chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash erythematous
Clinical narrative: Arm is real red; scratching like crazy; began itching; Looks like a big sunburn; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Arm is real red), INJECTION SITE PRURITUS (scratching like crazy), PRURITUS (began itching) and RASH ERYTHEMATOUS (Looks like a big sunburn) in a 93-year-old female patient 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 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 28-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Arm is real red), INJECTION SITE PRURITUS (scratching like crazy), PRURITUS (began itching) and RASH ERYTHEMATOUS (Looks like a big sunburn). At the time of the report, INJECTION SITE ERYTHEMA (Arm is real red), INJECTION SITE PRURITUS (scratching like crazy), PRURITUS (began itching) and RASH ERYTHEMATOUS (Looks like a big sunburn) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste on their mouth and throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste on their mouth and throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2IA) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Taste metallic with Flu shot. Concurrent medical conditions included Depression. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VITAMIN B12 NOS, ZINC, VITAMIN D NOS, CALCIUM, VITAMIN C [ASCORBIC ACID] and PROBIOTICS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste on their mouth and throat). On 03-Mar-2021, DYSGEUSIA (Metallic taste on their mouth and throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccinated while pregnant) in a 40-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 20-Apr-2021. On 27-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccinated while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 27-Feb-2021, EXPOSURE DURING PREGNANCY (vaccinated while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter.  Patient gave consent for safety to Follow-up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: her arm became warm to the touch; her arm became itchy; her arm became swollen; her arm became red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (her arm became warm to the touch), VACCINATION SITE PRURITUS (her arm became itchy), VACCINATION SITE SWELLING (her arm became swollen) and VACCINATION SITE ERYTHEMA (her arm became red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (her arm became warm to the touch), VACCINATION SITE PRURITUS (her arm became itchy), VACCINATION SITE SWELLING (her arm became swollen) and VACCINATION SITE ERYTHEMA (her arm became red). At the time of the report, VACCINATION SITE WARMTH (her arm became warm to the touch), VACCINATION SITE PRURITUS (her arm became itchy), VACCINATION SITE SWELLING (her arm became swollen) and VACCINATION SITE ERYTHEMA (her arm became red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment drug were not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Vaccination complication
Clinical narrative: not feeling well; energy bolt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well) and ENERGY INCREASED (energy bolt) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling well) and ENERGY INCREASED (energy bolt). At the time of the report, VACCINATION COMPLICATION (not feeling well) and ENERGY INCREASED (energy bolt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Peripheral coldness
Clinical narrative: cold in the hands and in the feet for about 15 hours; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (cold in the hands and in the feet for about 15 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE, QUINAPRIL, ATORVASTATIN, DULAGLUTIDE (TRULICITY) and REPAGLINIDE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (cold in the hands and in the feet for about 15 hours). At the time of the report, PERIPHERAL COLDNESS (cold in the hands and in the feet for about 15 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown (normal) couldn't get warm, took the temperature and was very normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she couldn't get warm, took the temperature and was very normal.  Treatment information was not provided.   Reporter did not allow further contact
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Hot to the touch at the injection site after the second dose; Itching at the injection site after the second dose; Redness at the injection site after the second dose; Swelling at the injection site after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to the touch at the injection site after the second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose), INJECTION SITE ERYTHEMA (Redness at the injection site after the second dose) and INJECTION SITE SWELLING (Swelling at the injection site after the second dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot to the touch at the injection site after the second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose), INJECTION SITE ERYTHEMA (Redness at the injection site after the second dose) and INJECTION SITE SWELLING (Swelling at the injection site after the second dose). At the time of the report, INJECTION SITE WARMTH (Hot to the touch at the injection site after the second dose) and INJECTION SITE SWELLING (Swelling at the injection site after the second dose) was resolving and INJECTION SITE PRURITUS (Itching at the injection site after the second dose) and INJECTION SITE ERYTHEMA (Redness at the injection site after the second dose) had not resolved.            No concomitant medications were reported. No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  Patient agreed to follow-up with Safety.   This case was linked to MOD-2021-032240 (Patient Link).
Age: 68.0
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 a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: pain in her arm; chills; headache; whole side from the vaccine in pain; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), CHILLS (chills), HEADACHE (headache) and VACCINATION SITE PAIN (whole side from the vaccine in pain) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm), CHILLS (chills), HEADACHE (headache) and VACCINATION SITE PAIN (whole side from the vaccine in pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 01-Mar-2021, PAIN IN EXTREMITY (pain in her arm), CHILLS (chills), HEADACHE (headache) and VACCINATION SITE PAIN (whole side from the vaccine in pain) 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.   No relevant concomitant medications were provided.  Patient used acetaminophen for symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensation of foreign body, Urticaria, Vulvovaginal pruritus
Clinical narrative: Body itching; Vagina was itchy; knot in her throat; Back was welting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body itching), VULVOVAGINAL PRURITUS (Vagina was itchy), SENSATION OF FOREIGN BODY (knot in her throat) and URTICARIA (Back was welting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PRURITUS (Body itching), VULVOVAGINAL PRURITUS (Vagina was itchy), SENSATION OF FOREIGN BODY (knot in her throat) and URTICARIA (Back was welting). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and MICONAZOLE NITRATE (MONISTAT) at an unspecified dose and frequency. On 29-Dec-2020, PRURITUS (Body itching) and SENSATION OF FOREIGN BODY (knot in her throat) had resolved. On 10-Jan-2021, VULVOVAGINAL PRURITUS (Vagina was itchy) and URTICARIA (Back was welting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Physician recommended not to take second dose.   This case was linked to MOD-2021-023215, MOD-2021-023215 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular swelling
Clinical narrative: Swollen right testicle; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (Swollen right testicle) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA), METFORMIN, LISINOPRIL and ATORVASTATIN for an unknown indication.    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 TESTICULAR SWELLING (Swollen right testicle). At the time of the report, TESTICULAR SWELLING (Swollen right testicle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Nasal congestion, Neck pain, Pruritus
Clinical narrative: itchy and red again and this lasted for 5 days.; itchy and red again and this lasted for 5 days.; bad headache, bad neck, and stuffy nose.; bad headache, bad neck, and stuffy nose.; bad headache, bad neck, and stuffy nose.; arm became red and itchy and that lasted for 5 days.; arm became red and itchy and that lasted for 5 days.; arm became pink and itchy.; arm became pink and itchy.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (arm became pink and itchy.), PRURITUS (arm became pink and itchy.), ERYTHEMA (arm became red and itchy and that lasted for 5 days.), NECK PAIN (bad headache, bad neck, and stuffy nose.) and NASAL CONGESTION (bad headache, bad neck, and stuffy nose.) in a 73-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.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SKIN DISCOLOURATION (arm became pink and itchy.) and PRURITUS (arm became pink and itchy.). On 09-Feb-2021, the patient experienced ERYTHEMA (arm became red and itchy and that lasted for 5 days.) and PRURITUS (arm became red and itchy and that lasted for 5 days.). On 11-Feb-2021, the patient experienced NECK PAIN (bad headache, bad neck, and stuffy nose.), NASAL CONGESTION (bad headache, bad neck, and stuffy nose.) and HEADACHE (bad headache, bad neck, and stuffy nose.). On 18-Feb-2021, the patient experienced PRURITUS (itchy and red again and this lasted for 5 days.) and ERYTHEMA (itchy and red again and this lasted for 5 days.). On 13-Feb-2021, SKIN DISCOLOURATION (arm became pink and itchy.), PRURITUS (arm became pink and itchy.), ERYTHEMA (arm became red and itchy and that lasted for 5 days.) and PRURITUS (arm became red and itchy and that lasted for 5 days.) had resolved. On 23-Feb-2021, PRURITUS (itchy and red again and this lasted for 5 days.) and ERYTHEMA (itchy and red again and this lasted for 5 days.) had resolved. At the time of the report, NECK PAIN (bad headache, bad neck, and stuffy nose.), NASAL CONGESTION (bad headache, bad neck, and stuffy nose.) and HEADACHE (bad headache, bad neck, and stuffy nose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In between her two episodes of itchy red arm, she was fine for five days.  No concomitant medications were reported. No treatment medication was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: itchy and red again and this lasted for 5 days.; itchy and red again and this lasted for 5 days.; bad headache, bad neck, and stuffy nose.; bad headache, bad neck, and stuffy nose.; bad headache, bad neck, and stuffy nose.; arm became red and itchy and that lasted for 5 days.; arm became red and itchy and that lasted for 5 days.; arm became pink and itchy.; arm became pink and itchy.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (arm became pink and itchy.), PRURITUS (arm became pink and itchy.), ERYTHEMA (arm became red and itchy and that lasted for 5 days.), NECK PAIN (bad headache, bad neck, and stuffy nose.) and NASAL CONGESTION (bad headache, bad neck, and stuffy nose.) in a 73-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.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SKIN DISCOLOURATION (arm became pink and itchy.) and PRURITUS (arm became pink and itchy.). On 09-Feb-2021, the patient experienced ERYTHEMA (arm became red and itchy and that lasted for 5 days.) and PRURITUS (arm became red and itchy and that lasted for 5 days.). On 11-Feb-2021, the patient experienced NECK PAIN (bad headache, bad neck, and stuffy nose.), NASAL CONGESTION (bad headache, bad neck, and stuffy nose.) and HEADACHE (bad headache, bad neck, and stuffy nose.). On 18-Feb-2021, the patient experienced PRURITUS (itchy and red again and this lasted for 5 days.) and ERYTHEMA (itchy and red again and this lasted for 5 days.). On 13-Feb-2021, SKIN DISCOLOURATION (arm became pink and itchy.), PRURITUS (arm became pink and itchy.), ERYTHEMA (arm became red and itchy and that lasted for 5 days.) and PRURITUS (arm became red and itchy and that lasted for 5 days.) had resolved. On 23-Feb-2021, PRURITUS (itchy and red again and this lasted for 5 days.) and ERYTHEMA (itchy and red again and this lasted for 5 days.) had resolved. At the time of the report, NECK PAIN (bad headache, bad neck, and stuffy nose.), NASAL CONGESTION (bad headache, bad neck, and stuffy nose.) and HEADACHE (bad headache, bad neck, and stuffy nose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In between her two episodes of itchy red arm, she was fine for five days.  No concomitant medications were reported. No treatment medication was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Incredible itchy (injection site)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Incredible itchy (injection site)). At the time of the report, VACCINATION SITE PRURITUS (Incredible itchy (injection site)) outcome was unknown. Concomitant medications include blood thinner and diabetes type 2. Patient applied Benadryl topic cream for vaccination site pruritus. Patient gave consent for Follow-up. This case was linked to MOD-2021-029897.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: 6 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (6 months pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy (Sensitivity to latex) and Gestational diabetes (pregnancy-related complications or other acute illnesses). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CHOLINE, MAGNESIUM OXIDE, RUBUS IDAEUS LEAF (RED RASPBERRY) and APPLE CIDER VINEGAR for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was date. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (6 months pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The vaginal delivery occurred on date, which was reported as Full-term. For neonate 1, the birth weight was 4064 grams (8lbs 15oz). The outcome was reported as Delivered NOS. On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (6 months pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: positive (Positive) Positive. On 01-Mar-2021, Ultrasound scan: normal growth (normal) Normal growth. On 29-Mar-2021, Blood glucose: diagnosis of gestational diabetes (abnormal) Diagnosis of gestational diabetes. On an unknown date, Ultrasound scan: normal (normal) 20 week anatomy scan.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's concomitant medication include Prenatal Vitamins in 2018 for her previous pregnancy. Previous pregnancy ended on date with live, full term birth.   This case was linked to MOD-2021-267640 (Parent-Child Link).   See case MOD-2021-267640 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow up received on 26-JUL-2021 updated Patient demographics, Pregnancy details, lab data, concomitant medications and Pregnancy outcome.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Nausea, Pain in extremity
Clinical narrative: Nausea; Chills; Hot body (Temperature Unknown); Very Bad Headache; Rash and two bumps on the left side of Neck; Sore Arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING HOT (Hot body (Temperature Unknown)), RASH (Rash and two bumps on the left side of Neck), HEADACHE (Very Bad Headache) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 26-Feb-2021, the patient experienced RASH (Rash and two bumps on the left side of Neck). On 27-Feb-2021, the patient experienced HEADACHE (Very Bad Headache). On 01-Mar-2021, the patient experienced FEELING HOT (Hot body (Temperature Unknown)) and CHILLS (Chills). On 02-Mar-2021, the patient experienced NAUSEA (Nausea). On 24-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 27-Feb-2021, RASH (Rash and two bumps on the left side of Neck) and HEADACHE (Very Bad Headache) had resolved. At the time of the report, FEELING HOT (Hot body (Temperature Unknown)), CHILLS (Chills) 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.   Treatment included Tylenol Orally, Benadrly orally.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Nausea; Chills; Hot body (Temperature Unknown); Very Bad Headache; Rash and two bumps on the left side of Neck; Sore Arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING HOT (Hot body (Temperature Unknown)), RASH (Rash and two bumps on the left side of Neck), HEADACHE (Very Bad Headache) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 26-Feb-2021, the patient experienced RASH (Rash and two bumps on the left side of Neck). On 27-Feb-2021, the patient experienced HEADACHE (Very Bad Headache). On 01-Mar-2021, the patient experienced FEELING HOT (Hot body (Temperature Unknown)) and CHILLS (Chills). On 02-Mar-2021, the patient experienced NAUSEA (Nausea). On 24-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 27-Feb-2021, RASH (Rash and two bumps on the left side of Neck) and HEADACHE (Very Bad Headache) had resolved. At the time of the report, FEELING HOT (Hot body (Temperature Unknown)), CHILLS (Chills) 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.   Treatment included Tylenol Orally, Benadrly orally.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt for 4 days/The 2nd day it hurt worst than flu shot), LIMB DISCOMFORT (It was pretty sore), ERYTHEMA (A little pinkish red color) and INFLAMMATION (A little inflamed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (arm hurt for 4 days after COVID-19 vaccine and the 2nd day it hurt worst than flu shot). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DEXLANSOPRAZOLE (DEXILANT), NEBIVOLOL, MONTELUKAST, ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL, LEVOTHYROXINE and OXYBUTYNIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt for 4 days/The 2nd day it hurt worst than flu shot), LIMB DISCOMFORT (It was pretty sore), ERYTHEMA (A little pinkish red color) and INFLAMMATION (A little inflamed). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain in arm, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Her arm hurt for 4 days/The 2nd day it hurt worst than flu shot), LIMB DISCOMFORT (It was pretty sore), ERYTHEMA (A little pinkish red color) and INFLAMMATION (A little inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient gave consent to safety for Follow-up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administer the vaccine to and individual under 18; This spontaneous case was reported by a nurse and describes the occurrence of   in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: NNI; Reporter's Comments: This case report concerns a 17-year-old male patient who was administered mRNA-1273 vaccine Lot# unknown (inappropriate age at vaccine administration). There was no associated adverse event reported  for the event of inappropriate age at vaccine administration
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Neck mass, Pain in extremity
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of NECK MASS (Rash and two bumps on the left side of Neck), PAIN IN EXTREMITY (Sore Arm), RASH (Rash and two bumps on the left side of Neck), PYREXIA (hot body temperature) and HEADACHE (very bad headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in April 2020. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 26-Feb-2021, the patient experienced NECK MASS (Rash and two bumps on the left side of Neck) and RASH (Rash and two bumps on the left side of Neck). On 27-Feb-2021, the patient experienced HEADACHE (very bad headache). On 01-Mar-2021, the patient experienced PYREXIA (hot body temperature) and CHILLS (chills). On 02-Mar-2021, the patient experienced NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) on 23-Feb-2021 for Pain in arm, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Feb-2021 for Rash and Neck mass, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. On 27-Feb-2021, NECK MASS (Rash and two bumps on the left side of Neck) and RASH (Rash and two bumps on the left side of Neck) had resolved, HEADACHE (very bad headache) outcome was unknown. At the time of the report, PYREXIA (hot body temperature), CHILLS (chills) 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. Treatment medications include Tylenol for headache. Patient gave consent to safety for Follow-up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of NECK MASS (Rash and two bumps on the left side of Neck), PAIN IN EXTREMITY (Sore Arm), RASH (Rash and two bumps on the left side of Neck), PYREXIA (hot body temperature) and HEADACHE (very bad headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in April 2020. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 26-Feb-2021, the patient experienced NECK MASS (Rash and two bumps on the left side of Neck) and RASH (Rash and two bumps on the left side of Neck). On 27-Feb-2021, the patient experienced HEADACHE (very bad headache). On 01-Mar-2021, the patient experienced PYREXIA (hot body temperature) and CHILLS (chills). On 02-Mar-2021, the patient experienced NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) on 23-Feb-2021 for Pain in arm, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Feb-2021 for Rash and Neck mass, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. On 27-Feb-2021, NECK MASS (Rash and two bumps on the left side of Neck) and RASH (Rash and two bumps on the left side of Neck) had resolved, HEADACHE (very bad headache) outcome was unknown. At the time of the report, PYREXIA (hot body temperature), CHILLS (chills) 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. Treatment medications include Tylenol for headache. Patient gave consent to safety for Follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) 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 02-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (complaining of diarrhea) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIARRHOEA (complaining of diarrhea). At the time of the report, DIARRHOEA (complaining of diarrhea) 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 information was provided.  No concomitant medication was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Feeling cold, Ocular discomfort
Clinical narrative: Funny cough that was dry and persistent; Lungs felt kind of heavy; Feels extremely cold; Funning feeling around eyes; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Funny cough that was dry and persistent), DYSPNOEA (Lungs felt kind of heavy), FEELING COLD (Feels extremely cold) and OCULAR DISCOMFORT (Funning feeling around eyes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COUGH (Funny cough that was dry and persistent), DYSPNOEA (Lungs felt kind of heavy), FEELING COLD (Feels extremely cold) and OCULAR DISCOMFORT (Funning feeling around eyes). At the time of the report, COUGH (Funny cough that was dry and persistent), DYSPNOEA (Lungs felt kind of heavy), FEELING COLD (Feels extremely cold) and OCULAR DISCOMFORT (Funning feeling around eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products included herbal products and supplements. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nasopharyngitis, Pain in extremity
Clinical narrative: Headache; Arm is really sore and kindy achy; Chills; So cold; Feeling crummy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore and kindy achy) and MALAISE (Feeling crummy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore and kindy achy) and MALAISE (Feeling crummy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is really sore and kindy achy) and MALAISE (Feeling crummy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Report received on 24-APR-2021 contains no new information.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Influenza like illness, Injection site pain, Neck pain
Clinical narrative: sore arm at the injection site; left neck pain; left elbow pain; skin sensitivity; weakness; flu-like symptoms; my whole body is sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity) and ASTHENIA (weakness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (my whole body is sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (my whole body is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sensitive skin
Clinical narrative: sore arm at the injection site; left neck pain; left elbow pain; skin sensitivity; weakness; flu-like symptoms; my whole body is sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity) and ASTHENIA (weakness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (my whole body is sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (my whole body is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule
Clinical narrative: Lump on the chest; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Lump on the chest) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 NODULE (Lump on the chest) and FATIGUE (Fatigue). At the time of the report, NODULE (Lump on the chest) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: ICEPACK   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: On 27-FEB-2021, patient received first dose on left arm and experienced Lump on the chest and was Fatigue. Treatment used was Icepack.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Feeling abnormal, Headache, Pyrexia
Clinical narrative: headache; feels terrible; feeling like something was wrong; sugar has been out of whack; Someone took her energy; temperature at 101.8; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature at 101.8), HEADACHE (headache), ASTHENIA (Someone took her energy), FEELING ABNORMAL (feeling like something was wrong) and BLOOD GLUCOSE DECREASED (sugar has been out of whack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (temperature at 101.8) and ASTHENIA (Someone took her energy). On 09-Feb-2021, the patient experienced FEELING ABNORMAL (feeling like something was wrong) and BLOOD GLUCOSE DECREASED (sugar has been out of whack). On 10-Feb-2021, the patient experienced HEADACHE (headache) and FEELING ABNORMAL (feels terrible). At the time of the report, PYREXIA (temperature at 101.8), HEADACHE (headache), ASTHENIA (Someone took her energy), FEELING ABNORMAL (feeling like something was wrong), BLOOD GLUCOSE DECREASED (sugar has been out of whack) and FEELING ABNORMAL (feels terrible) 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 treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Blood came gushing out and pooled on floor after shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Blood came gushing out and pooled on floor after shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001192117 and IDMG2601) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Blood came gushing out and pooled on floor after shot). At the time of the report, VACCINATION SITE HAEMORRHAGE (Blood came gushing out and pooled on floor after shot) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.