chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Stress, Vaccination site pain
Clinical narrative: stress would make the headaches come back; never had headaches before this, Headache moved from the back of his neck to the front of his forehead; a little fatigue; soreness around the injection site; couldn't sleep on that arm, it would wake him up; felt like someone was holding a candle inside of my head; there was a pressure inside my brain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), STRESS (stress would make the headaches come back) and HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead), FATIGUE (a little fatigue) and VACCINATION SITE PAIN (soreness around the injection site). On an unknown date, the patient experienced STRESS (stress would make the headaches come back). At the time of the report, INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), STRESS (stress would make the headaches come back), HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead), FATIGUE (a little fatigue) and VACCINATION SITE PAIN (soreness around the injection site) outcome was unknown.            This case was linked to MOD-2021-104324 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow-up
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Limb discomfort, Myalgia
Clinical narrative: felt like someone hit them in the arm with a baseball bat; muscle pain; fatigue; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like someone hit them in the arm with a baseball bat), MYALGIA (muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LIMB DISCOMFORT (felt like someone hit them in the arm with a baseball bat), MYALGIA (muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, LIMB DISCOMFORT (felt like someone hit them in the arm with a baseball bat), MYALGIA (muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-041373, MOD-2021-041373 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain all over; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain all over) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain all over). At the time of the report, PAIN (Pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported "FELT LIKE RINVOQ WAS NOT WORKING." Treatment of events was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Urticaria, Vaccination site reaction
Clinical narrative: getting the chills; itchy all over; started to get hives from the scratching; reaction from the vaccine; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (getting the chills), PRURITUS (itchy all over), URTICARIA (started to get hives from the scratching) and VACCINATION SITE REACTION (reaction from the vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISDEXAMFETAMINE DIMESYLATE for ADHD, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (getting the chills), PRURITUS (itchy all over), URTICARIA (started to get hives from the scratching) and VACCINATION SITE REACTION (reaction from the vaccine). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at a dose of 40 milligram. At the time of the report, CHILLS (getting the chills), PRURITUS (itchy all over), URTICARIA (started to get hives from the scratching) and VACCINATION SITE REACTION (reaction from the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant drugs includes Birth control pill, Vyvanse, Allegra.  Treatment includes H2-Blocker, Anti- Histamine, Pepcid 40 mg, Benadryl, Allegra.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia
Clinical narrative: Tachycardia; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations). At the time of the report, TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided No treatment information was provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Histamine level, Pruritus
Clinical narrative: getting a reaction from the vaccine; getting the chills; itchy all over; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (getting a reaction from the vaccine), CHILLS (getting the chills) and PRURITUS (itchy all over) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included ADHD since an unknown date. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Allergy.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced ADVERSE REACTION (getting a reaction from the vaccine), CHILLS (getting the chills) and PRURITUS (itchy all over). At the time of the report, ADVERSE REACTION (getting a reaction from the vaccine), CHILLS (getting the chills) and PRURITUS (itchy all over) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Histamine level: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Birth Control pills. Patient took an H2-blocker and anti-histamines to treat the symptoms. She stated that she took Allegra regularly during the day and that she added Benadryl every night to boost the dose of her anti-histamine, and Pepcid 40mg which she did not take on a regular basis.   This case was linked to MOD-2021-104392, MOD-2021-104392.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Rash erythematous, Rash pruritic, Rubber sensitivity, Urticaria
Clinical narrative: Latex allergy; Urticarial rash; Red rash; Itchy rash; Rash over arms; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RUBBER SENSITIVITY (Latex allergy), URTICARIA (Urticarial rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash) and RASH (Rash over arms) in a 68-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 26-Apr-2021, the patient experienced RUBBER SENSITIVITY (Latex allergy), URTICARIA (Urticarial rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Rash over arms) and RASH (Rash). At the time of the report, RUBBER SENSITIVITY (Latex allergy) had not resolved and URTICARIA (Urticarial rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Rash over arms) and RASH (Rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Sore arms; Outbreak of Hives; Sick; Severe muscle aches; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), URTICARIA (Outbreak of Hives), ILLNESS (Sick), MYALGIA (Severe muscle aches) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arms), URTICARIA (Outbreak of Hives), ILLNESS (Sick), MYALGIA (Severe muscle aches) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arms), URTICARIA (Outbreak of Hives), ILLNESS (Sick), MYALGIA (Severe muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Sometimes wakes up with wet and sweat; Tired and can hardly move; Everyday Fever after vaccination, I have fever 28 days after 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sometimes wakes up with wet and sweat), FATIGUE (Tired and can hardly move) and PYREXIA (Everyday Fever after vaccination, I have fever 28 days after 1st vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Tumor (hemotherapy which has protocol of chop-bleo and methrexate for tumor in throat) in 1986 and Anesthesia (patient had anesthesia with which she took 18hrs to wakeup and she was delicate person.). Concurrent medical conditions included Drug allergy (allergic to nausea medicines) and Penicillin allergy.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Everyday Fever after vaccination, I have fever 28 days after 1st vaccine). On an unknown date, the patient experienced HYPERHIDROSIS (Sometimes wakes up with wet and sweat) and FATIGUE (Tired and can hardly move). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sometimes wakes up with wet and sweat), FATIGUE (Tired and can hardly move) and PYREXIA (Everyday Fever after vaccination, I have fever 28 days after 1st vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (normal) 99 and 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Thyroid pills and Antidepressant pills.   This case was linked to MOD-2021-261798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021 and contains no new information
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (covid positive) 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 21-Apr-2021, the patient experienced COVID-19 (covid positive). At the time of the report, COVID-19 (covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   Her second dose was due on 04/23/21. However, she was diagnosed with covid positive on 04/21/21.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05-05-2021: No new information
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. 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.        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 relevant concomitant medications were provided.  In 2021, the patient experienced sore arm.. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. According to the reporter, there was no reasonable possibility of causal association between adalimumab and the event.   No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Malaise
Clinical narrative: Not feeling well; Head doesnt feel clear, feel disconnected all the time; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FEELING ABNORMAL (Head doesnt feel clear, feel disconnected all the time), CHILLS (Chills) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 033A21A) for COVID-19 vaccination.     The patient's past medical history included Hip surgery (Year ago but still have difficulty with her hip). Concurrent medical conditions included Heart disease, unspecified.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 MALAISE (Not feeling well), FEELING ABNORMAL (Head doesnt feel clear, feel disconnected all the time), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MALAISE (Not feeling well), FEELING ABNORMAL (Head doesnt feel clear, feel disconnected all the time), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-039828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Reporter information was updated and second dose and first dose Batch/LOT numbers were added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 025C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID (VIT C), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D3 for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (slightly sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (slightly sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-104726 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Rash, Somnolence, Vertigo
Clinical narrative: sleepiness; felt like vertigo; Head feeling heavy; 3 itchy red spots near inner right arm; slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), VERTIGO (felt like vertigo), HEAD DISCOMFORT (Head feeling heavy), RASH (3 itchy red spots near inner right arm) and NAUSEA (slight nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Endothelial corneal dystrophy, Squamous cell carcinoma in March 2019, Corneal transplant (Right eye) since October 2018 and Cataract operation (Left eye) since November 2019. Concurrent medical conditions included Vertigo, Benign positional vertigo, Coronary artery disease, Tinnitus, Chronic idiopathic constipation, Osteoarthritis, Osteopenia, Osteoporosis, Hypothyroidism, Anxiety, Lichen sclerosis atrophicus, Gluten sensitivity, Allergy (Lactose intolerance), Drug allergy (Aspirin), Drug allergy (Ibuprofen) and Drug allergy (Sertraline (Zoloft)). Concomitant products included ALPRAZOLAM for Anxiety, DIAZEPAM for Vertigo, LUBIPROSTONE (AMITIZA), LEVOTHYROXINE, ROSUVASTATIN from 20-Nov-2020 to an unknown date, CLOPIDOGREL from 15-Aug-2020 to an unknown date, ESTRADIOL from October 2020 to an unknown date, DIFLUPREDNATE (DUREZOL), LOTEPREDNOL ETABONATE (LOTEMAX), VITAMIN D3, DHEA, MULTIVITAMIN [VITAMINS NOS], CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), DOCUSATE SODIUM (COLACE), MACROGOL 3350 (MIRALAX), MAGNESIUM and BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM BREVE, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PRIMADOPHILUS BIFIDUS) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-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 SOMNOLENCE (sleepiness), VERTIGO (felt like vertigo), HEAD DISCOMFORT (Head feeling heavy), RASH (3 itchy red spots near inner right arm) and NAUSEA (slight nausea). The patient was treated with DIAZEPAM (VALIUM) for Vertigo, at a dose of 1 mg. On 09-May-2021, SOMNOLENCE (sleepiness), VERTIGO (felt like vertigo), HEAD DISCOMFORT (Head feeling heavy), RASH (3 itchy red spots near inner right arm) and NAUSEA (slight nausea) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to  (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: All event outcomes updated and start date and stop date is also provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM, DILTIAZEM HCL, ALENDRONATE SODIUM, LORATADINE, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-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 an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-037157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: On an unknown date new event (Soreness at the injection site) was added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Peripheral swelling, Vaccination site nodule
Clinical narrative: Can not sleep; Swollen arm; At first there was one bump at the injection site, now there is three bumps.; Arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE NODULE (At first there was one bump at the injection site, now there is three bumps.), PAIN IN EXTREMITY (Arm is really sore) and INSOMNIA (Can not sleep) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032AZI and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE NODULE (At first there was one bump at the injection site, now there is three bumps.) and PAIN IN EXTREMITY (Arm is really sore). On an unknown date, the patient experienced INSOMNIA (Can not sleep). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, at a dose of 400 mg and MELOXICAM (MOBIC) for Pain in extremity, at a dose of 7.5 mg. At the time of the report, PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE NODULE (At first there was one bump at the injection site, now there is three bumps.) and PAIN IN EXTREMITY (Arm is really sore) had not resolved and INSOMNIA (Can not sleep) outcome was unknown.            Patient received Pfizer paperwork but did not receive the Pfizer covid vaccine.  Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Injection site pain, Lethargy, Nausea
Clinical narrative: Lethargy; Aches; Nausea for 3 days; Sore left arm at Injection Site; Rash that went down my left arm and included my left hand; Fever for 101; Chills; significant immune response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION (significant immune response), PYREXIA (Fever for 101), CHILLS (Chills), LETHARGY (Lethargy) and PAIN (Aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Nov-2020. Concomitant products included SERTRALINE, BUPROPION, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), Combivent prn                                                  asthma and OTC Zyrtec for allergies                                       allergies 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 27-Jan-2021, the patient experienced IMMUNISATION (significant immune response). On 16-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (Fever for 101), LETHARGY (Lethargy), PAIN (Aches), NAUSEA (Nausea for 3 days), INJECTION SITE PAIN (Sore left arm at Injection Site) and RASH (Rash that went down my left arm and included my left hand). At the time of the report, IMMUNISATION (significant immune response), PYREXIA (Fever for 101), LETHARGY (Lethargy), PAIN (Aches), NAUSEA (Nausea for 3 days), INJECTION SITE PAIN (Sore left arm at Injection Site) and RASH (Rash that went down my left arm and included my left hand) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-024842 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Lethargy; Aches; Nausea for 3 days; Sore left arm at Injection Site; Rash that went down my left arm and included my left hand; Fever for 101; Chills; significant immune response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION (significant immune response), PYREXIA (Fever for 101), CHILLS (Chills), LETHARGY (Lethargy) and PAIN (Aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Nov-2020. Concomitant products included SERTRALINE, BUPROPION, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), Combivent prn                                                  asthma and OTC Zyrtec for allergies                                       allergies 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 27-Jan-2021, the patient experienced IMMUNISATION (significant immune response). On 16-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (Fever for 101), LETHARGY (Lethargy), PAIN (Aches), NAUSEA (Nausea for 3 days), INJECTION SITE PAIN (Sore left arm at Injection Site) and RASH (Rash that went down my left arm and included my left hand). At the time of the report, IMMUNISATION (significant immune response), PYREXIA (Fever for 101), LETHARGY (Lethargy), PAIN (Aches), NAUSEA (Nausea for 3 days), INJECTION SITE PAIN (Sore left arm at Injection Site) and RASH (Rash that went down my left arm and included my left hand) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-024842 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Drug dose administration interval too long; Fever; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) and PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) and PYREXIA (Fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) outcome was unknown and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Limb discomfort, Neck pain
Clinical narrative: slightly sore arm; pain in neck; pain in arms; pain in hips; feeling fatigue; right arm all of her joints began aching; getting less sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (getting less sleep), LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms) and PAIN (pain in hips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (getting less sleep) and ARTHRALGIA (right arm all of her joints began aching). On an unknown date, the patient experienced LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms), PAIN (pain in hips) and FATIGUE (feeling fatigue). The patient was treated with IBUPROFEN (ADVIL RELIVA) for Joint ache, at an unspecified dose and frequency. At the time of the report, INSOMNIA (getting less sleep), LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms), PAIN (pain in hips), FATIGUE (feeling fatigue) and ARTHRALGIA (right arm all of her joints began aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-104631 (Patient Link).   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: slightly sore arm; pain in neck; pain in arms; pain in hips; feeling fatigue; right arm all of her joints began aching; getting less sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (getting less sleep), LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms) and PAIN (pain in hips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (getting less sleep) and ARTHRALGIA (right arm all of her joints began aching). On an unknown date, the patient experienced LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms), PAIN (pain in hips) and FATIGUE (feeling fatigue). The patient was treated with IBUPROFEN (ADVIL RELIVA) for Joint ache, at an unspecified dose and frequency. At the time of the report, INSOMNIA (getting less sleep), LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms), PAIN (pain in hips), FATIGUE (feeling fatigue) and ARTHRALGIA (right arm all of her joints began aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-104631 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) 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 HYPERTENSION (High blood pressure). At the time of the report, HYPERTENSION (High blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Weight increased
Clinical narrative: Weight gain; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Covid-19 antibody test negative) and WEIGHT INCREASED (Weight gain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included CLL, Drug allergy, Blood pressure high and Weight gain. Concomitant products included OLMESARTAN for Blood pressure high, IBRUTINIB (IMBRUVICA) from 20-Jan-2019 to 08-Mar-2021 and VENETOCLAX from an unknown date to 08-Mar-2021 for CLL.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Covid-19 antibody test negative). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Covid-19 antibody test negative) and WEIGHT INCREASED (Weight gain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 antibody test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Hypoglycaemia
Clinical narrative: blood sugar levels had decreased without insulin; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (blood sugar levels had decreased without insulin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced HYPOGLYCAEMIA (blood sugar levels had decreased without insulin). At the time of the report, HYPOGLYCAEMIA (blood sugar levels had decreased without insulin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Blood glucose: decreased (Low) Blood glucose decreased.         No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: No new information.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug level decreased, Headache
Clinical narrative: Headache; possibly no/not enough Humira was on patient system; This spontaneous case was reported by a physician and describes the occurrence of DRUG LEVEL DECREASED (possibly no/not enough Humira was on patient system) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Alcohol use (one or two drinks, variety, occasionally) from 1974 to 2019. Concurrent medical conditions included Crohn's disease. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal).   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DRUG LEVEL DECREASED (possibly no/not enough Humira was on patient system). On 17-Mar-2021, the patient experienced HEADACHE (Headache). On 18-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, DRUG LEVEL DECREASED (possibly no/not enough Humira was on patient system) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15 Mar 2021, blood work was performed to determine if adalimumab was in the patient's system (results not provided).  Treatment information was not provided. On 16 Apr 2021, the patient received his second dose of mRNA-1273 (Moderna COVID-19 Vaccine) intramuscularly (lot number 027B21A, expiration date 18 Sep 2021).  Therefore, the action taken in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (small joint pain in hands), MYALGIA (diffuse muscle pain), PYREXIA (mild fever), FATIGUE (fatigue) and HEADACHE (headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008821-2A and 032M20A) for COVID-19 vaccination.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included METHYLPHENIDATE HCL, TAMSULOSIN, TRAZODONE and GABAPENTIN for an unknown indication.  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (mild fever). On an unknown date, the patient experienced ARTHRALGIA (small joint pain in hands), MYALGIA (diffuse muscle pain), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, ARTHRALGIA (small joint pain in hands), MYALGIA (diffuse muscle pain), PYREXIA (mild fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 38.2 degree Celsius High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the drug was not applicable. The patients  treatment medication information included 1000mg of Tylenol first episode 9:00AM second 3:30PM. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (small joint pain in hands), MYALGIA (diffuse muscle pain), PYREXIA (mild fever), FATIGUE (fatigue) and HEADACHE (headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008821-2A and 032M20A) for COVID-19 vaccination.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included METHYLPHENIDATE HCL, TAMSULOSIN, TRAZODONE and GABAPENTIN for an unknown indication.  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (mild fever). On an unknown date, the patient experienced ARTHRALGIA (small joint pain in hands), MYALGIA (diffuse muscle pain), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, ARTHRALGIA (small joint pain in hands), MYALGIA (diffuse muscle pain), PYREXIA (mild fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 38.2 degree Celsius High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the drug was not applicable. The patients  treatment medication information included 1000mg of Tylenol first episode 9:00AM second 3:30PM. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.