chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema
Clinical narrative: Rash; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) 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 19-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 RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 19-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the itchiness has diminished and the redness has lightened up. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up received on 04-JUL-2021 and contains no new information
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; Sore arm and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (Sore arm and pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Sore arm and pain). On 03-Feb-2021, PAIN IN EXTREMITY (Sore arm) and PAIN (Sore arm and pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: a little bit of a lighter rash; it felt like there was a lump underneath; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath). At the time of the report, RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included a quarter of a Benadryl and probably a little of Cortisone cream.    Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder, Heart rate increased, Pain, Pain in extremity, Palpitations
Clinical narrative: Arm Pain; Achiness; Anxious; Rapid Heart Beat; Heart Felt like dropping out of her chest; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid Heart Beat), PALPITATIONS (Heart Felt like dropping out of her chest), PAIN IN EXTREMITY (Arm Pain), PAIN (Achiness) and ANXIETY DISORDER (Anxious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid Heart Beat) and PALPITATIONS (Heart Felt like dropping out of her chest). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), PAIN (Achiness) and ANXIETY DISORDER (Anxious). At the time of the report, HEART RATE INCREASED (Rapid Heart Beat), PALPITATIONS (Heart Felt like dropping out of her chest), PAIN IN EXTREMITY (Arm Pain), PAIN (Achiness) and ANXIETY DISORDER (Anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Flushing, Pain
Clinical narrative: Flush; Bruising on the site; Chills; Difficulty of breathing; Itchiness; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FLUSHING (Flush), DYSPNOEA (Difficulty of breathing), PRURITUS (Itchiness) and PAIN (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Ambien                                                         Sleepin Aid for Sleep disorder NOS.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and PAIN (Body aches). On 28-Jan-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and PRURITUS (Itchiness). On 29-Jan-2021, the patient experienced FLUSHING (Flush), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills). On 19-Jan-2021, PAIN (Body aches) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and DYSPNOEA (Difficulty of breathing) had resolved and FLUSHING (Flush), PRURITUS (Itchiness), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site bruising
Clinical narrative: Flush; Bruising on the site; Chills; Difficulty of breathing; Itchiness; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FLUSHING (Flush), DYSPNOEA (Difficulty of breathing), PRURITUS (Itchiness) and PAIN (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Ambien                                                         Sleepin Aid for Sleep disorder NOS.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and PAIN (Body aches). On 28-Jan-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and PRURITUS (Itchiness). On 29-Jan-2021, the patient experienced FLUSHING (Flush), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills). On 19-Jan-2021, PAIN (Body aches) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and DYSPNOEA (Difficulty of breathing) had resolved and FLUSHING (Flush), PRURITUS (Itchiness), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Flushing, Pyrexia, SARS-CoV-2 test
Clinical narrative: Just 3 days before my second injection I completely lost my taste; low-grade fever; Facial flushing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), FLUSHING (Facial flushing), AGEUSIA (Just 3 days before my second injection I completely lost my taste) and PYREXIA (low-grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Cephalosporins: resulted in hives.), Allergy to antibiotic (Allergic to Bactrim.), Drug allergy (Allergic to Sulfa.), Iodine allergy, Allergy to antibiotic (Allergic to Erythromycin.), Allergy to antibiotic (Allergic to Cipro.), Drug allergy (Allergic to Prednisone.) and Allergy to antibiotic (Resulted in Urticaria, Swollen tongue.). Concomitant products included NADOLOL (CORGARD), ATORVASTATIN CALCIUM (LIPITOR) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Jan-2021, the patient experienced FLUSHING (Facial flushing) and PYREXIA (low-grade fever). On an unknown date, the patient experienced AGEUSIA (Just 3 days before my second injection I completely lost my taste). At the time of the report, VACCINATION SITE PAIN (sore arm), FLUSHING (Facial flushing), AGEUSIA (Just 3 days before my second injection I completely lost my taste) and PYREXIA (low-grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 - 99.5 (Inconclusive) 99.2 - 99.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-245849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received on 05-JUL-2021 : Lab data, Concomitant medications, Events Outcome were Updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Just 3 days before my second injection I completely lost my taste; low-grade fever; Facial flushing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), FLUSHING (Facial flushing), AGEUSIA (Just 3 days before my second injection I completely lost my taste) and PYREXIA (low-grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Cephalosporins: resulted in hives.), Allergy to antibiotic (Allergic to Bactrim.), Drug allergy (Allergic to Sulfa.), Iodine allergy, Allergy to antibiotic (Allergic to Erythromycin.), Allergy to antibiotic (Allergic to Cipro.), Drug allergy (Allergic to Prednisone.) and Allergy to antibiotic (Resulted in Urticaria, Swollen tongue.). Concomitant products included NADOLOL (CORGARD), ATORVASTATIN CALCIUM (LIPITOR) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Jan-2021, the patient experienced FLUSHING (Facial flushing) and PYREXIA (low-grade fever). On an unknown date, the patient experienced AGEUSIA (Just 3 days before my second injection I completely lost my taste). At the time of the report, VACCINATION SITE PAIN (sore arm), FLUSHING (Facial flushing), AGEUSIA (Just 3 days before my second injection I completely lost my taste) and PYREXIA (low-grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 - 99.5 (Inconclusive) 99.2 - 99.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-245849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received on 05-JUL-2021 : Lab data, Concomitant medications, Events Outcome were Updated.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash at the injection site; sore arm; Rash, redness at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Rash, redness at injection site), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (Rash at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Rash, redness at injection site) and VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Rash, redness at injection site), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-097395 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid after receiving the first dose of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid after receiving the first dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid after receiving the first dose of the vaccine) 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 concomitant medications were provided by the reporter. Patient received monoclonal antibody treatment for the COVID-19 infection. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: FU attached NNI.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Mild sore throat; Ear Pain; Headache; Tested Positive for COVID19; Fatigue; Injection site soreness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE ERYTHEMA (Injection site redness), HEADACHE (Headache) and OROPHARYNGEAL PAIN (Mild sore throat) in a 43-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.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness). On 23-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID19). On 24-Jan-2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Mild sore throat) and EAR PAIN (Ear Pain). On 26-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE ERYTHEMA (Injection site redness), OROPHARYNGEAL PAIN (Mild sore throat), EAR PAIN (Ear Pain) and SARS-COV-2 TEST POSITIVE (Tested Positive for COVID19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild sore throat; Ear Pain; Headache; Tested Positive for COVID19; Fatigue; Injection site soreness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE ERYTHEMA (Injection site redness), HEADACHE (Headache) and OROPHARYNGEAL PAIN (Mild sore throat) in a 43-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.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness). On 23-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID19). On 24-Jan-2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Mild sore throat) and EAR PAIN (Ear Pain). On 26-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE ERYTHEMA (Injection site redness), OROPHARYNGEAL PAIN (Mild sore throat), EAR PAIN (Ear Pain) and SARS-COV-2 TEST POSITIVE (Tested Positive for COVID19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site erythema, Vaccination site induration, Vomiting
Clinical narrative: Threw up 1 or 2 times; Hard nod in her right arm at the injection site; Red, hard nod in her right arm; Fatigue; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard nod in her right arm at the injection site), VACCINATION SITE ERYTHEMA (Red, hard nod in her right arm), FATIGUE (Fatigue), NAUSEA (nauseated) and VOMITING (Threw up 1 or 2 times) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Lung transplant (Patient with a double lung transplant). Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), TACROLIMUS (PROGRAF), METOPROLOL, AZITHROMYCIN, SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM), AZATHIOPRINE, FLUCONAZOLE, PREDNISONE, MAGNESIUM, BIOTIN and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard nod in her right arm at the injection site), VACCINATION SITE ERYTHEMA (Red, hard nod in her right arm), FATIGUE (Fatigue) and NAUSEA (nauseated). On 28-Jan-2021, the patient experienced VOMITING (Threw up 1 or 2 times). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Jan-2021, VOMITING (Threw up 1 or 2 times) had resolved. At the time of the report, VACCINATION SITE INDURATION (Hard nod in her right arm at the injection site), VACCINATION SITE ERYTHEMA (Red, hard nod in her right arm), FATIGUE (Fatigue) and NAUSEA (nauseated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was also provided as seven soft drink. After receiving the second dose of vaccine patient also experienced same adverse events like after first dose.   This case was linked to MOD-2021-253430.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow-up recieved on 11-JUL-2021 updated re-challenge to positive and added concomitant and treatment information from initial document.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: administration site started to turn red; slight pain at the sight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight pain at the sight) and VACCINATION SITE ERYTHEMA (administration site started to turn red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (slight pain at the sight). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (administration site started to turn red). On 26-Jan-2021, VACCINATION SITE PAIN (slight pain at the sight) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (administration site started to turn red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue; Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 FATIGUE (Fatigue), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Migraine, SARS-CoV-2 antibody test
Clinical narrative: Migraines; COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID) and MIGRAINE (Migraines) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020. Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) for Migraine.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced MIGRAINE (Migraines). At the time of the report, COVID-19 (COVID) and MIGRAINE (Migraines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Fatigue, Headache, Hyperhidrosis
Clinical narrative: pain in the back/when moving the back it hurts; feet and hands were sweaty; little bit of a headache; muscle aches; feel tired, like without desire; strong stomachaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (strong stomachaches), BACK PAIN (pain in the back/when moving the back it hurts), HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache) and MYALGIA (muscle aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (strong stomachaches). On an unknown date, the patient experienced BACK PAIN (pain in the back/when moving the back it hurts), HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache), MYALGIA (muscle aches) and FATIGUE (feel tired, like without desire). At the time of the report, ABDOMINAL PAIN UPPER (strong stomachaches) had not resolved, BACK PAIN (pain in the back/when moving the back it hurts) was resolving and HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache), MYALGIA (muscle aches) and FATIGUE (feel tired, like without desire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant drugs includes Blood pressure medications. The treatment includes 3 Tylenol 350 mg each one in a different day.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: date, Date of birth, Event was updated. On 05-Jul-2021: No new information
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in the back/when moving the back it hurts; feet and hands were sweaty; little bit of a headache; muscle aches; feel tired, like without desire; strong stomachaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (strong stomachaches), BACK PAIN (pain in the back/when moving the back it hurts), HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache) and MYALGIA (muscle aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (strong stomachaches). On an unknown date, the patient experienced BACK PAIN (pain in the back/when moving the back it hurts), HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache), MYALGIA (muscle aches) and FATIGUE (feel tired, like without desire). At the time of the report, ABDOMINAL PAIN UPPER (strong stomachaches) had not resolved, BACK PAIN (pain in the back/when moving the back it hurts) was resolving and HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache), MYALGIA (muscle aches) and FATIGUE (feel tired, like without desire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant drugs includes Blood pressure medications. The treatment includes 3 Tylenol 350 mg each one in a different day.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: date, Date of birth, Event was updated. On 05-Jul-2021: No new information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Dizziness, Pruritus
Clinical narrative: Itching at the injection site; side effects after vaccination; Light headedness; Weakness in all the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (side effects after vaccination), DIZZINESS (Light headedness), ASTHENIA (Weakness in all the body) and PRURITUS (Itching at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (hypersensitive to aspirin.). Concomitant products included ATENOLOL for Blood pressure high, DILTIAZEM, CITALOPRAM, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3), VITAMINS NOS, CALCIUM, MAGNESIUM and ZINC for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE EVENT (side effects after vaccination), DIZZINESS (Light headedness) and ASTHENIA (Weakness in all the body). On 25-Jan-2021, the patient experienced PRURITUS (Itching at the injection site). On 23-Jan-2021, ADVERSE EVENT (side effects after vaccination), DIZZINESS (Light headedness) and ASTHENIA (Weakness in all the body) had resolved. At the time of the report, PRURITUS (Itching at the injection site) outcome was unknown. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN FUL IN ARM; A spontaneous report was received from a concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was painful(Injection site pain), felt like a tetnus shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm was painful . On the second day, she reported that if felt like they had received a tetanus shot in their arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, arm was painful, felt like a tetnus shot was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site rash
Clinical narrative: pins and needle on her feet, calves, arms and wrists; rash on arm at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (pins and needle on her feet, calves, arms and wrists) and VACCINATION SITE RASH (rash on arm at the injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on arm at the injection site). On an unknown date, the patient experienced PARAESTHESIA (pins and needle on her feet, calves, arms and wrists). On 28-Jan-2021, VACCINATION SITE RASH (rash on arm at the injection site) had resolved. At the time of the report, PARAESTHESIA (pins and needle on her feet, calves, arms and wrists) 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.   The treatment information was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Excruciating pain in arm of injection; A spontaneous report was received from a consumer (reporting on self), concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events excruciating pain in the arm of the injection (Injection site pain)  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient experienced the events excruciating pain in the arm of the injection. She had to call EMT (emergency medical technician) and she had taken aspirin and it got better. On 02 Feb 2021 it was worse than it was when she first received the first dose.  Action taken with mRNA-1273 in response to the event was not reported.   Outcome of events of excruciating pain in the arm of the injection was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: sore arm; sleepy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (sleepy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (sleepy). On 29-Jan-2021, PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-022538 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Updated reporter and patient info. Dr listed in Initial SD is not primary reporter or husband; Sender's Comments:  MOD-2021-022538:cross linked to "patient 2" (husband)
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) 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 (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided. Reporter wife was fine. No major issues even after getting the second shot.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site injury, Injection site pain, Pruritus, Swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (injection site started hurting), ERYTHEMA (got red), SWELLING (swollen), PRURITUS (itchy) and INJECTION SITE INJURY (seems worse this morning) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LOSARTAN for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site started hurting), ERYTHEMA (got red), SWELLING (swollen) and PRURITUS (itchy). On 03-Feb-2021, the patient experienced INJECTION SITE INJURY (seems worse this morning). At the time of the report, INJECTION SITE PAIN (injection site started hurting), ERYTHEMA (got red), SWELLING (swollen), PRURITUS (itchy) and INJECTION SITE INJURY (seems worse this morning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant medication includes OTC supplements.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that covers torso of body/Rash that covers scalped), RASH PRURITIC (rash that itches) and HYPOACUSIS (Difficulty in hearing.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No medical history is provided and concomitant drugs are provided. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL HCT), CALCIUM and VITAMINS NOS for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH (Rash that covers torso of body/Rash that covers scalped), RASH PRURITIC (rash that itchies) and HYPOACUSIS (Difficulty in hearing.). At the time of the report, RASH (Rash that covers torso of body/Rash that covers scalped), RASH PRURITIC (rash that itchies) and HYPOACUSIS (Difficulty in hearing.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient took 2 Benadryl at 3 o´clock in the morning.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vaccination site reaction
Clinical narrative: Neckache; little dots on and around injection site 2-4 inches around; Aches; A spontaneous report was received from a Consumer concerning a 23-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events little dots on and around injection site 2-4 inches around(Injection site reaction), neckache(neck pain), aches(pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events little dots on and around injection site 2-4 inches around . On an unknown date, the patient experienced the events neckache . On an unknown date, the patient experienced the events aches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, little dots on and around injection site 2-4 inches around, neckache, aches was not reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; fatigue; fever; pain at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (Headache). On 27-Jan-2021, the patient experienced NAUSEA (Nausea). On 23-Jan-2021, FATIGUE (fatigue) and PYREXIA (fever) had resolved. On 27-Jan-2021, HEADACHE (Headache) had resolved. On 29-Jan-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2020, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nausea; fatigue; fever; pain at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (Headache). On 27-Jan-2021, the patient experienced NAUSEA (Nausea). On 23-Jan-2021, FATIGUE (fatigue) and PYREXIA (fever) had resolved. On 27-Jan-2021, HEADACHE (Headache) had resolved. On 29-Jan-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2020, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm the next day) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm the next day). At the time of the report, PAIN IN EXTREMITY (sore arm the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.    Reporter did not allow further contact