chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Headache, Malaise
Clinical narrative: Felt terrible; Weak; Felt very sick; Fever of 102 F; Had a very painful headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), ASTHENIA (Weak), MALAISE (Felt very sick), PYREXIA (Fever of 102 F) and HEADACHE (Had a very painful headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M2JA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had had hospitalized for two weeks.) on 01-Apr-2020. Concomitant products included TAMSULOSIN and FINASTERIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt terrible), ASTHENIA (Weak), MALAISE (Felt very sick), PYREXIA (Fever of 102 F) and HEADACHE (Had a very painful headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Fever of 102 F) had resolved. On 19-Mar-2021, FEELING ABNORMAL (Felt terrible), ASTHENIA (Weak), MALAISE (Felt very sick) and HEADACHE (Had a very painful headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2020, SARS-CoV-2 antibody test: positive (Positive) very bad case of COVID-19. On 16-Mar-2021, Body temperature: 102 f (High) 102 F.High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021  contains non-significant information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Felt terrible; Weak; Felt very sick; Fever of 102 F; Had a very painful headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), ASTHENIA (Weak), MALAISE (Felt very sick), PYREXIA (Fever of 102 F) and HEADACHE (Had a very painful headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M2JA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had had hospitalized for two weeks.) on 01-Apr-2020. Concomitant products included TAMSULOSIN and FINASTERIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt terrible), ASTHENIA (Weak), MALAISE (Felt very sick), PYREXIA (Fever of 102 F) and HEADACHE (Had a very painful headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Fever of 102 F) had resolved. On 19-Mar-2021, FEELING ABNORMAL (Felt terrible), ASTHENIA (Weak), MALAISE (Felt very sick) and HEADACHE (Had a very painful headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2020, SARS-CoV-2 antibody test: positive (Positive) very bad case of COVID-19. On 16-Mar-2021, Body temperature: 102 f (High) 102 F.High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021  contains non-significant information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Swollen tongue, Tongue pruritus
Clinical narrative: Burning sensation; Swollen tongue; Itching tongue; Cough; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), SWOLLEN TONGUE (Swollen tongue), TONGUE PRURITUS (Itching tongue) and COUGH (Cough) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included ATENOLOL and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation), SWOLLEN TONGUE (Swollen tongue), TONGUE PRURITUS (Itching tongue) and COUGH (Cough). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. On 29-Mar-2021, BURNING SENSATION (Burning sensation), SWOLLEN TONGUE (Swollen tongue) and TONGUE PRURITUS (Itching tongue) had resolved. At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication include Benadryl
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Vaccination site pain
Clinical narrative: cramps in the stomach; diarrhea; Pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramps in the stomach), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (Pain in injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in injection site). On 26-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (cramps in the stomach) and DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (cramps in the stomach), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (Pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: area now itches; certain parts of the area are hard; red area was the size of a fifty cent piece; (left)arm itches; (left)arm is red, at first was the size of a quarter; (left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red area was the size of a fifty cent piece), PRURITUS (area now itches), VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE INDURATION (certain parts of the area are hard) and VACCINATION SITE PRURITUS ((left)arm itches) in a 61-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 was provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), METOPROLOL and ATORVASTATIN for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE PRURITUS ((left)arm itches) and VACCINATION SITE ERYTHEMA ((left)arm is red, at first was the size of a quarter). On 28-Mar-2021, the patient experienced ERYTHEMA (red area was the size of a fifty cent piece) and VACCINATION SITE INDURATION (certain parts of the area are hard). On an unknown date, the patient experienced PRURITUS (area now itches). At the time of the report, ERYTHEMA (red area was the size of a fifty cent piece), PRURITUS (area now itches), VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE INDURATION (certain parts of the area are hard), VACCINATION SITE PRURITUS ((left)arm itches) and VACCINATION SITE ERYTHEMA ((left)arm is red, at first was the size of a quarter) had resolved.            Other concomitant medication included stomach medicine. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Outcome of the events updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: area now itches; certain parts of the area are hard; red area was the size of a fifty cent piece; (left)arm itches; (left)arm is red, at first was the size of a quarter; (left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red area was the size of a fifty cent piece), PRURITUS (area now itches), VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE INDURATION (certain parts of the area are hard) and VACCINATION SITE PRURITUS ((left)arm itches) in a 61-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 was provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), METOPROLOL and ATORVASTATIN for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE PRURITUS ((left)arm itches) and VACCINATION SITE ERYTHEMA ((left)arm is red, at first was the size of a quarter). On 28-Mar-2021, the patient experienced ERYTHEMA (red area was the size of a fifty cent piece) and VACCINATION SITE INDURATION (certain parts of the area are hard). On an unknown date, the patient experienced PRURITUS (area now itches). At the time of the report, ERYTHEMA (red area was the size of a fifty cent piece), PRURITUS (area now itches), VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE INDURATION (certain parts of the area are hard), VACCINATION SITE PRURITUS ((left)arm itches) and VACCINATION SITE ERYTHEMA ((left)arm is red, at first was the size of a quarter) had resolved.            Other concomitant medication included stomach medicine. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Outcome of the events updated
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Urticaria, Vaccination site pain
Clinical narrative: Hives all over the body; body aches; pain at the site of the injection on left arm; tiredness / fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), PAIN (body aches), VACCINATION SITE PAIN (pain at the site of the injection on left arm) and FATIGUE (tiredness / fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (LEXAPROFEN) and ALPRAZOLAM (XANAX) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN (body aches), VACCINATION SITE PAIN (pain at the site of the injection on left arm) and FATIGUE (tiredness / fatigue). On 29-Mar-2021, the patient experienced URTICARIA (Hives all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) was resolving and PAIN (body aches), VACCINATION SITE PAIN (pain at the site of the injection on left arm) and FATIGUE (tiredness / fatigue) had resolved. 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Shingles; Blisters; Skin rashes on the other side of body; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLISTER (Blisters) and RASH (Skin rashes on the other side of body) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HERPES ZOSTER (Shingles), BLISTER (Blisters) and RASH (Skin rashes on the other side of body). At the time of the report, HERPES ZOSTER (Shingles), BLISTER (Blisters) and RASH (Skin rashes on the other side of body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Pyrexia, Tremor
Clinical narrative: couldn't hold a cup with the tremors; tremors; felt weak; very weak; very dizzy; chills; fever of 104; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (couldn't hold a cup with the tremors), TREMOR (tremors), ASTHENIA (felt weak), ASTHENIA (very weak) and DIZZINESS (very dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALTRATE + D PLUS, VITAMIN B NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced TREMOR (couldn't hold a cup with the tremors), TREMOR (tremors), ASTHENIA (felt weak), ASTHENIA (very weak), DIZZINESS (very dizzy), CHILLS (chills) and PYREXIA (fever of 104). At the time of the report, TREMOR (couldn't hold a cup with the tremors), TREMOR (tremors), ASTHENIA (felt weak), ASTHENIA (very weak), DIZZINESS (very dizzy), CHILLS (chills) and PYREXIA (fever of 104) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-060719 (E2B Linked Report). This case was linked to MOD-2021-060719 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060719:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In March 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 (Soreness in his arm). In March 2021, PAIN IN EXTREMITY (Soreness in his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060654 (E2B Linked Report).; Sender's Comments:  MOD-2021-060654:Mother's case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: brain fog; couldn't do anything; fever subsided; 102°F fever; chills; tired; light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), PYREXIA (102°F fever), CHILLS (chills), FATIGUE (tired) and DISCOMFORT (couldn't do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (light headed) and FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (102°F fever), CHILLS (chills), DISCOMFORT (couldn't do anything), PYREXIA (fever subsided) and FEELING ABNORMAL (brain fog). At the time of the report, DIZZINESS (light headed), FATIGUE (tired), DISCOMFORT (couldn't do anything), PYREXIA (fever subsided) and FEELING ABNORMAL (brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: brain fog; couldn't do anything; fever subsided; 102°F fever; chills; tired; light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), PYREXIA (102°F fever), CHILLS (chills), FATIGUE (tired) and DISCOMFORT (couldn't do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (light headed) and FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (102°F fever), CHILLS (chills), DISCOMFORT (couldn't do anything), PYREXIA (fever subsided) and FEELING ABNORMAL (brain fog). At the time of the report, DIZZINESS (light headed), FATIGUE (tired), DISCOMFORT (couldn't do anything), PYREXIA (fever subsided) and FEELING ABNORMAL (brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pruritus
Clinical narrative: Generalized itching; Generalized body aches; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized body aches), PRURITUS (Generalized itching) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced NAUSEA (Nausea). On 05-Mar-2021, the patient experienced PAIN (Generalized body aches). On 10-Mar-2021, the patient experienced PRURITUS (Generalized itching). At the time of the report, PAIN (Generalized body aches), PRURITUS (Generalized itching) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell after the 1st dose of thre Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell after the 1st dose of thre Moderna COVID 19 vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain injury (Caregiver stated that her son is disabled with brain injury.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FALL (Fell after the 1st dose of thre Moderna COVID 19 vaccine). At the time of the report, FALL (Fell after the 1st dose of thre Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   No treatment information was reported however the patient was recommended tetanus shot.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Horrendous backache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Horrendous backache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced BACK PAIN (Horrendous backache). At the time of the report, BACK PAIN (Horrendous backache) outcome was unknown.            Concomitant products included Blood pressure pill for an unknown indication.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  The patient had Horrendous backache one week after administration. She felt better now.   This case was linked to MOD-2021-060751 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information was received on 12-May-2021 does not contains any new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: severe pain in chest; deep redness on chest; Rash on arm; Arm swelling; Rash under Breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under Breast), CHEST PAIN (severe pain in chest), ERYTHEMA (deep redness on chest), VACCINATION SITE RASH (Rash on arm) and VACCINATION SITE SWELLING (Arm swelling) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 RASH (Rash under Breast), VACCINATION SITE RASH (Rash on arm) and VACCINATION SITE SWELLING (Arm swelling). On an unknown date, the patient experienced CHEST PAIN (severe pain in chest) and ERYTHEMA (deep redness on chest). At the time of the report, RASH (Rash under Breast), CHEST PAIN (severe pain in chest), ERYTHEMA (deep redness on chest), VACCINATION SITE RASH (Rash on arm) and VACCINATION SITE SWELLING (Arm swelling) 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.   Concomitant medication was not provided.  Treatment medications: Anti allergic medication.  It was reported that, the patient did not have rash on arm or any swelling. It was strictly a severe pain in chest and then a deep redness on chest, in between breast, and abdomen, which left my skin as if it was severely burnt. Later the skin peeled. she was still experiencing side effects after the first shot and am never getting the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: New events chest pain and erythema were added. The patient would not get second shot.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid after the first dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, COVID-19: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine) to be not applicable.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VOMITING (Vomiting) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitivity to weather change (medical history reported as weather related issues).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a vaccine from vial that was punctured for more than 6 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a vaccine from vial that was punctured for more than 6 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a vaccine from vial that was punctured for more than 6 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given a vaccine from vial that was punctured for more than 6 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Not Provided)  with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Headache
Clinical narrative: breathing issues; loss of smell; loss of taste; fever; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever) and FATIGUE (extreme fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN TRIHYDRATE (AMOXYCILLIN ALMUS) and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever), FATIGUE (extreme fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PYREXIA (fever) had resolved. On 28-Feb-2021, FATIGUE (extreme fatigue) and HEADACHE (headache) had resolved. At the time of the report, RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 101 (High) 101. In April 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory disorder
Clinical narrative: breathing issues; loss of smell; loss of taste; fever; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever) and FATIGUE (extreme fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN TRIHYDRATE (AMOXYCILLIN ALMUS) and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever), FATIGUE (extreme fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PYREXIA (fever) had resolved. On 28-Feb-2021, FATIGUE (extreme fatigue) and HEADACHE (headache) had resolved. At the time of the report, RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 101 (High) 101. In April 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Feels like 2nd dose didn't go in the deltoid muscle; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Feels like 2nd dose didn't go in the deltoid muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Feels like 2nd dose didn't go in the deltoid muscle). On 02-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Feels like 2nd dose didn't go in the deltoid muscle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 029a21a with no associated AEs.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown. Not Provided          He has been taking tums for his nausea.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, COVID-19, Diarrhoea
Clinical narrative: Covid-19; Stomach upset; Diarrhea; Severe back pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea) and BACK PAIN (Severe back pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Covid-19), ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea) and BACK PAIN (Severe back pain). At the time of the report, COVID-19 (Covid-19), ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea) and BACK PAIN (Severe back pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included blood pressure medication.  The patient took paracetamol as treatment medication for the reported events.  Patient experienced delayed symptoms after the first dose of vaccine.   This case was linked to MOD-2021-060741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Followup information received on 13-May-2021 and Updated the event outcome from unknown to recovered for all the reported events. Added the information the patient denied to provide email address/fax.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue
Clinical narrative: Stomach is not feeling good; Weakness; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach is not feeling good), ASTHENIA (Weakness), CHILLS (Chills) and FATIGUE (Tiredness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach is not feeling good), ASTHENIA (Weakness), CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, ABDOMINAL DISCOMFORT (Stomach is not feeling good), ASTHENIA (Weakness), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatment were not reported.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ageusia, COVID-19, Diarrhoea, Pain
Clinical narrative: developed a rash all over her body which he PCP diagnosed as pityriasis rosea; positive for COVID; upset stomach; diarrhea; aching; no taste no smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), PAIN (aching) and AGEUSIA (no taste no smell) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (positive for COVID), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), PAIN (aching) and AGEUSIA (no taste no smell). On 13-Mar-2021, the patient experienced PITYRIASIS ROSEA (developed a rash all over her body which he PCP diagnosed as pityriasis rosea). On 10-Feb-2021, COVID-19 (positive for COVID), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), PAIN (aching) and AGEUSIA (no taste no smell) had resolved. At the time of the report, PITYRIASIS ROSEA (developed a rash all over her body which he PCP diagnosed as pityriasis rosea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: developed a rash all over her body which he PCP diagnosed as pityriasis rosea; positive for COVID; upset stomach; diarrhea; aching; no taste no smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), PAIN (aching) and AGEUSIA (no taste no smell) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (positive for COVID), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), PAIN (aching) and AGEUSIA (no taste no smell). On 13-Mar-2021, the patient experienced PITYRIASIS ROSEA (developed a rash all over her body which he PCP diagnosed as pityriasis rosea). On 10-Feb-2021, COVID-19 (positive for COVID), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), PAIN (aching) and AGEUSIA (no taste no smell) had resolved. At the time of the report, PITYRIASIS ROSEA (developed a rash all over her body which he PCP diagnosed as pityriasis rosea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Nausea
Clinical narrative: feeling dizzy; sick; feeling tired; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), MALAISE (sick), FATIGUE (feeling tired) and NAUSEA (nauseous) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (feeling dizzy), MALAISE (sick), FATIGUE (feeling tired) and NAUSEA (nauseous). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, DIZZINESS (feeling dizzy), MALAISE (sick), FATIGUE (feeling tired) and NAUSEA (nauseous) had resolved.        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 13-May-2021: The follow up received were the outcome of the event was updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing hair in clumps after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing hair in clumps after getting vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in December 2020).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (losing hair in clumps after getting vaccine). At the time of the report, ALOPECIA (losing hair in clumps after getting vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: sore throat; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 28-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: friends who got the Moderna vaccine had pain in the arm of the injection for 2 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (friends who got the Moderna vaccine had pain in the arm of the injection for 2 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (friends who got the Moderna vaccine had pain in the arm of the injection for 2 days). At the time of the report, PAIN IN EXTREMITY (friends who got the Moderna vaccine had pain in the arm of the injection for 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue, tinnitus ("static" sound in ear that comes and goes) and vaccination site pain (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine, (batch# 018B21A) for COVID-19 immunization. The patient's past medical history included no adverse event. Concomitant products included Tylenol Extra Strength, blood pressure medicine and Klonopin (clonazepam) for an unknown indication. On Mar 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 26, 2021, patient experienced fatigue, vaccination site pain (sore arm) and tinnitus ("static" sound in ear that comes and goes). At the time of the report, fatigue, vaccination site pain (sore arm) and tinnitus ("static" sound in ear that comes and goes) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.