chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Cannot Sleep; Pain at the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot Sleep) and VACCINATION SITE PAIN (Pain at the Injection Site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025BE18) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (Cannot Sleep) and VACCINATION SITE PAIN (Pain at the Injection Site). The patient was treated with IBUPROFEN at a dose of 200 milligram twice a day. At the time of the report, INSOMNIA (Cannot Sleep) and VACCINATION SITE PAIN (Pain at the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dysphonia, Dyspnoea, Oropharyngeal pain
Clinical narrative: hoarseness of voice; coughing; sneezing; sore throat; chest pain; body ache; I feel a little breathless; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and CHEST PAIN (chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O1ZAZ1A and O46A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain), PAIN (body ache) and DYSPNOEA (I feel a little breathless). At the time of the report, DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain), PAIN (body ache) and DYSPNOEA (I feel a little breathless) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non significant follow up received on 16-JUN-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sneezing
Clinical narrative: hoarseness of voice; coughing; sneezing; sore throat; chest pain; body ache; I feel a little breathless; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and CHEST PAIN (chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O1ZAZ1A and O46A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain), PAIN (body ache) and DYSPNOEA (I feel a little breathless). At the time of the report, DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain), PAIN (body ache) and DYSPNOEA (I feel a little breathless) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non significant follow up received on 16-JUN-2021, no new information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Lumpy Injection Site; Hard Injection Site; Itching Injection Site; Swollen Injection Site; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumpy Injection Site), VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE MASS (Lumpy Injection Site), VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site). At the time of the report, VACCINATION SITE MASS (Lumpy Injection Site), VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Tenderness, Vaccination site inflammation
Clinical narrative: Tenderness in the arm of vaccination; Inflammation at injection site; Redness in the arm of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at injection site), ERYTHEMA (Redness in the arm of vaccination) and TENDERNESS (Tenderness in the arm of vaccination) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at injection site) and ERYTHEMA (Redness in the arm of vaccination). On 10-Apr-2021, the patient experienced TENDERNESS (Tenderness in the arm of vaccination). On 10-Apr-2021, VACCINATION SITE INFLAMMATION (Inflammation at injection site) had resolved. At the time of the report, ERYTHEMA (Redness in the arm of vaccination) and TENDERNESS (Tenderness in the arm of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: dizzy; woke up at 3 AM sweating; woke up at 3 AM having a fast heartrate; weak; a headache; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, GABAPENTIN, MELATONIN (TRANSZONE), LISINOPRIL and PIOGLITAZONE for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). On 09-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak) and HEADACHE (a headache). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (a headache) outcome was unknown.            No treatment information were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: dizzy; woke up at 3 AM sweating; woke up at 3 AM having a fast heartrate; weak; a headache; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, GABAPENTIN, MELATONIN (TRANSZONE), LISINOPRIL and PIOGLITAZONE for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). On 09-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak) and HEADACHE (a headache). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (a headache) outcome was unknown.            No treatment information were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: joint pain in her knees and hips; tired; arm hurt from the injection site to her wrist.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurt from the injection site to her wrist.), FATIGUE (tired) and ARTHRALGIA (joint pain in her knees and hips) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm hurt from the injection site to her wrist.). On 05-Mar-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced ARTHRALGIA (joint pain in her knees and hips). On 04-Mar-2021, VACCINATION SITE PAIN (arm hurt from the injection site to her wrist.) had resolved. On 05-Mar-2021, FATIGUE (tired) had resolved. At the time of the report, ARTHRALGIA (joint pain in her knees and hips) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication information was provided. No treatment products information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient's wife called to report that her husband received his first shot on 3March2021 in his left non dominant deltoid. He was due for his second shot on 1April2021 however, on 8March2021 he was admitted to the hospital and just got out of rehab, so he missed his second shot. She states that his admission to the hospital was most likely unrelated to the vaccination and he had no side effects following the first dose. She needs help rescheduling another appointment for him, as the rehab center and the vaccination provider advised her to call Moderna.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Vaccination site pain
Clinical narrative: neck soreness; injection site soreness; felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck soreness), VACCINATION SITE PAIN (injection site soreness) and FATIGUE (felt extremely tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (neck soreness), VACCINATION SITE PAIN (injection site soreness) and FATIGUE (felt extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck soreness), VACCINATION SITE PAIN (injection site soreness) and FATIGUE (felt extremely tired) outcome was unknown.            No concomitant medication were provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non Significant follow up received on 14-JUN-2021 Contains AE contact information updated; Sender's Comments: .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Candida infection, Dry mouth, Ear discomfort, Fungal infection
Clinical narrative: yeast infection; pressure in the right ear with throbbing; blood pressure was measured at 208 over 200 something; like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body; thrush; dry mouth; raunchiest, smelliest bowel movements; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body), CANDIDA INFECTION (thrush), DRY MOUTH (dry mouth), MALABSORPTION (raunchiest, smelliest bowel movements) and FUNGAL INFECTION (yeast infection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included AMLODIPINE for Blood pressure high.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DRY MOUTH (like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body), CANDIDA INFECTION (thrush), DRY MOUTH (dry mouth) and MALABSORPTION (raunchiest, smelliest bowel movements). On an unknown date, the patient experienced FUNGAL INFECTION (yeast infection), EAR DISCOMFORT (pressure in the right ear with throbbing) and HYPERTENSION (blood pressure was measured at 208 over 200 something). At the time of the report, DRY MOUTH (like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body), CANDIDA INFECTION (thrush), DRY MOUTH (dry mouth), MALABSORPTION (raunchiest, smelliest bowel movements), FUNGAL INFECTION (yeast infection), EAR DISCOMFORT (pressure in the right ear with throbbing) and HYPERTENSION (blood pressure was measured at 208 over 200 something) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: 208/200 High. In 2021, Blood pressure measurement: 140/85 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications used were: Imodium for bowel movements, Ibuprofen for blood pressure,Terbinafine (powder) and Oral medication for yeast infection, gold bond powder for external yeast infection
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Malabsorption
Clinical narrative: yeast infection; pressure in the right ear with throbbing; blood pressure was measured at 208 over 200 something; like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body; thrush; dry mouth; raunchiest, smelliest bowel movements; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body), CANDIDA INFECTION (thrush), DRY MOUTH (dry mouth), MALABSORPTION (raunchiest, smelliest bowel movements) and FUNGAL INFECTION (yeast infection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included AMLODIPINE for Blood pressure high.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DRY MOUTH (like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body), CANDIDA INFECTION (thrush), DRY MOUTH (dry mouth) and MALABSORPTION (raunchiest, smelliest bowel movements). On an unknown date, the patient experienced FUNGAL INFECTION (yeast infection), EAR DISCOMFORT (pressure in the right ear with throbbing) and HYPERTENSION (blood pressure was measured at 208 over 200 something). At the time of the report, DRY MOUTH (like you took a vacuum cleaner hose, opened my mouth, and turned my vacuum on. It sucked every ounce of fluid out of my body), CANDIDA INFECTION (thrush), DRY MOUTH (dry mouth), MALABSORPTION (raunchiest, smelliest bowel movements), FUNGAL INFECTION (yeast infection), EAR DISCOMFORT (pressure in the right ear with throbbing) and HYPERTENSION (blood pressure was measured at 208 over 200 something) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: 208/200 High. In 2021, Blood pressure measurement: 140/85 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications used were: Imodium for bowel movements, Ibuprofen for blood pressure,Terbinafine (powder) and Oral medication for yeast infection, gold bond powder for external yeast infection
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site redness; Chills; Fatigue; Lymph node swelling under her armpit; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), CHILLS (Chills), FATIGUE (Fatigue), LYMPHADENOPATHY (Lymph node swelling under her armpit) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), CHILLS (Chills), FATIGUE (Fatigue), LYMPHADENOPATHY (Lymph node swelling under her armpit) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), CHILLS (Chills), FATIGUE (Fatigue), LYMPHADENOPATHY (Lymph node swelling under her armpit) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.            Concomitant medication were not reported. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 MAY 2021, Non significant: Email and address was updated
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: A few drops dripped out and flowed down my arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (A few drops dripped out and flowed down my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (A few drops dripped out and flowed down my arm). On 04-Apr-2021, PRODUCT ADMINISTRATION ERROR (A few drops dripped out and flowed down my arm) had resolved. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the shot) in a male 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 VACCINATION COMPLICATION (Reaction to the shot). At the time of the report, VACCINATION COMPLICATION (Reaction to the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. No allergies, lab data and current condition was reported by patient. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUN-2021 and it contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Feeling abnormal, Heart rate increased, Nausea
Clinical narrative: heart beating fast; achy; chills; nauseous; blood pressure spiked; feel fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED, FEELING ABNORMAL, HEART RATE INCREASED, PAIN, and CHILLS in a 58-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 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED and FEELING ABNORMAL. On 10-Apr-2021, the patient experienced HEART RATE INCREASED, PAIN, CHILLS, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency and BENADRYL at an unspecified dose and frequency. On 09-Apr-2021, BLOOD PRESSURE INCREASED had resolved. At the time of the report, FEELING ABNORMAL, HEART RATE INCREASED, PAIN, CHILLS, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: heart beating fast; achy; chills; nauseous; blood pressure spiked; feel fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED, FEELING ABNORMAL, HEART RATE INCREASED, PAIN, and CHILLS in a 58-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 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED and FEELING ABNORMAL. On 10-Apr-2021, the patient experienced HEART RATE INCREASED, PAIN, CHILLS, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency and BENADRYL at an unspecified dose and frequency. On 09-Apr-2021, BLOOD PRESSURE INCREASED had resolved. At the time of the report, FEELING ABNORMAL, HEART RATE INCREASED, PAIN, CHILLS, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dizziness, Nasal congestion, Pyrexia
Clinical narrative: Bad cough; Loss of Appetite; Dizziness; Having a hard time talking; Congestion; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included AMLODIPINE, LORATADINE and LOSARTAN for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion). On 02-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Bad cough; Loss of Appetite; Dizziness; Having a hard time talking; Congestion; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included AMLODIPINE, LORATADINE and LOSARTAN for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion). On 02-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed; The pain is in left arm from shoulder to elbow and into back.; My wife has severe arm pain where she got the shot. It really hurts her bad.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed), VACCINATION SITE PAIN (My wife has severe arm pain where she got the shot. It really hurts her bad.) and ARTHRALGIA (The pain is in left arm from shoulder to elbow and into back.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (My wife has severe arm pain where she got the shot. It really hurts her bad.). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed) and ARTHRALGIA (The pain is in left arm from shoulder to elbow and into back.). At the time of the report, PAIN IN EXTREMITY (She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed), VACCINATION SITE PAIN (My wife has severe arm pain where she got the shot. It really hurts her bad.) and ARTHRALGIA (The pain is in left arm from shoulder to elbow and into back.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer is taking ibuprofen, Tylenol, and has applied Bengay as advised by their HCP to try to alleviate the symptoms. On 11-Apr-2021, the patient experienced second episode of arm pain and she could barely raise her arm and was barely better by Monday (12-Apr-2021). She can't even sleep on her bed due to the pain.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up information includes therapy details were added. Event (Pain in extremity) verbatim and outcome was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chest pain, Chills, Diarrhoea
Clinical narrative: diarrhea; pain to the bone; chest pain; chills; fever of 102.1 degrees Fahrenheit; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030D21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, QUETIAPINE FUMARATE (SEROQUEL), FENOFIBRATE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), VITAMIN D [VITAMIN D NOS], ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]), PANTOPRAZOLE and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit). The patient was treated with IBUPROFEN at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.1 °F (Inconclusive) 102.1 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: diarrhea; pain to the bone; chest pain; chills; fever of 102.1 degrees Fahrenheit; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030D21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, QUETIAPINE FUMARATE (SEROQUEL), FENOFIBRATE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), VITAMIN D [VITAMIN D NOS], ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]), PANTOPRAZOLE and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit). The patient was treated with IBUPROFEN at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.1 °F (Inconclusive) 102.1 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slight fever; 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 PYREXIA (slight fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (slight fever). At the time of the report, PYREXIA (slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Magnetic resonance imaging, Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Type 1) since 30-May-1999, Coronary artery disease, Hypertension since 30-Jan-2015 and Drug allergy (Opioids). Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Diabetes, LISINOPRIL for Hypertension, TOPIRAMATE (TOPAMAX) for Migraine.    On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 31-Mar-2021 for Fever and Ache, at an unspecified dose and frequency; TRAMADOL on 08-Apr-2021 for Spasms and Inflammation, at an unspecified dose and frequency; TIZANIDINE on 08-Apr-2021 for Spasms and Inflammation, at an unspecified dose and frequency; NABUMETONE on 15-Apr-2021 at an unspecified dose and frequency; GABAPENTIN on 22-Apr-2021 for Allergy to vaccine, at an unspecified dose and frequency and GABAPENTIN on 29-Apr-2021 for Allergy to vaccine, at a dose of 300 mg. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: high (High) 101. On 08-Apr-2021, Magnetic resonance imaging: inconclusive (Inconclusive) spasms with some inflammation due to the vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       15-Apr-2021, Tizanidine dose increased. Other concomitant medications include Predisone (Lab work). 22-Apr-2021, Occupational Therapy was started immediately.   This case was linked to INC.-MOD-2021-072591 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 Contains patient demographics.Concomitant medications.treatment medications updated.; Sender's Comments:  INC.-MOD-2021-072591:CROSSLINKED WITH DOSE 2
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Not Feeling well; Body aches; My body was very sore; I Felt horrible; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not Feeling well), PAIN (Body aches), PYREXIA (Fever), PAIN (My body was very sore) and MALAISE (I Felt horrible) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Not Feeling well), PAIN (Body aches), PYREXIA (Fever), PAIN (My body was very sore) and MALAISE (I Felt horrible). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MALAISE (Not Feeling well), PAIN (Body aches), PYREXIA (Fever), PAIN (My body was very sore) and MALAISE (I Felt horrible) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: her left arm red; her left arm hot; her left arm hard; her left arm swollen; her left arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her left arm red), PARAESTHESIA (her left arm hot), LIMB DISCOMFORT (her left arm hard), PERIPHERAL SWELLING (her left arm swollen) and PRURITUS (her left arm itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESTRADIOL, BIOTIN (BIOTINE BAYER), AMLODIPINE, HYDROCHLOROTHIAZIDE, ATORVASTATIN and SERTRALINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ERYTHEMA (her left arm red), PARAESTHESIA (her left arm hot), LIMB DISCOMFORT (her left arm hard), PERIPHERAL SWELLING (her left arm swollen) and PRURITUS (her left arm itchy). At the time of the report, ERYTHEMA (her left arm red), PARAESTHESIA (her left arm hot), LIMB DISCOMFORT (her left arm hard), PERIPHERAL SWELLING (her left arm swollen) and PRURITUS (her left arm itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PRURITUS (itching all over body). At the time of the report, PRURITUS (itching all over body) had not resolved.            Concomitant product use was not provided by the reporter. The treatment information included Benadryl.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pyrexia
Clinical narrative: shoulder is hurting; fever of 100.8F; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder is hurting), PYREXIA (fever of 100.8F) and CHILLS (CHILLS) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ARTHRALGIA (shoulder is hurting), PYREXIA (fever of 100.8F) and CHILLS (CHILLS). At the time of the report, ARTHRALGIA (shoulder is hurting), PYREXIA (fever of 100.8F) and CHILLS (CHILLS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.8 (High) 100.8F.         Treatment was not reported.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) had not resolved.            No concomitant medication information was provided  No treatment product information was provided  Action taken with mRNA-1273 in response to the event was not applicable.