chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Rash, Rash pruritic
Clinical narrative: Thinks it is shingles or chicken pox; Itchiness on neck; Itchiness on arm; rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Thinks it is shingles or chicken pox), RASH PRURITIC (Itchiness on neck), PRURITUS (Itchiness on arm) and RASH (rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck). On 08-Mar-2021, the patient experienced RASH PRURITIC (Itchiness on neck) and PRURITUS (Itchiness on arm). On an unknown date, the patient experienced HERPES ZOSTER (Thinks it is shingles or chicken pox). The patient was treated with DIMETICONE, MENTHOL, PRAMOCAINE HYDROCHLORIDE (GOLD BOND ANTI-ITCH) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Thinks it is shingles or chicken pox), RASH PRURITIC (Itchiness on neck), PRURITUS (Itchiness on arm) and RASH (rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Decreased appetite, Headache
Clinical narrative: COVID like symptoms; Not Hungry; Hardly Moved; High Temperature <100 F; Joint Pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID like symptoms), DECREASED APPETITE (Not Hungry), MOBILITY DECREASED (Hardly Moved), PYREXIA (High Temperature <100 F) and ARTHRALGIA (Joint Pain) in a 79-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.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (COVID like symptoms), DECREASED APPETITE (Not Hungry), MOBILITY DECREASED (Hardly Moved), PYREXIA (High Temperature <100 F), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and CHILLS (Chills). On 08-Mar-2021, COVID-19 (COVID like symptoms), DECREASED APPETITE (Not Hungry), MOBILITY DECREASED (Hardly Moved), PYREXIA (High Temperature <100 F), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR received on 03-May-2021 and does not contain any new information, denied further follow up
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: COVID like symptoms; Not Hungry; Hardly Moved; High Temperature <100 F; Joint Pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID like symptoms), DECREASED APPETITE (Not Hungry), MOBILITY DECREASED (Hardly Moved), PYREXIA (High Temperature <100 F) and ARTHRALGIA (Joint Pain) in a 79-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.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (COVID like symptoms), DECREASED APPETITE (Not Hungry), MOBILITY DECREASED (Hardly Moved), PYREXIA (High Temperature <100 F), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and CHILLS (Chills). On 08-Mar-2021, COVID-19 (COVID like symptoms), DECREASED APPETITE (Not Hungry), MOBILITY DECREASED (Hardly Moved), PYREXIA (High Temperature <100 F), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR received on 03-May-2021 and does not contain any new information, denied further follow up
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Insomnia, Malaise
Clinical narrative: entire left shoulder area was swelling; like having "poison ivy"; red shoulder area; uncomfortable; tchy rash; difficulty sleeping; chills; sore left arm; feeling sluggish; difficulty focusing; pain at the injection site; a red circle at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping) and SLUGGISHNESS (feeling sluggish) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication:  1292263 (she was in a clinical trial with  for their COVID-19 vaccine) and FLU VACCINE VII (flu vaccine anually). Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE for Rosacea, VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), VISION BLURRED (difficulty focusing), SLUGGISHNESS (feeling sluggish), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site) and HEADACHE (headache). On 03-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 04-Mar-2021, the patient experienced SWELLING (entire left shoulder area was swelling), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area) and RASH (tchy rash). On an unknown date, the patient experienced MALAISE (uncomfortable). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping), SLUGGISHNESS (feeling sluggish), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area), RASH (tchy rash), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Ice on her arm for treatment.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash papular, Sluggishness, Swelling
Clinical narrative: entire left shoulder area was swelling; like having "poison ivy"; red shoulder area; uncomfortable; tchy rash; difficulty sleeping; chills; sore left arm; feeling sluggish; difficulty focusing; pain at the injection site; a red circle at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping) and SLUGGISHNESS (feeling sluggish) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication:  1292263 (she was in a clinical trial with  for their COVID-19 vaccine) and FLU VACCINE VII (flu vaccine anually). Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE for Rosacea, VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), VISION BLURRED (difficulty focusing), SLUGGISHNESS (feeling sluggish), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site) and HEADACHE (headache). On 03-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 04-Mar-2021, the patient experienced SWELLING (entire left shoulder area was swelling), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area) and RASH (tchy rash). On an unknown date, the patient experienced MALAISE (uncomfortable). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping), SLUGGISHNESS (feeling sluggish), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area), RASH (tchy rash), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Ice on her arm for treatment.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vision blurred
Clinical narrative: entire left shoulder area was swelling; like having "poison ivy"; red shoulder area; uncomfortable; tchy rash; difficulty sleeping; chills; sore left arm; feeling sluggish; difficulty focusing; pain at the injection site; a red circle at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping) and SLUGGISHNESS (feeling sluggish) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication:  1292263 (she was in a clinical trial with  for their COVID-19 vaccine) and FLU VACCINE VII (flu vaccine anually). Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE for Rosacea, VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), VISION BLURRED (difficulty focusing), SLUGGISHNESS (feeling sluggish), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site) and HEADACHE (headache). On 03-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 04-Mar-2021, the patient experienced SWELLING (entire left shoulder area was swelling), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area) and RASH (tchy rash). On an unknown date, the patient experienced MALAISE (uncomfortable). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping), SLUGGISHNESS (feeling sluggish), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area), RASH (tchy rash), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Ice on her arm for treatment.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Skin warm, Vertigo
Clinical narrative: vertigo; dizzy; skin becomes hot to the touch; super light-headed; super light-headed; Body aches; chills/shivering; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizzy), SKIN WARM (skin becomes hot to the touch), the first episode of DIZZINESS (super light-headed) and the second episode of DIZZINESS (super light-headed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills/shivering). On 05-Mar-2021, the patient experienced MYALGIA (Body aches). On 06-Mar-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizzy), SKIN WARM (skin becomes hot to the touch), the first episode of DIZZINESS (super light-headed) and the second episode of DIZZINESS (super light-headed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo), DIZZINESS (dizzy), SKIN WARM (skin becomes hot to the touch), the last episode of DIZZINESS (super light-headed), MYALGIA (Body aches) and CHILLS (chills/shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash around the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (rash around the injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash around the injection site). At the time of the report, VACCINATION SITE RASH (rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Pruritus, Vision blurred
Clinical narrative: blurry vision; nausea; itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes; unable to eat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes), FEEDING DISORDER (unable to eat), VISION BLURRED (blurry vision) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, AMLODIPINE, OXYCODONE, PARACETAMOL (TYLENOL) and OXYGEN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes), FEEDING DISORDER (unable to eat) and NAUSEA (nausea). On an unknown date, the patient experienced VISION BLURRED (blurry vision). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes), FEEDING DISORDER (unable to eat), VISION BLURRED (blurry vision) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pain
Clinical narrative: Pain; Discomfort; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DISCOMFORT (Discomfort) and CHILLS (Chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort) and CHILLS (Chills). At the time of the report, PAIN (Pain), DISCOMFORT (Discomfort) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Tremor, Vaccination site swelling
Clinical narrative: Chills and shaking after first dose; Extreme arm pain after first dose; Swelling at vaccine site after 1st dose; Chills and shaking after first dose; This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Chills and shaking after first dose), PAIN IN EXTREMITY (Extreme arm pain after first dose), VACCINATION SITE SWELLING (Swelling at vaccine site after 1st dose) and CHILLS (Chills and shaking after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 01-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 TREMOR (Chills and shaking after first dose), PAIN IN EXTREMITY (Extreme arm pain after first dose), VACCINATION SITE SWELLING (Swelling at vaccine site after 1st dose) and CHILLS (Chills and shaking after first dose). At the time of the report, TREMOR (Chills and shaking after first dose), PAIN IN EXTREMITY (Extreme arm pain after first dose), VACCINATION SITE SWELLING (Swelling at vaccine site after 1st dose) and CHILLS (Chills and shaking after first dose) 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.   No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Injection site rash, Pain in extremity
Clinical narrative: a rash on the injection site of 2inches and red which gradually got less red in 4-5 days; low grade fever; flushing of her cheeks "apple red"; headache; fatigue; soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), PAIN IN EXTREMITY (soreness of her arm), PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red") in a 66-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.     The patient's past medical history included No adverse event. Concomitant products included Thyroid pill for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and PAIN IN EXTREMITY (soreness of her arm). On 15-Feb-2021, the patient experienced PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red"). On 18-Feb-2021, the patient experienced INJECTION SITE RASH (a rash on the injection site of 2inches and red which gradually got less red in 4-5 days). On 05-Feb-2021, HEADACHE (headache), FATIGUE (fatigue) and PAIN IN EXTREMITY (soreness of her arm) had resolved. On 23-Feb-2021, PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red") had resolved. At the time of the report, INJECTION SITE RASH (a rash on the injection site of 2inches and red which gradually got less red in 4-5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a rash on the injection site of 2inches and red which gradually got less red in 4-5 days; low grade fever; flushing of her cheeks "apple red"; headache; fatigue; soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), PAIN IN EXTREMITY (soreness of her arm), PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red") in a 66-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.     The patient's past medical history included No adverse event. Concomitant products included Thyroid pill for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and PAIN IN EXTREMITY (soreness of her arm). On 15-Feb-2021, the patient experienced PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red"). On 18-Feb-2021, the patient experienced INJECTION SITE RASH (a rash on the injection site of 2inches and red which gradually got less red in 4-5 days). On 05-Feb-2021, HEADACHE (headache), FATIGUE (fatigue) and PAIN IN EXTREMITY (soreness of her arm) had resolved. On 23-Feb-2021, PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red") had resolved. At the time of the report, INJECTION SITE RASH (a rash on the injection site of 2inches and red which gradually got less red in 4-5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Urinary incontinence
Clinical narrative: Weak; Chills; Fever; Couldn't control my urine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), URINARY INCONTINENCE (Couldn't control my urine) and ASTHENIA (Weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN C [ASCORBIC ACID], METOPROLOL, CLOPIDOGREL, LISINOPRIL, HCTZ, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and URINARY INCONTINENCE (Couldn't control my urine). On 07-Mar-2021, the patient experienced ASTHENIA (Weak). On 07-Mar-2021, CHILLS (Chills), PYREXIA (Fever), URINARY INCONTINENCE (Couldn't control my urine) and ASTHENIA (Weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Myalgia, Nervousness, Pain in extremity
Clinical narrative: Red spot at injection site; Little itchy; muscle in her left arm is still a little bit sore; "her left arm still hurts a little bit"; "Moderna COVID Arm" (left arm); left arm was swollen; left arm hurt; left arm red; felt lightheaded/dizziness; vertigo; fainting feeling; nervous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo) and PRESYNCOPE (fainting feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Allergic to latex), Pollen allergy (Allergic to pollen), Dust allergy (Allergic to dust) and Grass allergy (Allergic to grass).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red) and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)). On 31-Mar-2021, the patient experienced MYALGIA (muscle in her left arm is still a little bit sore) and PAIN IN EXTREMITY ("her left arm still hurts a little bit"). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection site) and PRURITUS (Little itchy). On 27-Feb-2021, DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red), MYALGIA (muscle in her left arm is still a little bit sore), PAIN IN EXTREMITY ("her left arm still hurts a little bit") and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Presyncope, Pruritus, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Red spot at injection site; Little itchy; muscle in her left arm is still a little bit sore; "her left arm still hurts a little bit"; "Moderna COVID Arm" (left arm); left arm was swollen; left arm hurt; left arm red; felt lightheaded/dizziness; vertigo; fainting feeling; nervous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo) and PRESYNCOPE (fainting feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Allergic to latex), Pollen allergy (Allergic to pollen), Dust allergy (Allergic to dust) and Grass allergy (Allergic to grass).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red) and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)). On 31-Mar-2021, the patient experienced MYALGIA (muscle in her left arm is still a little bit sore) and PAIN IN EXTREMITY ("her left arm still hurts a little bit"). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection site) and PRURITUS (Little itchy). On 27-Feb-2021, DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red), MYALGIA (muscle in her left arm is still a little bit sore), PAIN IN EXTREMITY ("her left arm still hurts a little bit") and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Red spot at injection site; Little itchy; muscle in her left arm is still a little bit sore; "her left arm still hurts a little bit"; "Moderna COVID Arm" (left arm); left arm was swollen; left arm hurt; left arm red; felt lightheaded/dizziness; vertigo; fainting feeling; nervous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo) and PRESYNCOPE (fainting feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Allergic to latex), Pollen allergy (Allergic to pollen), Dust allergy (Allergic to dust) and Grass allergy (Allergic to grass).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red) and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)). On 31-Mar-2021, the patient experienced MYALGIA (muscle in her left arm is still a little bit sore) and PAIN IN EXTREMITY ("her left arm still hurts a little bit"). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection site) and PRURITUS (Little itchy). On 27-Feb-2021, DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red), MYALGIA (muscle in her left arm is still a little bit sore), PAIN IN EXTREMITY ("her left arm still hurts a little bit") and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pruritus, Urticaria
Clinical narrative: arms itchy; went to bed woke up with chills; weak; hives on legs on back are spotty and itchy; went to bed, woke up achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arms itchy), PAIN (went to bed, woke up achy), CHILLS (went to bed woke up with chills), ASTHENIA (weak) and URTICARIA (hives on legs on back are spotty and itchy) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, MIRABEGRON (MYRBETRIQ), TELMISARTAN (MICARDIS), FISH OIL and ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (went to bed, woke up achy). On 04-Mar-2021, the patient experienced PRURITUS (arms itchy), CHILLS (went to bed woke up with chills), ASTHENIA (weak) and URTICARIA (hives on legs on back are spotty and itchy). At the time of the report, PRURITUS (arms itchy), PAIN (went to bed, woke up achy), CHILLS (went to bed woke up with chills), ASTHENIA (weak) and URTICARIA (hives on legs on back are spotty and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinusitis
Clinical narrative: HEAD CONGESTION; SINUS INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION and SINUSITIS in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION and SINUSITIS. At the time of the report, NASAL CONGESTION and SINUSITIS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include medication for cholesterol problems, medication for thyroid problems, and pill from keeping the heart raising.  Treatment information include Antibiotics.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Weak; Chills; Headache; Body ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spinal stenosis (Lesion in cervical spine) and Eye disorder (Blood vessel bulging in the eye). Concurrent medical conditions included Hypothyroidism, Environmental allergy, Asthma, Hypertension (High blood pressure), Depression and Rheumatoid arthritis.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weak), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not reported.  No treatment information were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: soreness of the arm; very sore armpit on the same side; very swollen lymph node on their neck near the collar bone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the arm), AXILLARY PAIN (very sore armpit on the same side) and LYMPHADENOPATHY (very swollen lymph node on their neck near the collar bone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-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 IN EXTREMITY (soreness of the arm), AXILLARY PAIN (very sore armpit on the same side) and LYMPHADENOPATHY (very swollen lymph node on their neck near the collar bone). At the time of the report, PAIN IN EXTREMITY (soreness of the arm), AXILLARY PAIN (very sore armpit on the same side) and LYMPHADENOPATHY (very swollen lymph node on their neck near the collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Tinnitus
Clinical narrative: RINGING IN EARS; MUSCLE TIGHTNESS; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (RINGING IN EARS) and MUSCLE TIGHTNESS (MUSCLE TIGHTNESS) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21H) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (allergic to many antibiotics).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced TINNITUS (RINGING IN EARS) and MUSCLE TIGHTNESS (MUSCLE TIGHTNESS). At the time of the report, TINNITUS (RINGING IN EARS) and MUSCLE TIGHTNESS (MUSCLE TIGHTNESS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Headache, Malaise
Clinical narrative: Eating almost nothing, today ate a salty cracker and a banana; Abdominal Cramp; Malaise; bad Head ache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Eating almost nothing, today ate a salty cracker and a banana), ABDOMINAL PAIN (Abdominal Cramp), MALAISE (Malaise) and HEADACHE (bad Head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Eating almost nothing, today ate a salty cracker and a banana), ABDOMINAL PAIN (Abdominal Cramp), MALAISE (Malaise) and HEADACHE (bad Head ache). At the time of the report, DECREASED APPETITE (Eating almost nothing, today ate a salty cracker and a banana), ABDOMINAL PAIN (Abdominal Cramp), MALAISE (Malaise) and HEADACHE (bad Head ache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported. Treatment included IVD Medication.   This case was linked to MOD-2021-032429 (Patient Link).   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspepsia, Fatigue, Myalgia, Nausea
Clinical narrative: pain in back; tingling; heartburn; nausea; Fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN, PARAESTHESIA, DYSPEPSIA, FATIGUE, and MYALGIA in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE and MYALGIA. On 21-Feb-2021, the patient experienced BACK PAIN, PARAESTHESIA, DYSPEPSIA, and NAUSEA. At the time of the report, BACK PAIN, PARAESTHESIA, DYSPEPSIA, FATIGUE, MYALGIA, and NAUSEA outcome was unknown.            No concomitant medication reported  No treatment information was provided  COVID-19 Vaccination
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: pain in back; tingling; heartburn; nausea; Fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN, PARAESTHESIA, DYSPEPSIA, FATIGUE, and MYALGIA in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE and MYALGIA. On 21-Feb-2021, the patient experienced BACK PAIN, PARAESTHESIA, DYSPEPSIA, and NAUSEA. At the time of the report, BACK PAIN, PARAESTHESIA, DYSPEPSIA, FATIGUE, MYALGIA, and NAUSEA outcome was unknown.            No concomitant medication reported  No treatment information was provided  COVID-19 Vaccination
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient took third dose of moderna COVID-19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient took third dose of moderna COVID-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 EXTRA DOSE ADMINISTERED (Patient took third dose of moderna COVID-19 Vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Patient took third dose of moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Patient reported headache 3 days after receiving 2nd dose; felt tired; Patient started experiencing shaking, chills, aching, sore body and pain same day at night after; Patient started experiencing chills same day at night after receiving 2nd dose; Patient started experiencing shaking same day at night after receiving 2nd dose; Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), HEADACHE (Patient reported headache 3 days after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose) and FATIGUE (felt tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Mar-2021, the patient experienced TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose) and MYALGIA (Patient started experiencing shaking, chills, aching, sore body and pain same day at night after). On 04-Mar-2021, the patient experienced FATIGUE (felt tired). On 06-Mar-2021, the patient experienced HEADACHE (Patient reported headache 3 days after receiving 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), HEADACHE (Patient reported headache 3 days after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose), FATIGUE (felt tired) and MYALGIA (Patient started experiencing shaking, chills, aching, sore body and pain same day at night after) outcome was unknown.            Concomitant medication : Thyroid medication