chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: being sick; chills; feeling really bad fatigue; I can't sit for more than 15 minutes"; lifting arm is challenging; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (I can't sit for more than 15 minutes"), MALAISE (being sick), VACCINATION SITE PAIN (arm is sore), CHILLS (chills) and FATIGUE (feeling really bad fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore) and LIMB DISCOMFORT (lifting arm is challenging). On 25-Mar-2021, the patient experienced MOVEMENT DISORDER (I can't sit for more than 15 minutes"), CHILLS (chills) and FATIGUE (feeling really bad fatigue). On an unknown date, the patient experienced MALAISE (being sick). At the time of the report, MOVEMENT DISORDER (I can't sit for more than 15 minutes"), MALAISE (being sick), VACCINATION SITE PAIN (arm is sore), CHILLS (chills), FATIGUE (feeling really bad fatigue) and LIMB DISCOMFORT (lifting arm is challenging) outcome was unknown.        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 event was not applicable.  No concomitant medication reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Flatulence, Headache, Hot flush, Insomnia
Clinical narrative: bad side effects; cramps in her stomach; gas in her stomach; kept awake for two nights; hot and cold flashes; rashes; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights) and HOT FLUSH (hot and cold flashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights), HOT FLUSH (hot and cold flashes), RASH (rashes) and HEADACHE (severe headache). At the time of the report, VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights), HOT FLUSH (hot and cold flashes), RASH (rashes) and HEADACHE (severe headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: bad side effects; cramps in her stomach; gas in her stomach; kept awake for two nights; hot and cold flashes; rashes; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights) and HOT FLUSH (hot and cold flashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights), HOT FLUSH (hot and cold flashes), RASH (rashes) and HEADACHE (severe headache). At the time of the report, VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights), HOT FLUSH (hot and cold flashes), RASH (rashes) and HEADACHE (severe headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided    Reporter did not allow further contact
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006Y21A) 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 24-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epistaxis
Clinical narrative: slight nosebleeds; chills for few days; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (slight nosebleeds) and CHILLS (chills for few days) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced EPISTAXIS (slight nosebleeds) and CHILLS (chills for few days). At the time of the report, EPISTAXIS (slight nosebleeds) and CHILLS (chills for few days) outcome was unknown.            No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.   This case was linked to MOD-2021-022042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: confirm information is NNI
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site induration, Vaccination site pain
Clinical narrative: hurts a little bit; it's hard to lift her arm; "Feels like she was exercising and did too much"; Inject site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurts a little bit), VACCINATION SITE PAIN (Inject site pain), VACCINATION SITE INDURATION (it's hard to lift her arm) and MYALGIA ("Feels like she was exercising and did too much") in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) 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 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Inject site pain). On 25-Mar-2021, the patient experienced PAIN (hurts a little bit), VACCINATION SITE INDURATION (it's hard to lift her arm) and MYALGIA ("Feels like she was exercising and did too much"). At the time of the report, PAIN (hurts a little bit), VACCINATION SITE PAIN (Inject site pain), VACCINATION SITE INDURATION (it's hard to lift her arm) and MYALGIA ("Feels like she was exercising and did too much") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vitreous floaters
Clinical narrative: Floaters in right eye like a piece of fuzz going across your eye; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Floaters in right eye like a piece of fuzz going across your eye) and CHILLS (Chills) in a 68-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 Cataract (Cataract surgery).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced VITREOUS FLOATERS (Floaters in right eye like a piece of fuzz going across your eye). At the time of the report, VITREOUS FLOATERS (Floaters in right eye like a piece of fuzz going across your eye) had not resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ear and it's been ongoing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear and it's been ongoing) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and LABETALOL HYDROCHLORIDE (NORMODYNE) for Hypertension, LEVOTHYROXINE SODIUM for Thyroiditis NOS, VITAMIN D NOS and CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM & ZINC [CALCIUM;MAGNESIUM;ZINC]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 8:00 AM, the patient experienced TINNITUS (ringing in the ear and it's been ongoing). At the time of the report, TINNITUS (ringing in the ear and it's been ongoing) had not resolved.        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 treatment medication was  reported   This case was linked to US-MODERNATX, INC.-MOD-2021-119527 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient contact details: Email address updated. On 13-May-2021: Additional information was received on 13-may-2021, patient demographic details , concomitant medications and their indications are updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-119527:2nd dose case
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 82-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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 23-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up contain No newinformation
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site warmth, Rash, Rash erythematous
Clinical narrative: injection site hot; red (rash)/ red (rash); super hot; rash/ rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site hot), RASH ERYTHEMATOUS (red (rash)/ red (rash)), FEELING HOT (super hot) and RASH (rash/ rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) 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) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced RASH (rash/ rash). On 25-Mar-2021, the patient experienced INJECTION SITE WARMTH (injection site hot), RASH ERYTHEMATOUS (red (rash)/ red (rash)) and FEELING HOT (super hot). On 24-Mar-2021, RASH (rash/ rash) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site hot), RASH ERYTHEMATOUS (red (rash)/ red (rash)) and FEELING HOT (super hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: pain/ache near left breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain/ache near left breast) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE, ONDANSETRON, CALCIUM ACETATE, OXYCODONE, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    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 BREAST PAIN (pain/ache near left breast). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, BREAST PAIN (pain/ache near left breast) outcome was unknown.            No treatment information was provided. Other concomitant medications include linakane cream, diorite, mitidrain before dialysis, panaprosol 40 mg, c-pap, carisoprodol 350mg BID for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 24-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication taken. No treatment information provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fatigue; Fever 101.5°F; Fever 99.7°F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever 101.5°F) and PYREXIA (Fever 99.7°F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MLS319813) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever 101.5°F) and PYREXIA (Fever 99.7°F). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever 101.5°F) and PYREXIA (Fever 99.7°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Pyrexia: 101.5 (abnormal) 98.7° F to 101.5°Fand back to 99.7°F..         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-229294 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Mouth swelling, Oral disorder, Swollen tongue
Clinical narrative: roof of mouth is swollen; roof of mouth has painful bumps; her tongue is swollen and painfu; her tongue is swollen and painfu; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (roof of mouth is swollen), ORAL DISORDER (roof of mouth has painful bumps), SWOLLEN TONGUE (her tongue is swollen and painfu) and GLOSSODYNIA (her tongue is swollen and painfu) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included UTI (UTI double infection) from 19-Mar-2021 to 01-Apr-2021 and Colostomy on 25-Jun-2015. Concomitant products included LOSARTAN for Blood pressure management, VITAMIN D [VITAMIN D NOS], ASCORBIC ACID (VIT C), ACETYLSALICYLIC ACID (ASPIRIN 81) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MOUTH SWELLING (roof of mouth is swollen), ORAL DISORDER (roof of mouth has painful bumps), SWOLLEN TONGUE (her tongue is swollen and painfu) and GLOSSODYNIA (her tongue is swollen and painfu). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 07-Apr-2021, MOUTH SWELLING (roof of mouth is swollen), ORAL DISORDER (roof of mouth has painful bumps), SWOLLEN TONGUE (her tongue is swollen and painfu) and GLOSSODYNIA (her tongue is swollen and painfu) had resolved.        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.   It was reported by HCP  that patient was not recommended to take second dose of COVID-19 Vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added Patient demographics and medical history . Added Concomitant medications and changed outcome of the events from unknown to recovered
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itchy fingers and itchy under the finger nails; ache in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ache in the arm) and PRURITUS (itchy fingers and itchy under the finger nails) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease and Myasthenia gravis.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (ache in the arm). On 25-Mar-2021, the patient experienced PRURITUS (itchy fingers and itchy under the finger nails). On 24-Mar-2021, PAIN IN EXTREMITY (ache in the arm) had resolved. On 25-Mar-2021, PRURITUS (itchy fingers and itchy under the finger nails) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Form was attached and outcome of events updated.Patient provided email address.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: injection site heat; injection site redness; fatigue; aching muscles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site heat), VACCINATION SITE ERYTHEMA (injection site redness), FATIGUE (fatigue) and MYALGIA (aching muscles) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol since an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (aching muscles). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site heat) and VACCINATION SITE ERYTHEMA (injection site redness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site heat), VACCINATION SITE ERYTHEMA (injection site redness), FATIGUE (fatigue) and MYALGIA (aching muscles) outcome was unknown.            Other concomitant drugs include Cholesterol medication. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided      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. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Patient's reported that side of her back has been hurting since day 1; Patient's arm was sore since day 1 after receiving 2nd dose; Patient's arm was red since day 1; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Patient's reported that side of her back has been hurting since day 1), VACCINATION SITE PAIN (Patient's arm was sore since day 1 after receiving 2nd dose) and VACCINATION SITE ERYTHEMA (Patient's arm was red since day 1) 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 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Mar-2021, the patient experienced BACK PAIN (Patient's reported that side of her back has been hurting since day 1), VACCINATION SITE PAIN (Patient's arm was sore since day 1 after receiving 2nd dose) and VACCINATION SITE ERYTHEMA (Patient's arm was red since day 1). At the time of the report, BACK PAIN (Patient's reported that side of her back has been hurting since day 1) was resolving and VACCINATION SITE PAIN (Patient's arm was sore since day 1 after receiving 2nd dose) and VACCINATION SITE ERYTHEMA (Patient's arm was red since day 1) outcome was unknown.            Concomitant medication history not provided.   Treatment information was unknown.  Additional information was received on 11-May-2021, event outcome was updated for Back pain, no and the patient denied further contact.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received event outcome for event back pain updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: hot flashes; stomach upset; horrible headache; joint pain; injection site pain; fatigue; muscle pain/hurt/achy all over; chills; felt like they had COVID-19 all over again; swollen joints; they could hardly walk; got hot; bouts of diarrhea; dizziness; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints) and GAIT DISTURBANCE (they could hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided by reporter.  The patient's past medical history included No adverse event. Concomitant products included HYDROXYZINE for Anxiety, ACETYLSALICYLIC ACID (ASPIRIN 81) for DOCTOR RECOMMANDED, VITAMIN D3 for LOW VITAMIN D3 LEVEL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for SEASONAL ALLERGIES, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for VITAMINS TO HELP EYE HEALTH.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 23-Mar-2021, the patient experienced COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEADACHE (horrible headache), HOT FLUSH (hot flushes), ABDOMINAL DISCOMFORT (stomach upset), ARTHRALGIA (joint pain) and INJECTION SITE PAIN (injection site pain). At the time of the report, COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       comeds added in initial additional document .   This case was linked to MOD-2021-130422 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR Form-events updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Headache, Hot flush
Clinical narrative: hot flashes; stomach upset; horrible headache; joint pain; injection site pain; fatigue; muscle pain/hurt/achy all over; chills; felt like they had COVID-19 all over again; swollen joints; they could hardly walk; got hot; bouts of diarrhea; dizziness; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints) and GAIT DISTURBANCE (they could hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided by reporter.  The patient's past medical history included No adverse event. Concomitant products included HYDROXYZINE for Anxiety, ACETYLSALICYLIC ACID (ASPIRIN 81) for DOCTOR RECOMMANDED, VITAMIN D3 for LOW VITAMIN D3 LEVEL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for SEASONAL ALLERGIES, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for VITAMINS TO HELP EYE HEALTH.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 23-Mar-2021, the patient experienced COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEADACHE (horrible headache), HOT FLUSH (hot flushes), ABDOMINAL DISCOMFORT (stomach upset), ARTHRALGIA (joint pain) and INJECTION SITE PAIN (injection site pain). At the time of the report, COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       comeds added in initial additional document .   This case was linked to MOD-2021-130422 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR Form-events updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Joint swelling, Myalgia, Suspected COVID-19
Clinical narrative: hot flashes; stomach upset; horrible headache; joint pain; injection site pain; fatigue; muscle pain/hurt/achy all over; chills; felt like they had COVID-19 all over again; swollen joints; they could hardly walk; got hot; bouts of diarrhea; dizziness; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints) and GAIT DISTURBANCE (they could hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided by reporter.  The patient's past medical history included No adverse event. Concomitant products included HYDROXYZINE for Anxiety, ACETYLSALICYLIC ACID (ASPIRIN 81) for DOCTOR RECOMMANDED, VITAMIN D3 for LOW VITAMIN D3 LEVEL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for SEASONAL ALLERGIES, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for VITAMINS TO HELP EYE HEALTH.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 23-Mar-2021, the patient experienced COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEADACHE (horrible headache), HOT FLUSH (hot flushes), ABDOMINAL DISCOMFORT (stomach upset), ARTHRALGIA (joint pain) and INJECTION SITE PAIN (injection site pain). At the time of the report, COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       comeds added in initial additional document .   This case was linked to MOD-2021-130422 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR Form-events updated
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: "woke up this morning and felt dizzy and almost fell."; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS ("woke up this morning and felt dizzy and almost fell.") in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL, ATORVASTATIN, ALPRAZOLAM, INSULIN ASPART (NOVOLOG), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMIN D NOS, PANTOPRAZOLE and TETRABENAZINE (TETRAZIN [TETRABENAZINE]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS ("woke up this morning and felt dizzy and almost fell."). At the time of the report, DIZZINESS ("woke up this morning and felt dizzy and almost fell.") 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.   Other concomitant medications include Lantus every night, HCT Lisinipril 20mg daily, hyrdolizine hcl daily for an unknown indication. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: depressed; tired all day; slight temperature; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DEPRESSED MOOD (depressed), FATIGUE (tired all day) and PYREXIA (slight temperature) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Mar-2021, the patient experienced FATIGUE (tired all day) and PYREXIA (slight temperature). On 21-Mar-2021, the patient experienced DEPRESSED MOOD (depressed). On 21-Mar-2021, FATIGUE (tired all day) and PYREXIA (slight temperature) had resolved. On 23-Mar-2021, DEPRESSED MOOD (depressed) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Patient was treated with Fluids. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: really bad arm pain; hurts like crazy; hardly lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad arm pain), PAIN (hurts like crazy) and PAIN IN EXTREMITY (hardly lift her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN IN EXTREMITY (really bad arm pain), PAIN (hurts like crazy) and PAIN IN EXTREMITY (hardly lift her arm). At the time of the report, PAIN IN EXTREMITY (really bad arm pain), PAIN (hurts like crazy) and PAIN IN EXTREMITY (hardly lift her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pyrexia, Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: vaccination site pain; Injection site redness; Vaccination site swelling; fever; Rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling), PYREXIA (fever) and RASH (Rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro).    On 15-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Vaccination site swelling). 16-Mar-2021, the patient experienced PYREXIA (fever) and RASH (Rash). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown and PYREXIA (fever) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up was received included allergy and  newevents
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: right knee pain; tiredness; fever 100F; body ache; joint pain; she started to feel very bad; she couldn't stand; she has had zikavirus and felt like the same; gum pain; face swollen; feet pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain) and SWELLING FACE (face swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, VALSARTAN and OXYBUTYNIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and ARTHRALGIA (joint pain). On 24-Mar-2021, the patient experienced ARTHRALGIA (right knee pain), FATIGUE (tiredness) and PYREXIA (fever 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and PYREXIA (fever 100F) had resolved. At the time of the report, ARTHRALGIA (right knee pain), FATIGUE (tiredness) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Myalgia, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: right knee pain; tiredness; fever 100F; body ache; joint pain; she started to feel very bad; she couldn't stand; she has had zikavirus and felt like the same; gum pain; face swollen; feet pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain) and SWELLING FACE (face swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, VALSARTAN and OXYBUTYNIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and ARTHRALGIA (joint pain). On 24-Mar-2021, the patient experienced ARTHRALGIA (right knee pain), FATIGUE (tiredness) and PYREXIA (fever 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and PYREXIA (fever 100F) had resolved. At the time of the report, ARTHRALGIA (right knee pain), FATIGUE (tiredness) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Zika virus infection
Clinical narrative: right knee pain; tiredness; fever 100F; body ache; joint pain; she started to feel very bad; she couldn't stand; she has had zikavirus and felt like the same; gum pain; face swollen; feet pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain) and SWELLING FACE (face swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, VALSARTAN and OXYBUTYNIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and ARTHRALGIA (joint pain). On 24-Mar-2021, the patient experienced ARTHRALGIA (right knee pain), FATIGUE (tiredness) and PYREXIA (fever 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and PYREXIA (fever 100F) had resolved. At the time of the report, ARTHRALGIA (right knee pain), FATIGUE (tiredness) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.