chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects last from the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects last from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects last from the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects last from 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 product use was provided by the reporter. No treatment medication was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to patient with punctured vial that had been punctured for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) 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 medication information was provided.  No Treatment medication information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) 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 medication information was provided.  No Treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up information received contains significant information. Added suspect start date. Added Reporters Email id from the initial Source document.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion, Alcohol use (A year ago), Marijuana use (Not in the last 6 months) and Pregnancy (live full-time birth).    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 PAIN IN EXTREMITY (Arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-014833 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: headache; Felt tired; Very bad chills; Muscle aches; Joint aches; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Felt tired), CHILLS (Very bad chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (Felt tired), CHILLS (Very bad chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches) and NAUSEA (Nauseated). On 18-Feb-2021, CHILLS (Very bad chills), MYALGIA (Muscle aches) and NAUSEA (Nauseated) had resolved. On 19-Feb-2021, HEADACHE (headache), FATIGUE (Felt tired) and ARTHRALGIA (Joint aches) had resolved.            No concomitant medications were reported.  Patient did not take any treatment for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: headache; Felt tired; Very bad chills; Muscle aches; Joint aches; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Felt tired), CHILLS (Very bad chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (Felt tired), CHILLS (Very bad chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches) and NAUSEA (Nauseated). On 18-Feb-2021, CHILLS (Very bad chills), MYALGIA (Muscle aches) and NAUSEA (Nauseated) had resolved. On 19-Feb-2021, HEADACHE (headache), FATIGUE (Felt tired) and ARTHRALGIA (Joint aches) had resolved.            No concomitant medications were reported.  Patient did not take any treatment for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (get breast cancer in 2000. It was stage 1, took a chemo pill for 5 years did not need chemotherapy), Smoker (as a result of smoking all of my adult life I have mild COPD (I quit smoking in 2008).) in 2018, Lumpectomy, Mastectomy NOS and Radiation therapy. Concurrent medical conditions included Allergy to antibiotic (Bactrim- Break out in hives), Pollen allergy (Oak pollen= wheezing), COPD since 2018, Asthma (Since 1956) since 1995, Dyspnea (Patient went For ECHO on 9/6/2021), Depression, Anxiety, GERD and High cholesterol. Concomitant products included FAMOTIDINE from 2007 to an unknown date for Acid reflux (oesophageal), CLONAZEPAM from 2005 to an unknown date for Anxiety, SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, ALBUTEROL [SALBUTAMOL] and PREDNISONE for COPD, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) from 1995 to an unknown date and VALPROATE SEMISODIUM (DIVALPROEX) from 1995 to an unknown date for Depression, FENOFIBRATE and PRAVASTATIN SODIUM from 2008 to an unknown date for High cholesterol, CALCIUM and VITAMIN D3 for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment and Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    This case was linked to MOD-2021-193745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant  follow-up information included patient height, weight, current conditions, concomitant medications and suspect batch number added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Chest pain, Fatigue, Headache, Immunodeficiency
Clinical narrative: Chest pain; Arm Pain; Neck pain; Neck stiffness; Immunocompromised; Weird eye sensation; Head pain; Super Tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness) and IMMUNODEFICIENCY (Immunocompromised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Immunocompromised.).    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness), IMMUNODEFICIENCY (Immunocompromised), ABNORMAL SENSATION IN EYE (Weird eye sensation), HEADACHE (Head pain) and FATIGUE (Super Tired). At the time of the report, CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness), IMMUNODEFICIENCY (Immunocompromised), ABNORMAL SENSATION IN EYE (Weird eye sensation), HEADACHE (Head pain) and FATIGUE (Super Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used included only vitamins.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: attached- Contact info updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Chest pain; Arm Pain; Neck pain; Neck stiffness; Immunocompromised; Weird eye sensation; Head pain; Super Tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness) and IMMUNODEFICIENCY (Immunocompromised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Immunocompromised.).    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness), IMMUNODEFICIENCY (Immunocompromised), ABNORMAL SENSATION IN EYE (Weird eye sensation), HEADACHE (Head pain) and FATIGUE (Super Tired). At the time of the report, CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness), IMMUNODEFICIENCY (Immunocompromised), ABNORMAL SENSATION IN EYE (Weird eye sensation), HEADACHE (Head pain) and FATIGUE (Super Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used included only vitamins.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: attached- Contact info updated
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Having a heart attack; 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 MYOCARDIAL INFARCTION (Having a heart attack) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced MYOCARDIAL INFARCTION (Having a heart attack) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Having a heart attack) outcome was unknown.            No concomitant medications were provided.  Treatment medications was not provided.  Very limited information regarding the events has been provided at this time; Sender's Comments: Very limited information regarding the events has been provided at this time
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Gastrointestinal pain, Product dose omission issue, Symptom recurrence
Clinical narrative: Didn't get the second dose.; Residual effects about every 2-3 weeks; Chills; vomiting; Painful excruciating gut pain; cold sweats; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.), GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy (Platinum-based chemotherapy). Previously administered products included for an unreported indication: Flu vaccine in November 2020. Concurrent medical conditions included Prostate cancer since 11-Jan-2017, Drug allergy (Allergic to cholchicine), Bladder cancer since 11-Jan-2017, Bone cancer since 11-Jan-2017, Acid reflux (esophageal) and Blood pressure high. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), FLUTICASONE for Allergy, SIMVASTATIN for Cholesterol, BROMELAINS (BROMELAIN) for Digestion impaired, ATENOLOL for Hypertension, PEMBROLIZUMAB (KEYTRUDA) from August 2018 to June 2021 for an unknown indication.    On 05-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 11:00 PM, the patient experienced GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), CHILLS (Chills) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.) and SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), CHILLS (Chills) and VOMITING (vomiting) had resolved with sequelae. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.) had resolved and SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient refused to get his 2nd shot  Patient stated that he gets residual effect about 2-3 weeks for the past 5 months and it has not given up. Patient reports he experienced very similar reaction after receiving the flu vaccine in November, not as severe,  but same timing, no residual effects since last year.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Updated patient demographics, updated medical history, added concomitant medication, events were added, outcome and causality of events were updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Didn't get the second dose.; Residual effects about every 2-3 weeks; Chills; vomiting; Painful excruciating gut pain; cold sweats; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.), GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy (Platinum-based chemotherapy). Previously administered products included for an unreported indication: Flu vaccine in November 2020. Concurrent medical conditions included Prostate cancer since 11-Jan-2017, Drug allergy (Allergic to cholchicine), Bladder cancer since 11-Jan-2017, Bone cancer since 11-Jan-2017, Acid reflux (esophageal) and Blood pressure high. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), FLUTICASONE for Allergy, SIMVASTATIN for Cholesterol, BROMELAINS (BROMELAIN) for Digestion impaired, ATENOLOL for Hypertension, PEMBROLIZUMAB (KEYTRUDA) from August 2018 to June 2021 for an unknown indication.    On 05-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 11:00 PM, the patient experienced GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), CHILLS (Chills) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.) and SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), CHILLS (Chills) and VOMITING (vomiting) had resolved with sequelae. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.) had resolved and SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient refused to get his 2nd shot  Patient stated that he gets residual effect about 2-3 weeks for the past 5 months and it has not given up. Patient reports he experienced very similar reaction after receiving the flu vaccine in November, not as severe,  but same timing, no residual effects since last year.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Updated patient demographics, updated medical history, added concomitant medication, events were added, outcome and causality of events were updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Skin discomfort
Clinical narrative: itchy; skin problem; redness; sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (itchy), SKIN DISCOMFORT (skin problem), ERYTHEMA (redness) and PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 0R2A21A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder NOS. Previously administered products included for Product used for unknown indication: Flu vaccine. Concurrent medical conditions included Hypertension. Concomitant products included LABETALOL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRURITUS (itchy), SKIN DISCOMFORT (skin problem), ERYTHEMA (redness) and PAIN IN EXTREMITY (sore arm). The patient was treated with HYDROCORTISONE for Itching, at a dose of 1 dosage form and DIMETICONE, GLYCEROL (CETAPHIL [DIMETICONE;GLYCEROL]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), SKIN DISCOMFORT (skin problem) and ERYTHEMA (redness) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.            Patient does not have a working computer and requested letter be sent by regular mail to address on file.  Treatment information was included salpicon, antihistamine  by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up document attached included no new significant information. Data correction made on initial relevant history information and treatment information, event start date were added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Leukopenia, White blood cell count
Clinical narrative: White blood cell count decreased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LEUKOPENIA (White blood cell count decreased) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient has been cancer free since 04-Apr-2008.) from 2006 to 04-Apr-2008. Concurrent medical conditions included Scoliosis and Anxiety. Concomitant products included DIAZEPAM for Anxiety, MAGNESIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, VITAMIN D NOS and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced LEUKOPENIA (White blood cell count decreased) (seriousness criterion medically significant). At the time of the report, LEUKOPENIA (White blood cell count decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: 3.0 to 3.1k (Low) 3.0 to 3.1k. On 23-Jul-2021, White blood cell count: 3.4k (Low) 3.4k.         No treatment information was provided.  Patients white blood cell count has been around 4100 since her cancer treatments were completed.  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. However, underlying medical history of breast cancer and use of concomitant medication are contributory factors to the event.; 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. However, underlying medical history of breast cancer and use of concomitant medication are contributory factors to the event.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely tired) 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 FATIGUE (Extremely tired). At the time of the report, FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Telephone Contact Report received and the reporter declined for further follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, SARS-CoV-2 test
Clinical narrative: Metallic taste with food; Terrible smell; This spontaneous case was reported by a physician and describes the occurrence of DYSGEUSIA (Metallic taste with food) and PAROSMIA (Terrible smell) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, CANDESARTAN and PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DYSGEUSIA (Metallic taste with food) (seriousness criterion disability) and PAROSMIA (Terrible smell) (seriousness criterion disability). At the time of the report, DYSGEUSIA (Metallic taste with food) had not resolved and PAROSMIA (Terrible smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Did not test positive for Covid at that time.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not take any medications to treat symptoms.  The patient was still experiencing the lingering metallic taste and was concerned about that. The patient reports it as disabling and depressing.  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. However, use of concomitant medication sumatriptan (usually prescribed for migraine) could probably be a contributory factor.; 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. However, use of concomitant medication sumatriptan (usually prescribed for migraine) could probably be a contributory factor.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Intentional product use issue, Thirst
Clinical narrative: Waited 8 weeks to receive second shot; Stomach is bloated; Excessive thirst; More tired; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Waited 8 weeks to receive second shot), ABDOMINAL DISTENSION (Stomach is bloated), THIRST (Excessive thirst) and FATIGUE (More tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Waited 8 weeks to receive second shot), ABDOMINAL DISTENSION (Stomach is bloated), THIRST (Excessive thirst) and FATIGUE (More tired). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Waited 8 weeks to receive second shot), ABDOMINAL DISTENSION (Stomach is bloated), THIRST (Excessive thirst) and FATIGUE (More tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reporter Patient reported that she is doing fine and told that the symptoms reported might not be for vaccine as her symptoms were because of other health issues.  patient declined for further Follow-up   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: follow up document received in which event outcome is updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Breast pain, Burning sensation, Cough
Clinical narrative: Cough; breast was sore; nipple was red and hot; pain in the back; Hip was burning; not sleeping well; right upper thigh was hot and burning; couldn't get out of bed; could hardly walk - had to use cane; legs were hurting; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back) and BURNING SENSATION (Hip was burning) in a 75-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.     The patient's past medical history included Colon cancer (11 years ago), Oral infection in December 2020, Temporomandibular joint disorder in December 2020, Pain (teeth filling sore under tongue, gum aching) in December 2020 and Surgery. Concurrent medical conditions included Diabetes (type 2 diabetes) and Cancer (carcinoid cancer). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METFORMIN, VITAMIN D3, CYANOCOBALAMIN (B12-VITAMIN) and LINAGLIPTIN (TRAJENTA) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs were hurting) and GAIT DISTURBANCE (could hardly walk - had to use cane). On an unknown date, the patient experienced COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back), BURNING SENSATION (Hip was burning), INSOMNIA (not sleeping well), FEELING HOT (right upper thigh was hot and burning) and ASTHENIA (couldn't get out of bed). The patient was treated with DICLOFENAC SODIUM (VOLTAREN EX) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back), BURNING SENSATION (Hip was burning), PAIN IN EXTREMITY (legs were hurting), INSOMNIA (not sleeping well), GAIT DISTURBANCE (could hardly walk - had to use cane), FEELING HOT (right upper thigh was hot and burning) and ASTHENIA (couldn't get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-038139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow-up appended.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gait disturbance, Insomnia, Nipple inflammation, Pain in extremity
Clinical narrative: Cough; breast was sore; nipple was red and hot; pain in the back; Hip was burning; not sleeping well; right upper thigh was hot and burning; couldn't get out of bed; could hardly walk - had to use cane; legs were hurting; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back) and BURNING SENSATION (Hip was burning) in a 75-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.     The patient's past medical history included Colon cancer (11 years ago), Oral infection in December 2020, Temporomandibular joint disorder in December 2020, Pain (teeth filling sore under tongue, gum aching) in December 2020 and Surgery. Concurrent medical conditions included Diabetes (type 2 diabetes) and Cancer (carcinoid cancer). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METFORMIN, VITAMIN D3, CYANOCOBALAMIN (B12-VITAMIN) and LINAGLIPTIN (TRAJENTA) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs were hurting) and GAIT DISTURBANCE (could hardly walk - had to use cane). On an unknown date, the patient experienced COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back), BURNING SENSATION (Hip was burning), INSOMNIA (not sleeping well), FEELING HOT (right upper thigh was hot and burning) and ASTHENIA (couldn't get out of bed). The patient was treated with DICLOFENAC SODIUM (VOLTAREN EX) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back), BURNING SENSATION (Hip was burning), PAIN IN EXTREMITY (legs were hurting), INSOMNIA (not sleeping well), GAIT DISTURBANCE (could hardly walk - had to use cane), FEELING HOT (right upper thigh was hot and burning) and ASTHENIA (couldn't get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-038139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow-up appended.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Myalgia, Vertigo
Clinical narrative: vertigo; increased imbalance issue; achy sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), BALANCE DISORDER (increased imbalance issue), MYALGIA (achy sore arm) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vestibular vertigo (Significant increase in all conditions to the point the patient is unable to function but 10-15% of the day.) since 2010 and Disorder equilibrium (Patient had learned to manage equilibrium.) since 2010.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (achy sore arm) and FATIGUE (fatigue). On 11-Mar-2021, the patient experienced BALANCE DISORDER (increased imbalance issue). On 12-Mar-2021, the patient experienced VERTIGO (vertigo). On 13-Mar-2021, MYALGIA (achy sore arm) and FATIGUE (fatigue) had resolved. On 14-Mar-2021, BALANCE DISORDER (increased imbalance issue) had resolved. On 15-Mar-2021, VERTIGO (vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were  Lifewave X39 general wellness 1 patch each morning for general health from 2019 and Lifewave silent night sleep 1 patch before bed for general health from 2019 . No treatment details were reported for first dose events.   This case was linked to MOD-2021-270239 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up received and current conditions added, concomitant medication added and new event.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Calf discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Calf discomfort) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Calf discomfort). At the time of the report, LIMB DISCOMFORT (Calf discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported  No treatment medication information was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Additional information included patient initials
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Pain in extremity
Clinical narrative: Some dizziness; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Some dizziness) and PAIN IN EXTREMITY (Arm pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Food allergy (Other products) and Drug allergy (cephalosporin antibiotic (Ceclor) Allergy). Concomitant products included ALBUTEROL [SALBUTAMOL] from 28-Dec-2000 to an unknown date and FLUTICASONE PROPIONATE (FLOVENT) from 28-Dec-2000 to an unknown date for Asthma.    On 04-Mar-2021 at 1:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Some dizziness). 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with BUSPIRONE for Anxiety, at an unspecified dose and frequency; HYDROXYZINE for Anxiety, at an unspecified dose and frequency; MECLIZINE [MECLOZINE] for Anxiety, at an unspecified dose and frequency and MECLIZINE [MECLOZINE] on 20-Apr-2021 for Anxiety, at a dose of 25 mg. On 08-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, DIZZINESS (Some dizziness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Electrocardiogram: normal (normal) All results were normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       he didn't take lorazepam and psudoephidrine was prescribed under treatment medication   This case was linked to MOD-2021-296537 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Patient's demographics (height, weight) ethnic group and race was updated. Patient's allergies and outcome was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Neoplasm
Clinical narrative: neoplasm; lumps under their arm,Lump was large; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lumps under their arm,Lump was large) and NEOPLASM (neoplasm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amlodipine.), Hypertension and Drug allergy (Benazepril.). Concomitant products included AMLODIPINE BESYLATE from 06-Jun-2021 to an unknown date for Blood pressure.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced AXILLARY MASS (lumps under their arm,Lump was large). On an unknown date, the patient experienced NEOPLASM (neoplasm). At the time of the report, AXILLARY MASS (lumps under their arm,Lump was large) had resolved with sequelae and NEOPLASM (neoplasm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has taken an eye ointment with an antibiotic and steroid.    Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Reporter address, patient demographics, allergic condition, medical history, concomitant medication and event outcome and details were updated.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown/not provided. Concomitant product used included high blood pressure medication (NOS). Treatment information not provided. This case linked to MOD-2021-200424 (patient link). Reporter did not allow further contact.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Incorrect route of product administration, Otitis externa
Clinical narrative: swimmers ear; brain felt itchy; fatigue; headache; received second vaccine in left thigh; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OTITIS EXTERNA (swimmers ear), PRURITUS (brain felt itchy), FATIGUE (fatigue) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle disorder NOS (muscle problems) and Nervous system disorder NOS (Nerve problems).   On 05-Apr-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 03-May-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received second vaccine in left thigh). On an unknown date, the patient experienced OTITIS EXTERNA (swimmers ear) and PRURITUS (brain felt itchy). On 08-May-2021, DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received second vaccine in left thigh) had resolved. At the time of the report, OTITIS EXTERNA (swimmers ear) and PRURITUS (brain felt itchy) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-271787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non-significant follow up appended. no new information received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: swimmers ear; brain felt itchy; fatigue; headache; received second vaccine in left thigh; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OTITIS EXTERNA (swimmers ear), PRURITUS (brain felt itchy), FATIGUE (fatigue) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle disorder NOS (muscle problems) and Nervous system disorder NOS (Nerve problems).   On 05-Apr-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 03-May-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received second vaccine in left thigh). On an unknown date, the patient experienced OTITIS EXTERNA (swimmers ear) and PRURITUS (brain felt itchy). On 08-May-2021, DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received second vaccine in left thigh) had resolved. At the time of the report, OTITIS EXTERNA (swimmers ear) and PRURITUS (brain felt itchy) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-271787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non-significant follow up appended. no new information received.