chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pain
Clinical narrative: Increased bleeding during period; Itching; Vaginal dryness; Vaginal pain; Difficulty sleeping; Circular pattern; Sharp pain; Tendon pain; Bump on underarm; Arm pain; Tirdness; Headache; Nausea; Throwing up; Arm swelling; Not being able to lift up arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain) and TENDON PAIN (Tendon pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), LIMB DISCOMFORT (Not being able to lift up arm) and VOMITING (Throwing up). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Tirdness), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced MASS (Bump on underarm). On 16-Mar-2021, the patient experienced PAIN (Sharp pain), TENDON PAIN (Tendon pain) and RASH (Circular pattern). On 17-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 22-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness) and VULVOVAGINAL PAIN (Vaginal pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain), TENDON PAIN (Tendon pain), INSOMNIA (Difficulty sleeping), HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness), VULVOVAGINAL PAIN (Vaginal pain), LIMB DISCOMFORT (Not being able to lift up arm), RASH (Circular pattern), FATIGUE (Tirdness), VOMITING (Throwing up), HEADACHE (Headache) and NAUSEA (Nausea) 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 medications were reported
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Dry mouth, Ear swelling, Erythema, Insomnia
Clinical narrative: itchy hive like rash on middle of both arms; dizziness; dry mouth; left ear red/swollen; right ear is red; didn't sleep well; back of neck felt like sunburn; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red) and INSOMNIA (didn't sleep well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    No Medical History information was reported.   On 21-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 started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 21-Mar-2021, the patient experienced DIZZINESS (dizziness), DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red), INSOMNIA (didn't sleep well) and SUNBURN (back of neck felt like sunburn). On 22-Mar-2021, the patient experienced RASH PRURITIC (itchy hive like rash on middle of both arms). On 23-Mar-2021, DIZZINESS (dizziness) had resolved. At the time of the report, DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red), INSOMNIA (didn't sleep well), SUNBURN (back of neck felt like sunburn) and RASH PRURITIC (itchy hive like rash on middle of both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash pruritic, Sunburn
Clinical narrative: itchy hive like rash on middle of both arms; dizziness; dry mouth; left ear red/swollen; right ear is red; didn't sleep well; back of neck felt like sunburn; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red) and INSOMNIA (didn't sleep well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    No Medical History information was reported.   On 21-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 started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 21-Mar-2021, the patient experienced DIZZINESS (dizziness), DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red), INSOMNIA (didn't sleep well) and SUNBURN (back of neck felt like sunburn). On 22-Mar-2021, the patient experienced RASH PRURITIC (itchy hive like rash on middle of both arms). On 23-Mar-2021, DIZZINESS (dizziness) had resolved. At the time of the report, DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red), INSOMNIA (didn't sleep well), SUNBURN (back of neck felt like sunburn) and RASH PRURITIC (itchy hive like rash on middle of both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) 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 AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Hypoaesthesia
Clinical narrative: Cant move her arm; Pain increased; Left arm felt numb; Dizzy; Joint swollen; Fever 103; Needle pain where joint is; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), HYPOAESTHESIA (Left arm felt numb), HYPOKINESIA (Cant move her arm) and PAIN (Pain increased) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), PYREXIA (Fever 103), ARTHRALGIA (Needle pain where joint is) and CHILLS (Chills). On 20-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm felt numb). On 22-Mar-2021, the patient experienced HYPOKINESIA (Cant move her arm) and PAIN (Pain increased). The patient was treated with PARACETAMOL (TYLENOL) for Numbness, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Joint pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), HYPOAESTHESIA (Left arm felt numb), PAIN (Pain increased), PYREXIA (Fever 103), ARTHRALGIA (Needle pain where joint is) and CHILLS (Chills) outcome was unknown and HYPOKINESIA (Cant move her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 103 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Joint swelling, Pain, Pyrexia
Clinical narrative: Cant move her arm; Pain increased; Left arm felt numb; Dizzy; Joint swollen; Fever 103; Needle pain where joint is; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), HYPOAESTHESIA (Left arm felt numb), HYPOKINESIA (Cant move her arm) and PAIN (Pain increased) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), PYREXIA (Fever 103), ARTHRALGIA (Needle pain where joint is) and CHILLS (Chills). On 20-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm felt numb). On 22-Mar-2021, the patient experienced HYPOKINESIA (Cant move her arm) and PAIN (Pain increased). The patient was treated with PARACETAMOL (TYLENOL) for Numbness, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Joint pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), HYPOAESTHESIA (Left arm felt numb), PAIN (Pain increased), PYREXIA (Fever 103), ARTHRALGIA (Needle pain where joint is) and CHILLS (Chills) outcome was unknown and HYPOKINESIA (Cant move her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 103 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient reported she has received both doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Jul-2021. On 31-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine). The delivery occurred  on 11-Jul-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Headache, Joint injury, Pain in extremity
Clinical narrative: Hurt her knee; Headache; Sore left armpit; Sore left breast; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast), PAIN IN EXTREMITY (Sore left arm), JOINT INJURY (Hurt her knee) and HEADACHE (Headache) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast) and PAIN IN EXTREMITY (Sore left arm). On 23-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced JOINT INJURY (Hurt her knee). On 13-Mar-2021, AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast) and PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, JOINT INJURY (Hurt her knee) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little tired and achy in the arm; a little tired and achy in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm). On 20-Feb-2021, PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm) 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.   Treatment medication was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Pruritus, Rash
Clinical narrative: Affected area was red; Itchy around her eyes; Rash on face; Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach); Itchy face; Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)) and ERYTHEMA (Affected area was red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)) and EYE PRURITUS (Itchy around her eyes). On 12-Feb-2021, the patient experienced ERYTHEMA (Affected area was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)), ERYTHEMA (Affected area was red) and EYE PRURITUS (Itchy around her eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Hypertension, Laboratory test
Clinical narrative: Increase blood pressure; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation). At the time of the report, HYPERTENSION (Increase blood pressure) had resolved and PALPITATIONS (Palpitation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: unknown (High) increased. On 20-Mar-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 20-Mar-2021, Heart rate: unknown (High) increased. On 20-Mar-2021, Laboratory test: unknown (Inconclusive) Unknown.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  Intravenous fluid and some medicine was given as treatment medication  Patient experienced palpitation, increased heart rate and increased blood pressure in evening for that he visited Emergency room where he kept for observation for 5 hours and Lab investigations and EKG done to rule out heart problem. Intravenous fluid and some medicine was given. No information of concomitant medication. His blood pressure never high.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Increase blood pressure; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation). At the time of the report, HYPERTENSION (Increase blood pressure) had resolved and PALPITATIONS (Palpitation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: unknown (High) increased. On 20-Mar-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 20-Mar-2021, Heart rate: unknown (High) increased. On 20-Mar-2021, Laboratory test: unknown (Inconclusive) Unknown.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  Intravenous fluid and some medicine was given as treatment medication  Patient experienced palpitation, increased heart rate and increased blood pressure in evening for that he visited Emergency room where he kept for observation for 5 hours and Lab investigations and EKG done to rule out heart problem. Intravenous fluid and some medicine was given. No information of concomitant medication. His blood pressure never high.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-225724 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Headache, Myalgia
Clinical narrative: Burning Sensation Hip Replacement; Fatigue; Achy Joints; Headache; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning Sensation Hip Replacement), FATIGUE (Fatigue), ARTHRALGIA (Achy Joints), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement (In 2019. Made of Titanium and Ceramic material.). Concurrent medical conditions included Allergy (Allergic to PCN). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LOSARTAN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BURNING SENSATION (Burning Sensation Hip Replacement), FATIGUE (Fatigue), ARTHRALGIA (Achy Joints), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea). On 18-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved. At the time of the report, BURNING SENSATION (Burning Sensation Hip Replacement) and ARTHRALGIA (Achy Joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Burning Sensation Hip Replacement; Fatigue; Achy Joints; Headache; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning Sensation Hip Replacement), FATIGUE (Fatigue), ARTHRALGIA (Achy Joints), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement (In 2019. Made of Titanium and Ceramic material.). Concurrent medical conditions included Allergy (Allergic to PCN). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LOSARTAN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BURNING SENSATION (Burning Sensation Hip Replacement), FATIGUE (Fatigue), ARTHRALGIA (Achy Joints), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea). On 18-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved. At the time of the report, BURNING SENSATION (Burning Sensation Hip Replacement) and ARTHRALGIA (Achy Joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: delayed reaction known as "covid arm"; itchy big red warm spot on the injection site; itchy big red warm spot on the injection site; itchy big red warm spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema and Allergy (skin allergy).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported that she took Benadryl daily for allergies.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030220A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN for an unknown indication.   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 23-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Patient was taking blood pressure pills,cholesterol pills,type 2 diabetes pills as concomitant medication. Action taken for Moderna COVID-19 Vaccine was not applicable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Injection site pruritus, Nervousness, Pain
Clinical narrative: Stayed in Bed all day; Shaky (Not sure if she had a fever); Achy Body; Joint Pain; Itching below and to the right of injection site; Big Red Spot (as big as her hand) below and to the right of injection site; Swollen below and to the right of injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain) and INJECTION SITE PRURITUS (Itching below and to the right of injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain), INJECTION SITE PRURITUS (Itching below and to the right of injection site), VACCINATION SITE ERYTHEMA (Big Red Spot (as big as her hand) below and to the right of injection site) and VACCINATION SITE SWELLING (Swollen below and to the right of injection site). At the time of the report, ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain), INJECTION SITE PRURITUS (Itching below and to the right of injection site), VACCINATION SITE ERYTHEMA (Big Red Spot (as big as her hand) below and to the right of injection site) and VACCINATION SITE SWELLING (Swollen below and to the right of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Stayed in Bed all day; Shaky (Not sure if she had a fever); Achy Body; Joint Pain; Itching below and to the right of injection site; Big Red Spot (as big as her hand) below and to the right of injection site; Swollen below and to the right of injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain) and INJECTION SITE PRURITUS (Itching below and to the right of injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain), INJECTION SITE PRURITUS (Itching below and to the right of injection site), VACCINATION SITE ERYTHEMA (Big Red Spot (as big as her hand) below and to the right of injection site) and VACCINATION SITE SWELLING (Swollen below and to the right of injection site). At the time of the report, ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain), INJECTION SITE PRURITUS (Itching below and to the right of injection site), VACCINATION SITE ERYTHEMA (Big Red Spot (as big as her hand) below and to the right of injection site) and VACCINATION SITE SWELLING (Swollen below and to the right of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in her right ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus in her right ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 032L20A) for COVID-19 vaccination.     No medical history reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (Tinnitus in her right ear). At the time of the report, TINNITUS (Tinnitus in her right ear) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment information was reported.  Per reporter, the patient's was being getting an ENT referral from her primary care doctor.    Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Reporter has no further information about the event.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Influenza, Pain
Clinical narrative: rapid test and it was COVID positive; basic flu symptoms; Soreness; Fever; Fatigue; second dose might be over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days), COVID-19 (rapid test and it was COVID positive), INFLUENZA (basic flu symptoms), PAIN (Soreness) and PYREXIA (Fever) in a 52-year-old male patient 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 Hypertension and Allergy (Allergy NOS). Concomitant products included FLUTICASONE for Allergy, METOPROLOL for Blood pressure, VITAMIN C [ASCORBIC ACID] for Vitamin C supplementation, VITAMIN D NOS for Vitamin D supplementation, ZINC for Zinc supplementation.    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 PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days), PAIN (Soreness), PYREXIA (Fever) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced INFLUENZA (basic flu symptoms). On 24-Mar-2021, the patient experienced COVID-19 (rapid test and it was COVID positive). The patient was treated with IBUPROFEN for Fever and Headache, at a dose of 200 mg, 3 tablets; PREDNISONE at a dose of 10 mg and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) at a dose of 875 mg. On 22-Mar-2021, PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days) had resolved. At the time of the report, COVID-19 (rapid test and it was COVID positive), INFLUENZA (basic flu symptoms), PAIN (Soreness), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 101f (High) 101F. On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2021, Body temperature: 100.7f (High) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021,contains significant information, added new event. On 10-May-2021: Follow-up information received on 11-May-2021,contains significant information. Added Medical History, Lab data, Suspect drug details, Concomitant medications
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: rapid test and it was COVID positive; basic flu symptoms; Soreness; Fever; Fatigue; second dose might be over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days), COVID-19 (rapid test and it was COVID positive), INFLUENZA (basic flu symptoms), PAIN (Soreness) and PYREXIA (Fever) in a 52-year-old male patient 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 Hypertension and Allergy (Allergy NOS). Concomitant products included FLUTICASONE for Allergy, METOPROLOL for Blood pressure, VITAMIN C [ASCORBIC ACID] for Vitamin C supplementation, VITAMIN D NOS for Vitamin D supplementation, ZINC for Zinc supplementation.    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 PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days), PAIN (Soreness), PYREXIA (Fever) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced INFLUENZA (basic flu symptoms). On 24-Mar-2021, the patient experienced COVID-19 (rapid test and it was COVID positive). The patient was treated with IBUPROFEN for Fever and Headache, at a dose of 200 mg, 3 tablets; PREDNISONE at a dose of 10 mg and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) at a dose of 875 mg. On 22-Mar-2021, PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days) had resolved. At the time of the report, COVID-19 (rapid test and it was COVID positive), INFLUENZA (basic flu symptoms), PAIN (Soreness), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 101f (High) 101F. On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2021, Body temperature: 100.7f (High) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021,contains significant information, added new event. On 10-May-2021: Follow-up information received on 11-May-2021,contains significant information. Added Medical History, Lab data, Suspect drug details, Concomitant medications
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Up all night long; Heart racing; Shortness of breath; Bed ridden; Delayed the second shot; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported) and COVID-19.    On 10-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 INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) and FATIGUE (Extreme fatigue). At the time of the report, INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) outcome was unknown and BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Up all night long; Heart racing; Shortness of breath; Bed ridden; Delayed the second shot; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported) and COVID-19.    On 10-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 INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) and FATIGUE (Extreme fatigue). At the time of the report, INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) outcome was unknown and BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Disorientation, Fatigue
Clinical narrative: Diarrhea; Disoriented; Chills; Being tired; Headache; Muscle ache; Vomiting; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills) and FATIGUE (Being tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment also included nausea medicine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, SARS-CoV-2 test, Vomiting
Clinical narrative: Diarrhea; Disoriented; Chills; Being tired; Headache; Muscle ache; Vomiting; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills) and FATIGUE (Being tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment also included nausea medicine.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: A weird lump in her throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (A weird lump in her throat) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (A weird lump in her throat). On 12-Mar-2021, OROPHARYNGEAL DISCOMFORT (A weird lump in her throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.