chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site coldness, Vaccination site haemorrhage
Clinical narrative: some of the vaccine may have escaped during injection; felt a cold sensation at the injection site; gauze was covered with blood; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (some of the vaccine may have escaped during injection), VACCINATION SITE COLDNESS (felt a cold sensation at the injection site) and VACCINATION SITE HAEMORRHAGE (gauze was covered with blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for an unknown indication.     No Medical History information was reported.   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) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (some of the vaccine may have escaped during injection), VACCINATION SITE COLDNESS (felt a cold sensation at the injection site) and VACCINATION SITE HAEMORRHAGE (gauze was covered with blood). On 04-Mar-2021, INCORRECT DOSE ADMINISTERED (some of the vaccine may have escaped during injection) had resolved. At the time of the report, VACCINATION SITE COLDNESS (felt a cold sensation at the injection site) and VACCINATION SITE HAEMORRHAGE (gauze was covered with blood) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Action taken with the mRNA-1273 in response to the events was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swelling in ankle; Swelling in wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist). At the time of the report, JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Vomiting
Clinical narrative: trouble breathing; felt bad; Vomit; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit). At the time of the report, DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time as patient didn't give consent for follow up
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Nausea, Pain in extremity
Clinical narrative: Head feels heavy; Dizziness; Arm is sore to touch; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea). At the time of the report, HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Prenatal screening test, Ultrasound foetal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B (No changes) in 2018 and Alcohol use (social 1-2 drinks/week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Sep-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Prenatal screening test: negative (Negative) Negative. In 2021, Ultrasound foetal: normal (normal) No abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received on 12-JUL-2021 Contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment details was not reported by the reporter.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash which increased in size up to 1 x 6 in below the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L204) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site). The patient was treated with CEFALEXIN (CEPHALEXINE) for Vaccination site rash, at a dose of UNK dosage form. On 25-Feb-2021, VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: aching all over the body; very tired/sleepy; head ache; sore arm at injection sit e; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e). At the time of the report, PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatments were reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: side effects after my two shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after my two shots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Asthma.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after my two shots). At the time of the report, VACCINATION COMPLICATION (side effects after my two shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) tested twice with negative results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided for the second dose.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm started hurting; Arm is red; Arm hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Arthritis, ZOLPIDEM TARTRATE (AMBIEN), VITAMINS NOS and CALCIUM for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Painful arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included an unspecified antidepressant.  Treatment included ibuprofen (ADVIL), which she already takes for arthritis, but it did not help. The patient consulted a doctor, but she cannot remember what he recommended.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event outcomes updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site papule, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAPULE (Progressively worsened into "red bump" and "hives"), VACCINATION SITE PRURITUS (Itching initially at the site of the injection), VACCINATION SITE URTICARIA (Progressively worsened into "red bump" and "hives") and VACCINATION SITE ERYTHEMA (Redness initially at the site of the injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history provided by reporter. Concurrent medical conditions included Allergy to antibiotic (Allergies to Amoxicillin), Drug allergy (Allergies to Statins) and Drug allergy (Allergies to percocet). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching initially at the site of the injection) and VACCINATION SITE ERYTHEMA (Redness initially at the site of the injection). On 07-Mar-2021, the patient experienced VACCINATION SITE PAPULE (Progressively worsened into "red bump" and "hives") and VACCINATION SITE URTICARIA (Progressively worsened into "red bump" and "hives"). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAPULE (Progressively worsened into "red bump" and "hives"), VACCINATION SITE PRURITUS (Itching initially at the site of the injection), VACCINATION SITE URTICARIA (Progressively worsened into "red bump" and "hives") and VACCINATION SITE ERYTHEMA (Redness initially at the site of the injection) 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. Concomitant product used was not provided by the reporter.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the appointment the patient had gotten for her second dose was 47 days after the first shot; A spontaneous report  was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and got the appointment for his second dose 47 days after the first shot (inappropriate schedule of product administration).  The patient's medical history was not reported. Concomitant product use was not reported.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection and had gotten the appointment for his second dose 47 days after the first shot on 30 Mar 2021.  Treatment information was also not provided .  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event was considered as unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034913:Wife's case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Pruritus, Pyrexia, Skin warm
Clinical narrative: Red; Hot to touch; Itchy; raise in temperature; Large bump on injection site a size of tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Large bump on injection site a size of tennis ball), ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Large bump on injection site a size of tennis ball). On 26-Feb-2021, the patient experienced ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature). At the time of the report, INJECTION SITE MASS (Large bump on injection site a size of tennis ball), ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE INDURATION, the second episode of VACCINATION SITE INDURATION, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic fatigue (symptoms worse after the vaccine) in 1990 and Epstein-Barr virus infection in 1990. Concomitant products included SERTRALINE, DOXYCYCLINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of VACCINATION SITE INDURATION, VACCINATION SITE PAIN and VACCINATION SITE ERYTHEMA. On 10-Mar-2021, the patient experienced the second episode of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING and VACCINATION SITE PAIN. On 25-Feb-2021, VACCINATION SITE PAIN and VACCINATION SITE ERYTHEMA had resolved. On 14-Mar-2021, last episode of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING and VACCINATION SITE PAIN had resolved. ON 10mar2021, post vaccination, the patient reported that she experienced pain, swelling, redness at the injection site. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes on 11-May-2021: Follow-up information received on 11-May-2021 will be processed with initial report. Follow-up updated patient demographics, concomitant medications, adverse events start/stop dates and outcome. On 14-Jun-2021: No specific follow-up information recorded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Myalgia, Pyrexia
Clinical narrative: Always sleepy; Lethargy; Body aches; Fever to 102.4 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Always sleepy), LETHARGY (Lethargy), MYALGIA (Body aches), PYREXIA (Fever to 102.4 F) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (Occasional atrial fibrillation; No recent change in status of chronic condition) since 1999. Concomitant products included METOPROLOL for Atrial fibrillation, APIXABAN (ELIQUIS) for Atrial fibrillation and Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, VITAMIN C [ASCORBIC ACID], VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Prevention, LISINOPRIL and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SOMNOLENCE (Always sleepy), LETHARGY (Lethargy) and MYALGIA (Body aches). 15-Feb-2021, the patient experienced PYREXIA (Fever to 102.4 F) and CHILLS (Chills). At the time of the report, SOMNOLENCE (Always sleepy), LETHARGY (Lethargy), MYALGIA (Body aches) and CHILLS (Chills) had not resolved and PYREXIA (Fever to 102.4 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 102.4 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included paracetamol.   This case was linked to MOD-2021-060090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated contact information, patient information, medical history, lab data,concomitant medications, rechallenge results; Added event (FEVER).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Always sleepy; Lethargy; Body aches; Fever to 102.4 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Always sleepy), LETHARGY (Lethargy), MYALGIA (Body aches), PYREXIA (Fever to 102.4 F) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (Occasional atrial fibrillation; No recent change in status of chronic condition) since 1999. Concomitant products included METOPROLOL for Atrial fibrillation, APIXABAN (ELIQUIS) for Atrial fibrillation and Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, VITAMIN C [ASCORBIC ACID], VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Prevention, LISINOPRIL and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SOMNOLENCE (Always sleepy), LETHARGY (Lethargy) and MYALGIA (Body aches). 15-Feb-2021, the patient experienced PYREXIA (Fever to 102.4 F) and CHILLS (Chills). At the time of the report, SOMNOLENCE (Always sleepy), LETHARGY (Lethargy), MYALGIA (Body aches) and CHILLS (Chills) had not resolved and PYREXIA (Fever to 102.4 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 102.4 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included paracetamol.   This case was linked to MOD-2021-060090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated contact information, patient information, medical history, lab data,concomitant medications, rechallenge results; Added event (FEVER).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Skin burning sensation
Clinical narrative: Allergic reaction / allergy on his scalp; Felt like it burned; This spontaneous case was reported by a physician and describes the occurrence of DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ISOSORBIDE, LISINOPRIL and SERTRALINE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned). At the time of the report, DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Impaired work ability, Muscle tightness
Clinical narrative: missed day of work; feeling sluggish or tired; left arm hurting; lower back tightness; sweating a lot; feeling spacey; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot), FEELING ABNORMAL (feeling spacey) and IMPAIRED WORK ABILITY (missed day of work) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for an unknown indication.    The patient's past medical history included Anxiety.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 started ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot) and FEELING ABNORMAL (feeling spacey). 09-Mar-2021, the patient experienced FATIGUE (feeling sluggish or tired). On 10-Mar-2021, the patient experienced IMPAIRED WORK ABILITY (missed day of work). On 09-Mar-2021, HYPERHIDROSIS (sweating a lot) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), FEELING ABNORMAL (feeling spacey), IMPAIRED WORK ABILITY (missed day of work) and FATIGUE (feeling sluggish or tired) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD-2021-136100, MOD-2021-136100 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: missed day of work; feeling sluggish or tired; left arm hurting; lower back tightness; sweating a lot; feeling spacey; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot), FEELING ABNORMAL (feeling spacey) and IMPAIRED WORK ABILITY (missed day of work) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for an unknown indication.    The patient's past medical history included Anxiety.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 started ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot) and FEELING ABNORMAL (feeling spacey). 09-Mar-2021, the patient experienced FATIGUE (feeling sluggish or tired). On 10-Mar-2021, the patient experienced IMPAIRED WORK ABILITY (missed day of work). On 09-Mar-2021, HYPERHIDROSIS (sweating a lot) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), FEELING ABNORMAL (feeling spacey), IMPAIRED WORK ABILITY (missed day of work) and FATIGUE (feeling sluggish or tired) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD-2021-136100, MOD-2021-136100 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A211A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1-2 glasses/week) on 12-Jul-2020. Concurrent medical conditions included Subfertility. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date, VITAMIN D [VITAMIN D NOS], IRON and OMEGA-3 [OMEGA-3 NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 26-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2020, Pregnancy test: positive (Positive) Positive. On 07-Jan-2021, Glucose tolerance test: no findings (normal) No findings. On 03-Nov-2021, Ultrasound scan: no findings (normal) No findings.     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 treatment information was provided by the reporter.  Estimated date of conception was reported as 08-Jul-2021. The number of fetus was reported as 1 and prenatal care was established. There was no complications or acute illness during the pregnancy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), ENALAPRIL, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include topical gel for arthritis.  Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Somnolence
Clinical narrative: Dizziness; Sleepy; Not feeling myself; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SOMNOLENCE (Sleepy) and MALAISE (Not feeling myself) in an 86-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), SOMNOLENCE (Sleepy) and MALAISE (Not feeling myself). At the time of the report, DIZZINESS (Dizziness), SOMNOLENCE (Sleepy) and MALAISE (Not feeling myself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient did not want to take the 2nd dose because of the reaction she had after receiving the 1st dose   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional document attached and does not contain any new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (Blurred vision) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included DORZOLAMIDE HCL for Eye drop instillation, LATANOPROST for an unknown indication.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Site effect of moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE DRUG REACTION (Site effect of moderna 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Site effect of moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (Site effect of moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Chills; Mild ar m soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild ar m soreness) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 020L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension, LEVOTHYROXINE for Parathyroid tumor malignant.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild ar m soreness). On 17-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Mild ar m soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up recieved on  28-APR-2021 included added patient birth date demographics, stop date of event chills secondary reporter contact information
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: tiny rash; little pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (tiny rash) and PAIN (little pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (tiny rash) and PAIN (little pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (tiny rash) and PAIN (little pain) outcome was unknown.            no concomitant medications reported.   This case was linked to MOD-2021-016861 (Parent-Child Link).   See case MOD-2021-016861 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Joint swelling, Lip swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: Swollen lip; Swollen tongue; Swollen throat; swollen inside part of the right cheeck / swollen right cheeck; Swollen right arm/ Swollen right hand; Vaccine is making her sick; all joints on the right side of my body are swollen and stiff,; Swollen right wrist; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck) and PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U1AZIA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2020, the patient experienced OEDEMA PERIPHERAL (Swollen right wrist). On 02-Mar-2021, the patient experienced LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck), PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand), ILLNESS (Vaccine is making her sick) and JOINT SWELLING (all joints on the right side of my body are swollen and stiff,). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck), PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand), OEDEMA PERIPHERAL (Swollen right wrist), ILLNESS (Vaccine is making her sick) and JOINT SWELLING (all joints on the right side of my body are swollen and stiff,) had not resolved.            Treatment drug as reported is Certax  On 01-JUN-2021, Patient provided follow-up information in stating that the patient's condition remains unchanged. In addition to the swollen limbs previously reported, the patient states that the patient's right foot is also swollen.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow-up added,
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: Swollen lip; Swollen tongue; Swollen throat; swollen inside part of the right cheeck / swollen right cheeck; Swollen right arm/ Swollen right hand; Vaccine is making her sick; all joints on the right side of my body are swollen and stiff,; Swollen right wrist; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck) and PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U1AZIA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2020, the patient experienced OEDEMA PERIPHERAL (Swollen right wrist). On 02-Mar-2021, the patient experienced LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck), PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand), ILLNESS (Vaccine is making her sick) and JOINT SWELLING (all joints on the right side of my body are swollen and stiff,). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck), PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand), OEDEMA PERIPHERAL (Swollen right wrist), ILLNESS (Vaccine is making her sick) and JOINT SWELLING (all joints on the right side of my body are swollen and stiff,) had not resolved.            Treatment drug as reported is Certax  On 01-JUN-2021, Patient provided follow-up information in stating that the patient's condition remains unchanged. In addition to the swollen limbs previously reported, the patient states that the patient's right foot is also swollen.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow-up added,
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness) in a 78-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 PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness). At the time of the report, PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-015824.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: soreness in arm so great and right after the shot was heavy and now upper arm still very sore; pain; fatigue but unsure if from vaccine since she suffers from migraines; Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore), PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included MELATONIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore), PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore) had not resolved and PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatments were reported.  Patient was planned to reach out to HCP on 11-MAR-2021.