chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Malaise, Pain in extremity
Clinical narrative: had a typical reaction to the third shot, but this is ridiculous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 001a21a and 036B21a) for COVID-19 prophylaxis.     Patient had no allergies and never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous). At the time of the report, IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) outcome was unknown.            No concomitant medication reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The adverse event did not cause patient to seek medical care. No treatment medication details reported.   This case was linked to MOD-2022-587908, MOD-2022-587879, MOD-2022-587915, MOD-2022-587913 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: had a typical reaction to the third shot, but this is ridiculous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 001a21a and 036B21a) for COVID-19 prophylaxis.     Patient had no allergies and never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous). At the time of the report, IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) outcome was unknown.            No concomitant medication reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The adverse event did not cause patient to seek medical care. No treatment medication details reported.   This case was linked to MOD-2022-587908, MOD-2022-587879, MOD-2022-587915, MOD-2022-587913 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Erythema, Fatigue, Feeding disorder
Clinical narrative: had a typical reaction to the third shot, but this is ridiculous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 001a21a and 036B21a) for COVID-19 prophylaxis.     Patient had no allergies and never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous). At the time of the report, IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) outcome was unknown.            No concomitant medication reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The adverse event did not cause patient to seek medical care. No treatment medication details reported.   This case was linked to MOD-2022-587908, MOD-2022-587879, MOD-2022-587915, MOD-2022-587913 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Night sweats, Pruritus, Pyrexia
Clinical narrative: had a typical reaction to the third shot, but this is ridiculous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 001a21a and 036B21a) for COVID-19 prophylaxis.     Patient had no allergies and never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous). At the time of the report, IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) outcome was unknown.            No concomitant medication reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The adverse event did not cause patient to seek medical care. No treatment medication details reported.   This case was linked to MOD-2022-587908, MOD-2022-587879, MOD-2022-587915, MOD-2022-587913 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: had a typical reaction to the third shot, but this is ridiculous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 001a21a and 036B21a) for COVID-19 prophylaxis.     Patient had no allergies and never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous). At the time of the report, IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) outcome was unknown.            No concomitant medication reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The adverse event did not cause patient to seek medical care. No treatment medication details reported.   This case was linked to MOD-2022-587908, MOD-2022-587879, MOD-2022-587915, MOD-2022-587913 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: had a typical reaction to the third shot, but this is ridiculous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 001a21a and 036B21a) for COVID-19 prophylaxis.     Patient had no allergies and never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous). At the time of the report, IMMUNISATION REACTION (had a typical reaction to the third shot, but this is ridiculous) outcome was unknown.            No concomitant medication reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The adverse event did not cause patient to seek medical care. No treatment medication details reported.   This case was linked to MOD-2022-587908, MOD-2022-587879, MOD-2022-587915, MOD-2022-587913 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Malaise, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats) and ERYTHEMA (arm is red  and itchy.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0038a22a, 071f21a, 036B21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced FATIGUE (was tired). On 11-Jun-2022, the patient experienced ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.), PYREXIA (fever, fever got better) and VOMITING (throws up). At the time of the report, ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.) and VOMITING (throws up) had not resolved, FATIGUE (was tired) outcome was unknown and PYREXIA (fever, fever got better) was resolving. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported. This case was linked to MOD-2022-587938, MOD-2022-587915, MOD-2022-587913, MOD-2022-587879 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats) and ERYTHEMA (arm is red  and itchy.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0038a22a, 071f21a, 036B21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced FATIGUE (was tired). On 11-Jun-2022, the patient experienced ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.), PYREXIA (fever, fever got better) and VOMITING (throws up). At the time of the report, ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.) and VOMITING (throws up) had not resolved, FATIGUE (was tired) outcome was unknown and PYREXIA (fever, fever got better) was resolving. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported. This case was linked to MOD-2022-587938, MOD-2022-587915, MOD-2022-587913, MOD-2022-587879 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Erythema, Fatigue, Feeding disorder
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats) and ERYTHEMA (arm is red  and itchy.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0038a22a, 071f21a, 036B21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced FATIGUE (was tired). On 11-Jun-2022, the patient experienced ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.), PYREXIA (fever, fever got better) and VOMITING (throws up). At the time of the report, ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.) and VOMITING (throws up) had not resolved, FATIGUE (was tired) outcome was unknown and PYREXIA (fever, fever got better) was resolving. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported. This case was linked to MOD-2022-587938, MOD-2022-587915, MOD-2022-587913, MOD-2022-587879 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Night sweats, Pruritus, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats) and ERYTHEMA (arm is red  and itchy.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0038a22a, 071f21a, 036B21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced FATIGUE (was tired). On 11-Jun-2022, the patient experienced ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.), PYREXIA (fever, fever got better) and VOMITING (throws up). At the time of the report, ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.) and VOMITING (throws up) had not resolved, FATIGUE (was tired) outcome was unknown and PYREXIA (fever, fever got better) was resolving. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported. This case was linked to MOD-2022-587938, MOD-2022-587915, MOD-2022-587913, MOD-2022-587879 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats) and ERYTHEMA (arm is red  and itchy.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0038a22a, 071f21a, 036B21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced FATIGUE (was tired). On 11-Jun-2022, the patient experienced ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.), PYREXIA (fever, fever got better) and VOMITING (throws up). At the time of the report, ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.) and VOMITING (throws up) had not resolved, FATIGUE (was tired) outcome was unknown and PYREXIA (fever, fever got better) was resolving. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported. This case was linked to MOD-2022-587938, MOD-2022-587915, MOD-2022-587913, MOD-2022-587879 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats) and ERYTHEMA (arm is red  and itchy.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0038a22a, 071f21a, 036B21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced FATIGUE (was tired). On 11-Jun-2022, the patient experienced ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.), PYREXIA (fever, fever got better) and VOMITING (throws up). At the time of the report, ILLNESS (is so ill/this is horrendous), BEDRIDDEN (bed ridden), FEEDING DISORDER (can not  eat), NIGHT SWEATS (has night sweats), ERYTHEMA (arm is red  and itchy.), DIARRHOEA (Diarrhea), PRURITUS (arm itchy.), HEADACHE (but she does have headaches, terrible headaches.) and VOMITING (throws up) had not resolved, FATIGUE (was tired) outcome was unknown and PYREXIA (fever, fever got better) was resolving. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported. This case was linked to MOD-2022-587938, MOD-2022-587915, MOD-2022-587913, MOD-2022-587879 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Malaise, Pain in extremity
Clinical narrative: after her first dose she had a sore arm,; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after her first dose she had a sore arm,) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. Patient not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (after her first dose she had a sore arm,). At the time of the report, PAIN IN EXTREMITY (after her first dose she had a sore arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient is not a big baby about symptom or antivaxxer. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported.   This case was linked to MOD-2022-587913, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: after her first dose she had a sore arm,; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after her first dose she had a sore arm,) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. Patient not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (after her first dose she had a sore arm,). At the time of the report, PAIN IN EXTREMITY (after her first dose she had a sore arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient is not a big baby about symptom or antivaxxer. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported.   This case was linked to MOD-2022-587913, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Erythema, Fatigue, Feeding disorder
Clinical narrative: after her first dose she had a sore arm,; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after her first dose she had a sore arm,) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. Patient not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (after her first dose she had a sore arm,). At the time of the report, PAIN IN EXTREMITY (after her first dose she had a sore arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient is not a big baby about symptom or antivaxxer. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported.   This case was linked to MOD-2022-587913, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Night sweats, Pruritus, Pyrexia
Clinical narrative: after her first dose she had a sore arm,; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after her first dose she had a sore arm,) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. Patient not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (after her first dose she had a sore arm,). At the time of the report, PAIN IN EXTREMITY (after her first dose she had a sore arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient is not a big baby about symptom or antivaxxer. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported.   This case was linked to MOD-2022-587913, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: after her first dose she had a sore arm,; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after her first dose she had a sore arm,) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. Patient not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (after her first dose she had a sore arm,). At the time of the report, PAIN IN EXTREMITY (after her first dose she had a sore arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient is not a big baby about symptom or antivaxxer. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported.   This case was linked to MOD-2022-587913, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: after her first dose she had a sore arm,; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (after her first dose she had a sore arm,) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. Patient not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (after her first dose she had a sore arm,). At the time of the report, PAIN IN EXTREMITY (after her first dose she had a sore arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient is not a big baby about symptom or antivaxxer. Concomitant medications were not reported. Patient did not seek any medical care. Treatment details was not reported.   This case was linked to MOD-2022-587913, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Drug ineffective, Palpitations
Clinical narrative: She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder); Lack of effect with Moderna Covid-19 vaccine; you get dizzy; flip flopped; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder)), DRUG INEFFECTIVE (Lack of effect with Moderna Covid-19 vaccine), DIZZINESS (you get dizzy) and PALPITATIONS (flip flopped) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 027A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose twice a day. On an unknown date, the patient experienced COVID-19 (She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder)), DRUG INEFFECTIVE (Lack of effect with Moderna Covid-19 vaccine), DIZZINESS (you get dizzy) and PALPITATIONS (flip flopped). At the time of the report, COVID-19 (She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder)) and DRUG INEFFECTIVE (Lack of effect with Moderna Covid-19 vaccine) outcome was unknown and DIZZINESS (you get dizzy) and PALPITATIONS (flip flopped) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Shortness of breath: with the Moderna shot, It lasted three months and not all the time. Caller said that her blood pressure is not high.  Lack of effect with Moderna Covid-19 vaccine. Patient has Covid.  No concomitant medication was provided by reporter.  Company Comment: This is an spontaneous case concerning a 65-years-old female patient with medical history of co-suspect product PAXLOVID for COVID-19 disease who experienced the unexpected events of Covid-19 (AESI), Drug ineffective, palpitations and other expected event unknown days after  2nd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 65-years-old female patient with medical history of co-suspect product PAXLOVID for COVID-19 disease who experienced the unexpected events of Covid-19 (AESI), Drug ineffective, palpitations and other expected event unknown days after  2nd.  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Drug ineffective
Clinical narrative: No difference in condition since being of Humira; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (No difference in condition since being of Humira) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    There was no reported medical history.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DRUG INEFFECTIVE (No difference in condition since being of Humira) and ARTHRALGIA (Joint pain). At the time of the report, DRUG INEFFECTIVE (No difference in condition since being of Humira) and ARTHRALGIA (Joint pain) outcome was unknown.            No Concomitant product use was reported.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of JOINT PAIN and NO DIFFERENCE IN CONDITION SINCE BEING OF HUMIRA was not reported for Humira.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious, event of Drug Ineffective, (reported No difference in condition since being of Humira) and Arthralgia which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The event of Drug Ineffective is in relationship with the co-suspect drug Humira based on the narrative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.Sender's Comments: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious, event of Drug Ineffective, (reported No difference in condition since being of Humira) and Arthralgia which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The event of Drug Ineffective is in relationship with the co-suspect drug Humira based on the narrative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Colitis, Colonoscopy
Clinical narrative: Active Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Active Colitis) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and MESALAMINE for an unknown indication.    Concurrent medical conditions included Crohn's disease.   On 24-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) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and MESALAMINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced COLITIS (Active Colitis). At the time of the report, COLITIS (Active Colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, Colonoscopy: active colitis Active colitis.         No concomitant medication was reported. No treatment medication was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Prostatic specific antigen
Clinical narrative: flu like symptoms/fever/ headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) 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.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Prostatic specific antigen: 3.73 (normal) Result: 3.73. On 11-May-2022, Prostatic specific antigen: 4.43 (High) Elevated to 4.43. On 10-Jun-2022, Prostatic specific antigen: 4.64 (High) measured at 4.64.         Concomitant medications details were not reported by the reporter.  Reportedly, the symptoms occurred the same day as the injection, but much later in the day around 8-9 PM. It was stated that these symptoms that had experienced were typical to what he had reading on all the websites.   Additionally, Patient had been going to receive PSA tests for his prostate for the past 10 years and over the past 2-3 years he had been going to receive these tests more often and was scheduled to had this test at the beginning of MAY. Patient had discussed these findings with his urologist who recommended to received an MRI of his prostate and also had been following the research of another urologist online who had been seeing similar trends in patients after vaccination.   Patient had not taken any medications or treatments for any of his symptoms.   This case was linked to MOD-2022-588193, MOD-2022-588203, MOD-2022-588204 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: People are having Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (People are having Bell's palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (People are having Bell's palsy). At the time of the report, BELL'S PALSY (People are having Bell's palsy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. The caller reported that other people also had bell's palsy associated with the Moderna and Pfizer vaccine.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the non-serious expected of Bell's palsy which occurred on an unknown date and non reported onset latency with an unspecified dose number of mRNA-1273. No concomitant medication or treatment information was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the non-serious expected of Bell's palsy which occurred on an unknown date and non reported onset latency with an unspecified dose number of mRNA-1273. No concomitant medication or treatment information was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 8MAR2021; After beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 8MAR2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 8MAR2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 8MAR2021) outcome was unknown.        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.   No concomitant information was reported. The vial was initially stored in the refrigerator on 8-Mar-2021. It was unknown whether the vials underwent any temperature excursions. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 19-Apr-2021 but administered on 13-Oct-2021; After beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-Apr-2021 but administered on 13-Oct-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-Apr-2021 but administered on 13-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-Apr-2021 but administered on 13-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Inappropriate schedule of product administration
Clinical narrative: confused; More than 35 days between first and second dose; This spontaneous case was reported by a patient and describes the occurrence of CONFUSIONAL STATE (confused) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Handicap ((Disabled Veteran)).   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose). On an unknown date, the patient experienced CONFUSIONAL STATE (confused). At the time of the report, CONFUSIONAL STATE (confused) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: mild headache the following morning; sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and HEADACHE (mild headache the following morning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (primary series). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced HEADACHE (mild headache the following morning). In November 2021, the patient experienced VACCINATION SITE PAIN (sore left arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In November 2021, HEADACHE (mild headache the following morning) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient received her Moderna COVID-19 vaccine in her left arm shoulder deltoid muscle. The patient reported that she was concerned because there were two different vial presentations of the Moderna COVID-19 vaccine that wrong doses might be given to patients from the wrong vial.  No treatment information was provided by the reporter for the event vaccination site pain.