chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant during first shot; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant during first shot) in a 38-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, Full-term Birth) since April 2018. Concurrent medical conditions included Drug allergy (Cephzil). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 25-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 26-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant during first shot). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy. The delivery occurred in March 2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant during first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-065323 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Rash
Clinical narrative: Heartbeat really fast; Rash in the face; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heartbeat really fast) and RASH (Rash in the face) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (Heartbeat really fast) and RASH (Rash in the face). At the time of the report, HEART RATE INCREASED (Heartbeat really fast) and RASH (Rash in the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Pain in extremity, Urticaria
Clinical narrative: body aches; big red welt; big red welt; sore arm; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), URTICARIA (big red welt), ERYTHEMA (big red welt), PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PAIN (body aches), URTICARIA (big red welt), ERYTHEMA (big red welt), PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches). At the time of the report, PAIN (body aches), URTICARIA (big red welt), ERYTHEMA (big red welt), PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Decreased appetite, Iron deficiency, Malaise
Clinical narrative: Tingling from left knee down to leg; Didn't feel well; Taste was off; Didn't feel like eating; Feet and toes turned black and blue; Lemonade smelled like gas; Lemonade tested like it sat for a month; Blueberries tasted like mold; acute iron deficiency; Had fever of 104 F that back down to 99 F; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating) and SKIN DISCOLOURATION (Feet and toes turned black and blue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart valve disorders.   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 an unknown date, the patient experienced PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating), SKIN DISCOLOURATION (Feet and toes turned black and blue), PAROSMIA (Lemonade smelled like gas), TASTE DISORDER (Lemonade tested like it sat for a month), TASTE DISORDER (Blueberries tasted like mold), IRON DEFICIENCY (acute iron deficiency) and PYREXIA (Had fever of 104 F that back down to 99 F). At the time of the report, PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating), SKIN DISCOLOURATION (Feet and toes turned black and blue), PAROSMIA (Lemonade smelled like gas), TASTE DISORDER (Lemonade tested like it sat for a month), TASTE DISORDER (Blueberries tasted like mold), IRON DEFICIENCY (acute iron deficiency) and PYREXIA (Had fever of 104 F that back down to 99 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 104 (High) Had fever of 104 F that back down to 99 F.         No treatment medication were provided. No concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient visited to the ER on 30-MAR-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-065283 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up Appended - New event added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065283:1st dose case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Parosmia, Pyrexia, Skin discolouration, Taste disorder
Clinical narrative: Tingling from left knee down to leg; Didn't feel well; Taste was off; Didn't feel like eating; Feet and toes turned black and blue; Lemonade smelled like gas; Lemonade tested like it sat for a month; Blueberries tasted like mold; acute iron deficiency; Had fever of 104 F that back down to 99 F; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating) and SKIN DISCOLOURATION (Feet and toes turned black and blue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart valve disorders.   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 an unknown date, the patient experienced PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating), SKIN DISCOLOURATION (Feet and toes turned black and blue), PAROSMIA (Lemonade smelled like gas), TASTE DISORDER (Lemonade tested like it sat for a month), TASTE DISORDER (Blueberries tasted like mold), IRON DEFICIENCY (acute iron deficiency) and PYREXIA (Had fever of 104 F that back down to 99 F). At the time of the report, PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating), SKIN DISCOLOURATION (Feet and toes turned black and blue), PAROSMIA (Lemonade smelled like gas), TASTE DISORDER (Lemonade tested like it sat for a month), TASTE DISORDER (Blueberries tasted like mold), IRON DEFICIENCY (acute iron deficiency) and PYREXIA (Had fever of 104 F that back down to 99 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 104 (High) Had fever of 104 F that back down to 99 F.         No treatment medication were provided. No concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient visited to the ER on 30-MAR-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-065283 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up Appended - New event added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065283:1st dose case
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding) in a  patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012A21A) , while the mother received the product for COVID-19 vaccination.     Concomitant product exposures included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 25-Feb-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The mother's last menstrual period was on 26-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (breastfeeding). The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding) had resolved.            Treatment medication was not provided   This case was linked to MOD-2021-065319 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site for days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site for days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site for days). At the time of the report, INJECTION SITE PAIN (Injection site for days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Somnolence, Vaccination site erythema
Clinical narrative: Red round rash at injection site.; Rash at injection site.; Slept like a log; Fever; Chills; Was really tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Was really tired) and VACCINATION SITE ERYTHEMA (Red round rash at injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Was really tired). On 01-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red round rash at injection site.) and VACCINATION SITE RASH (Rash at injection site.). At the time of the report, SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Was really tired), VACCINATION SITE ERYTHEMA (Red round rash at injection site.) and VACCINATION SITE RASH (Rash at injection site.) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact details updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red round rash at injection site.; Rash at injection site.; Slept like a log; Fever; Chills; Was really tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Was really tired) and VACCINATION SITE ERYTHEMA (Red round rash at injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Was really tired). On 01-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red round rash at injection site.) and VACCINATION SITE RASH (Rash at injection site.). At the time of the report, SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Was really tired), VACCINATION SITE ERYTHEMA (Red round rash at injection site.) and VACCINATION SITE RASH (Rash at injection site.) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact details updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dizziness, Retching
Clinical narrative: dizziness (vertigo); sensitive stomach; dry heaves; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness (vertigo)), ABDOMINAL PAIN (sensitive stomach), RETCHING (dry heaves) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus (Lupus: but is not on an immunosuppressant medication).    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (dizziness (vertigo)), ABDOMINAL PAIN (sensitive stomach), RETCHING (dry heaves) and CHILLS (chills). On 26-Feb-2021, RETCHING (dry heaves) and CHILLS (chills) had resolved. At the time of the report, DIZZINESS (dizziness (vertigo)) and ABDOMINAL PAIN (sensitive stomach) outcome was unknown. Not Provided          No concomitant medication reported  No treatment medication reported  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN, FLECAINIDE, FUROSEMIDE, VALSARTAN and APIXABAN (ELIQUIS) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Treatment included Over the counter medicine Action taken with mRNA-1273 in response to the event was not applicable
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: sore shoulder; pain in legs; pain in calf; pain in bottom of feet; swelling of ankles; swollen foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore shoulder), PAIN IN EXTREMITY (pain in legs), PAIN IN EXTREMITY (pain in calf), PAIN IN EXTREMITY (pain in bottom of feet) and JOINT SWELLING (swelling of ankles) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Prostate cancer.    On 30-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 PAIN (sore shoulder), PAIN IN EXTREMITY (pain in legs), PAIN IN EXTREMITY (pain in calf), PAIN IN EXTREMITY (pain in bottom of feet), JOINT SWELLING (swelling of ankles) and OEDEMA PERIPHERAL (swollen foot). At the time of the report, PAIN (sore shoulder), PAIN IN EXTREMITY (pain in legs), PAIN IN EXTREMITY (pain in calf), PAIN IN EXTREMITY (pain in bottom of feet), JOINT SWELLING (swelling of ankles) and OEDEMA PERIPHERAL (swollen foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were unknown Treatment was included tub soak
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: lightheaded; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), HEADACHE (headache) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by reporter.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheaded), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIZZINESS (lightheaded), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included antidepressant, blood pressure medication, heart pill Treatment medication was taking medication for the headache, but nothing for the nausea
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache
Clinical narrative: Redness in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR) and PANTOPRAZOLE for an unknown indication.   On 25-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in arm) and HEADACHE (Headache). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065351:Dose 2
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Arm pain of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Arm pain of injection) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Constipation and Colonoscopy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm pain of injection). On 26-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 15-Mar-2021, VACCINATION SITE PAIN (Arm pain of injection) had resolved. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (slight fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (Headache) and PYREXIA (slight fever). At the time of the report, HEADACHE (Headache) and PYREXIA (slight fever) outcome was unknown.         Treatment was unknown Action taken with mRNA-1273 in response to the event was not applicable
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Ocular hyperaemia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Blood inside the eye; Burning sensation on the eye; Hot R arm of injection; Itchiness R arm of injection; Redness R arm of injection; Swelling R arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Blood inside the eye), EYE IRRITATION (Burning sensation on the eye), VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection) and VACCINATION SITE ERYTHEMA (Redness R arm of injection) in a 50-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.     Concomitant products included OMEPRAZOLE 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 VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection), VACCINATION SITE ERYTHEMA (Redness R arm of injection) and VACCINATION SITE SWELLING (Swelling R arm of injection). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood inside the eye) and EYE IRRITATION (Burning sensation on the eye). At the time of the report, OCULAR HYPERAEMIA (Blood inside the eye), EYE IRRITATION (Burning sensation on the eye), VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection), VACCINATION SITE ERYTHEMA (Redness R arm of injection) and VACCINATION SITE SWELLING (Swelling R arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not receive any treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Blood inside the eye; Burning sensation on the eye; Hot R arm of injection; Itchiness R arm of injection; Redness R arm of injection; Swelling R arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Blood inside the eye), EYE IRRITATION (Burning sensation on the eye), VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection) and VACCINATION SITE ERYTHEMA (Redness R arm of injection) in a 50-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.     Concomitant products included OMEPRAZOLE 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 VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection), VACCINATION SITE ERYTHEMA (Redness R arm of injection) and VACCINATION SITE SWELLING (Swelling R arm of injection). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood inside the eye) and EYE IRRITATION (Burning sensation on the eye). At the time of the report, OCULAR HYPERAEMIA (Blood inside the eye), EYE IRRITATION (Burning sensation on the eye), VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection), VACCINATION SITE ERYTHEMA (Redness R arm of injection) and VACCINATION SITE SWELLING (Swelling R arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not receive any treatment.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site developed "egg shaped raised area"; Injection site became "hot to the touch"; Injection site became red; Injection site became painful; Injection site became swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection site developed "egg shaped raised area"), VACCINATION SITE WARMTH (Injection site became "hot to the touch"), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Anxiety and Thyroiditis NOS. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, VITAMIN D3 and VITAMIN B12 NOS for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 VACCINATION SITE WARMTH (Injection site became "hot to the touch"), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became swollen). On 01-Apr-2021, the patient experienced VACCINATION SITE MASS (Injection site developed "egg shaped raised area"). At the time of the report, VACCINATION SITE MASS (Injection site developed "egg shaped raised area"), VACCINATION SITE WARMTH (Injection site became "hot to the touch"), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became swollen) had resolved.            The other concomitant medications include Thyroid Medication, High Blood Pressure Medication and Anti-Anxiety Medication. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received on 14-May-2021 and outcome of the event was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Tremor, Vaccination site pain
Clinical narrative: stomach upset; arm and hands shaking; tenderness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), TREMOR (arm and hands shaking) and VACCINATION SITE PAIN (tenderness in injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement (had heart attack and had two stents). Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT), PANTOPRAZOLE, HCTZ, SUCRALFATE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), POTASSIUM CHLORIDE (POTASSIUM [POTASSIUM CHLORIDE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness in injection site). On 26-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset) and TREMOR (arm and hands shaking). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), TREMOR (arm and hands shaking) and VACCINATION SITE PAIN (tenderness in injection site) outcome was unknown.            Treatment medications include IV infusions with Reglan and Zofran for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Fatigue, Neck pain
Clinical narrative: stomach is upset but nothing major with diarrhea; cramping in my stomach; severe diarrhea; slightly sore where vaccine was injected; couldn't move upper arm it was very painful; It was progressing toward shoulder and neck; normal soreness in arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramping in my stomach), ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea), PAIN (couldn't move upper arm it was very painful), DIARRHOEA (severe diarrhea) and NECK PAIN (It was progressing toward shoulder and neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included ESCITALOPRAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (couldn't move upper arm it was very painful), NECK PAIN (It was progressing toward shoulder and neck), PAIN IN EXTREMITY (normal soreness in arm) and FATIGUE (tired). On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (slightly sore where vaccine was injected). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (cramping in my stomach) and DIARRHOEA (severe diarrhea). On 01-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, ABDOMINAL PAIN UPPER (cramping in my stomach), ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea), PAIN (couldn't move upper arm it was very painful), DIARRHOEA (severe diarrhea), NECK PAIN (It was progressing toward shoulder and neck), PAIN IN EXTREMITY (normal soreness in arm), FATIGUE (tired) and VACCINATION SITE PAIN (slightly sore where vaccine was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-103307 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: stomach is upset but nothing major with diarrhea; cramping in my stomach; severe diarrhea; slightly sore where vaccine was injected; couldn't move upper arm it was very painful; It was progressing toward shoulder and neck; normal soreness in arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramping in my stomach), ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea), PAIN (couldn't move upper arm it was very painful), DIARRHOEA (severe diarrhea) and NECK PAIN (It was progressing toward shoulder and neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included ESCITALOPRAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (couldn't move upper arm it was very painful), NECK PAIN (It was progressing toward shoulder and neck), PAIN IN EXTREMITY (normal soreness in arm) and FATIGUE (tired). On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (slightly sore where vaccine was injected). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (cramping in my stomach) and DIARRHOEA (severe diarrhea). On 01-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, ABDOMINAL PAIN UPPER (cramping in my stomach), ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea), PAIN (couldn't move upper arm it was very painful), DIARRHOEA (severe diarrhea), NECK PAIN (It was progressing toward shoulder and neck), PAIN IN EXTREMITY (normal soreness in arm), FATIGUE (tired) and VACCINATION SITE PAIN (slightly sore where vaccine was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-103307 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling at injection site; Very red at injection site; Dizziness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (tiredness), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Very red at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE and VITAMINS NOS for an unknown indication.    On 09-Feb-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 DIZZINESS (Dizziness) and FATIGUE (tiredness). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Very red at injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DIZZINESS (Dizziness), FATIGUE (tiredness), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Very red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-022964 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under 18years patient received Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18years patient received Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18years patient received Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18years patient received Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Vaccination site pruritus; Hardness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulphur). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment reported by the reporter
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose; Received Moderna vaccine at 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine at 16 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine at 16 years of age). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose). On 22-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine at 16 years of age) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details was provided.  No treatment drug was provided.   This case was linked to MOD-2021-065366, MOD-2021-210740, MOD-2021-210713 (Patient Link).; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) and Inappropriate schedule of vaccine administration for second dose for mRNA-1273 (lot number unknown) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Chills, Dysuria, Hyperhidrosis, Pollakiuria
Clinical narrative: sweats so bad water is pouring off of his body; lost control of bowels while sleeping; burning feeling when urinating; urinating every 5-10 minutes; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats so bad water is pouring off of his body), ANAL INCONTINENCE (lost control of bowels while sleeping), DYSURIA (burning feeling when urinating), POLLAKIURIA (urinating every 5-10 minutes) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-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 29-Mar-2021, the patient experienced HYPERHIDROSIS (sweats so bad water is pouring off of his body), ANAL INCONTINENCE (lost control of bowels while sleeping), DYSURIA (burning feeling when urinating), POLLAKIURIA (urinating every 5-10 minutes) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats so bad water is pouring off of his body), ANAL INCONTINENCE (lost control of bowels while sleeping), DYSURIA (burning feeling when urinating), POLLAKIURIA (urinating every 5-10 minutes) and CHILLS (chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Induration, Pain in extremity, Skin papilloma
Clinical narrative: bumpy growths all over my chest and abdomen; warts; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INDURATION (bumpy growths all over my chest and abdomen) and SKIN PAPILLOMA (warts) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced INDURATION (bumpy growths all over my chest and abdomen) and SKIN PAPILLOMA (warts). On 14-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, INDURATION (bumpy growths all over my chest and abdomen) and SKIN PAPILLOMA (warts) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) "way high" both times and was hard to control but stabilized after 24 hours..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.   This case was linked to MOD-2021-049848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received : Skin papilloma and Induration events are added.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles in eye; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles in eye) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles in eye). At the time of the report, HERPES ZOSTER (Shingles in eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Samcyclovir   This case was linked to US-MODERNATX, INC.-MOD-2021-065635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065635:Cross-linked