chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced NAUSEA (Nauseous). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CARBAMAZEPINE (TEGRETOL), RISPERIDONE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nasopharyngitis
Clinical narrative: cold symptoms; severe muscle pain and joint pain; severe muscle and joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), MYALGIA (severe muscle pain and joint pain), ARTHRALGIA (severe muscle and joint pain) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms), MYALGIA (severe muscle pain and joint pain), ARTHRALGIA (severe muscle and joint pain) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (cold symptoms), MYALGIA (severe muscle pain and joint pain), ARTHRALGIA (severe muscle and joint pain) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood glucose increased, Heart rate increased, Hypertension, Swelling
Clinical narrative: mouth blisters; itching at vaccination site; redness that is expanding; hardness at vaccination site; bumps and whelps around injection site; Glucose high; Blood pressure levels jumps very high (2-40 increase in numbers); welts; heart rate increased; pain at vaccination site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021. The most recent information was received on 31-Mar-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at vaccination site), VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (redness that is expanding), VACCINATION SITE INDURATION (hardness at vaccination site) and SWELLING (bumps and whelps around injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at vaccination site), BLOOD GLUCOSE INCREASED (Glucose high), HYPERTENSION (Blood pressure levels jumps very high (2-40 increase in numbers)), URTICARIA (welts) and HEART RATE INCREASED (heart rate increased). On 17-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (redness that is expanding), VACCINATION SITE INDURATION (hardness at vaccination site) and SWELLING (bumps and whelps around injection site). On an unknown date, the patient experienced BLISTER (mouth blisters). At the time of the report, VACCINATION SITE PAIN (pain at vaccination site), VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (redness that is expanding), VACCINATION SITE INDURATION (hardness at vaccination site), SWELLING (bumps and whelps around injection site), BLOOD GLUCOSE INCREASED (Glucose high), HYPERTENSION (Blood pressure levels jumps very high (2-40 increase in numbers)), BLISTER (mouth blisters), URTICARIA (welts) and HEART RATE INCREASED (heart rate increased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included OTC Hydrocortisone 1% spray, and ice pack   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Significant follow up appended On 12-Apr-2021: NonSignificant follow up appended
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: mouth blisters; itching at vaccination site; redness that is expanding; hardness at vaccination site; bumps and whelps around injection site; Glucose high; Blood pressure levels jumps very high (2-40 increase in numbers); welts; heart rate increased; pain at vaccination site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021. The most recent information was received on 31-Mar-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at vaccination site), VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (redness that is expanding), VACCINATION SITE INDURATION (hardness at vaccination site) and SWELLING (bumps and whelps around injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at vaccination site), BLOOD GLUCOSE INCREASED (Glucose high), HYPERTENSION (Blood pressure levels jumps very high (2-40 increase in numbers)), URTICARIA (welts) and HEART RATE INCREASED (heart rate increased). On 17-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (redness that is expanding), VACCINATION SITE INDURATION (hardness at vaccination site) and SWELLING (bumps and whelps around injection site). On an unknown date, the patient experienced BLISTER (mouth blisters). At the time of the report, VACCINATION SITE PAIN (pain at vaccination site), VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (redness that is expanding), VACCINATION SITE INDURATION (hardness at vaccination site), SWELLING (bumps and whelps around injection site), BLOOD GLUCOSE INCREASED (Glucose high), HYPERTENSION (Blood pressure levels jumps very high (2-40 increase in numbers)), BLISTER (mouth blisters), URTICARIA (welts) and HEART RATE INCREASED (heart rate increased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included OTC Hydrocortisone 1% spray, and ice pack   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Significant follow up appended On 12-Apr-2021: NonSignificant follow up appended
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat) and ABDOMINAL PAIN UPPER (stomach ache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Cancer (Cancer with radiation). Concomitant products included NAPROXEN, GABAPENTIN, MULTIVITAMIN [VITAMINS NOS] and POTASSIUM for an unknown indication.On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VOMITING (vomiting), NAUSEA (Nausea), FATIGUE (tiredness) and HEADACHE (headache). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), PAIN (Body Pain), CHILLS (chills) and MYALGIA (muscle aches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 31-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (stomach ache), PAIN (Body Pain), VOMITING (vomiting), NAUSEA (Nausea), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication includes: Allergy medications.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat) and ABDOMINAL PAIN UPPER (stomach ache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Cancer (Cancer with radiation). Concomitant products included NAPROXEN, GABAPENTIN, MULTIVITAMIN [VITAMINS NOS] and POTASSIUM for an unknown indication.On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VOMITING (vomiting), NAUSEA (Nausea), FATIGUE (tiredness) and HEADACHE (headache). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), PAIN (Body Pain), CHILLS (chills) and MYALGIA (muscle aches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 31-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (stomach ache), PAIN (Body Pain), VOMITING (vomiting), NAUSEA (Nausea), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication includes: Allergy medications.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat) and ABDOMINAL PAIN UPPER (stomach ache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Cancer (Cancer with radiation). Concomitant products included NAPROXEN, GABAPENTIN, MULTIVITAMIN [VITAMINS NOS] and POTASSIUM for an unknown indication.On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VOMITING (vomiting), NAUSEA (Nausea), FATIGUE (tiredness) and HEADACHE (headache). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), PAIN (Body Pain), CHILLS (chills) and MYALGIA (muscle aches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 31-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weakness), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (stomach ache), PAIN (Body Pain), VOMITING (vomiting), NAUSEA (Nausea), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication includes: Allergy medications.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Tenderness
Clinical narrative: the area is tender to the touch; 4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges; wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (the area is tender to the touch), ERYTHEMA (4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges) and GAIT DISTURBANCE (wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder.   On 24-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced GAIT DISTURBANCE (wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything). On 31-Mar-2021, the patient experienced TENDERNESS (the area is tender to the touch) and ERYTHEMA (4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges). On 26-Mar-2021, GAIT DISTURBANCE (wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything) had resolved. At the time of the report, TENDERNESS (the area is tender to the touch) and ERYTHEMA (4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges) outcome was unknown.            Concomitant medications include: Thyroid medication. No treatment  medications were reported.  Action taken with mRNA-1272 with respect to events was Not Applicable.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Bone pain, Cold sweat, Eye pain
Clinical narrative: Difficulty in recovering after going up stairs; pain in the back and chest; started feeling pain on the back; Mild pain on the R arm of injection; Feels weak and fatigated; Bone pain; Cold sweating; Pain when trying to open the eyes; Feels weak / felt weak for three days.; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Difficulty in recovering after going up stairs), NON-CARDIAC CHEST PAIN (pain in the back and chest), BACK PAIN (started feeling pain on the back), BONE PAIN (Bone pain) and COLD SWEAT (Cold sweating) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 042620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Two open heart surgery). Concomitant products included WARFARIN for Heart enlarged, VITAMINS NOS for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced BONE PAIN (Bone pain), COLD SWEAT (Cold sweating), EYE PAIN (Pain when trying to open the eyes) and ASTHENIA (Feels weak / felt weak for three days.). On an unknown date, the patient experienced PAIN (Difficulty in recovering after going up stairs), NON-CARDIAC CHEST PAIN (pain in the back and chest), BACK PAIN (started feeling pain on the back), VACCINATION SITE PAIN (Mild pain on the R arm of injection) and FATIGUE (Feels weak and fatigated). At the time of the report, PAIN (Difficulty in recovering after going up stairs), NON-CARDIAC CHEST PAIN (pain in the back and chest), BACK PAIN (started feeling pain on the back), BONE PAIN (Bone pain), COLD SWEAT (Cold sweating), EYE PAIN (Pain when trying to open the eyes), ASTHENIA (Feels weak / felt weak for three days.), VACCINATION SITE PAIN (Mild pain on the R arm of injection) and FATIGUE (Feels weak and fatigated) outcome was unknown.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JUN-2021 contained significant information Event Felt weak for 3 days , Bone pain, Cold sweating, Pain when trying to opening eye (Unknown) was updated On 28-Jun-2021: Follow up received on 29-JUN-2021 contained No New Information Non significant information
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Non-cardiac chest pain, Pain, Vaccination site pain
Clinical narrative: Difficulty in recovering after going up stairs; pain in the back and chest; started feeling pain on the back; Mild pain on the R arm of injection; Feels weak and fatigated; Bone pain; Cold sweating; Pain when trying to open the eyes; Feels weak / felt weak for three days.; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Difficulty in recovering after going up stairs), NON-CARDIAC CHEST PAIN (pain in the back and chest), BACK PAIN (started feeling pain on the back), BONE PAIN (Bone pain) and COLD SWEAT (Cold sweating) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 042620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Two open heart surgery). Concomitant products included WARFARIN for Heart enlarged, VITAMINS NOS for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced BONE PAIN (Bone pain), COLD SWEAT (Cold sweating), EYE PAIN (Pain when trying to open the eyes) and ASTHENIA (Feels weak / felt weak for three days.). On an unknown date, the patient experienced PAIN (Difficulty in recovering after going up stairs), NON-CARDIAC CHEST PAIN (pain in the back and chest), BACK PAIN (started feeling pain on the back), VACCINATION SITE PAIN (Mild pain on the R arm of injection) and FATIGUE (Feels weak and fatigated). At the time of the report, PAIN (Difficulty in recovering after going up stairs), NON-CARDIAC CHEST PAIN (pain in the back and chest), BACK PAIN (started feeling pain on the back), BONE PAIN (Bone pain), COLD SWEAT (Cold sweating), EYE PAIN (Pain when trying to open the eyes), ASTHENIA (Feels weak / felt weak for three days.), VACCINATION SITE PAIN (Mild pain on the R arm of injection) and FATIGUE (Feels weak and fatigated) outcome was unknown.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JUN-2021 contained significant information Event Felt weak for 3 days , Bone pain, Cold sweating, Pain when trying to opening eye (Unknown) was updated On 28-Jun-2021: Follow up received on 29-JUN-2021 contained No New Information Non significant information
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Felt like flu; Freezing; Sweat porously; Fluid in ear; Chills; Fever; Sore body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear) and PYREXIA (Fever) in a female patient of an unknown age 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 31-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Sore body). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear), PYREXIA (Fever), MYALGIA (Sore body) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101 (High) Fever 101 degrees F. On an unknown date, Body temperature: 102 (High) Ran 102 temperature.         Concomitant product use was not provided by the reporter. Treatment information was not provided. She states that no medications resolved the headache. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. As per client, MO error in DOB capture.   This case was linked to MOD-2021-065271, MOD-2021-130965, MOD-2021-131034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added new events headache, fluid in ear, felt like flu, freezing, chills and sweat porously.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Otorrhoea, Pyrexia
Clinical narrative: Felt like flu; Freezing; Sweat porously; Fluid in ear; Chills; Fever; Sore body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear) and PYREXIA (Fever) in a female patient of an unknown age 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 31-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Sore body). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear), PYREXIA (Fever), MYALGIA (Sore body) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101 (High) Fever 101 degrees F. On an unknown date, Body temperature: 102 (High) Ran 102 temperature.         Concomitant product use was not provided by the reporter. Treatment information was not provided. She states that no medications resolved the headache. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. As per client, MO error in DOB capture.   This case was linked to MOD-2021-065271, MOD-2021-130965, MOD-2021-131034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added new events headache, fluid in ear, felt like flu, freezing, chills and sweat porously.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: a red spot at injection site; a red spot that hurts and itches on the injection site; A red spot that hurts on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a red spot that hurts and itches on the injection site), VACCINATION SITE PAIN (A red spot that hurts on injection site) and VACCINATION SITE ERYTHEMA (a red spot at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (a red spot that hurts and itches on the injection site) and VACCINATION SITE PAIN (A red spot that hurts on injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a red spot at injection site). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (a red spot that hurts and itches on the injection site), VACCINATION SITE PAIN (A red spot that hurts on injection site) and VACCINATION SITE ERYTHEMA (a red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes: Ventolin (Inhaler Device)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: injection site lump; injection site itching; injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (injection site lump), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE MASS (injection site lump), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, INJECTION SITE MASS (injection site lump), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) 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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: Sick with a cough; Sick/started to feel sick; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Sick with a cough) and MALAISE (Sick/started to feel sick) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MNA) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced COUGH (Sick with a cough) and MALAISE (Sick/started to feel sick). At the time of the report, COUGH (Sick with a cough) and MALAISE (Sick/started to feel sick) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-MAY-2021.Date of birth and outcome was updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Patient has gout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Patient has gout) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gout.    On 22-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 GOUT (Patient has gout). At the time of the report, GOUT (Patient has gout) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: vomiting; fatigue; sweats; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 01-Apr-2021, the patient experienced VOMITING (vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweats), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I am pregnant and would like to be a part of the Moderna pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and would like to be a part of the Moderna pregnancy registry) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20a) for COVID-19 vaccination.     Medical history and current conditions were not reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, HYDROXYCHLOROQUINE for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Jul-2021. On 22-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and would like to be a part of the Moderna pregnancy registry). On 22-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and would like to be a part of the Moderna pregnancy registry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Headache, SARS-CoV-2 test
Clinical narrative: Tested COVID-19 positive; Loss of Taste; Little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID-19 positive), AGEUSIA (Loss of Taste) and HEADACHE (Little bit of headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AGEUSIA (Loss of Taste) and HEADACHE (Little bit of headache). On 24-Mar-2021, the patient experienced COVID-19 (Tested COVID-19 positive). At the time of the report, COVID-19 (Tested COVID-19 positive) and HEADACHE (Little bit of headache) outcome was unknown and AGEUSIA (Loss of Taste) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     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.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: brain fog; body aches; felt feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), PAIN (body aches), PYREXIA (felt feverish) and CHILLS (chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Diabetes, Lactose intolerant, Food allergy (Allergy to corn syrup) and Alcohol allergy (Allergy to sugar alcohol).   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 19-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog), PAIN (body aches), PYREXIA (felt feverish) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (brain fog), PAIN (body aches), PYREXIA (felt feverish) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site gets hot), LIMB DISCOMFORT (couldn't lift arm), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't lift arm) and VACCINATION SITE PAIN (arm hurt). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site gets hot), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen). On 22-Mar-2021, LIMB DISCOMFORT (couldn't lift arm) and VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site gets hot), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment details were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site gets hot), LIMB DISCOMFORT (couldn't lift arm), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't lift arm) and VACCINATION SITE PAIN (arm hurt). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site gets hot), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen). On 22-Mar-2021, LIMB DISCOMFORT (couldn't lift arm) and VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site gets hot), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment details were provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: moves his left arm it is annoying; Little bit of ache in his left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (moves his left arm it is annoying) and ARTHRALGIA (Little bit of ache in his left shoulder) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016321A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (moves his left arm it is annoying) and ARTHRALGIA (Little bit of ache in his left shoulder). At the time of the report, PAIN IN EXTREMITY (moves his left arm it is annoying) and ARTHRALGIA (Little bit of ache in his left shoulder) 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Somnolence
Clinical narrative: very sleepy and drowsy; my joints were hurting; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy and drowsy), ARTHRALGIA (my joints were hurting) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (very sleepy and drowsy), ARTHRALGIA (my joints were hurting) and HEADACHE (mild headache). On 31-Mar-2021, SOMNOLENCE (very sleepy and drowsy), ARTHRALGIA (my joints were hurting) and HEADACHE (mild headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes: Blood pressure pill No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hand soreness disappeared; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand soreness disappeared) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A310 and 00321A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LIOTHYRONINE SODIUM (CYTOMEL), TESTOSTERONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hand soreness disappeared). At the time of the report, PAIN IN EXTREMITY (hand soreness disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Ultrasound scan
Clinical narrative: Menstrual cycle abnormal; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle abnormal) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle abnormal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medications were reported. No concomitant medications were reported.  lab data - Patient had a biopsy done to test the lining of the uterus wand is awaiting results
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and PROBIOTICS NOS at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes: BRAT Diet No concomitant medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pyrexia, Vomiting
Clinical narrative: Very weak after 2nd dose; Chills after 2nd dose; Very high fever after 2nd dose; Threw up a lot after 2nd dose; Shivering after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak after 2nd dose), CHILLS (Chills after 2nd dose), PYREXIA (Very high fever after 2nd dose), VOMITING (Threw up a lot after 2nd dose) and CHILLS (Shivering after 2nd dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Very weak after 2nd dose), CHILLS (Chills after 2nd dose), PYREXIA (Very high fever after 2nd dose), VOMITING (Threw up a lot after 2nd dose) and CHILLS (Shivering after 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Very weak after 2nd dose), CHILLS (Chills after 2nd dose), PYREXIA (Very high fever after 2nd dose), VOMITING (Threw up a lot after 2nd dose) and CHILLS (Shivering after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 Fahrenheit.         Concomitant medications like Diabetes medication, Thyroid medication, High blood pressure medication, Cholesterol medications were included. The treatment also include  liquids and  Cool rags.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information was received on 13-May-2021 does not contain any new information. On 06-Aug-2021: TCR attached and contains no significant information.