chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Memory impairment, Muscular weakness, Nausea
Clinical narrative: Dizzy; Arm pain; Weakness in legs; Problem with memory; Sickly feely; Itchy all over; A bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory) and ILLNESS (Sickly feely) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory), ILLNESS (Sickly feely), PRURITUS (Itchy all over) and NAUSEA (A bit of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory), ILLNESS (Sickly feely), PRURITUS (Itchy all over) and NAUSEA (A bit of nausea) outcome was unknown.            Concomitant medications were not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Dizzy; Arm pain; Weakness in legs; Problem with memory; Sickly feely; Itchy all over; A bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory) and ILLNESS (Sickly feely) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory), ILLNESS (Sickly feely), PRURITUS (Itchy all over) and NAUSEA (A bit of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory), ILLNESS (Sickly feely), PRURITUS (Itchy all over) and NAUSEA (A bit of nausea) outcome was unknown.            Concomitant medications were not reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Cant fall asleep due to pain; Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test; Constant Throbbing pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test), PAIN (Constant Throbbing pain in arm) and SLEEP DISORDER (Cant fall asleep due to pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21) for COVID-19 vaccination.     The patient's past medical history included Heart attack (had two heart attacks in the past) and Stent placement (he has had two stints put in in the past) since an unknown date.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test) and PAIN (Constant Throbbing pain in arm). On an unknown date, the patient experienced SLEEP DISORDER (Cant fall asleep due to pain). At the time of the report, PAIN IN EXTREMITY (Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test), PAIN (Constant Throbbing pain in arm) and SLEEP DISORDER (Cant fall asleep due to pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypokinesia, Malaise, Pain in extremity
Clinical narrative: headache; shakes; couldn't hold anything/could not hold phone; didn't feel well; fever 102.1; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided.  Concomitant products included MORPHINE, GABAPENTIN, ATORVASTATIN, OMEPRAZOLE, ESCITALOPRAM, FENOFIBRATE, ARIPIPRAZOLE, TRAZODONE, TOPIRAMATE, METOPROLOL, FLUDROCORTISONE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced TREMOR (shakes), HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts). On 24-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (shakes) and HEADACHE (headache) had not resolved and HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 102.1 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: headache; shakes; couldn't hold anything/could not hold phone; didn't feel well; fever 102.1; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided.  Concomitant products included MORPHINE, GABAPENTIN, ATORVASTATIN, OMEPRAZOLE, ESCITALOPRAM, FENOFIBRATE, ARIPIPRAZOLE, TRAZODONE, TOPIRAMATE, METOPROLOL, FLUDROCORTISONE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced TREMOR (shakes), HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts). On 24-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (shakes) and HEADACHE (headache) had not resolved and HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 102.1 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over the body; Itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (mild).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient denied having any food allergies.  No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Somnolence
Clinical narrative: sleeping a lot; weak; tired; sore and achy muscles; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeping a lot), ASTHENIA (weak), FATIGUE (tired) and MYALGIA (sore and achy muscles) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced SOMNOLENCE (sleeping a lot), ASTHENIA (weak), FATIGUE (tired) and MYALGIA (sore and achy muscles). At the time of the report, SOMNOLENCE (sleeping a lot), ASTHENIA (weak), FATIGUE (tired) and MYALGIA (sore and achy muscles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: Body aches; Chills; Diarrhea; Nauseous; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nauseous), PYREXIA (Felt feverish), MYALGIA (Body aches) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced NAUSEA (Nauseous) and PYREXIA (Felt feverish). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 23-Mar-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at a dose of 1 UNK. At the time of the report, DIARRHOEA (Diarrhea) had resolved and NAUSEA (Nauseous), PYREXIA (Felt feverish), MYALGIA (Body aches) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99 (High) Feverish.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; Chills; Diarrhea; Nauseous; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nauseous), PYREXIA (Felt feverish), MYALGIA (Body aches) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced NAUSEA (Nauseous) and PYREXIA (Felt feverish). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 23-Mar-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at a dose of 1 UNK. At the time of the report, DIARRHOEA (Diarrhea) had resolved and NAUSEA (Nauseous), PYREXIA (Felt feverish), MYALGIA (Body aches) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99 (High) Feverish.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTENSION (High blood pressure). At the time of the report, HYPERTENSION (High blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood pressure measurement: high (High) High.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Bursitis, Diarrhoea, Dizziness, Headache
Clinical narrative: Fever of 101.5 F; nauseated; diarrhea; headache; light headed; hot around the injection site; very red around the injection site; hard around the injection site; Bursitis on the left arm; soreness spread under the left arm; soreness spread around the left breast; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache) and DIZZINESS (light headed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast). At the time of the report, PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is treated with Tylenol.   This case was linked to MOD-2021-056285 (Linked Report). This case was linked to MOD-2021-247019 (Patient Link).; Sender's Comments:  MOD-2021-056285:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site mass
Clinical narrative: Fever of 101.5 F; nauseated; diarrhea; headache; light headed; hot around the injection site; very red around the injection site; hard around the injection site; Bursitis on the left arm; soreness spread under the left arm; soreness spread around the left breast; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache) and DIZZINESS (light headed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast). At the time of the report, PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is treated with Tylenol.   This case was linked to MOD-2021-056285 (Linked Report). This case was linked to MOD-2021-247019 (Patient Link).; Sender's Comments:  MOD-2021-056285:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Fever of 101.5 F; nauseated; diarrhea; headache; light headed; hot around the injection site; very red around the injection site; hard around the injection site; Bursitis on the left arm; soreness spread under the left arm; soreness spread around the left breast; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache) and DIZZINESS (light headed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast). At the time of the report, PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is treated with Tylenol.   This case was linked to MOD-2021-056285 (Linked Report). This case was linked to MOD-2021-247019 (Patient Link).; Sender's Comments:  MOD-2021-056285:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Fatigue; Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills ) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills ). On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills ) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: Bump on same arm but on shoulder blade; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bump on same arm but on shoulder blade) and VACCINATION SITE PAIN (Pain at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (Bump on same arm but on shoulder blade) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with IBUPROFEN for Root canal procedure, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Bump on same arm but on shoulder blade) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-078103 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078103:Dose 1
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: He experienced swelling in the parotid gland around the jaw; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (He experienced swelling in the parotid gland around the jaw) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN, METFORMIN, ROSUVASTATIN CALCIUM and CETIRIZINE for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LYMPHADENOPATHY (He experienced swelling in the parotid gland around the jaw). At the time of the report, LYMPHADENOPATHY (He experienced swelling in the parotid gland around the jaw) was resolving.            No treatment medication reported
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rashes all over his body; fever of 100.8°F; rash on his left breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his left breast), RASH (rashes all over his body) and PYREXIA (fever of 100.8°F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 024m20a) for an unknown indication.     Concurrent medical conditions included Allergy.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced RASH (rash on his left breast). On 18-Mar-2021, the patient experienced RASH (rashes all over his body) and PYREXIA (fever of 100.8°F). On 11-Mar-2021, RASH (rash on his left breast) had resolved. On 19-Mar-2021, PYREXIA (fever of 100.8°F) had resolved. At the time of the report, RASH (rashes all over his body) outcome was unknown.            Treatment information were Steroid cream, antibiotics (only for the symptoms following the 1st dose), Advil provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non Significant Follow-up Append
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: Felt sluggish; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish) and PAIN IN EXTREMITY (Arm was sore) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, LISINOPRIL, TAMSULOSIN and APIXABAN (ELIQUIS) for an unknown indication.   On 27-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 an unknown date, the patient experienced SLUGGISHNESS (Felt sluggish) and PAIN IN EXTREMITY (Arm was sore). At the time of the report, SLUGGISHNESS (Felt sluggish) and PAIN IN EXTREMITY (Arm was sore) outcome was unknown. Not Provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; A spontaneous report was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced missed dose/second dose past 42 days of first dose.   The patient's medical history was not provided. Concomitant product use was unknown by the reporter.   On 13 Jan 2021 , approximately 42 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in unknown site for prophylaxis of COVID-19 infection.   On 24 Mar 2021, the patient experienced missed dose/second dose past 42 days of first dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event missed dose/second dose past 42 days of first dose , were considered not resolved during the time of this report.; Reporter's Comments: This report refers to a case of Product dose omission issue,  for mRNA-1273, lot #: 013L20A,  with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Feeling abnormal, Neck pain, Palpitations
Clinical narrative: Neck swollen; Neck hurting; Heart palpitation; feeling weird; felt like she was going to faint/Light headed; Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed), BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit), SWELLING (Neck swollen) and NECK PAIN (Neck hurting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart murmur and Thyroid disorder.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed), BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit) and PALPITATIONS (Heart palpitation). On 03-Mar-2021, the patient experienced SWELLING (Neck swollen) and NECK PAIN (Neck hurting). At the time of the report, FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed) and PALPITATIONS (Heart palpitation) had resolved and BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit), SWELLING (Neck swollen) and NECK PAIN (Neck hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information received on 11-MAY-2021, TCR added but NNI updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Neck swollen; Neck hurting; Heart palpitation; feeling weird; felt like she was going to faint/Light headed; Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed), BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit), SWELLING (Neck swollen) and NECK PAIN (Neck hurting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart murmur and Thyroid disorder.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed), BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit) and PALPITATIONS (Heart palpitation). On 03-Mar-2021, the patient experienced SWELLING (Neck swollen) and NECK PAIN (Neck hurting). At the time of the report, FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed) and PALPITATIONS (Heart palpitation) had resolved and BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit), SWELLING (Neck swollen) and NECK PAIN (Neck hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information received on 11-MAY-2021, TCR added but NNI updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: arm swelling; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelling) and PAIN (Aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history reported by the reporter.     On 20-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 PERIPHERAL SWELLING (arm swelling) and PAIN (Aches). The patient was treated with PARACETAMOL (TYLENOL) on 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelling) and PAIN (Aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021 contains non-significant information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound breast
Clinical narrative: swelling under the lymph nodes both arms; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling under the lymph nodes both arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced LYMPHADENOPATHY (swelling under the lymph nodes both arms). At the time of the report, LYMPHADENOPATHY (swelling under the lymph nodes both arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Mammogram: normal (normal) normal. On 18-Jan-2021, Ultrasound breast: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-030765 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Eructation, Fatigue
Clinical narrative: Tingling in arms and legs; Can't stand up; Dizziness; GI blowup; GERD; Burping; Confusion; Brain fog; No energy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in arms and legs), ASTHENIA (Can't stand up), DIZZINESS (Dizziness), GASTROINTESTINAL INFECTION (GI blowup) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal). Concomitant products included LOSARTAN and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PARAESTHESIA (Tingling in arms and legs), ASTHENIA (Can't stand up), DIZZINESS (Dizziness), GASTROINTESTINAL INFECTION (GI blowup), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), ERUCTATION (Burping), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Brain fog) and FATIGUE (No energy). At the time of the report, PARAESTHESIA (Tingling in arms and legs), ASTHENIA (Can't stand up), DIZZINESS (Dizziness), GASTROINTESTINAL INFECTION (GI blowup), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), ERUCTATION (Burping), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Brain fog) and FATIGUE (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       07 Dec 2020 Patient thinks he had COVID-19 but could not get tested. Patient lost sense of taste and smell and other neurological symptoms such as muscle cramping. Symptoms lingered through January. Treatment for the events included rest.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal infection, Gastrooesophageal reflux disease, Paraesthesia
Clinical narrative: Tingling in arms and legs; Can't stand up; Dizziness; GI blowup; GERD; Burping; Confusion; Brain fog; No energy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in arms and legs), ASTHENIA (Can't stand up), DIZZINESS (Dizziness), GASTROINTESTINAL INFECTION (GI blowup) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal). Concomitant products included LOSARTAN and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PARAESTHESIA (Tingling in arms and legs), ASTHENIA (Can't stand up), DIZZINESS (Dizziness), GASTROINTESTINAL INFECTION (GI blowup), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), ERUCTATION (Burping), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Brain fog) and FATIGUE (No energy). At the time of the report, PARAESTHESIA (Tingling in arms and legs), ASTHENIA (Can't stand up), DIZZINESS (Dizziness), GASTROINTESTINAL INFECTION (GI blowup), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), ERUCTATION (Burping), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Brain fog) and FATIGUE (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       07 Dec 2020 Patient thinks he had COVID-19 but could not get tested. Patient lost sense of taste and smell and other neurological symptoms such as muscle cramping. Symptoms lingered through January. Treatment for the events included rest.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given 15-20 minutes after the 6 hour vial puncture expiration; A spontaneous report was received concerning a 78 Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported dose given 15-20 minutes after the 6 hour vial puncture expiration (Expired product administered ).  The patient's medical history was not known .Products used are unknown.  On 23 Mar 20201, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) via unknown route for prophylaxis of COVID-19 infection.   On 23-Mar-2021, a patient received the Moderna vaccine 15-20 minutes after the 6 hour vial puncture expiration. It was reported that, the patient was monitored for 15 minutes after the vaccine and no adverse events noted by staff.    Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was considered as unknown; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 041L20A)  with no associated AEs
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A2117) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-033484 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033484:Mother Case MOD21-043047
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: chills; headache; fever; muscle aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02TIA21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 09-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 CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA in response to the event was not applicable. Patient took the second dose of vaccine on 06 Apr 2021 with batch number 027B21A.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information was received on 12 May 2021 wherein contact details(reporter address) and 1st dose lot number was added, 2nd dose start date and lot number was added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; headache; fever; muscle aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02TIA21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 09-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 CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA in response to the event was not applicable. Patient took the second dose of vaccine on 06 Apr 2021 with batch number 027B21A.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information was received on 12 May 2021 wherein contact details(reporter address) and 1st dose lot number was added, 2nd dose start date and lot number was added.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old and was vaccinated with the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and was vaccinated with the 1st dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and was vaccinated with the 1st dose). On 31-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and was vaccinated with the 1st dose) had resolved.            Concomitant product information was not provided. Treatment information was not provided Patient stated that she was feeling well   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up information received on 11 Jun 2021 Dose 2 information was added; Sender's Comments: .