chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Oedema, Vaccination complication
Clinical narrative: feel like doing things one day but next day they feel lousy; Don't have any energy; got worse after receiving the Moderna COVID-19 vaccine; blew up with fluids; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like doing things one day but next day they feel lousy), ASTHENIA (Don't have any energy), VACCINATION COMPLICATION (got worse after receiving the Moderna COVID-19 vaccine) and OEDEMA (blew up with fluids) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel like doing things one day but next day they feel lousy), ASTHENIA (Don't have any energy), VACCINATION COMPLICATION (got worse after receiving the Moderna COVID-19 vaccine) and OEDEMA (blew up with fluids). At the time of the report, FEELING ABNORMAL (feel like doing things one day but next day they feel lousy), ASTHENIA (Don't have any energy), VACCINATION COMPLICATION (got worse after receiving the Moderna COVID-19 vaccine) and OEDEMA (blew up with fluids) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.  No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contained new events - Vaccination Complication and oedema and updated product information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gout, Headache, Lymphadenopathy, Pain
Clinical narrative: Gout; Body aches; Swollen glands; Headaches; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout), PAIN (Body aches), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and PYREXIA (Fever of 101 F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout), PAIN (Body aches), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and PYREXIA (Fever of 101 F). At the time of the report, GOUT (Gout), PAIN (Body aches), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and PYREXIA (Fever of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Gout; Body aches; Swollen glands; Headaches; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout), PAIN (Body aches), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and PYREXIA (Fever of 101 F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout), PAIN (Body aches), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and PYREXIA (Fever of 101 F). At the time of the report, GOUT (Gout), PAIN (Body aches), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and PYREXIA (Fever of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Inappropriate schedule of product administration
Clinical narrative: HCP advised her to wait for 90 days to take the second dose; COVID-19; Sudden loss of taste; Sudden loss of smell; Malaise; Congestion of nose; Congestion of throat; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise) and NASAL CONGESTION (Congestion of nose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise), NASAL CONGESTION (Congestion of nose), OROPHARYNGEAL DISCOMFORT (Congestion of throat) and FATIGUE (Fatigue). On 15-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP advised her to wait for 90 days to take the second dose). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise), NASAL CONGESTION (Congestion of nose), OROPHARYNGEAL DISCOMFORT (Congestion of throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP advised her to wait for 90 days to take the second dose) and FATIGUE (Fatigue) 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 include asthma medicine. Treatment provided include, over the  counter pain and cold medicine. The patient was also quarantined due to COVID-19. Action taken with mRNA-1273 in response to the event; HCP advised her to wait for 90 days to take the second dose was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Oropharyngeal discomfort
Clinical narrative: HCP advised her to wait for 90 days to take the second dose; COVID-19; Sudden loss of taste; Sudden loss of smell; Malaise; Congestion of nose; Congestion of throat; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise) and NASAL CONGESTION (Congestion of nose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise), NASAL CONGESTION (Congestion of nose), OROPHARYNGEAL DISCOMFORT (Congestion of throat) and FATIGUE (Fatigue). On 15-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP advised her to wait for 90 days to take the second dose). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise), NASAL CONGESTION (Congestion of nose), OROPHARYNGEAL DISCOMFORT (Congestion of throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP advised her to wait for 90 days to take the second dose) and FATIGUE (Fatigue) 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 include asthma medicine. Treatment provided include, over the  counter pain and cold medicine. The patient was also quarantined due to COVID-19. Action taken with mRNA-1273 in response to the event; HCP advised her to wait for 90 days to take the second dose was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Tinnitus
Clinical narrative: He felt dizzy again when he woke up early morning to use restroom; Today starting around at 8AM, his head feels as if it is stuffed (like heavy head); he feels like his ears will pop; Yesterday, he experienced a brief episode of dizziness while driving; Patient felt tired on same day of receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient felt tired on same day of receiving 1st dose), DIZZINESS (Yesterday, he experienced a brief episode of dizziness while driving), DIZZINESS (He felt dizzy again when he woke up early morning to use restroom), HEAD DISCOMFORT (Today starting around at 8AM, his head feels as if it is stuffed (like heavy head)) and TINNITUS (he feels like his ears will pop) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history report provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN and CLONAZEPAM for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (Patient felt tired on same day of receiving 1st dose). On 08-Apr-2021, the patient experienced DIZZINESS (Yesterday, he experienced a brief episode of dizziness while driving). On 09-Apr-2021, the patient experienced DIZZINESS (He felt dizzy again when he woke up early morning to use restroom), HEAD DISCOMFORT (Today starting around at 8AM, his head feels as if it is stuffed (like heavy head)) and TINNITUS (he feels like his ears will pop). At the time of the report, FATIGUE (Patient felt tired on same day of receiving 1st dose), DIZZINESS (Yesterday, he experienced a brief episode of dizziness while driving), DIZZINESS (He felt dizzy again when he woke up early morning to use restroom), HEAD DISCOMFORT (Today starting around at 8AM, his head feels as if it is stuffed (like heavy head)) and TINNITUS (he feels like his ears will pop) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        no treatment details reported.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: trembling in his toes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling in his toes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetic. Concomitant products included METFORMIN for Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (trembling in his toes). At the time of the report, TREMOR (trembling in his toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included blood pressure medication  No treatment details reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received contained non significant information. The reporter's contact information updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Pain in extremity
Clinical narrative: sore arm; hot flashes; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HOT FLUSH (hot flashes) and HEADACHE (mild headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HOT FLUSH (hot flashes) and HEADACHE (mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm), HOT FLUSH (hot flashes) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included. No treatment medication included.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Achy; Shivers; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (Shivers) and PYREXIA (Low grade fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy), CHILLS (Shivers) and PYREXIA (Low grade fever). At the time of the report, PAIN (Achy), CHILLS (Shivers) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications information was reported.   This case was linked to MOD-2021-072953 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-May-2021, contains non-significant information, reporter contact information updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZIA and 021BZIA) for COVID-19 vaccination.     The patient's past medical history included Flu (Patient had flu vaccine 1975.). Concurrent medical conditions included Allergy to antibiotic (Patient is allergic to doxycycline.), Allergy to antibiotic (Patient is allergic to Levaquin) and Food allergy. Concomitant products included ROSUVASTATIN and SIMVASTATIN for High cholesterol, COLECALCIFEROL (VITAMIN D 3), MAGNESIUM, ZINC PICOLINATE and CURCUMIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2020, SARS-CoV-2 antibody test: positive (Positive) Positive. Patient had swab in nose test..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.Patient did not receive any treatment.   This case was linked to MOD-2021-126299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information received on 11-MAY-2021.Added patient demographics,past history,Lot no of suspect drug, concamitant drugs.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; This spontaneous case was reported by a physician and describes the occurrence of PAIN (PAIN) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Latex allergy. Concomitant products included LOVASTATIN, NIFEDIPINE, LEVOTHYROXINE, FUROSEMIDE and VITAMIN B COMPLEX for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (PAIN). At the time of the report, PAIN (PAIN) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Anti-itch cream (Sheffield). Patient did not experienced ant immediate side effects after first dose, but itching happened before second dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-072903 ; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072903:1st dose vaccine
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Hypokinesia, Impaired work ability, Insomnia, Movement disorder, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA, PAIN, HYPOKINESIA, MOVEMENT DISORDER, and IMPAIRED WORK ABILITY in a 65-year-old patient of an unknown gender 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 Knee surgery. Concurrent medical conditions included Arthritis.    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 INSOMNIA, PAIN, HYPOKINESIA, MOVEMENT DISORDER, IMPAIRED WORK ABILITY, and VACCINATION SITE RASH. At the time of the report, INSOMNIA, PAIN, HYPOKINESIA, MOVEMENT DISORDER, IMPAIRED WORK ABILITY, and VACCINATION SITE RASH had resolved.        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.   This case was linked to US-MODERNATX, INC-MOD-2021-072904.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information received on 11-May-2021 as patient denied further follow-up. Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072904: Linked dose 2 case.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA, PAIN, HYPOKINESIA, MOVEMENT DISORDER, and IMPAIRED WORK ABILITY in a 65-year-old patient of an unknown gender 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 Knee surgery. Concurrent medical conditions included Arthritis.    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 INSOMNIA, PAIN, HYPOKINESIA, MOVEMENT DISORDER, IMPAIRED WORK ABILITY, and VACCINATION SITE RASH. At the time of the report, INSOMNIA, PAIN, HYPOKINESIA, MOVEMENT DISORDER, IMPAIRED WORK ABILITY, and VACCINATION SITE RASH had resolved.        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.   This case was linked to US-MODERNATX, INC-MOD-2021-072904.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information received on 11-May-2021 as patient denied further follow-up. Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072904: Linked dose 2 case.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache). On 09-Apr-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-072912 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072912:Second dose case
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache for 4 hours now; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (normal pain in the injection site) and HEADACHE (headache for 4 hours now) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017BZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (TENSION MIGRAINE). Concomitant products included ORPHENADRINE CITRATE (NORFLEX [ORPHENADRINE CITRATE]) for Muscle relaxant.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 08-Apr-2021, the patient experienced HEADACHE (headache for 4 hours now). At the time of the report, VACCINATION SITE PAIN (normal pain in the injection site) and HEADACHE (headache for 4 hours now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Tylenol for headache.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included LOVASTATIN, NIFEDIPINE, LEVOTHYROXINE, FUROSEMIDE and VITAMIN B COMPLEX for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that the itching happened before her second dose, she took Anti-itch cream (Sheffield) for treatment   This case was linked to US-MODERNATX, INC.-MOD-2021-072899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072899:1st dose vaccine
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like was hit by a Mack truck), PAIN (body aches), DIARRHOEA (diarrhea), FATIGUE (fatigue) and HEADACHE (headache) in a 72-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. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING ABNORMAL (felt like was hit by a Mack truck), PAIN (body aches), DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, FEELING ABNORMAL (felt like was hit by a Mack truck), PAIN (body aches), DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like was hit by a Mack truck), PAIN (body aches), DIARRHOEA (diarrhea), FATIGUE (fatigue) and HEADACHE (headache) in a 72-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. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING ABNORMAL (felt like was hit by a Mack truck), PAIN (body aches), DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, FEELING ABNORMAL (felt like was hit by a Mack truck), PAIN (body aches), DIARRHOEA (diarrhea), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 18Mar2021 and the second dose on 6Apr2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18Mar2021 and the second dose on 6Apr2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mental disability NOS.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18Mar2021 and the second dose on 6Apr2021). On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18Mar2021 and the second dose on 6Apr2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nurse states she has a patient who thinks she received the second dose a week too early. She has no symptoms from the vaccine but says the patient is mentally dysfunctional. Nurse thinks she got the first dose on 18Mar2021 and the second dose on 6Apr2021. Nurse wants to know if this was ok.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site warmth, Muscle spasms
Clinical narrative: right leg cramps; fatigue; feeling warmth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (feeling warmth), MUSCLE SPASMS (right leg cramps) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, HYDROCHLOROTHIAZIDE, VITAMIN D NOS, PRAVASTATIN and RETINOL, VITAMIN D NOS (VITAMIN A & D [RETINOL;VITAMIN D NOS]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE WARMTH (feeling warmth) and FATIGUE (fatigue). On 26-Mar-2021, the patient experienced MUSCLE SPASMS (right leg cramps). On 11-Mar-2021, INJECTION SITE WARMTH (feeling warmth) and FATIGUE (fatigue) had resolved. At the time of the report, MUSCLE SPASMS (right leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient's doctor instructed her to stop taking the medicine(Pravastatin) 2 weeks ago due to the pain in her leg. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarge lymph nodes under left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarge lymph nodes under left armpit) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlarge lymph nodes under left armpit). At the time of the report, LYMPHADENOPATHY (Enlarge lymph nodes under left armpit) outcome was unknown. Not Provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: wiped out; shakes; left arm, lower abdomen and both hips ached; felt hot and cold; left arm, lower abdomen and both hips ached; Fever; left arm, lower abdomen and both hips ached; little headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached) and PYREXIA (Fever) in a 67-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 Arthritis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 08-Apr-2021, the patient experienced TREMOR (shakes), ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached), PYREXIA (Fever), ARTHRALGIA (left arm, lower abdomen and both hips ached) and HEADACHE (little headache). On 09-Apr-2021, the patient experienced FATIGUE (wiped out). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, TREMOR (shakes) and FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold) had resolved. On 09-Apr-2021, HEADACHE (little headache) had resolved. At the time of the report, ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached), PYREXIA (Fever), ARTHRALGIA (left arm, lower abdomen and both hips ached) and FATIGUE (wiped out) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Patient received Tylenol treatment for Fever and Aches  No concomitant medications provided.   INC.-MOD-2021-072901:First dose case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: wiped out; shakes; left arm, lower abdomen and both hips ached; felt hot and cold; left arm, lower abdomen and both hips ached; Fever; left arm, lower abdomen and both hips ached; little headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached) and PYREXIA (Fever) in a 67-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 Arthritis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 08-Apr-2021, the patient experienced TREMOR (shakes), ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached), PYREXIA (Fever), ARTHRALGIA (left arm, lower abdomen and both hips ached) and HEADACHE (little headache). On 09-Apr-2021, the patient experienced FATIGUE (wiped out). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, TREMOR (shakes) and FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold) had resolved. On 09-Apr-2021, HEADACHE (little headache) had resolved. At the time of the report, ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached), PYREXIA (Fever), ARTHRALGIA (left arm, lower abdomen and both hips ached) and FATIGUE (wiped out) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Patient received Tylenol treatment for Fever and Aches  No concomitant medications provided.   INC.-MOD-2021-072901:First dose case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Vaccination site pain
Clinical narrative: Dizziness; Shoulder Pain; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ARTHRALGIA (Shoulder Pain) and VACCINATION SITE PAIN (Injection site pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A 21A) for COVID-19 vaccination.     The patient's past medical history included Dog bite.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness), ARTHRALGIA (Shoulder Pain) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, DIZZINESS (Dizziness), ARTHRALGIA (Shoulder Pain) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medications are Provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Oligomenorrhoea
Clinical narrative: got my menstrual cycle twice with 2-3 months between each cycle; loss of menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (loss of menstrual cycle) and OLIGOMENORRHOEA (got my menstrual cycle twice with 2-3 months between each cycle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin), Drug allergy (sulfur), Hair dye sensitivity and Perfume sensitivity. Concomitant products included MULTI VITAMIN & MINERAL from 01-Jan-2021 to an unknown date, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) from 01-Jan-2021 to an unknown date and BIOTIN from 01-Jan-2021 to an unknown date for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MENSTRUATION DELAYED (loss of menstrual cycle). On an unknown date, the patient experienced OLIGOMENORRHOEA (got my menstrual cycle twice with 2-3 months between each cycle). At the time of the report, MENSTRUATION DELAYED (loss of menstrual cycle) outcome was unknown and OLIGOMENORRHOEA (got my menstrual cycle twice with 2-3 months between each cycle) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. vitamin c route of administration was reported which was not clear.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow-up received on 23 Jul 2021 contains concomitant list and events were added On 23-Jul-2021: NNI FU - No new information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Feeling abnormal
Clinical narrative: allergic reaction; feeling sick; Feels lousy; can't breathe; arm has been painful, tender; arm swollen; dizzy; weakness; shaking; didn't get of bed for 2 days and she just can't function; can't even think; feeling  hot and  cold; hands and feet are cold and just can't get warm; sweaty; heartbeat is racing; lethargic; fever; redness; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe) and PAIN IN EXTREMITY (arm has been painful, tender) in a 68-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.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided   Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-053149 (E2B Linked Report).; Sender's Comments:  MOD-2021-053149:First dose
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis, Hypersensitivity, Hypokinesia
Clinical narrative: allergic reaction; feeling sick; Feels lousy; can't breathe; arm has been painful, tender; arm swollen; dizzy; weakness; shaking; didn't get of bed for 2 days and she just can't function; can't even think; feeling  hot and  cold; hands and feet are cold and just can't get warm; sweaty; heartbeat is racing; lethargic; fever; redness; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe) and PAIN IN EXTREMITY (arm has been painful, tender) in a 68-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.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided   Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-053149 (E2B Linked Report).; Sender's Comments:  MOD-2021-053149:First dose
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pain in extremity, Palpitations, Peripheral coldness
Clinical narrative: allergic reaction; feeling sick; Feels lousy; can't breathe; arm has been painful, tender; arm swollen; dizzy; weakness; shaking; didn't get of bed for 2 days and she just can't function; can't even think; feeling  hot and  cold; hands and feet are cold and just can't get warm; sweaty; heartbeat is racing; lethargic; fever; redness; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe) and PAIN IN EXTREMITY (arm has been painful, tender) in a 68-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.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided   Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-053149 (E2B Linked Report).; Sender's Comments:  MOD-2021-053149:First dose