chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Immune system disorder, Joint stiffness
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system), JOINT STIFFNESS (Joint stifness), OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), PYREXIA (Fever) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B210A4 and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy. On 02-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 PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Pain and aching in the leg hip joints and shoulder) and MYALGIA (aching in the leg hip joints, muscles, and shoulder). In April 2021, the patient experienced OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), FATIGUE (Fatigue) and ARTHRALGIA (Pain and aching in the leg hip joints, muscles, and shoulder). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system) and JOINT STIFFNESS (Joint stifness). The patient was treated with IBUPROFEN at a dose of 600 mg every eight hours; IBUPROFEN at a dose of 400 mg four times per day; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; PREDNISONE on 16-Apr-2021 at a dose of 10 mg; 6 days; PREDNISONE at a dose of 40 mg; 5days; PREDNISONE at a dose of 30 mg; 5 days; PREDNISONE at a dose of 20 mg; 5days; PREDNISONE at a dose of 10 mg; 5 days and TRAMADOL at a dose of 50 mg every eight hours. At the time of the report, IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system), JOINT STIFFNESS (Joint stifness), OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Pain and aching in the leg hip joints and shoulder), MYALGIA (aching in the leg hip joints, muscles, and shoulder) and ARTHRALGIA (Pain and aching in the leg hip joints, muscles, and shoulder) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-085643. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added patient's demographic, treatments and events.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system), JOINT STIFFNESS (Joint stifness), OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), PYREXIA (Fever) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B210A4 and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy. On 02-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 PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Pain and aching in the leg hip joints and shoulder) and MYALGIA (aching in the leg hip joints, muscles, and shoulder). In April 2021, the patient experienced OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), FATIGUE (Fatigue) and ARTHRALGIA (Pain and aching in the leg hip joints, muscles, and shoulder). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system) and JOINT STIFFNESS (Joint stifness). The patient was treated with IBUPROFEN at a dose of 600 mg every eight hours; IBUPROFEN at a dose of 400 mg four times per day; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; PREDNISONE on 16-Apr-2021 at a dose of 10 mg; 6 days; PREDNISONE at a dose of 40 mg; 5days; PREDNISONE at a dose of 30 mg; 5 days; PREDNISONE at a dose of 20 mg; 5days; PREDNISONE at a dose of 10 mg; 5 days and TRAMADOL at a dose of 50 mg every eight hours. At the time of the report, IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system), JOINT STIFFNESS (Joint stifness), OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Pain and aching in the leg hip joints and shoulder), MYALGIA (aching in the leg hip joints, muscles, and shoulder) and ARTHRALGIA (Pain and aching in the leg hip joints, muscles, and shoulder) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-085643. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added patient's demographic, treatments and events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Illness, Myalgia, Nausea
Clinical narrative: sick; Pain in arm; Abnormal breathing; swollen throat; Pain/ Ache; dizziness; Muscle pain; Fever; Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat) and PAIN (Pain/ Ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat), PAIN (Pain/ Ache), DIZZINESS (dizziness), MYALGIA (Muscle pain), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat), PAIN (Pain/ Ache), DIZZINESS (dizziness), MYALGIA (Muscle pain), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown. Unknown          This case was linked to MOD-2021-085700, MOD-2021-085700 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pharyngeal swelling, Pyrexia, Respiration abnormal
Clinical narrative: sick; Pain in arm; Abnormal breathing; swollen throat; Pain/ Ache; dizziness; Muscle pain; Fever; Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat) and PAIN (Pain/ Ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat), PAIN (Pain/ Ache), DIZZINESS (dizziness), MYALGIA (Muscle pain), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat), PAIN (Pain/ Ache), DIZZINESS (dizziness), MYALGIA (Muscle pain), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown. Unknown          This case was linked to MOD-2021-085700, MOD-2021-085700 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sick; Pain in arm; Abnormal breathing; swollen throat; Pain/ Ache; dizziness; Muscle pain; Fever; Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat) and PAIN (Pain/ Ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat), PAIN (Pain/ Ache), DIZZINESS (dizziness), MYALGIA (Muscle pain), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, ILLNESS (sick), PAIN IN EXTREMITY (Pain in arm), RESPIRATION ABNORMAL (Abnormal breathing), PHARYNGEAL SWELLING (swollen throat), PAIN (Pain/ Ache), DIZZINESS (dizziness), MYALGIA (Muscle pain), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown. Unknown          This case was linked to MOD-2021-085700, MOD-2021-085700 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pain in extremity
Clinical narrative: her arm was sore; chills; body aches; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (her arm was sore), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (her arm was sore), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (her arm was sore), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Headache
Clinical narrative: Feeling terrible bad; Pounding head ache; no appetite at all.still persisting until the day of the call; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite at all.still persisting until the day of the call), FEELING ABNORMAL (Feeling terrible bad) and HEADACHE (Pounding head ache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced DECREASED APPETITE (no appetite at all.still persisting until the day of the call) and HEADACHE (Pounding head ache). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling terrible bad). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 mg and NAPROXEN SODIUM (ALEVE) for Headache, at a dose of 200 mg. At the time of the report, DECREASED APPETITE (no appetite at all.still persisting until the day of the call) had not resolved and FEELING ABNORMAL (Feeling terrible bad) and HEADACHE (Pounding head ache) outcome was unknown.                Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant follow up: Event outcome updated. Patient states:I still have and no appetite
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Broke out in rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced RASH (Broke out in rash). At the time of the report, RASH (Broke out in rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment details reported.   This case was linked to MOD-2021-085776 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost sense of taste / Still cant taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost sense of taste / Still cant taste) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for Cholesterol, CALCIUM and VITAMIN D NOS for Supplementation therapy, LEVOTHYROXINE for Thyroid stimulating hormone deficiency.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced AGEUSIA (Lost sense of taste / Still cant taste). At the time of the report, AGEUSIA (Lost sense of taste / Still cant taste) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.  Patient reported that even after second dose of the vaccine, still cant taste.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information added on 16JUN2021 contains significant information which includes contact information, height, weight, race and new event.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia, Pyrexia, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: feels like trying to go numb but never goes numb; extremely sore and very very painful at the injection site; 101.6 temperature 6-8 hours after the vaccine; tingling in the left arm all the way from shoulder down to fingers; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling in the left arm all the way from shoulder down to fingers), HYPOAESTHESIA (feels like trying to go numb but never goes numb), VACCINATION SITE PAIN (extremely sore and very very painful at the injection site) and PYREXIA (101.6 temperature 6-8 hours after the vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (stable) on 01-Jan-2021. Concurrent medical conditions included Lung cancer since 22-Aug-2015. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, HYDROCODONE for Pain, PEMBROLIZUMAB (KEYTRUDA), ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) and CYANOCOBALAMIN (B12-VITAMIN) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling in the left arm all the way from shoulder down to fingers), VACCINATION SITE PAIN (extremely sore and very very painful at the injection site) and PYREXIA (101.6 temperature 6-8 hours after the vaccine). On an unknown date, the patient experienced HYPOAESTHESIA (feels like trying to go numb but never goes numb). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling in the left arm all the way from shoulder down to fingers) had not resolved and HYPOAESTHESIA (feels like trying to go numb but never goes numb), VACCINATION SITE PAIN (extremely sore and very very painful at the injection site) and PYREXIA (101.6 temperature 6-8 hours after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 101.6 (High) For the second dose he had 101.6 temperature 6-8 hours after the vaccine.         Other concomitants include blood pressure medication and Novolin N & R Treatment medicines include  brain MRI (21Apr2021)   This case was linked to MOD-2021-085745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Event outcome, reporter causality, med history, con meds
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching at the injection sight.; three red sores on her arm near the injection sight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection sight.) and VACCINATION SITE ERYTHEMA (three red sores on her arm near the injection sight) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection sight.) and VACCINATION SITE ERYTHEMA (three red sores on her arm near the injection sight). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection sight.) and VACCINATION SITE ERYTHEMA (three red sores on her arm near the injection sight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-085787 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Muscle ache) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include blood pressure medications. Treatment include Tylenol   This case was linked to MOD-2021-027347 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Pain in extremity, Peripheral swelling
Clinical narrative: Blood pressure went up; Both hands hurting; Left hand hurting; Left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left hand hurting), PERIPHERAL SWELLING (Left arm swollen), BLOOD PRESSURE INCREASED (Blood pressure went up) and PAIN IN EXTREMITY (Both hands hurting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included LISINOPRIL, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and MAGNESIUM for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left hand hurting) and PERIPHERAL SWELLING (Left arm swollen). On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Both hands hurting). On 21-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up). On 13-Apr-2021, PAIN IN EXTREMITY (Left hand hurting) and PERIPHERAL SWELLING (Left arm swollen) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure went up) and PAIN IN EXTREMITY (Both hands hurting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Eye swelling, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: swelling in the eye; swelling in the head; pain in the arm; it was like very hot; head started itching a lot; Felt like balls, hives in the head; appeared like a little balloon on the eyelids; both eyes had swollen eyelids; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swelling in the eye), SWELLING (swelling in the head), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot) and PRURITUS (head started itching a lot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced EYE SWELLING (swelling in the eye), SWELLING (swelling in the head), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot), PRURITUS (head started itching a lot), URTICARIA (Felt like balls, hives in the head), SWELLING OF EYELID (appeared like a little balloon on the eyelids) and BLEPHARITIS (both eyes had swollen eyelids). The patient was treated with IBUPROFEN at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. On 22-Apr-2021, SWELLING (swelling in the head), PRURITUS (head started itching a lot) and URTICARIA (Felt like balls, hives in the head) had resolved. At the time of the report, EYE SWELLING (swelling in the eye), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot), SWELLING OF EYELID (appeared like a little balloon on the eyelids) and BLEPHARITIS (both eyes had swollen eyelids) 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling of eyelid, Urticaria
Clinical narrative: swelling in the eye; swelling in the head; pain in the arm; it was like very hot; head started itching a lot; Felt like balls, hives in the head; appeared like a little balloon on the eyelids; both eyes had swollen eyelids; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swelling in the eye), SWELLING (swelling in the head), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot) and PRURITUS (head started itching a lot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced EYE SWELLING (swelling in the eye), SWELLING (swelling in the head), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot), PRURITUS (head started itching a lot), URTICARIA (Felt like balls, hives in the head), SWELLING OF EYELID (appeared like a little balloon on the eyelids) and BLEPHARITIS (both eyes had swollen eyelids). The patient was treated with IBUPROFEN at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. On 22-Apr-2021, SWELLING (swelling in the head), PRURITUS (head started itching a lot) and URTICARIA (Felt like balls, hives in the head) had resolved. At the time of the report, EYE SWELLING (swelling in the eye), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot), SWELLING OF EYELID (appeared like a little balloon on the eyelids) and BLEPHARITIS (both eyes had swollen eyelids) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: chills that progress to shaking; chills that progress to shaking; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills that progress to shaking) and TREMOR (chills that progress to shaking) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills that progress to shaking) and TREMOR (chills that progress to shaking). At the time of the report, CHILLS (chills that progress to shaking) and TREMOR (chills that progress to shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment details reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rash pruritic
Clinical narrative: Itchy rash on leg and forehead; Pain in neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on leg and forehead) and NECK PAIN (Pain in neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash on leg and forehead) and NECK PAIN (Pain in neck). At the time of the report, RASH PRURITIC (Itchy rash on leg and forehead) and NECK PAIN (Pain in neck) outcome was unknown. Not Provided          Treatment medication was not provided.   This case was linked to MOD-2021-085748 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old Patient Received Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old Patient Received Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old Patient Received Vaccine). On 22-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old Patient Received Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication details was reported.   This case was linked to MOD21-065941, MOD21-069614, MOD21-069622 (E2B Linked Report).; Sender's Comments:  MOD21-065941: MOD21-069614: MOD21-069622:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Malaise, Vomiting
Clinical narrative: feeling unwell; diarrhea; threw up all night; Stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (feeling unwell), DIARRHOEA (diarrhea) and VOMITING (threw up all night) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and VOMITING (threw up all night). On 22-Apr-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced MALAISE (feeling unwell). On 21-Apr-2021, VOMITING (threw up all night) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (feeling unwell) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever for 12 hours) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever for 12 hours). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever for 12 hours) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (abnormal) score of 20..         No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-085723 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pruritus, Rash
Clinical narrative: rash is still getting worse,Rash is still spreading all over her; itches on face; bumps (rash), increased spreading all over; felt itching started from thighs (above knees); itches were horribly over a week especially bends of the arms (elbows); second dose was on the day 25th (before day 26); soreness; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was on the day 25th (before day 26)), PRURITUS (felt itching started from thighs (above knees)), PRURITUS (itches were horribly over a week especially bends of the arms (elbows)), PRURITUS (itches on face) and RASH (bumps (rash), increased spreading all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was on the day 25th (before day 26)), MYALGIA (soreness) and FATIGUE (Tired). On 12-Apr-2021, the patient experienced PRURITUS (felt itching started from thighs (above knees)), PRURITUS (itches were horribly over a week especially bends of the arms (elbows)) and RASH (bumps (rash), increased spreading all over). On 22-Apr-2021, the patient experienced PRURITUS (itches on face). On 28-Apr-2021, the patient experienced RASH (rash is still getting worse,Rash is still spreading all over her). The patient was treated with METHYLPREDNISOLONE at a dose of 4 mg and TRIAMCINOLONE ACETONIDE at a dose of .25 gram twice a day. On 29-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was on the day 25th (before day 26)) had resolved. At the time of the report, PRURITUS (felt itching started from thighs (above knees)), PRURITUS (itches were horribly over a week especially bends of the arms (elbows)), PRURITUS (itches on face), RASH (bumps (rash), increased spreading all over), MYALGIA (soreness), FATIGUE (Tired) and RASH (rash is still getting worse,Rash is still spreading all over her) outcome was unknown.            This case was linked to MOD-2021-085763 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: follow up received on 28-apr-2021 has new Events were updated 1)Given steroid treatments and steroid shots2) rash is still getting worse3)Rash is still spreading all over her
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: I might not get the second dose for more than 35 days; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I might not get the second dose for more than 35 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21H) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm). On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I might not get the second dose for more than 35 days). At the time of the report, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I might not get the second dose for more than 35 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: terrible diarrhea; Patient started with nausea 4 days after receiving 2nd dose; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (terrible diarrhea), NAUSEA (Patient started with nausea 4 days after receiving 2nd dose) and VOMITING (vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, LOSARTAN and PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 18-Apr-2021, the patient experienced DIARRHOEA (terrible diarrhea), NAUSEA (Patient started with nausea 4 days after receiving 2nd dose) and VOMITING (vomiting). At the time of the report, DIARRHOEA (terrible diarrhea), NAUSEA (Patient started with nausea 4 days after receiving 2nd dose) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment was reported
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site mass
Clinical narrative: Lump on left collar bone (side of injection); Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump on left collar bone (side of injection)) and CHILLS (Chills) in a 29-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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (Chills). On 29-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump on left collar bone (side of injection)). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MASS (Lump on left collar bone (side of injection)) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia
Clinical narrative: swollen lymph; muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph), MYALGIA (muscle pain) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph), MYALGIA (muscle pain) and CHILLS (Chills).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Acute pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXCARBAZEPINE for Epilepsy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above included, on 26-Jul-2021 Follow up received and contains No New Information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Headache, Illness
Clinical narrative: Sickness; Myalgia; No strength; Low back pain; Headache; Feeling unwell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), PYREXIA (Fever), ILLNESS (Sickness), MYALGIA (Myalgia) and ASTHENIA (No strength) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced MALAISE (Feeling unwell), ILLNESS (Sickness), MYALGIA (Myalgia), ASTHENIA (No strength), BACK PAIN (Low back pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK; IBUPROFEN at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency and VITAMIN B12 NOS at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling unwell), PYREXIA (Fever), ILLNESS (Sickness), MYALGIA (Myalgia), ASTHENIA (No strength), BACK PAIN (Low back pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.3 98.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Sickness; Myalgia; No strength; Low back pain; Headache; Feeling unwell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), PYREXIA (Fever), ILLNESS (Sickness), MYALGIA (Myalgia) and ASTHENIA (No strength) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced MALAISE (Feeling unwell), ILLNESS (Sickness), MYALGIA (Myalgia), ASTHENIA (No strength), BACK PAIN (Low back pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK; IBUPROFEN at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency and VITAMIN B12 NOS at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling unwell), PYREXIA (Fever), ILLNESS (Sickness), MYALGIA (Myalgia), ASTHENIA (No strength), BACK PAIN (Low back pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.3 98.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ear/it seems like the vaccine has elevated that; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ear/it seems like the vaccine has elevated that) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037D21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included METFORMIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced TINNITUS (Ringing in my ear/it seems like the vaccine has elevated that). At the time of the report, TINNITUS (Ringing in my ear/it seems like the vaccine has elevated that) outcome was unknown.            Relevant concomitant medications included heart Medications for the heart rate.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and Non Significant information added patient was not willing to fill out form again and wants to be taken off from FU list