chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, Pyrexia
Clinical narrative: period came on 2 weeks early and very heavy; period came on 2 weeks early and very heavy; patient is crying a lot; moody; anxious; nervous; sad; Pain; chills; low grade fever; muscle aches; nauseous; This spontaneous case was reported by a patient and describes the occurrence of MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody) and ANXIETY (anxious) in a 44-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 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous). At the time of the report, MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pain in extremity, Rash, Rash pruritic, Urticaria
Clinical narrative: Hives on different part of his body; Pimple bumps; Very itchy; Sore arm; Rashes on different part of his body, rash on scalps; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on different part of his body), ACNE (Pimple bumps), RASH PRURITIC (Very itchy), PAIN IN EXTREMITY (Sore arm) and RASH (Rashes on different part of his body, rash on scalps) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on different part of his body), ACNE (Pimple bumps), RASH PRURITIC (Very itchy), PAIN IN EXTREMITY (Sore arm) and RASH (Rashes on different part of his body, rash on scalps). At the time of the report, URTICARIA (Hives on different part of his body), ACNE (Pimple bumps), RASH PRURITIC (Very itchy) and RASH (Rashes on different part of his body, rash on scalps) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  Patient experienced sore arm after the shot which subsided after some days. Few weeks after getting the second shot he started having hives, rashes and pimple bumps at different parts of his body including his scalps. The rashes were off and on, they were also very itchy. He called his cardiologist because he thought it was his heart medications that was causing the symptoms. He was planning to call his primary healthcare provider. Patient had issues with is hearing aid, his helped with some of the information.  Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: Loss of appetite; low grade fever; Chills; Nausea; Muscle pain; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID- 19 positive.) in November 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE 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 DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache) was resolving.        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 details was reported. No treatment medication details was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of appetite; low grade fever; Chills; Nausea; Muscle pain; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID- 19 positive.) in November 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE 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 DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache) was resolving.        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 details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included many types of unspecified allergies. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient experienced vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm). At the time of the report, vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. Treatment included, a disinfectant, organic apple cider vinegar and hydrogen peroxide.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: ¨little bruising on right arm after the 2nd shot ¨; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (¨little bruising on right arm after the 2nd shot ¨) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (¨little bruising on right arm after the 2nd shot ¨). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of one hour before the 1st and the 2nd Moderna shot. At the time of the report, VACCINATION SITE BRUISING (¨little bruising on right arm after the 2nd shot ¨) outcome was unknown. Not Provided          Other concomitant medications were reported included Lupus Medication,Blood pressure medication,medicine for depression and cholesterol medicine.   This case was linked to US-MODERNATX, INC.-MOD-2021-080362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non Significant:Contact information updated. On 19-Jul-2021: Follow up information received and contains non significant information- Husbands Information provided; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080362:Husband case
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Pyrexia
Clinical narrative: fever; was tired for a couple of days; heartbeat was unbelievably fast; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heartbeat was unbelievably fast), PYREXIA (fever) and FATIGUE (was tired for a couple of days) 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 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PALPITATIONS (heartbeat was unbelievably fast). On an unknown date, the patient experienced PYREXIA (fever) and FATIGUE (was tired for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) on 16-Apr-2021 at a dose of 1 dosage form. At the time of the report, PALPITATIONS (heartbeat was unbelievably fast), PYREXIA (fever) and FATIGUE (was tired for a couple of days) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Illness, Nausea
Clinical narrative: fell a couple of times; wanted to sleep all day; Super sick; felt strange, terrible; felt dizzy; like throwing up; felt like throwing up; Second shot was given more than 36 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible) and DIZZINESS (felt dizzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0101A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was diagnosed with Co-vid 19 back in Mar2020) in March 2020 and Back surgery. Concomitant products included OXYCODONE for Pain, COLECALCIFEROL (VIT D3), CALCIUM and TIZANIDINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) 1 dosage form. On 16-Apr-2021, the patient experienced OFF LABEL USE (Second shot was given more than 36 days after first shot). On 17-Apr-2021, the patient experienced FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Apr-2021, OFF LABEL USE (Second shot was given more than 36 days after first shot) had resolved. At the time of the report, FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up) outcome was unknown.            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.   This case was linked to MOD21-078174 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Somnolence, Vomiting
Clinical narrative: fell a couple of times; wanted to sleep all day; Super sick; felt strange, terrible; felt dizzy; like throwing up; felt like throwing up; Second shot was given more than 36 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible) and DIZZINESS (felt dizzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0101A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was diagnosed with Co-vid 19 back in Mar2020) in March 2020 and Back surgery. Concomitant products included OXYCODONE for Pain, COLECALCIFEROL (VIT D3), CALCIUM and TIZANIDINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) 1 dosage form. On 16-Apr-2021, the patient experienced OFF LABEL USE (Second shot was given more than 36 days after first shot). On 17-Apr-2021, the patient experienced FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Apr-2021, OFF LABEL USE (Second shot was given more than 36 days after first shot) had resolved. At the time of the report, FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up) outcome was unknown.            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.   This case was linked to MOD21-078174 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on the neck,about  the size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the neck,about  the size of a dime) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph node on the neck,about  the size of a dime). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the neck,about  the size of a dime) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Musculoskeletal stiffness, Myalgia, Pain in extremity, Swelling
Clinical narrative: body aches; arm stiffness & shoulder stiffness; tenderness; warm neck; swollen neck; severe arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck) and SWELLING (swollen neck) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness). On 19-Mar-2021, MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided No  Concomitant medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-080626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080626:2nd dose case
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: body aches; arm stiffness & shoulder stiffness; tenderness; warm neck; swollen neck; severe arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck) and SWELLING (swollen neck) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness). On 19-Mar-2021, MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided No  Concomitant medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-080626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080626:2nd dose case
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: side effects after first and second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) in a patient of an unknown age and gender 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 ADVERSE DRUG REACTION (side effects after first and second dose of vaccine). At the time of the report, ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080584 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080584:
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reported.
Age: 88.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Erythema, Peripheral swelling
Clinical narrative: diarrhea recurrent; erythema of extremities; swelling arm; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On 20-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm). At the time of the report, DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: side effects after first and second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects after first and second dose of 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects after first and second dose of vaccine). At the time of the report, ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080553 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080553:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Confusional state, Dyspnoea
Clinical narrative: myalgia; Trouble breathing; Couldn't pull myself out the bed and didn't get out the bed; Confusion; Chills; Joint pain; Headache; Fatigue, but nothing serious; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue, but nothing serious) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Bypass surgery (5 Bypass surgeries). Concurrent medical conditions included Arthritis, Diabetes and Heart disease, unspecified.   On 16-Apr-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) 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue, but nothing serious). On 17-Apr-2021, the patient experienced MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), CONFUSIONAL STATE (Confusion), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 17-Apr-2021, CONFUSIONAL STATE (Confusion) had resolved. On 19-Apr-2021, MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), FATIGUE (Fatigue, but nothing serious), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant product use was reported. Treatment medication for the event included Percocet.   This case was linked to MOD-2021-163938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR added on 25 May 2021 and updated patient second dose information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: myalgia; Trouble breathing; Couldn't pull myself out the bed and didn't get out the bed; Confusion; Chills; Joint pain; Headache; Fatigue, but nothing serious; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue, but nothing serious) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Bypass surgery (5 Bypass surgeries). Concurrent medical conditions included Arthritis, Diabetes and Heart disease, unspecified.   On 16-Apr-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) 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue, but nothing serious). On 17-Apr-2021, the patient experienced MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), CONFUSIONAL STATE (Confusion), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 17-Apr-2021, CONFUSIONAL STATE (Confusion) had resolved. On 19-Apr-2021, MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), FATIGUE (Fatigue, but nothing serious), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant product use was reported. Treatment medication for the event included Percocet.   This case was linked to MOD-2021-163938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR added on 25 May 2021 and updated patient second dose information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus, Psoriasis
Clinical narrative: Flared up on forearms and lasted for 3 days; Had quite a bit of itching on arms and next to hands; Swollen on backs of hands, had redness, took a week to 10 days for redness to go away; She believes this was an allergic reaction; Swollen on backs of hands, had redness, took a week to 10 days for redness to go away; 1-2 hours after, broke out with a rash on backs of both hands; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flared up on forearms and lasted for 3 days), PRURITUS (Had quite a bit of itching on arms and next to hands), PERIPHERAL SWELLING (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away), HYPERSENSITIVITY (She believes this was an allergic reaction) and ERYTHEMA (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis. Concomitant products included ROSUVASTATIN, HYDROXYCHLOROQUINE, AMLODIPINE, METFORMIN, CARVEDILOL, WARFARIN, ISOSORBIDE MONONITRATE, POTASSIUM CHLORIDE (KLOR-CON), FUROSEMIDE, CINNAMON [CINNAMOMUM VERUM] and VITAMINS NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PSORIASIS (Flared up on forearms and lasted for 3 days), PRURITUS (Had quite a bit of itching on arms and next to hands), PERIPHERAL SWELLING (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away), HYPERSENSITIVITY (She believes this was an allergic reaction), ERYTHEMA (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away) and RASH (1-2 hours after, broke out with a rash on backs of both hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLOBETASOL at an unspecified dose and frequency. At the time of the report, PSORIASIS (Flared up on forearms and lasted for 3 days), PRURITUS (Had quite a bit of itching on arms and next to hands), PERIPHERAL SWELLING (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away), HYPERSENSITIVITY (She believes this was an allergic reaction), ERYTHEMA (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away) and RASH (1-2 hours after, broke out with a rash on backs of both hands) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Flared up on forearms and lasted for 3 days; Had quite a bit of itching on arms and next to hands; Swollen on backs of hands, had redness, took a week to 10 days for redness to go away; She believes this was an allergic reaction; Swollen on backs of hands, had redness, took a week to 10 days for redness to go away; 1-2 hours after, broke out with a rash on backs of both hands; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flared up on forearms and lasted for 3 days), PRURITUS (Had quite a bit of itching on arms and next to hands), PERIPHERAL SWELLING (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away), HYPERSENSITIVITY (She believes this was an allergic reaction) and ERYTHEMA (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis. Concomitant products included ROSUVASTATIN, HYDROXYCHLOROQUINE, AMLODIPINE, METFORMIN, CARVEDILOL, WARFARIN, ISOSORBIDE MONONITRATE, POTASSIUM CHLORIDE (KLOR-CON), FUROSEMIDE, CINNAMON [CINNAMOMUM VERUM] and VITAMINS NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PSORIASIS (Flared up on forearms and lasted for 3 days), PRURITUS (Had quite a bit of itching on arms and next to hands), PERIPHERAL SWELLING (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away), HYPERSENSITIVITY (She believes this was an allergic reaction), ERYTHEMA (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away) and RASH (1-2 hours after, broke out with a rash on backs of both hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLOBETASOL at an unspecified dose and frequency. At the time of the report, PSORIASIS (Flared up on forearms and lasted for 3 days), PRURITUS (Had quite a bit of itching on arms and next to hands), PERIPHERAL SWELLING (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away), HYPERSENSITIVITY (She believes this was an allergic reaction), ERYTHEMA (Swollen on backs of hands, had redness, took a week to 10 days for redness to go away) and RASH (1-2 hours after, broke out with a rash on backs of both hands) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headaches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (body aches) and HEADACHE (headaches). On 28-Feb-2021, MYALGIA (body aches) and HEADACHE (headaches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on his legs that was itchy; Rash on his legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on his legs that was itchy) and RASH (Rash on his legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 26-Feb-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 RASH PRURITIC (Rash on his legs that was itchy) and RASH (Rash on his legs). At the time of the report, RASH PRURITIC (Rash on his legs that was itchy) and RASH (Rash on his legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-080613.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: his arm hurt and a little achey; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (his arm hurt and a little achey) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (his arm hurt and a little achey). At the time of the report, VACCINATION SITE PAIN (his arm hurt and a little achey) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. No treatment information was provided by reporter.   This case was linked to MOD21-078429, MOD21-078495, MOD21-078496 (E2B Linked Report). This case was linked to MOD-2021-080630 (Patient Link).; Sender's Comments:  MOD21-078429: MOD21-078495: MOD21-078496:
Sex: F
Vaccine: COVID19
Symptoms: Glassy eyes, Neuralgia, Vision blurred
Clinical narrative: my nerve endings felt off; my eyes have become glassy; my vision is blurred; This spontaneous case was reported by a consumer and describes the occurrence of GLASSY EYES (my eyes have become glassy), VISION BLURRED (my vision is blurred) and NEURALGIA (my nerve endings felt off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced GLASSY EYES (my eyes have become glassy) and VISION BLURRED (my vision is blurred). On an unknown date, the patient experienced NEURALGIA (my nerve endings felt off). At the time of the report, GLASSY EYES (my eyes have become glassy) and VISION BLURRED (my vision is blurred) had not resolved and NEURALGIA (my nerve endings felt off) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment for the events included eye drops, eye wash, and allergy pills.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Rash
Clinical narrative: Flu-like symptoms; Rash on legs; Body aches; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), RASH (Rash on legs) and MYALGIA (Body aches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-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 INFLUENZA LIKE ILLNESS (Flu-like symptoms), RASH (Rash on legs) and MYALGIA (Body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), RASH (Rash on legs) and MYALGIA (Body aches) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-080601 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Numbness of the right leg; Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of the right leg) and PAIN (Pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Gangrene (Gangrene on the same foot of 3 toe amputation), Heartburn, Surgical procedure (13 surgical procedures. Multiple surgeries in her knee, back and brain.) and Toe amputation (3 toe amputation). Concurrent medical conditions included Disability, Cardiovascular risk (Risk of stroke due to the pain), Pain (Pain due to an injury in 2019) since 2019, Stress, Anxiety and Inflammation.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness of the right leg) and PAIN (Pain). At the time of the report, HYPOAESTHESIA (Numbness of the right leg) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include medications for stress, anxiety, pain and inflammation. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient information updated. Historical condition and concomitant medication information updated. An event added.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Insomnia, Nightmare, Pain in extremity
Clinical narrative: More trouble falling asleep since vaccine; Vivid bad dreams since vaccine; Hot flashes after 1st dose; Sore arm after 1st dose; Waking up more at night since vaccine; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (More trouble falling asleep since vaccine), NIGHTMARE (Vivid bad dreams since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose) and SLEEP DISORDER (Waking up more at night since vaccine) in a 23-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.     Concurrent medical conditions included Autoinflammatory disease. Concomitant products included COLCHICINE for Autoinflammatory disease.    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 INSOMNIA (More trouble falling asleep since vaccine), NIGHTMARE (Vivid bad dreams since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose), SLEEP DISORDER (Waking up more at night since vaccine) and FATIGUE (Fatigue after 1st dose). At the time of the report, INSOMNIA (More trouble falling asleep since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose), SLEEP DISORDER (Waking up more at night since vaccine) and FATIGUE (Fatigue after 1st dose) outcome was unknown and NIGHTMARE (Vivid bad dreams since vaccine) had not resolved. Not Provided          The co-suspect medication included antidepressants. The patient was taking them since Dec-2020. In Feb-2021, the dose was increased. Patient's doctor suspected that her symptoms were more likely due to antidepressants. The dose of antidepressants was decreased. Even after the dose was reduced,the patient still had some dreams.      Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: More trouble falling asleep since vaccine; Vivid bad dreams since vaccine; Hot flashes after 1st dose; Sore arm after 1st dose; Waking up more at night since vaccine; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (More trouble falling asleep since vaccine), NIGHTMARE (Vivid bad dreams since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose) and SLEEP DISORDER (Waking up more at night since vaccine) in a 23-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.     Concurrent medical conditions included Autoinflammatory disease. Concomitant products included COLCHICINE for Autoinflammatory disease.    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 INSOMNIA (More trouble falling asleep since vaccine), NIGHTMARE (Vivid bad dreams since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose), SLEEP DISORDER (Waking up more at night since vaccine) and FATIGUE (Fatigue after 1st dose). At the time of the report, INSOMNIA (More trouble falling asleep since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose), SLEEP DISORDER (Waking up more at night since vaccine) and FATIGUE (Fatigue after 1st dose) outcome was unknown and NIGHTMARE (Vivid bad dreams since vaccine) had not resolved. Not Provided          The co-suspect medication included antidepressants. The patient was taking them since Dec-2020. In Feb-2021, the dose was increased. Patient's doctor suspected that her symptoms were more likely due to antidepressants. The dose of antidepressants was decreased. Even after the dose was reduced,the patient still had some dreams.      Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm hurts; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). On 18-Apr-2021, PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-080544 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080544:1st dose of vaccine