chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 73-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 Diabetes since an unknown date and Gastroesophageal reflux. Concurrent medical conditions included Drug allergy (allergic to naproxen), Drug allergy (allergic to gabapentin), Allergic reaction to antibiotics (allergic to clindamycin), Drug allergy (allergic to lyrica) and Blood pressure high. Concomitant products included LISINOPRIL, METFORMIN, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CITALOPRAM and TRAZODONE for an unknown indication.    On 17-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021 at 4:00 AM, the patient experienced DIARRHOEA (Diarrhea). On 21-Mar-2021, DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Diarrhea was frequent for three days including overnight. The fourth day was just one time. No treatment information was provided.   This case was linked to MOD-2021-116306 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Patient demographics updated, medical history updated, concomitant medications updated, Action taken with Moderna vaccine, outcome of the event updated from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: an injection was done in the glutinous muscle; A spontaneous report was received from a nurse concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate route of vaccination that was at glutinious muscle instead of deltoid muscle  The patient's medical history is not provided.  On 19 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown)  in the glutinous muscle for prophylaxis of COVID-19 infection.   On 19 Mar 2021, prior to receiving mRNA-1273, HCP called asking for alternative injection site location, after speaking to her she stated that an injection was done in glutinous muscle.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was considered as unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: temperature of 101.5; muscle pain; joint pain; nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 101.5), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Mar-2021, the patient experienced PYREXIA (temperature of 101.5), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 101.5), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) outcome was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Arm felt warm; Redness; Arm felt hard; Headache; Tender; Felt lymph nodes under her armpit, swollen and tender; Hardness; Swollen arm at injection site; Felt feverish; Chills; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm felt warm), PAIN IN EXTREMITY (Tender), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard) and LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swollen arm at injection site), PYREXIA (Felt feverish), CHILLS (Chills), ARTHRALGIA (Joint pain) and the first episode of HEADACHE (Headache). On 16-Mar-2021, the patient experienced LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Tender). On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm felt warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard) and the second episode of HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swollen arm at injection site), PYREXIA (Felt feverish), CHILLS (Chills) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm felt warm), PAIN IN EXTREMITY (Tender), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard), LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender) and the last episode of HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm felt warm; Redness; Arm felt hard; Headache; Tender; Felt lymph nodes under her armpit, swollen and tender; Hardness; Swollen arm at injection site; Felt feverish; Chills; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm felt warm), PAIN IN EXTREMITY (Tender), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard) and LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swollen arm at injection site), PYREXIA (Felt feverish), CHILLS (Chills), ARTHRALGIA (Joint pain) and the first episode of HEADACHE (Headache). On 16-Mar-2021, the patient experienced LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Tender). On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm felt warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard) and the second episode of HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swollen arm at injection site), PYREXIA (Felt feverish), CHILLS (Chills) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm felt warm), PAIN IN EXTREMITY (Tender), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard), LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender) and the last episode of HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after the 1st dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 1st dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after the 1st dose of the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm after the 1st dose of the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication provided.  No treatment drugs were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore Throat; Chills; Muscle Ache; Sore Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), MYALGIA (Muscle Ache) and VACCINATION SITE PAIN (Sore Injection Site) in a 65-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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), MYALGIA (Muscle Ache) and VACCINATION SITE PAIN (Sore Injection Site). In February 2021, OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), MYALGIA (Muscle Ache) and VACCINATION SITE PAIN (Sore Injection Site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken to  mRNA-1273 (Moderna COVID-19 Vaccine) not applicable. Concomitant and treatment information were not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Feeling hot, Hypoaesthesia
Clinical narrative: Felt "loopy and drunk; Face is Numb; Face is hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (Felt "loopy and drunk), HYPOAESTHESIA (Face is Numb) and FEELING HOT (Face is hot) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING DRUNK (Felt "loopy and drunk), HYPOAESTHESIA (Face is Numb) and FEELING HOT (Face is hot). At the time of the report, FEELING DRUNK (Felt "loopy and drunk), HYPOAESTHESIA (Face is Numb) and FEELING HOT (Face is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were prolided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhinalgia
Clinical narrative: pain in the forehead and the bone of the nose; pain in the forehead and the bone of the nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINALGIA (pain in the forehead and the bone of the nose) and HEADACHE (pain in the forehead and the bone of the nose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced RHINALGIA (pain in the forehead and the bone of the nose) and HEADACHE (pain in the forehead and the bone of the nose). At the time of the report, RHINALGIA (pain in the forehead and the bone of the nose) and HEADACHE (pain in the forehead and the bone of the nose) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-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 VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided treatment was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-051618 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051618:Husband's case
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at injection (right arm); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection (right arm)) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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 10-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection (right arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, INJECTION SITE PAIN (pain at injection (right arm)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was unknown
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Renal pain
Clinical narrative: arm  soreness; back, kidney pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  soreness) and RENAL PAIN (back, kidney pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm  soreness) and RENAL PAIN (back, kidney pain). At the time of the report, PAIN IN EXTREMITY (arm  soreness) and RENAL PAIN (back, kidney pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; fever; body aches; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031321A) 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 18-Mar-2021, the patient experienced HEADACHE (headache), PYREXIA (fever), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PYREXIA (fever), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills) had not resolved. 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 medication was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of ARTHRALGIA (Joint Pain), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 05-Feb-2021, ARTHRALGIA (Joint Pain), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: arm was red; swollen; painful arm; red circle around the site of injection; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (arm was red), PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (painful arm) and VACCINATION SITE ERYTHEMA (red circle around the site of injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the site of injection). On an unknown date, the patient experienced ERYTHEMA (arm was red), PERIPHERAL SWELLING (swollen) and PAIN IN EXTREMITY (painful arm). At the time of the report, ERYTHEMA (arm was red), PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (painful arm) and VACCINATION SITE ERYTHEMA (red circle around the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up Information was received on 24-MAY-2021 : updated patient demographics, concomitant medicines, 2nd dose details updated, added new event Erythema, pain in extremity. updated outcome of events injection site erythema, peripheral swelling from unknown to Recovered
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 19-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet) and PAIN (Extreme pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain that resembles rotor cup issues). On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet), PAIN (Extreme pain), MYALGIA (Body aches), ARTHRALGIA (Joiint pain), CHILLS (Extreme chills), HEADACHE (Dull head ache) and PYREXIA (Feverish). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 600 milligram once a day and ACETAMINOPHEN at a dose of 500 milligram. On 19-Mar-2021, PAIN IN EXTREMITY (arm pain that resembles rotor cup issues) outcome was unknown. At the time of the report, SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet), PAIN (Extreme pain), MYALGIA (Body aches), ARTHRALGIA (Joiint pain), CHILLS (Extreme chills), HEADACHE (Dull head ache) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Heating pad under the feet conducted as a treatment for cold feet.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral coldness, Poor quality sleep, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet) and PAIN (Extreme pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain that resembles rotor cup issues). On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet), PAIN (Extreme pain), MYALGIA (Body aches), ARTHRALGIA (Joiint pain), CHILLS (Extreme chills), HEADACHE (Dull head ache) and PYREXIA (Feverish). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 600 milligram once a day and ACETAMINOPHEN at a dose of 500 milligram. On 19-Mar-2021, PAIN IN EXTREMITY (arm pain that resembles rotor cup issues) outcome was unknown. At the time of the report, SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet), PAIN (Extreme pain), MYALGIA (Body aches), ARTHRALGIA (Joiint pain), CHILLS (Extreme chills), HEADACHE (Dull head ache) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Heating pad under the feet conducted as a treatment for cold feet.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet) and PAIN (Extreme pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain that resembles rotor cup issues). On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet), PAIN (Extreme pain), MYALGIA (Body aches), ARTHRALGIA (Joiint pain), CHILLS (Extreme chills), HEADACHE (Dull head ache) and PYREXIA (Feverish). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 600 milligram once a day and ACETAMINOPHEN at a dose of 500 milligram. On 19-Mar-2021, PAIN IN EXTREMITY (arm pain that resembles rotor cup issues) outcome was unknown. At the time of the report, SUSPECTED COVID-19 (COVID), ASTHENIA (Don't feel very energetic), POOR QUALITY SLEEP (Couldn't even sleep), PERIPHERAL COLDNESS (Cold feet), PAIN (Extreme pain), MYALGIA (Body aches), ARTHRALGIA (Joiint pain), CHILLS (Extreme chills), HEADACHE (Dull head ache) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Heating pad under the feet conducted as a treatment for cold feet.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache
Clinical narrative: Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: 140/90 (High) elevated over 140/90 and high (High) risen to greater than 160/95.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided included blood pressure medications and diabetic medications.  No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE SWELLING (swollen arm), NAUSEA (nauseated) and FATIGUE (very tired) in a 39-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE SWELLING (swollen arm), NAUSEA (nauseated) and FATIGUE (very tired). In February 2021, VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE SWELLING (swollen arm), NAUSEA (nauseated) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: shoulder under the neck piece, started being sore and swollen and is painful while they showe; shoulder under the neck piece, started being sore and swollen and is painful while they showe; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder under the neck piece, started being sore and swollen and is painful while they showe) and JOINT SWELLING (shoulder under the neck piece, started being sore and swollen and is painful while they showe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medial history reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (shoulder under the neck piece, started being sore and swollen and is painful while they showe) and JOINT SWELLING (shoulder under the neck piece, started being sore and swollen and is painful while they showe). At the time of the report, ARTHRALGIA (shoulder under the neck piece, started being sore and swollen and is painful while they showe) 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pyrexia
Clinical narrative: sick for about a week; felt like she had the flu; low grade fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (sick for about a week), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (low grade fever) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No treatment information was provided by the reporter.  Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), TIZANIDINE, OXYCODONE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced MALAISE (sick for about a week), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MALAISE (sick for about a week), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medicines include Requip, Carbidopa/levodopa, Tizanidine ,Oxycodone, Symbicort, ProAir  Treatment medicines were not include  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD-2021-040719 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling very tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Feeling very tired). At the time of the report, FATIGUE (Feeling very tired) had not resolved.            No Concomitant medications were reported No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable    This case was linked to MOD-2021-051713 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: painful, can raise his arm up but it is painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful, can raise his arm up but it is painful) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (painful, can raise his arm up but it is painful). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (painful, can raise his arm up but it is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes blood pressure pill
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes Diabetes medicines treatment information includes Infusion of bam
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Diarrhoea
Clinical narrative: lower abdominal pain; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (lower abdominal pain) and DIARRHOEA (diarrhea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Diarrhea and Cholecystectomy (5 years ago his gallbladder was removed). Concurrent medical conditions included Diabetic.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 18-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal pain) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN LOWER (lower abdominal pain) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Sore arm; Was extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Was extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 003A21A) 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Was extremely tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Was extremely tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 antibody test: positive Positive.         The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling very tired, more so than after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling very tired, more so than after the first dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-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 FATIGUE (feeling very tired, more so than after the first dose). At the time of the report, FATIGUE (feeling very tired, more so than after the first dose) outcome was unknown.            No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-051704 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Incorrect route of product administration, Pain
Clinical narrative: administered incorrectly/ little to far into like the shoulder area; can't move her arm; lot of pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered incorrectly/ little to far into like the shoulder area), HYPOKINESIA (can't move her arm) and PAIN (lot of pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 14-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered incorrectly/ little to far into like the shoulder area), HYPOKINESIA (can't move her arm) and PAIN (lot of pain). On 14-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered incorrectly/ little to far into like the shoulder area) had resolved. At the time of the report, HYPOKINESIA (can't move her arm) and PAIN (lot of pain) had not resolved. Not Provided           Concomitant products included were blood pressure medication. No treatment medications were reported.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with AEs of hypokinesia and pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Myalgia
Clinical narrative: Dizziness; No appetite; Achy; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), MYALGIA (Achy) and FATIGUE (Exhausted) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), MYALGIA (Achy) and FATIGUE (Exhausted). At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), MYALGIA (Achy) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Lightheadedness, like vertigo when she stands up; Cannot get out of bed; Extreme Fatigue; Fever; Sweat; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat), DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed), NAUSEA (Nausea) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METFORMIN for an unknown indication.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPERHIDROSIS (Sweat), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 16-Mar-2021, the patient experienced DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed) and FATIGUE (Extreme Fatigue). At the time of the report, HYPERHIDROSIS (Sweat), DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Extreme Fatigue) and PYREXIA (Fever) outcome was unknown.            Other concomitant medications included Alavert for allergy, Herbal Supplement, Asthma medication.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Lightheadedness, like vertigo when she stands up; Cannot get out of bed; Extreme Fatigue; Fever; Sweat; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat), DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed), NAUSEA (Nausea) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METFORMIN for an unknown indication.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPERHIDROSIS (Sweat), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 16-Mar-2021, the patient experienced DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed) and FATIGUE (Extreme Fatigue). At the time of the report, HYPERHIDROSIS (Sweat), DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Extreme Fatigue) and PYREXIA (Fever) outcome was unknown.            Other concomitant medications included Alavert for allergy, Herbal Supplement, Asthma medication.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in my arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm). At the time of the report, PAIN IN EXTREMITY (Pain in my arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Illness, Nasopharyngitis, Nausea
Clinical narrative: feels dizzy; feeling really bad; freezer; Very sick; nauseous; throwing; A spontaneous report was received from a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels dizzy/ dizziness ,nauseous/ nausea, felt like she was going to pass out/loss of consciousness, throwing up/vomiting, feeling really bad/feeling abnormal, freezer and cold /nasopharyngitis and very sick/illness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 18 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On  19  Mar 2021, after receiving mRNA-1273, the patient felt dizzy ,nauseous and felt like she was going to pass out. She tried to talk on the phone but she was throwing up and feeling really bad. She was freezer and cold. Very sick. She's going to the ER right then.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, dizziness, nausea, loss of consciousness , vomiting ,feeling abnormal, nasopharyngitis and illness were not considered to be resolved at the time of the report.; 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 and a causal relationship cannot be excluded. Further information has been requested.