chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Body aches; rash is now over most of her torso but a lite rash; One degree fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), RASH (rash is now over most of her torso but a lite rash) and PYREXIA (One degree fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Laparoscopic surgery on 08-Apr-2021.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Body aches), RASH (rash is now over most of her torso but a lite rash) and PYREXIA (One degree fever). At the time of the report, PAIN (Body aches), RASH (rash is now over most of her torso but a lite rash) and PYREXIA (One degree fever) outcome was unknown.            Treatment information was not provided. No concomitant medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
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 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 05-Feb-2020 and Thrombus in September 2017. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Aug-2020 and the estimated date of delivery was 24-May-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 12-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: positive (Positive) Positive.         On 5-Feb-2020, the patient had a previous pregnancy end in live, full-term birth. On an unknown date, an ultrasound, glucose, and genetic testing was performed with unknown findings. Concomitant medication reported as blood thinner.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Somnolence
Clinical narrative: chills; nauseous; slept all day; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), FATIGUE (felt tired), CHILLS (chills) and NAUSEA (nauseous) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced SOMNOLENCE (slept all day) and FATIGUE (felt tired). On 10-Apr-2021, the patient experienced CHILLS (chills) and NAUSEA (nauseous). The patient was treated with CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM BICARBONATE (GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE;SODIUM BICARBONATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (slept all day), FATIGUE (felt tired), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: whole-body hurts; can hardly move arm; has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole-body hurts), PAIN IN EXTREMITY (can hardly move arm) and PYREXIA (has a temperature) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020. Concurrent medical conditions included Drug allergy (Codeine (nausea)).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (whole-body hurts), PAIN IN EXTREMITY (can hardly move arm) and PYREXIA (has a temperature). At the time of the report, PAIN (whole-body hurts), PAIN IN EXTREMITY (can hardly move arm) and PYREXIA (has a temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash, Rash pruritic
Clinical narrative: arm is achy and hurting; itchy rash; spot of 6 inches and 4 inches long rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm is achy and hurting), RASH PRURITIC (itchy rash) and RASH (spot of 6 inches and 4 inches long rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (arm is achy and hurting), RASH PRURITIC (itchy rash) and RASH (spot of 6 inches and 4 inches long rash). At the time of the report, INJECTION SITE PAIN (arm is achy and hurting), RASH PRURITIC (itchy rash) and RASH (spot of 6 inches and 4 inches long rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 021B21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), ATORVASTATIN CALCIUM (LIPITOR), CALCIUM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) outcome was unknown.            No Treatment information was reported.   This case was linked to MOD-2021-074969, MOD-2021-074969 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Paraesthesia
Clinical narrative: tingles on the left eye; dizziness; tired for a couple of days; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired for a couple of days), HEADACHE (headache), CHILLS (chills), PARAESTHESIA (tingles on the left eye) and DIZZINESS (dizziness) in a 51-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 (No medical history reported.).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (tired for a couple of days), HEADACHE (headache) and CHILLS (chills). On 11-Apr-2021, the patient experienced PARAESTHESIA (tingles on the left eye) and DIZZINESS (dizziness). At the time of the report, FATIGUE (tired for a couple of days), HEADACHE (headache), CHILLS (chills), PARAESTHESIA (tingles on the left eye) and DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took acetaminophen on 10-Apr-21 for treatment of headache.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LOSARTAN for Blood pressure, LEVOTHYROXINE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go). At the time of the report, TINNITUS (Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant FU TCR received : event outcome and patient contact information updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea
Clinical narrative: Patient started experiencing diarrhea on same day after receiving 1st dose; All day Friday, she didn't feel like eating; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Patient started experiencing diarrhea on same day after receiving 1st dose) and DECREASED APPETITE (All day Friday, she didn't feel like eating) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, VITAMIN D NOS, IRON, METFORMIN, OMEPRAZOLE, CARVEDILOL, LOSARTAN, ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA (Patient started experiencing diarrhea on same day after receiving 1st dose) and DECREASED APPETITE (All day Friday, she didn't feel like eating). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Patient started experiencing diarrhea on same day after receiving 1st dose) and DECREASED APPETITE (All day Friday, she didn't feel like eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: are was more tender than first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (are was more tender than first shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 2018.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (are was more tender than first shot). At the time of the report, VACCINATION SITE PAIN (are was more tender than first shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-074929 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling from below behind my knees and down the legs, it is a bubbly feeling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from below behind my knees and down the legs, it is a bubbly feeling) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling from below behind my knees and down the legs, it is a bubbly feeling). At the time of the report, PARAESTHESIA (tingling from below behind my knees and down the legs, it is a bubbly feeling) outcome was unknown. Not Provided          No concomitant medications were reported. No Treatments were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074983 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074983:2nd dose
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Peripheral swelling, Vomiting
Clinical narrative: Arm was swollen; vomiting; Sweats; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HYPERHIDROSIS (Sweats), HEADACHE (Headache) and PERIPHERAL SWELLING (Arm was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A. and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VOMITING (vomiting), HYPERHIDROSIS (Sweats) and HEADACHE (Headache). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm was swollen). At the time of the report, VOMITING (vomiting), HYPERHIDROSIS (Sweats) and HEADACHE (Headache) outcome was unknown and PERIPHERAL SWELLING (Arm was swollen) had not resolved. Not Provided          No concomitant medications were provided. No treatment details were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 2 significant spells, one 5 minutes after second dose of vaccine, causing patient to feel very dizzy and felt like passing out; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (2 significant spells, one 5 minutes after second dose of vaccine, causing patient to feel very dizzy and felt like passing out) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer, Thyroidectomy and Lupus anticoagulant hypoprothrombinemia syndrome since an unknown date. Concurrent medical conditions included Syncope vasovagal, Hashimoto's disease, Menopause and Sleep disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, ALLOPURINOL (ELAVIL [ALLOPURINOL]) for Menopause and Sleep disorder, MAGNESIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (2 significant spells, one 5 minutes after second dose of vaccine, causing patient to feel very dizzy and felt like passing out). The patient was treated with ALPRAZOLAM (XANAX) at a dose of 1 dosage form. On 02-Feb-2021, DIZZINESS (2 significant spells, one 5 minutes after second dose of vaccine, causing patient to feel very dizzy and felt like passing out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-074923 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Erythema, Gait inability, Gingival bleeding
Clinical narrative: Itching; Swelling; Redness; Bruising all over body, bruising on both ankles; Gums would bleed when she brushed her teeth; could not walk; Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments; Serious muscle and joint pain; Serious muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles) and GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Tetanus (Anaphylactic reaction). Concurrent medical conditions included Autoimmune disorder, Neurological disorder NOS, Gastrointestinal infection, Ulcer and Acid reflux (oesophageal). Concomitant products included FIDAXOMICIN (DIFICID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles), GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth), GAIT INABILITY (could not walk), LIGAMENT PAIN (Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments), ARTHRALGIA (Serious muscle and joint pain) and MYALGIA (Serious muscle and joint pain). At the time of the report, PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles), GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth), GAIT INABILITY (could not walk), LIGAMENT PAIN (Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments), ARTHRALGIA (Serious muscle and joint pain) and MYALGIA (Serious muscle and joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicines for ulcer and acid reflux.   Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ligament pain, Myalgia, Pruritus, Swelling
Clinical narrative: Itching; Swelling; Redness; Bruising all over body, bruising on both ankles; Gums would bleed when she brushed her teeth; could not walk; Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments; Serious muscle and joint pain; Serious muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles) and GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Tetanus (Anaphylactic reaction). Concurrent medical conditions included Autoimmune disorder, Neurological disorder NOS, Gastrointestinal infection, Ulcer and Acid reflux (oesophageal). Concomitant products included FIDAXOMICIN (DIFICID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles), GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth), GAIT INABILITY (could not walk), LIGAMENT PAIN (Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments), ARTHRALGIA (Serious muscle and joint pain) and MYALGIA (Serious muscle and joint pain). At the time of the report, PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles), GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth), GAIT INABILITY (could not walk), LIGAMENT PAIN (Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments), ARTHRALGIA (Serious muscle and joint pain) and MYALGIA (Serious muscle and joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicines for ulcer and acid reflux.   Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cerebral disorder, Depression, Headache, Pain
Clinical narrative: got really very very hyper; brain zaps which is a serotonin reaction in the brain; depression got worse; anxious; achy; immediately got a headache; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious) and PAIN (achy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM and BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, NIACIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for Depression, AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious), PAIN (achy) and HEADACHE (immediately got a headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious), PAIN (achy) and HEADACHE (immediately got a headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event/s was not applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow up received on 4-may-2021 contain no new information; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Psychomotor hyperactivity
Clinical narrative: got really very very hyper; brain zaps which is a serotonin reaction in the brain; depression got worse; anxious; achy; immediately got a headache; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious) and PAIN (achy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM and BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, NIACIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for Depression, AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious), PAIN (achy) and HEADACHE (immediately got a headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious), PAIN (achy) and HEADACHE (immediately got a headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event/s was not applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow up received on 4-may-2021 contain no new information; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: not getting the second dose; chills; very tired; headaches; muscle pain; nausea; vomiting; heart palpitations; lethargic; couldn't do anything for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), LETHARGY (lethargic), FEELING ABNORMAL (couldn't do anything for 2 weeks), PRODUCT DOSE OMISSION ISSUE (not getting the second dose) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-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 PALPITATIONS (heart palpitations), LETHARGY (lethargic), FEELING ABNORMAL (couldn't do anything for 2 weeks), CHILLS (chills), FATIGUE (very tired), HEADACHE (headaches), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not getting the second dose). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart palpitations), LETHARGY (lethargic), FEELING ABNORMAL (couldn't do anything for 2 weeks), CHILLS (chills), FATIGUE (very tired), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved, PRODUCT DOSE OMISSION ISSUE (not getting the second dose) outcome was unknown and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Product dose omission issue, Vomiting
Clinical narrative: not getting the second dose; chills; very tired; headaches; muscle pain; nausea; vomiting; heart palpitations; lethargic; couldn't do anything for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), LETHARGY (lethargic), FEELING ABNORMAL (couldn't do anything for 2 weeks), PRODUCT DOSE OMISSION ISSUE (not getting the second dose) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-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 PALPITATIONS (heart palpitations), LETHARGY (lethargic), FEELING ABNORMAL (couldn't do anything for 2 weeks), CHILLS (chills), FATIGUE (very tired), HEADACHE (headaches), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not getting the second dose). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart palpitations), LETHARGY (lethargic), FEELING ABNORMAL (couldn't do anything for 2 weeks), CHILLS (chills), FATIGUE (very tired), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved, PRODUCT DOSE OMISSION ISSUE (not getting the second dose) outcome was unknown and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good) and PYREXIA (she had a low grade fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE and DESVENLAFAXINE SUCCINATE (PRISTIQ) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good), PYREXIA (she had a low grade fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (throughout the day she feels exhausted / very very tired). At the time of the report, DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good), PYREXIA (she had a low grade fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (throughout the day she feels exhausted / very very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: No new information was provided in the source document.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good) and PYREXIA (she had a low grade fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE and DESVENLAFAXINE SUCCINATE (PRISTIQ) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good), PYREXIA (she had a low grade fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (throughout the day she feels exhausted / very very tired). At the time of the report, DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good), PYREXIA (she had a low grade fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (throughout the day she feels exhausted / very very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: No new information was provided in the source document.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), RHINORRHOEA (Runny Nose) and COUGH (Cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), RHINORRHOEA (Runny Nose) and COUGH (Cough). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), RHINORRHOEA (Runny Nose) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No Treatments were reported
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval of 17 days between shots; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of 17 days between shots) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of 17 days between shots). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of 17 days between shots) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060664 (E2B Linked Report). This case was linked to MOD-2021-086049 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060664:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year-old patient received the 1st Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old patient received the 1st Moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old patient received the 1st Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old patient received the 1st Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.  Medical history was not provided by reporter. Concomitant products included SYNTHROID, AMLODIPINE, METOPROLOL, ISOSORBIDE, ATORVASTATIN, VITAMINS, and ASPIRIN for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN. At the time of the report, PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-074967.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: sore neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sore neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced NECK PAIN (sore neck). At the time of the report, NECK PAIN (sore neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis pain in joints in body; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis pain in joints in body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis pain in joints in body). At the time of the report, ARTHRITIS (Arthritis pain in joints in body) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment medications were not provided. Action taken with the product mRNA-1273 was not Applicable
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH 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 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RASH. On 17-Mar-2021, RASH had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: very tired; Slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and HYPERSOMNIA (Slept all day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Drug allergy (codeine) and Contrast media allergy.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (very tired) and HYPERSOMNIA (Slept all day). At the time of the report, FATIGUE (very tired) and HYPERSOMNIA (Slept all day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.  Treatment information not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Oropharyngeal pain, Sinusitis
Clinical narrative: cough; Sore throat; acute bronchitis; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), BRONCHITIS (acute bronchitis), COUGH (cough) and OROPHARYNGEAL PAIN (Sore throat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 047B21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included ESTRADIOL, PROPRANOLOL, ATORVASTATIN, VITAMINE C and CALCIUM for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SINUSITIS (sinus infection). On 02-Apr-2021, the patient experienced BRONCHITIS (acute bronchitis). On an unknown date, the patient experienced COUGH (cough) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with DEXAMETHASONE 13-Apr-2021 at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; BENZONATATE for Cough, at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. On 19-Apr-2021, BRONCHITIS (acute bronchitis) had resolved. At the time of the report, SINUSITIS (sinus infection), COUGH (cough) and OROPHARYNGEAL PAIN (Sore throat) had resolved. Not Provided          Patient took steroid shot for sinus infection   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: completed ADR form
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: problem sleeping because of arm; can't put arm behind her back; a little bit swollen; arm has been hurting, it really hurts, it still hurts; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (problem sleeping because of arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't put arm behind her back), VACCINATION SITE SWELLING (a little bit swollen) and VACCINATION SITE PAIN (arm has been hurting, it really hurts, it still hurts) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007A21A and 031M20A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, ISOSORBIDE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMINS NOS for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INSOMNIA (problem sleeping because of arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't put arm behind her back), VACCINATION SITE SWELLING (a little bit swollen) and VACCINATION SITE PAIN (arm has been hurting, it really hurts, it still hurts). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, INSOMNIA (problem sleeping because of arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't put arm behind her back), VACCINATION SITE SWELLING (a little bit swollen) and VACCINATION SITE PAIN (arm has been hurting, it really hurts, it still hurts) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: decreased stamina; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (decreased stamina) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), ATORVASTATIN CALCIUM (LIPITOR), CALCIUM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (decreased stamina). At the time of the report, FATIGUE (decreased stamina) outcome was unknown.            No treatment details were provided.   This case was linked to MOD-2021-074941 (Patient Link).