chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Injection site erythema, Insomnia
Clinical narrative: Abscess tooth; No Energy; Diarrhea; Chills all night; injection site red; injection site red and swollen; Injection site itchy; chills; Up all night; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TOOTH ABSCESS (Abscess tooth), ASTHENIA (No Energy), INSOMNIA (Up all night) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (Up all night) and CHILLS (chills). On 14-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy). On 15-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site red and swollen). On 23-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and CHILLS (Chills all night). On 24-Feb-2021, the patient experienced ASTHENIA (No Energy). On an unknown date, the patient experienced TOOTH ABSCESS (Abscess tooth). On 08-Feb-2021, INSOMNIA (Up all night) had resolved. On 09-Feb-2021, DIARRHOEA (diarrhea) and CHILLS (chills) had resolved. On 21-Feb-2021, VACCINATION SITE SWELLING (injection site red and swollen) had resolved. On 23-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, TOOTH ABSCESS (Abscess tooth), ASTHENIA (No Energy), VACCINATION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and CHILLS (Chills all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. Concomitant medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: follow up information received it does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Abscess tooth; No Energy; Diarrhea; Chills all night; injection site red; injection site red and swollen; Injection site itchy; chills; Up all night; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TOOTH ABSCESS (Abscess tooth), ASTHENIA (No Energy), INSOMNIA (Up all night) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (Up all night) and CHILLS (chills). On 14-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy). On 15-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site red and swollen). On 23-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and CHILLS (Chills all night). On 24-Feb-2021, the patient experienced ASTHENIA (No Energy). On an unknown date, the patient experienced TOOTH ABSCESS (Abscess tooth). On 08-Feb-2021, INSOMNIA (Up all night) had resolved. On 09-Feb-2021, DIARRHOEA (diarrhea) and CHILLS (chills) had resolved. On 21-Feb-2021, VACCINATION SITE SWELLING (injection site red and swollen) had resolved. On 23-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, TOOTH ABSCESS (Abscess tooth), ASTHENIA (No Energy), VACCINATION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and CHILLS (Chills all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. Concomitant medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: follow up information received it does not contain any new information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Site of the injection it is bumpy; Site of the injection a little itchy; Site of the injection it is red; Painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful), VACCINATION SITE MASS (Site of the injection it is bumpy), VACCINATION SITE PRURITUS (Site of the injection a little itchy) and VACCINATION SITE ERYTHEMA (Site of the injection it is red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful). On an unknown date, the patient experienced VACCINATION SITE MASS (Site of the injection it is bumpy), VACCINATION SITE PRURITUS (Site of the injection a little itchy) and VACCINATION SITE ERYTHEMA (Site of the injection it is red). At the time of the report, PAIN IN EXTREMITY (Painful) had resolved and VACCINATION SITE MASS (Site of the injection it is bumpy), VACCINATION SITE PRURITUS (Site of the injection a little itchy) and VACCINATION SITE ERYTHEMA (Site of the injection it is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Product administered at inappropriate site, Vaccination site erythema, Vaccination site movement impairment
Clinical narrative: Bursitis on site of injection; Injection was given too high on shoulder; Restricted movement on injection site; redness on injection site; A spontaneous report was received from a physician concerning a 63-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) too high on the shoulder (product administered at inappropriate site) and developed bursitis and redness on injection site (vaccination site erythema) and restricted movement (vaccination site movement impairment).   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.  On 19 Feb,2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19, Feb 2021, the patient received Moderna's COVID-19 Vaccine (mRNA-1273) too high on the shoulder and developed bursitis and redness on injection site and restricted movement. Treatment for the event was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event, vaccine was given too high on the shoulder, was considered resolved. The outcome of the events, developed bursitis and redness at the injection site and restricted movement, were considered unknown.; Reporter'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Her arm got red; swelling that spread to inner arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Her arm got red) and PERIPHERAL SWELLING (swelling that spread to inner arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Her arm got red) and PERIPHERAL SWELLING (swelling that spread to inner arm). At the time of the report, ERYTHEMA (Her arm got red) and PERIPHERAL SWELLING (swelling that spread to inner arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swollen at injection site, Looks like a mosquito bite; Red at injection site, Looks like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen at injection site, Looks like a mosquito bite) and VACCINATION SITE ERYTHEMA (Red at injection site, Looks like a mosquito bite) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at injection site, Looks like a mosquito bite) and VACCINATION SITE ERYTHEMA (Red at injection site, Looks like a mosquito bite). At the time of the report, VACCINATION SITE SWELLING (Swollen at injection site, Looks like a mosquito bite) and VACCINATION SITE ERYTHEMA (Red at injection site, Looks like a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extrasystoles, Fatigue, Feeling abnormal, Fibromyalgia
Clinical narrative: Fever; Chills; Headache; Extreme fatigue; Pain all over her body; After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.; Hasn't felt good for 7 weeks; Heart palpitations as if she had 10 cups of coffee; Racing/ skipping heartbeat for 8-9 days; Brain fogs; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days) and FEELING ABNORMAL (Brain fogs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days), FEELING ABNORMAL (Brain fogs), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Pain all over her body). On 14-Jan-2021, the patient experienced PYREXIA (Fever ). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 UNK. At the time of the report, FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), FEELING ABNORMAL (Brain fogs), PYREXIA (Fever ), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Pain all over her body) outcome was unknown and EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's fibromyalgia was controlled before the vaccine with supplements and a special diet. After vaccination, she restarted Tylenol around the clock to treat her pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Palpitations, Pyrexia
Clinical narrative: Fever; Chills; Headache; Extreme fatigue; Pain all over her body; After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.; Hasn't felt good for 7 weeks; Heart palpitations as if she had 10 cups of coffee; Racing/ skipping heartbeat for 8-9 days; Brain fogs; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days) and FEELING ABNORMAL (Brain fogs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days), FEELING ABNORMAL (Brain fogs), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Pain all over her body). On 14-Jan-2021, the patient experienced PYREXIA (Fever ). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 UNK. At the time of the report, FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), FEELING ABNORMAL (Brain fogs), PYREXIA (Fever ), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Pain all over her body) outcome was unknown and EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's fibromyalgia was controlled before the vaccine with supplements and a special diet. After vaccination, she restarted Tylenol around the clock to treat her pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Pain in extremity
Clinical narrative: reaction; Soreness in arm; This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE REACTION (reaction) and PAIN IN EXTREMITY (Soreness in arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM;COLECALCIFEROL]) for Prevention.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (reaction) and PAIN IN EXTREMITY (Soreness in arm). At the time of the report, ADVERSE REACTION (reaction) and PAIN IN EXTREMITY (Soreness in 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.   Treatment information was not provided.   This case was linked to MOD-2021-031439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Follow-up information received on 31-MAR-2021 contains significant information- Patient contact details, patient demographics, concomitant medications, event added. On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in the arm; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling in the arm) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm). At the time of the report, PERIPHERAL SWELLING (Swelling in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Non significant follow up: Contact details updated
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation, Fatigue
Clinical narrative: had all the symptoms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (had all the symptoms) and FATIGUE (fatigue) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (had all the symptoms) and FATIGUE (fatigue). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (had all the symptoms) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Poor quality sleep
Clinical narrative: Hurt all over; more than normal. I hurt all the way down, from my shoulders all the way down to; Exaggerated (compared to normal) arthritic pain; Didn't sleep well last night; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Didn't sleep well last night), PAIN (Hurt all over; more than normal. I hurt all the way down, from my shoulders all the way down to) and ARTHRALGIA (Exaggerated (compared to normal) arthritic pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced POOR QUALITY SLEEP (Didn't sleep well last night) and ARTHRALGIA (Exaggerated (compared to normal) arthritic pain). On an unknown date, the patient experienced PAIN (Hurt all over; more than normal. I hurt all the way down, from my shoulders all the way down to). At the time of the report, POOR QUALITY SLEEP (Didn't sleep well last night), PAIN (Hurt all over; more than normal. I hurt all the way down, from my shoulders all the way down to) and ARTHRALGIA (Exaggerated (compared to normal) arthritic pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used were Lisinopril 5mg and Gabapentin 100mg BID. Treatment information were not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Tinnitus
Clinical narrative: low today; my ears started ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (my ears started ringing) and MALAISE (low today) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced TINNITUS (my ears started ringing). On 26-Feb-2021, the patient experienced MALAISE (low today). At the time of the report, TINNITUS (my ears started ringing) and MALAISE (low today) 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.   Concomitant medication details were not provided. Treatment details were not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Body aches; Bad cough; Positive SARS-CoV-2 test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2 test), PAIN (Body aches) and COUGH (Bad cough) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEPRAZOLE, LOSARTAN, METOPROLOL, HYDROCHLOROTHIAZIDE, WARFARIN and ROSUVASTATIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2 test). On 19-Feb-2021, the patient experienced PAIN (Body aches) and COUGH (Bad cough). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 11-Feb-2021, SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2 test) outcome was unknown. At the time of the report, PAIN (Body aches) and COUGH (Bad cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: 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.   Treatment details included (1) unspecified infusion.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Rash erythematous
Clinical narrative: Red rash; Developed delayed cutaneous hypersensitivity Covid arm rash on the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Developed delayed cutaneous hypersensitivity Covid arm rash on the arm of injection) and RASH ERYTHEMATOUS (Red rash) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Bladder cancer (Patient was dealing with a catheter and the possibility of more surgery and chemo.). Concurrent medical conditions included Drug allergy (HCTZ). Concomitant products included TOCAINIDE, METOPROLOL SUCCINATE (TOPROL), ATORVASTATIN, RIVAROXABAN (XARELTO), MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and FLECAINIDE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DERMATITIS ALLERGIC (Developed delayed cutaneous hypersensitivity Covid arm rash on the arm of injection). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash). At the time of the report, DERMATITIS ALLERGIC (Developed delayed cutaneous hypersensitivity Covid arm rash on the arm of injection) and RASH ERYTHEMATOUS (Red rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DERMATITIS ALLERGIC (Developed delayed cutaneous hypersensitivity Covid arm rash on the arm of injection) to be possibly related. No further causality assessment was provided for RASH ERYTHEMATOUS (Red rash).    No concomitant medication information was provided  No treatment medications were reported.  On 03 JUL 2021 patients wife reported that her husband just had surgery for bladder cancer and we are consumed at the moment with recovery, dealing with a catheter and the possibility of more surgery and chemo.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Follow up information received on 03 JUL 2021. Procedural history (Bladder cancer) was updated. On 13-Jul-2021: Live follow up information received on 13 JUL 2021. Patient demographic (height, weight), suspect product details (Anatomical Location), event details (Rash erythematous), event outcome, concomitant medications, causality of the event Dermatitis allergic was possible were updated.
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: Muscle Atrophy, size of a quarter at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE ATROPHY (Muscle Atrophy, size of a quarter at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCLE ATROPHY (Muscle Atrophy, size of a quarter at injection site). At the time of the report, MUSCLE ATROPHY (Muscle Atrophy, size of a quarter at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Lip dry, Lip swelling, Noninfective gingivitis
Clinical narrative: Extreme weakness; Swelled lower lip; Inflammation in lower gum; lower lip is swelled up too and very dry; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extreme weakness), LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum), LIP DRY (lower lip is swelled up too and very dry) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Joint pain and Back pain. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and CELECOXIB (CELEBREX) for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 18-Feb-2021, the patient experienced ASTHENIA (Extreme weakness), LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum) and LIP DRY (lower lip is swelled up too and very dry). On 17-Feb-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 18-Feb-2021, ASTHENIA (Extreme weakness) had resolved. At the time of the report, LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum) and LIP DRY (lower lip is swelled up too and very dry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant medications included Unspecified medicines for joint pain, back pain and reflux  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non-Significant Follow up received: Reporter contact information updated
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme weakness; Swelled lower lip; Inflammation in lower gum; lower lip is swelled up too and very dry; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extreme weakness), LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum), LIP DRY (lower lip is swelled up too and very dry) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Joint pain and Back pain. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and CELECOXIB (CELEBREX) for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 18-Feb-2021, the patient experienced ASTHENIA (Extreme weakness), LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum) and LIP DRY (lower lip is swelled up too and very dry). On 17-Feb-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 18-Feb-2021, ASTHENIA (Extreme weakness) had resolved. At the time of the report, LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum) and LIP DRY (lower lip is swelled up too and very dry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant medications included Unspecified medicines for joint pain, back pain and reflux  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non-Significant Follow up received: Reporter contact information updated
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eyelid disorder, Eyelid irritation, Fatigue, Ocular hyperaemia
Clinical narrative: eyelid swollen; eye red; eyelid red; eyelid warm to touch; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch) and PYREXIA (fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch), PYREXIA (fever) and FATIGUE (tired). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: eyelid swollen; eye red; eyelid red; eyelid warm to touch; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch) and PYREXIA (fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch), PYREXIA (fever) and FATIGUE (tired). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pain, Pyrexia
Clinical narrative: Chest pain; Pain in neck and shoulder; High Temp 103 F; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN (Pain in neck and shoulder) and PYREXIA (High Temp 103 F) in a 74-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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced CHEST PAIN (Chest pain), PAIN (Pain in neck and shoulder) and PYREXIA (High Temp 103 F). On 31-Jan-2021, CHEST PAIN (Chest pain), PAIN (Pain in neck and shoulder) and PYREXIA (High Temp 103 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 103 f (High) High Temp 103 F.         No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Malaise, Pain
Clinical narrative: Cannot move around; Aching so bad; I feel horrible; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feel like have covid again, aching so bad, cannot move around and feel horrible.  The patient's medical history was not provided. Concomitant medications reported were Metformin, Lantus, Humalog for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the events feel like have covid again, aching so bad, cannot move around and feel horrible.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feel like have covid again, aching so bad, cannot move around and feel horrible was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Hyperhidrosis, Vaccination site pain
Clinical narrative: Sweating; shortness of breath; coughing; felt tired; soreness on site of infection; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), DYSPNOEA (shortness of breath), COUGH (coughing), FATIGUE (felt tired) and VACCINATION SITE PAIN (soreness on site of infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Fibromyalgia.   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) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), DYSPNOEA (shortness of breath), COUGH (coughing), FATIGUE (felt tired) and VACCINATION SITE PAIN (soreness on site of infection). At the time of the report, HYPERHIDROSIS (Sweating), DYSPNOEA (shortness of breath), FATIGUE (felt tired) and VACCINATION SITE PAIN (soreness on site of infection) outcome was unknown and COUGH (coughing) had not resolved.            NO concomitant was provided. Patient treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up  received and contains medical history, second dose date .
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Leakage during administration; Needle hub was not fully connected to syringe; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Leakage during administration) and DEVICE CONNECTION ISSUE (Needle hub was not fully connected to syringe) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced UNDERDOSE (Leakage during administration) and DEVICE CONNECTION ISSUE (Needle hub was not fully connected to syringe). On 26-Feb-2021, UNDERDOSE (Leakage during administration) and DEVICE CONNECTION ISSUE (Needle hub was not fully connected to syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: hot; itchy; the injection site arm swollen; red; it was nothing; it was achy or whatever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it was achy or whatever), INJECTION SITE WARMTH (hot), PAIN (it was nothing), INJECTION SITE PRURITUS (itchy) and INJECTION SITE SWELLING (the injection site arm swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, SPIRONOLACTONE, VENLAFAXINE, CARVEDILOL, ATORVASTATIN, POTASSIUM CHLORIDE, METFORMIN, FUROSEMIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN), TRAZODONE and LEVOMEFOLIC ACID for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (it was achy or whatever) and PAIN (it was nothing). On 24-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itchy), INJECTION SITE SWELLING (the injection site arm swollen) and INJECTION SITE ERYTHEMA (red). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 1 dosage form. At the time of the report, PAIN (it was achy or whatever), INJECTION SITE WARMTH (hot), PAIN (it was nothing), INJECTION SITE PRURITUS (itchy), INJECTION SITE SWELLING (the injection site arm swollen) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Receive 2 doses of the moderna vaccine within a 10minute period of each other; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receive 2 doses of the moderna vaccine within a 10minute period of each other) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 mg. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 mg. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receive 2 doses of the moderna vaccine within a 10minute period of each other). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at an unspecified dose and frequency. On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receive 2 doses of the moderna vaccine within a 10minute period of each other) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is on blood pressure concomitant medications.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Received Follow up 30 MAR 2021: Updated reporter Email address. Patient demography and Medical history. Lot/Batch number of vaccine, Dose units, Anatomical site and route of administration. Treatment medication reported. On 15-Jul-2021: Non-Significant Follow-up Appended on 15 JUL 2021: No new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Urticaria
Clinical narrative: Broke out in hives; Trouble breathing, shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Trouble breathing, shortness of breath) and URTICARIA (Broke out in hives) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced DYSPHONIA (Trouble breathing, shortness of breath). On 24-Feb-2021, the patient experienced URTICARIA (Broke out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 24-Feb-2021, URTICARIA (Broke out in hives) had resolved. At the time of the report, DYSPHONIA (Trouble breathing, shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Irritability, Nausea, Pain in extremity
Clinical narrative: Feel a little fussy; A lot of pain in my left arm to my shoulder and fingers; Vomit, vomited for about 20 minutes; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Feel a little fussy), PAIN IN EXTREMITY (A lot of pain in my left arm to my shoulder and fingers), VOMITING (Vomit, vomited for about 20 minutes), NAUSEA (Nausea) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN B NOS and COLECALCIFEROL (D) for an unknown indication.   On 04-Feb-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 04-Feb-2021, the patient experienced IRRITABILITY (Feel a little fussy), PAIN IN EXTREMITY (A lot of pain in my left arm to my shoulder and fingers), VOMITING (Vomit, vomited for about 20 minutes), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 04-Feb-2021, IRRITABILITY (Feel a little fussy), VOMITING (Vomit, vomited for about 20 minutes) and NAUSEA (Nausea) had resolved. On 07-Feb-2021, PAIN IN EXTREMITY (A lot of pain in my left arm to my shoulder and fingers) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 contains non-significant information (Contact information updated).