; This spontaneous case was reported by a nurse and describes the occurrence of MILIARIA (it's like holding a lot of heat) and RASH (painful rashes popped up on both her knees 7  8 that were slightly risen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (painful rashes popped up on both her knees 7  8 that were slightly risen). On an unknown date, the patient experienced MILIARIA (it's like holding a lot of heat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MILIARIA (it's like holding a lot of heat) and RASH (painful rashes popped up on both her knees 7  8 that were slightly risen) 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.   No concomitant medications were reported.  Steroid shot,  Steroid cream are taken as treatment medicines.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Lymphadenopathy, Vaccination site inflammation
Clinical narrative: backache; lymph node inflammation; arthralgia; headache; pain at the vaccination site; Vaccination site inflammation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation) and ARTHRALGIA (arthralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and VACCINATION SITE PAIN (pain at the vaccination site). On 17-Apr-2021, the patient experienced BACK PAIN (backache), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache). At the time of the report, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: backache; lymph node inflammation; arthralgia; headache; pain at the vaccination site; Vaccination site inflammation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation) and ARTHRALGIA (arthralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and VACCINATION SITE PAIN (pain at the vaccination site). On 17-Apr-2021, the patient experienced BACK PAIN (backache), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache). At the time of the report, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blister, Herpes zoster, Myalgia
Clinical narrative: it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.; diagnosed with shingles; Backache; developed a backache that felt like a sore muscle which grew worse until Sunday night; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with shingles), BLISTER (it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.), BACK PAIN (Backache) and MYALGIA (developed a backache that felt like a sore muscle which grew worse until Sunday night) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Varicella zoster vaccine (10 years ago). Past adverse reactions to the above products included No adverse event with Varicella zoster vaccine.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced BACK PAIN (Backache) and MYALGIA (developed a backache that felt like a sore muscle which grew worse until Sunday night). On 21-Mar-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles). On an unknown date, the patient experienced BLISTER (it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency; GABAPENTIN at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed with shingles), BLISTER (it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.), BACK PAIN (Backache) and MYALGIA (developed a backache that felt like a sore muscle which grew worse until Sunday night) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.  Follow-up received on x date included no new information   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: No new information was reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling hot, Headache, Influenza
Clinical narrative: The flu; Sore throat; Sputum; Cough; Headache; Fever; Chills; The hots; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum) and COUGH (Cough) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING HOT (The hots) and CHILLS (Chills). On 15-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough) and HEADACHE (Headache). At the time of the report, FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant medication list was not provided. No treatment was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-219010 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: The flu; Sore throat; Sputum; Cough; Headache; Fever; Chills; The hots; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum) and COUGH (Cough) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING HOT (The hots) and CHILLS (Chills). On 15-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough) and HEADACHE (Headache). At the time of the report, FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant medication list was not provided. No treatment was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-219010 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Eye pruritus, Headache, Peripheral swelling
Clinical narrative: Burning in eyes; itching eyes; swelling arm; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) 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 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.