chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngitis streptococcal, SARS-CoV-1 test, Sensation of foreign body
Clinical narrative: sore throat, but different; white bumps in her throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat, but different) and SENSATION OF FOREIGN BODY (white bumps in her throat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 081A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Diabetes mellitus.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat, but different) and SENSATION OF FOREIGN BODY (white bumps in her throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat, but different) and SENSATION OF FOREIGN BODY (white bumps in her throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pharyngitis streptococcal: negative Negative. On an unknown date, SARS-CoV-1 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 03-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) had 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-072040, MOD-2021-072040 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of product dose omission issue (she did not received the second since the Jan 15, 2021) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (she did not received the second since the Jan 15, 2021). At the time of the report, product dose omission issue (she did not received the second since the Jan 15, 2021) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication or treatment information reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), ERYTHEMA (redness), FEELING HOT (arm warm to touch) and PRURITUS (itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness), ERYTHEMA (redness), FEELING HOT (arm warm to touch) and PRURITUS (itchy). At the time of the report, PAIN IN EXTREMITY (Soreness), ERYTHEMA (redness), FEELING HOT (arm warm to touch) and PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site urticaria
Clinical narrative: 12 inch long hive area near injection site; Bruising around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising around injection site) and VACCINATION SITE URTICARIA (12 inch long hive area near injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruising around injection site). On 29-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (12 inch long hive area near injection site). On 31-Mar-2021, VACCINATION SITE URTICARIA (12 inch long hive area near injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruising around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Speech disorder, Vaccination site pain
Clinical narrative: tingling sensation; cannot talk straight; pain in left arm; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation), SPEECH DISORDER (cannot talk straight), VACCINATION SITE PAIN (pain in left arm) and NAUSEA (nauseous) in a 30-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling sensation), SPEECH DISORDER (cannot talk straight), VACCINATION SITE PAIN (pain in left arm) and NAUSEA (nauseous). At the time of the report, PARAESTHESIA (tingling sensation), SPEECH DISORDER (cannot talk straight), VACCINATION SITE PAIN (pain in left arm) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: A large open wound on shin of leg; This spontaneous case was reported by a consumer and describes the occurrence of WOUND (A large open wound on shin of leg) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WOUND (A large open wound on shin of leg). At the time of the report, WOUND (A large open wound on shin of leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not receive any treatment. Action taken with mRNA-1273 in response to the event was not applicable
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Discomfort, Dizziness, Fatigue, Nausea
Clinical narrative: General discomfort, nausea and dizziness; General discomfort, nausea and dizziness; Lack of apetite; Tiredness; General discomfort, nausea and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General discomfort, nausea and dizziness), DIZZINESS (General discomfort, nausea and dizziness), DECREASED APPETITE (Lack of apetite), FATIGUE (Tiredness) and NAUSEA (General discomfort, nausea and dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 30-Mar-2021, the patient experienced DISCOMFORT (General discomfort, nausea and dizziness), DIZZINESS (General discomfort, nausea and dizziness), DECREASED APPETITE (Lack of apetite), FATIGUE (Tiredness) and NAUSEA (General discomfort, nausea and dizziness). At the time of the report, DISCOMFORT (General discomfort, nausea and dizziness), DIZZINESS (General discomfort, nausea and dizziness), DECREASED APPETITE (Lack of apetite), FATIGUE (Tiredness) and NAUSEA (General discomfort, nausea and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.  on 2 Apr 2021, symptoms diminished except fatigue.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: wife is going on 60 days post-dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (wife is going on 60 days post-dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 PRODUCT DOSE OMISSION ISSUE (wife is going on 60 days post-dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (wife is going on 60 days post-dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date); This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-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 SARS-COV-2 TEST POSITIVE (Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date)). At the time of the report, SARS-COV-2 TEST POSITIVE (Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.; The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.) and RASH (The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 19-Mar-2021, the patient experienced URTICARIA (The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.) and RASH (The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, URTICARIA (The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.) and RASH (The rash and hives are full body mostly on his back and feet sometimes on his arm and chest.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Fatigue, Injection site hypersensitivity, Pyrexia
Clinical narrative: had a bad reaction; allergy reaction on shot area with the band aid; tiredness; chills; her friend also had a fever after the 2nd dose of Moderna covid vaccine that lasted for a day; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had a bad reaction), INJECTION SITE HYPERSENSITIVITY (allergy reaction on shot area with the band aid), PYREXIA (her friend also had a fever after the 2nd dose of Moderna covid vaccine that lasted for a day), FATIGUE (tiredness) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) 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) (unknown route) 1 dosage form. On an unknown date, 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 experienced ADVERSE REACTION (had a bad reaction), INJECTION SITE HYPERSENSITIVITY (allergy reaction on shot area with the band aid), PYREXIA (her friend also had a fever after the 2nd dose of Moderna covid vaccine that lasted for a day), FATIGUE (tiredness) and CHILLS (chills). At the time of the report, ADVERSE REACTION (had a bad reaction), INJECTION SITE HYPERSENSITIVITY (allergy reaction on shot area with the band aid), FATIGUE (tiredness) and CHILLS (chills) outcome was unknown and PYREXIA (her friend also had a fever after the 2nd dose of Moderna covid vaccine that lasted for a day) had resolved.            The caller stated that a friend of hers had a bad reaction and stated that she asked her friend to email Moderna regarding the adverse reaction. She stated that her friend also had a fever after the 2nd dose of Moderna covid vaccine that lasted for a day. No additional information was obtained as that was all the information the caller was able to provide. Treatment Unknown   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: one events and outcome of the events updated
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received COVID-19 vaccine while pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY. At the time of the report, EXPOSURE DURING PREGNANCY (received COVID-19 vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Calves were getting tight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Calves were getting tight) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Calves were getting tight). At the time of the report, PAIN IN EXTREMITY (Calves were getting tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment drugs were provided       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographics updated. second dose events added.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose 12Jan2021 has not gotten second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose 12Jan2021 has not gotten second dose yet) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CITALOPRAM for an unknown indication.    On 12-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 (first dose 12Jan2021 has not gotten second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose 12Jan2021 has not gotten second dose yet) had resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Blepharospasm, Decreased appetite, Flatulence
Clinical narrative: loss of appetite; Anxiety; extreme thirst; On and off GI problem; Gas; Stomach loudly numbling; eye twitching; Both toes have been tingling, feet and claves tingling; Both toes have been twitching, feet and calves began twitching; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Both toes have been tingling, feet and claves tingling), MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching), DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety) and THIRST (extreme thirst) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Mar-2021, the patient experienced PARAESTHESIA (Both toes have been tingling, feet and claves tingling) and MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety), THIRST (extreme thirst), GASTROINTESTINAL DISORDER (On and off GI problem), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach loudly numbling) and BLEPHAROSPASM (eye twitching). At the time of the report, PARAESTHESIA (Both toes have been tingling, feet and claves tingling), MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching), DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety), THIRST (extreme thirst), GASTROINTESTINAL DISORDER (On and off GI problem), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach loudly numbling) and BLEPHAROSPASM (eye twitching) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (UNKNOWN ROUTE), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: ADR appended
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Muscle twitching, Paraesthesia, Thirst
Clinical narrative: loss of appetite; Anxiety; extreme thirst; On and off GI problem; Gas; Stomach loudly numbling; eye twitching; Both toes have been tingling, feet and claves tingling; Both toes have been twitching, feet and calves began twitching; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Both toes have been tingling, feet and claves tingling), MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching), DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety) and THIRST (extreme thirst) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Mar-2021, the patient experienced PARAESTHESIA (Both toes have been tingling, feet and claves tingling) and MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety), THIRST (extreme thirst), GASTROINTESTINAL DISORDER (On and off GI problem), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach loudly numbling) and BLEPHAROSPASM (eye twitching). At the time of the report, PARAESTHESIA (Both toes have been tingling, feet and claves tingling), MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching), DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety), THIRST (extreme thirst), GASTROINTESTINAL DISORDER (On and off GI problem), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach loudly numbling) and BLEPHAROSPASM (eye twitching) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (UNKNOWN ROUTE), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: ADR appended
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Myalgia, Pain in extremity
Clinical narrative: stomach ache; vomiting; body ache; headache; 102°F fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE for Sinus infection, ESTRADIOL and PROGESTERONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache), HEADACHE (headache) and PYREXIA (102°F fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache), HEADACHE (headache) and PYREXIA (102°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high.         Concomitant medications included Antibiotics and Cough syrup with Codeine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: stomach ache; vomiting; body ache; headache; 102°F fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE for Sinus infection, ESTRADIOL and PROGESTERONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache), HEADACHE (headache) and PYREXIA (102°F fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache), HEADACHE (headache) and PYREXIA (102°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high.         Concomitant medications included Antibiotics and Cough syrup with Codeine.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in her left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced TINNITUS. At the time of the report, TINNITUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Vaccination site pruritus
Clinical narrative: Twitching Deltoid Muscle Injection Site (Visible); Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching Deltoid Muscle Injection Site (Visible)) and VACCINATION SITE PRURITUS (Itching Injection Site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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 26-Mar-2021, the patient experienced MUSCLE TWITCHING (Twitching Deltoid Muscle Injection Site (Visible)) and VACCINATION SITE PRURITUS (Itching Injection Site). On 31-Mar-2021, VACCINATION SITE PRURITUS (Itching Injection Site) had resolved. At the time of the report, MUSCLE TWITCHING (Twitching Deltoid Muscle Injection Site (Visible)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received and it contains No New Information
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Insomnia
Clinical narrative: sleepless nights; loss of taste; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless nights), AGEUSIA (loss of taste) and FATIGUE (feeling tired) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced INSOMNIA (sleepless nights), AGEUSIA (loss of taste) and FATIGUE (feeling tired). At the time of the report, INSOMNIA (sleepless nights), AGEUSIA (loss of taste) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: achiness; soreness; Fatigue; joint pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achiness), PAIN IN EXTREMITY (soreness), FATIGUE (Fatigue), ARTHRALGIA (joint pain) and CHILLS (chills) in a 54-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.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN (ZOCOR) and TESTOSTERONE (ANDROGEL) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (achiness), PAIN IN EXTREMITY (soreness), FATIGUE (Fatigue), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (achiness), PAIN IN EXTREMITY (soreness), FATIGUE (Fatigue), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) 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.   Treatment information was not reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face was tingly), HYPOAESTHESIA (face was numb) and HYPOAESTHESIA ORAL (nose and mouth as well) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included High cholesterol and Thyroid disorder. Concurrent medical conditions included Allergy (Allergic to Bactrim). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PARAESTHESIA (face was tingly) and HYPOAESTHESIA (face was numb). 23-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (nose and mouth as well). At the time of the report, PARAESTHESIA (face was tingly), HYPOAESTHESIA (face was numb) and HYPOAESTHESIA ORAL (nose and mouth as well) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: hard,red,lump on left arm; hard, red, lump on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (hard,red,lump on left arm) and VACCINATION SITE ERYTHEMA (hard, red, lump on left arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (hard,red,lump on left arm) and VACCINATION SITE ERYTHEMA (hard, red, lump on left arm). At the time of the report, VACCINATION SITE MASS (hard,red,lump on left arm) and VACCINATION SITE ERYTHEMA (hard, red, lump on left arm) 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Rash
Clinical narrative: Headache; Redness/erythema; Rash on torso; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/erythema), RASH (Rash on torso) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 04?B21) for COVID-19 vaccination.     The patient's past medical history included Stomach virus. Concomitant products included MULTIVITAMIN [VITAMINS NOS] 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 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (Redness/erythema) and RASH (Rash on torso). On 04-Apr-2021, the patient experienced HEADACHE (Headache). On 04-Apr-2021, ERYTHEMA (Redness/erythema) and RASH (Rash on torso) had resolved. At the time of the report, HEADACHE (Headache) had resolved.            No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May 2021:Added patient demographics, reporter information, second dose, concomitant medication. Event details were added and updated.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: used 5/8 needle to inject the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (used 5/8 needle to inject the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (used 5/8 needle to inject the vaccine). On 31-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (used 5/8 needle to inject the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Treatment information was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: unknown (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. As reported  patient experienced signs and symptoms of COVID-19. Concomitant medications were not reported. Treatment information was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Nausea, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.; a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.; a knot size lump appeared which was hard and very itchy, since then it has been getting bigger; nausea; arm pain for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain for about a week), INDURATION (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PRURITUS (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PERIPHERAL SWELLING (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain for about a week). On 24-Mar-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced INDURATION (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PRURITUS (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.) and PERIPHERAL SWELLING (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger). At the time of the report, PAIN IN EXTREMITY (arm pain for about a week), INDURATION (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PRURITUS (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PERIPHERAL SWELLING (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   This case was linked to MOD-2021-136899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Updated email Id.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Fatigue, Flushing, Malaise
Clinical narrative: exhaustion; arm pain; over all not feeling well; feverish; flush; chills; got cold; extreme fatigue; arm felt hot, burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish) and FLUSHING (flush) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish), FLUSHING (flush), CHILLS (chills), BODY TEMPERATURE DECREASED (got cold), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm felt hot, burning at the injection site). At the time of the report, FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish), FLUSHING (flush), CHILLS (chills), BODY TEMPERATURE DECREASED (got cold), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm felt hot, burning at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: exhaustion; arm pain; over all not feeling well; feverish; flush; chills; got cold; extreme fatigue; arm felt hot, burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish) and FLUSHING (flush) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish), FLUSHING (flush), CHILLS (chills), BODY TEMPERATURE DECREASED (got cold), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm felt hot, burning at the injection site). At the time of the report, FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish), FLUSHING (flush), CHILLS (chills), BODY TEMPERATURE DECREASED (got cold), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm felt hot, burning at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol addiction (minimal) on 14-Aug-2020. Concurrent medical conditions included Seasonal allergy (Seasonal Allergies). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from August 2020 to an unknown date and IRON from February 2021 to an unknown date for Pregnancy.    On 09-Mar-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Jul-2020 and the estimated date of delivery was 19-Apr-2021. On 09-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 09-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2020, Pregnancy test: positive (Positive) Positive. In December 2020, Ultrasound scan: normal (normal) Normal. In January 2021, Ultrasound scan: normal (normal) minor concerns another test done in January 2021, ended up being normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included topical hydrocortisone which varies 1 percent and 1 to 3 times  daily route ear used for rash.  Lab tests included, glucose on ??-Jan-2021 had no findings- routine blood panel found patient low on iron.  Conception date of patient was found to be 01 Aug 2020. Number of fetus was found to be one.  Patient was scheduled for second dose on 19-Apr-2021.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle at the injection site became very sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle at the injection site became very sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     no medical history was reported by reporter.  The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced MYALGIA (muscle at the injection site became very sore). At the time of the report, MYALGIA (muscle at the injection site became very sore) 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.   patient reports that he had his 1st dose of the Moderna Covid-19 vaccine on 01Apr2021 through their local county health department.  On the night of the vaccination, his muscle at the injection site became very sore. Consent to follow up obtained. patient wants to know if he can apple Bio freeze to the injection area. no concomitant medication was provided. AE contact Information Updated  in Followup document . Caller is returning call / email from Safety.  Contact information updated.  Patient stated that they were unable to reply to original email with completed form from Safety.  It was returned undeliverable.  Please resend email.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non Significant follow up - Event and Narrative updated On 11-Jun-2021: Initial Additional-1 : To confirm