chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: rash at injection site; rash on forehead; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) and RASH (rash on forehead) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and RASH (rash on forehead). At the time of the report, VACCINATION SITE RASH (rash at injection site) and RASH (rash on forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications provided  Treatment medication was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Rash
Clinical narrative: achey in legs and head/sore arm; body aches and still has them; real fatigued for a couple days; rash size of quarter on her buttcheek; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (achey in legs and head), RASH (rash size of quarter on her buttcheek), VACCINATION SITE PAIN (sore arm), MYALGIA (body aches and still has them) and FATIGUE (real fatigued for a couple days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced RASH (rash size of quarter on her buttcheek) and VACCINATION SITE PAIN (sore arm). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (achey in legs and head), MYALGIA (body aches and still has them) and FATIGUE (real fatigued for a couple days). On 22-Mar-2021, RASH (rash size of quarter on her buttcheek) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (achey in legs and head), MYALGIA (body aches and still has them) and FATIGUE (real fatigued for a couple days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. Treatment history includes Advil and Tylenol.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter address, Vaccine lot numbers and dates, pt height/weight, race, PMH, product history, event narrative and outcome.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed second vaccine dose (more than 3 months since first shot); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second vaccine dose (more than 3 months since first shot)) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 PRODUCT DOSE OMISSION ISSUE (missed second vaccine dose (more than 3 months since first shot)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second vaccine dose (more than 3 months since first shot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vomiting
Clinical narrative: React strongly to the second dose; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (React strongly to the second dose) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (React strongly to the second dose) and VOMITING (Vomiting). At the time of the report, ADVERSE REACTION (React strongly to the second dose) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was reporting their own adverse event and states that they read online that women react strongly to the second dose of the vaccine.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-118427, MOD-2021-073217 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: got cold; tired; fever of 101.2; threw up; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got cold), FATIGUE (tired), PYREXIA (fever of 101.2) and VOMITING (threw up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017321A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced NASOPHARYNGITIS (got cold), FATIGUE (tired) and PYREXIA (fever of 101.2). On 12-Apr-2021, PYREXIA (fever of 101.2) had resolved. At the time of the report, NASOPHARYNGITIS (got cold), FATIGUE (tired) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 160/100 (abnormal) 160/100. On an unknown date, Body temperature: 101.2 (High) 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: got cold; tired; fever of 101.2; threw up; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got cold), FATIGUE (tired), PYREXIA (fever of 101.2) and VOMITING (threw up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017321A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced NASOPHARYNGITIS (got cold), FATIGUE (tired) and PYREXIA (fever of 101.2). On 12-Apr-2021, PYREXIA (fever of 101.2) had resolved. At the time of the report, NASOPHARYNGITIS (got cold), FATIGUE (tired) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 160/100 (abnormal) 160/100. On an unknown date, Body temperature: 101.2 (High) 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash; Red itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red itchy rash) and RASH ERYTHEMATOUS (Red itchy rash) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL (COREG), ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and SPIRONOLACTONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH PRURITIC (Red itchy rash) and RASH ERYTHEMATOUS (Red itchy rash). At the time of the report, RASH PRURITIC (Red itchy rash) and RASH ERYTHEMATOUS (Red itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Afterwards I didn't notice anything, but if I touched the area or put my arm in a certain position, then i would notice sensitivity or discomfort.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Afterwards I didn't notice anything, but if I touched the area or put my arm in a certain position, then i would notice sensitivity or discomfort.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Afterwards I didn't notice anything, but if I touched the area or put my arm in a certain position, then i would notice sensitivity or discomfort.). At the time of the report, LIMB DISCOMFORT (Afterwards I didn't notice anything, but if I touched the area or put my arm in a certain position, then i would notice sensitivity or discomfort.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Nausea, Pain in extremity
Clinical narrative: woke up with conjunctivitis in both eyes; nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CONJUNCTIVITIS (woke up with conjunctivitis in both eyes) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea). On 11-Apr-2021, the patient experienced CONJUNCTIVITIS (woke up with conjunctivitis in both eyes). At the time of the report, PAIN IN EXTREMITY (sore arm), CONJUNCTIVITIS (woke up with conjunctivitis in both eyes) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and CHILLS (Chills) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-Jun-2021 and does not contain any new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vertigo
Clinical narrative: Very tired; vertigo; the arm which was injected was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm which was injected was sore), VERTIGO (vertigo) and FATIGUE (Very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date. Previously administered products included for an unreported indication: Shingles. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ROSUVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 31-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (the arm which was injected was sore). On 01-Apr-2021, the patient experienced VERTIGO (vertigo). On an unknown date, the patient experienced FATIGUE (Very tired). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Vertigo, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (the arm which was injected was sore) had resolved, VERTIGO (vertigo) had not resolved and FATIGUE (Very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received her first Moderna Covid-19 dose at 1:15 pm on 31Mar2021 injected intramuscularly into her left, non-dominant arm.   Within three to five hours after the Moderna first dose, the arm which was injected was sore. The symptom resolved within three or four days later. Since the morning following the dose, she has had ongoing vertigo. She iced the sore arm and just tried not to lay on her left side. She has tried Dramamine for the vertigo symptom. She thinks that the Dramamine made her very tired. It was reported that She could not drive for a couple of days, because the vertigo was so bad. Because of the vertigo, she was crashing into furniture and having to hold onto walls while walking.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm hurt after second dose; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt after second dose) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt after second dose) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt after second dose) and FATIGUE (Tired) outcome was unknown. Not Provided          no concomitant medications are provided. Action taken with mRNA-1273 in response to the event was not applicable
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: when lift arm it bothers her a little bit; knot at injection site; warm to touch; arm is itchy; redness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (when lift arm it bothers her a little bit), VACCINATION SITE NODULE (knot at injection site), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (redness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (when lift arm it bothers her a little bit), VACCINATION SITE NODULE (knot at injection site), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, LIMB DISCOMFORT (when lift arm it bothers her a little bit), VACCINATION SITE NODULE (knot at injection site), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: shortness of breath; weakness; tired; Body aches; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 16B21A) 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12-04-2021:Reporter information filled, patient Date of birth and age added, product indication added, events and event assessment done, source document and email of follow-up added along with call center ref number, regulatory report scheduled On 11-May-2021: FU received, Patient not interested in further follow up
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: shortness of breath; weakness; tired; Body aches; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 16B21A) 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12-04-2021:Reporter information filled, patient Date of birth and age added, product indication added, events and event assessment done, source document and email of follow-up added along with call center ref number, regulatory report scheduled On 11-May-2021: FU received, Patient not interested in further follow up
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 10-Apr-2021.    This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Significant medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        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 Concomitant medications are provided Nurse also stated, that this could be a possible side effect from Moderna COVID-19 Vaccine.   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: shortness of breath; Dizziness; sweating; fever; nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating), PYREXIA (fever) and NAUSEA (nauseas) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     NO INFORMATION WAS UPDATED.  Concomitant products included PYRIDOXINE HYDROCHLORIDE, TRYPTOPHAN, L- (TRYPTOPHAN [PYRIDOXINE HYDROCHLORIDE;TRYPTOPHAN, L-]) from 01-Jan-2019 to an unknown date and LEPIDIUM MEYENII ROOT (MACA 2H) from 01-Jan-2019 to an unknown date for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (fever) and NAUSEA (nauseas). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and HYPERHIDROSIS (sweating). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (shortness of breath), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating), PYREXIA (fever) and NAUSEA (nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol for 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: follow-up received and added patient demographics, concomitant and treatment information, event outcome updated to recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: shortness of breath; Dizziness; sweating; fever; nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating), PYREXIA (fever) and NAUSEA (nauseas) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     NO INFORMATION WAS UPDATED.  Concomitant products included PYRIDOXINE HYDROCHLORIDE, TRYPTOPHAN, L- (TRYPTOPHAN [PYRIDOXINE HYDROCHLORIDE;TRYPTOPHAN, L-]) from 01-Jan-2019 to an unknown date and LEPIDIUM MEYENII ROOT (MACA 2H) from 01-Jan-2019 to an unknown date for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (fever) and NAUSEA (nauseas). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and HYPERHIDROSIS (sweating). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (shortness of breath), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating), PYREXIA (fever) and NAUSEA (nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol for 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: follow-up received and added patient demographics, concomitant and treatment information, event outcome updated to recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Head discomfort
Clinical narrative: head congestion; chest congestion; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (chest congestion) and DYSPNOEA (shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 24-Mar-2021, the patient experienced HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (chest congestion) and DYSPNOEA (shortness of breath). At the time of the report, HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (chest congestion) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: getting hives randomly; big red blotches on her arm, neck, and foot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (getting hives randomly) and RASH MACULAR (big red blotches on her arm, neck, and foot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Allergy to plants. Concomitant products included LORATADINE for Allergy, OMEPRAZOLE for Heartburn.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced URTICARIA (getting hives randomly) and RASH MACULAR (big red blotches on her arm, neck, and foot). At the time of the report, URTICARIA (getting hives randomly) had resolved and RASH MACULAR (big red blotches on her arm, neck, and foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has been getting hives randomly after getting the vaccine. She has gotten big red blotches on her arm, neck, and foot. When she rubbed her arm against a cardboard box, she got a hive on that spot.The hives last about 20 minutes.   Treatment medication was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm; nausea; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Dry eye syndrome.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (slight fever). In February 2021, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Severe leg pain during day and night; A lot of cramping even in bottom of feet; Lots of pain in right eye; Trouble seeing, blurry vision; Severe fatigue; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Lots of pain in right eye), VISION BLURRED (Trouble seeing, blurry vision), PAIN IN EXTREMITY (Severe leg pain during day and night), MUSCLE SPASMS (A lot of cramping even in bottom of feet) and FATIGUE (Severe fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. OZ9A21A and O16B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Severe fatigue) and MYALGIA (Muscle ache). On 18-Mar-2021, the patient experienced EYE PAIN (Lots of pain in right eye) and VISION BLURRED (Trouble seeing, blurry vision). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe leg pain during day and night) and MUSCLE SPASMS (A lot of cramping even in bottom of feet). The patient was treated with DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN/POLYMYXIN B/DEXAMETHASONE) (ophthalmic) at a dose of UNK UNK, q6h. At the time of the report, EYE PAIN (Lots of pain in right eye) was resolving, VISION BLURRED (Trouble seeing, blurry vision) had not resolved and PAIN IN EXTREMITY (Severe leg pain during day and night), MUSCLE SPASMS (A lot of cramping even in bottom of feet), FATIGUE (Severe fatigue) and MYALGIA (Muscle ache) outcome was unknown.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up document received on 15 Jul 2021. new events added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Severe leg pain during day and night; A lot of cramping even in bottom of feet; Lots of pain in right eye; Trouble seeing, blurry vision; Severe fatigue; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Lots of pain in right eye), VISION BLURRED (Trouble seeing, blurry vision), PAIN IN EXTREMITY (Severe leg pain during day and night), MUSCLE SPASMS (A lot of cramping even in bottom of feet) and FATIGUE (Severe fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. OZ9A21A and O16B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Severe fatigue) and MYALGIA (Muscle ache). On 18-Mar-2021, the patient experienced EYE PAIN (Lots of pain in right eye) and VISION BLURRED (Trouble seeing, blurry vision). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe leg pain during day and night) and MUSCLE SPASMS (A lot of cramping even in bottom of feet). The patient was treated with DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN/POLYMYXIN B/DEXAMETHASONE) (ophthalmic) at a dose of UNK UNK, q6h. At the time of the report, EYE PAIN (Lots of pain in right eye) was resolving, VISION BLURRED (Trouble seeing, blurry vision) had not resolved and PAIN IN EXTREMITY (Severe leg pain during day and night), MUSCLE SPASMS (A lot of cramping even in bottom of feet), FATIGUE (Severe fatigue) and MYALGIA (Muscle ache) outcome was unknown.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up document received on 15 Jul 2021. new events added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Sore arm; Diarrhea; mild headache; chills; fever; joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain) and NAUSEA (Nausea) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-124459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Updated dose 2 information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Diarrhea; mild headache; chills; fever; joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain) and NAUSEA (Nausea) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-124459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Updated dose 2 information.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of severe diarrhea in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027A21A) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient had severe diarrhea. At the time of the report, severe diarrhea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm warm to touch), VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore, couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy) and VACCINATION SITE PAIN (arm soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm warm to touch) and VACCINATION SITE PAIN (arm soreness). On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore, couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy), VACCINATION SITE ERYTHEMA (arm became very red), VACCINATION SITE SWELLING (arm became raised) and LYMPH NODE PAIN (a little tenderness in the lymph nodes). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 02-Apr-2021, VACCINATION SITE WARMTH (arm warm to touch) and VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore,couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy), VACCINATION SITE ERYTHEMA (arm became very red), VACCINATION SITE SWELLING (arm became raised) and LYMPH NODE PAIN (a little tenderness in the lymph nodes) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Further follow up consent denied.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm warm to touch), VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore, couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy) and VACCINATION SITE PAIN (arm soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm warm to touch) and VACCINATION SITE PAIN (arm soreness). On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore, couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy), VACCINATION SITE ERYTHEMA (arm became very red), VACCINATION SITE SWELLING (arm became raised) and LYMPH NODE PAIN (a little tenderness in the lymph nodes). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 02-Apr-2021, VACCINATION SITE WARMTH (arm warm to touch) and VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore,couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy), VACCINATION SITE ERYTHEMA (arm became very red), VACCINATION SITE SWELLING (arm became raised) and LYMPH NODE PAIN (a little tenderness in the lymph nodes) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Further follow up consent denied.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Feeling abnormal, Feeling cold, Feeling hot, Headache
Clinical narrative: wasn't feeling good at all; had 102degF temperature; really bad headache; next day, I was so sick; burning up; felt like I was freezing inside; had to call out from work; whole day I didn't eat anything; was in bed all day; arm hurt so bad; could not even lift up my arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (next day, I was so sick), FEELING HOT (burning up), FEELING COLD (felt like I was freezing inside), IMPAIRED WORK ABILITY (had to call out from work) and EATING DISORDER (whole day I didn't eat anything) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so bad) and LIMB DISCOMFORT (could not even lift up my arm). On 31-Mar-2021, the patient experienced ILLNESS (next day, I was so sick), FEELING HOT (burning up), FEELING COLD (felt like I was freezing inside), IMPAIRED WORK ABILITY (had to call out from work), EATING DISORDER (whole day I didn't eat anything), FEELING ABNORMAL (was in bed all day), PYREXIA (had 102degF temperature) and HEADACHE (really bad headache). On 01-Apr-2021, the patient experienced MALAISE (wasn't feeling good at all). At the time of the report, ILLNESS (next day, I was so sick), FEELING HOT (burning up), FEELING COLD (felt like I was freezing inside), IMPAIRED WORK ABILITY (had to call out from work), EATING DISORDER (whole day I didn't eat anything), FEELING ABNORMAL (was in bed all day), MALAISE (wasn't feeling good at all), PAIN IN EXTREMITY (arm hurt so bad), LIMB DISCOMFORT (could not even lift up my arm), PYREXIA (had 102degF temperature) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported  No treatment was reported