chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of swelling, erythema (redness/currently the arm is not red, just pink), pruritus (itching), burning sensation (burning feeling in her arm) and warm skin (warm arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M20A) for COVID-19 vaccination. The occurrence of additional events detailed below. Concurrent medical conditions included arthritis. Concomitant products included hydrochlorothiazide for fluid retention, omeprazole and  simvastatin for an unknown indication. On Feb 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 25, 2021, patient experienced swelling, erythema (redness/currently the arm is not red, just pink), burning sensation (burning feeling in her arm) and pain in extremity (arm is sore). Feb 25, 2021, patient experienced pruritus (itching) and pain (soreness). On Mar 17, 2021, patient experienced warm skin (warm arm) and macular rash (spotting near forearm). At the time of the report, swelling, pruritus (itching), burning sensation (burning feeling in her arm) and pain (soreness) outcome was unknown, erythema (redness/currently the arm is not red, just pink): resolving and warm skin (warm arm), macular rash (spotting near forearm) and pain in extremity (arm is sore): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment medications or causality assessments provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin warm, Swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of swelling, erythema (redness/currently the arm is not red, just pink), pruritus (itching), burning sensation (burning feeling in her arm) and warm skin (warm arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M20A) for COVID-19 vaccination. The occurrence of additional events detailed below. Concurrent medical conditions included arthritis. Concomitant products included hydrochlorothiazide for fluid retention, omeprazole and  simvastatin for an unknown indication. On Feb 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 25, 2021, patient experienced swelling, erythema (redness/currently the arm is not red, just pink), burning sensation (burning feeling in her arm) and pain in extremity (arm is sore). Feb 25, 2021, patient experienced pruritus (itching) and pain (soreness). On Mar 17, 2021, patient experienced warm skin (warm arm) and macular rash (spotting near forearm). At the time of the report, swelling, pruritus (itching), burning sensation (burning feeling in her arm) and pain (soreness) outcome was unknown, erythema (redness/currently the arm is not red, just pink): resolving and warm skin (warm arm), macular rash (spotting near forearm) and pain in extremity (arm is sore): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment medications or causality assessments provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Urinary incontinence
Clinical narrative: lost control of her bladder; Chills; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (lost control of her bladder), CHILLS (Chills) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002A21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, CALCIUM, COLECALCIFEROL (CALTRATE D [CALCIUM;COLECALCIFEROL]) and DENOSUMAB for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (headache). On 24-Feb-2021, the patient experienced URINARY INCONTINENCE (lost control of her bladder). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of 1 dosage form. On 23-Feb-2021, CHILLS (Chills) and HEADACHE (headache) had resolved. On 25-Feb-2021, URINARY INCONTINENCE (lost control of her bladder) had resolved.            sore arm was reported in  the event which was experienced after 1st dose vaccine event reported unknown.   This case was linked to MOD-2021-048104 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity, Prenatal screening test
Clinical narrative: Arm hurt; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Baby born at 36.5 weeks. (Live pre term birth)) on Nov-2018. Concurrent medical conditions included Hypothyroidism since March 2021. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] for Pregnancy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Nov-2020 and the estimated date of delivery was 16-Aug-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prenatal screening test: (normal) prenatal screening for Down syndrome and chromosome abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow-up received updated medical history, lab data and patient details.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BACK PAIN (lower back pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Back pain, at an unspecified dose and frequency. On 16-Mar-2021, BACK PAIN (lower back pain) had resolved. Not applicable          No concomitant medication provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Regulatory Authority form received on 24-MAY-2021 and patient DOB updated. event outcome updated , treatment information added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Testicular disorder, Testicular pain, Testicular swelling
Clinical narrative: area looked swollen and reddish for one testicle; area looked swollen and reddish for one testicle; Sore scrotum; Other testicle looked small like it wasn't there; This spontaneous case was reported by a health care professional and describes the occurrence of TESTICULAR SWELLING (area looked swollen and reddish for one testicle), ERYTHEMA (area looked swollen and reddish for one testicle), TESTICULAR PAIN (Sore scrotum) and TESTICULAR DISORDER (Other testicle looked small like it wasn't there) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Orchiectomy. Concurrent medical conditions included Hypertension, Diabetes, Testicular cancer and Pancreatitis.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TESTICULAR SWELLING (area looked swollen and reddish for one testicle), ERYTHEMA (area looked swollen and reddish for one testicle), TESTICULAR PAIN (Sore scrotum) and TESTICULAR DISORDER (Other testicle looked small like it wasn't there). At the time of the report, TESTICULAR SWELLING (area looked swollen and reddish for one testicle), ERYTHEMA (area looked swollen and reddish for one testicle), TESTICULAR PAIN (Sore scrotum) and TESTICULAR DISORDER (Other testicle looked small like it wasn't there) 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.   Concomitant medications included hypertension medications 2 times, diabetic medications 2 times, pain medication, eye drops 4 times.  Treatment information included ice pack.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia oral, Swollen tongue, Vaccination site pain
Clinical narrative: tongue swelling; tingling on tip of tongue; tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swelling), PARAESTHESIA ORAL (tingling on tip of tongue), FATIGUE (tired) and VACCINATION SITE PAIN (sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swelling), PARAESTHESIA ORAL (tingling on tip of tongue), FATIGUE (tired) and VACCINATION SITE PAIN (sore arm). At the time of the report, SWOLLEN TONGUE (tongue swelling), PARAESTHESIA ORAL (tingling on tip of tongue), FATIGUE (tired) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment included Benadryl and prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: fever of 101.4; very very achy; very cold; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very very achy), NASOPHARYNGITIS (very cold), FATIGUE (very tired) and PYREXIA (fever of 101.4) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 001L20A) for COVID-19 vaccination.     No medical history was provided.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-Mar-2021, the patient experienced PAIN (very very achy), NASOPHARYNGITIS (very cold) and FATIGUE (very tired). On 17-Mar-2021, the patient experienced PYREXIA (fever of 101.4). At the time of the report, PAIN (very very achy), NASOPHARYNGITIS (very cold), FATIGUE (very tired) and PYREXIA (fever of 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 101.4 (High) Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Additional Information received included no new significant Information On 22-Jul-2021: Possible NNI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain lower, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain) and fatigue (felt tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included fibromyalgia and irritable bowel syndrome. Concomitant products included hydrocodone for an unknown indication (treatment medication). On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain), fatigue (felt tired) and pyrexia (fever). At the time of the report, abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain), fatigue (felt tired) and pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain) and fatigue (felt tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included fibromyalgia and irritable bowel syndrome. Concomitant products included hydrocodone for an unknown indication (treatment medication). On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain), fatigue (felt tired) and pyrexia (fever). At the time of the report, abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain), fatigue (felt tired) and pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Swelling around neck; Body aches; Swelling at injection site; Severe headache; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around neck), PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Migraine (Reported as cluster migraine  headaches..). Concurrent medical conditions included Drug allergy (Allergic to codeine.), Drug allergy (Allergic to sulfa drugs.), Allergy to nuts, Fruit allergy and Drug allergy (Patient Is allergic to any pain medicine.). Concomitant products included VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache), PYREXIA (Fever) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced SWELLING (Swelling around neck). At the time of the report, SWELLING (Swelling around neck) outcome was unknown and PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache), PYREXIA (Fever) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: postive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment medication includes steroid injection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: Swelling around neck; Body aches; Swelling at injection site; Severe headache; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around neck), PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Migraine (Reported as cluster migraine  headaches..). Concurrent medical conditions included Drug allergy (Allergic to codeine.), Drug allergy (Allergic to sulfa drugs.), Allergy to nuts, Fruit allergy and Drug allergy (Patient Is allergic to any pain medicine.). Concomitant products included VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache), PYREXIA (Fever) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced SWELLING (Swelling around neck). At the time of the report, SWELLING (Swelling around neck) outcome was unknown and PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache), PYREXIA (Fever) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: postive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment medication includes steroid injection.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Feels like going to bed; Feeling tired; Headache; Bodyache; Shaking; Nausea; Shortness of Breath; Chill; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), SOMNOLENCE (Feels like going to bed), DYSPNOEA (Shortness of Breath), CHILLS (Chill) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced TREMOR (Shaking), DYSPNOEA (Shortness of Breath), CHILLS (Chill), PYREXIA (Fever) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Bodyache). On an unknown date, the patient experienced SOMNOLENCE (Feels like going to bed) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), SOMNOLENCE (Feels like going to bed), DYSPNOEA (Shortness of Breath), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Bodyache) and FATIGUE (Feeling tired) outcome was unknown, CHILLS (Chill) had not resolved and HEADACHE (Headache) had resolved.            Concomitant medication use provided by the reporter included blood pressure medication.  Action taken with the product mRNA-1273 is not Applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence, Tremor
Clinical narrative: Feels like going to bed; Feeling tired; Headache; Bodyache; Shaking; Nausea; Shortness of Breath; Chill; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), SOMNOLENCE (Feels like going to bed), DYSPNOEA (Shortness of Breath), CHILLS (Chill) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced TREMOR (Shaking), DYSPNOEA (Shortness of Breath), CHILLS (Chill), PYREXIA (Fever) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Bodyache). On an unknown date, the patient experienced SOMNOLENCE (Feels like going to bed) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), SOMNOLENCE (Feels like going to bed), DYSPNOEA (Shortness of Breath), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Bodyache) and FATIGUE (Feeling tired) outcome was unknown, CHILLS (Chill) had not resolved and HEADACHE (Headache) had resolved.            Concomitant medication use provided by the reporter included blood pressure medication.  Action taken with the product mRNA-1273 is not Applicable.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoacusis, Sensory disturbance, Tinnitus, Vaccination site nodule
Clinical narrative: EAR RINGING; VERTIGO TYPE FEELING; FEELS LITTLE BUMP AT THE INJECTION SITE; EARS FEELS LIKE DRUM RINGING; NO FEELING IN THE ENTIRE LEFT SIDE; A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE; LEFT EAR IS HEARING EVERYTHING MUFFLED; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING) and SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE) in a 64-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 Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING), SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE), FEELING ABNORMAL (A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE) and HYPOACUSIS (LEFT EAR IS HEARING EVERYTHING MUFFLED). At the time of the report, TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING), SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE), FEELING ABNORMAL (A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE) and HYPOACUSIS (LEFT EAR IS HEARING EVERYTHING MUFFLED) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: EAR RINGING; VERTIGO TYPE FEELING; FEELS LITTLE BUMP AT THE INJECTION SITE; EARS FEELS LIKE DRUM RINGING; NO FEELING IN THE ENTIRE LEFT SIDE; A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE; LEFT EAR IS HEARING EVERYTHING MUFFLED; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING) and SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE) in a 64-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 Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING), SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE), FEELING ABNORMAL (A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE) and HYPOACUSIS (LEFT EAR IS HEARING EVERYTHING MUFFLED). At the time of the report, TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING), SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE), FEELING ABNORMAL (A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE) and HYPOACUSIS (LEFT EAR IS HEARING EVERYTHING MUFFLED) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Hypoacusis, Lymphadenopathy, Nausea
Clinical narrative: postnasal drip; trouble hearing; she has some redness; soreness; swelling of lymph nodes; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (postnasal drip), HYPOACUSIS (trouble hearing), ERYTHEMA (she has some redness), PAIN IN EXTREMITY (soreness) and LYMPHADENOPATHY (swelling of lymph nodes) in a 93-year-old female 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.     Concurrent medical conditions included Drug allergy (Loratade, but patient stated that she didn't take this medication), Thyroid disorder NOS and Blood pressure.    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 UPPER-AIRWAY COUGH SYNDROME (postnasal drip), HYPOACUSIS (trouble hearing), ERYTHEMA (she has some redness), PAIN IN EXTREMITY (soreness), LYMPHADENOPATHY (swelling of lymph nodes), NAUSEA (nausea) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN on 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, UPPER-AIRWAY COUGH SYNDROME (postnasal drip), HYPOACUSIS (trouble hearing), ERYTHEMA (she has some redness), PAIN IN EXTREMITY (soreness), LYMPHADENOPATHY (swelling of lymph nodes), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on concomitant medication for thyroid and blood pressure. 27-Feb-2021 she was advised to have Tylenol, victim and plenty of water.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: outcome updated.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Upper-airway cough syndrome
Clinical narrative: postnasal drip; trouble hearing; she has some redness; soreness; swelling of lymph nodes; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (postnasal drip), HYPOACUSIS (trouble hearing), ERYTHEMA (she has some redness), PAIN IN EXTREMITY (soreness) and LYMPHADENOPATHY (swelling of lymph nodes) in a 93-year-old female 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.     Concurrent medical conditions included Drug allergy (Loratade, but patient stated that she didn't take this medication), Thyroid disorder NOS and Blood pressure.    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 UPPER-AIRWAY COUGH SYNDROME (postnasal drip), HYPOACUSIS (trouble hearing), ERYTHEMA (she has some redness), PAIN IN EXTREMITY (soreness), LYMPHADENOPATHY (swelling of lymph nodes), NAUSEA (nausea) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN on 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, UPPER-AIRWAY COUGH SYNDROME (postnasal drip), HYPOACUSIS (trouble hearing), ERYTHEMA (she has some redness), PAIN IN EXTREMITY (soreness), LYMPHADENOPATHY (swelling of lymph nodes), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on concomitant medication for thyroid and blood pressure. 27-Feb-2021 she was advised to have Tylenol, victim and plenty of water.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: outcome updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site rash (rash on injection site, her rash became worse) and vaccination site pruritus (itching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. Concurrent medical conditions included drug hypersensitivity and allergy to antibiotic. On Feb 23, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 25, 2021, patient experienced vaccination site rash (rash on injection site, her rash became worse). On Mar 15, 2021, patient experienced vaccination site pruritus (itching). At the time of the report, vaccination site rash (rash on injection site, her rash became worse) and vaccination site pruritus (itching) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (rapid/raised heart beat) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced increased heart rate (rapid/raised heart beat). At the time of the report, increased heart rate (rapid/raised heart beat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic, Urticaria
Clinical narrative: raised rash; very itchy.; welt; Rash started out on both legs and now her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised rash), RASH PRURITIC (very itchy.), URTICARIA (welt) and RASH (Rash started out on both legs and now her arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Disability. Concomitant products included ATENOLOL, VENLAFAXINE, DILTIAZEM, MONTELUKAST, FENOFIBRATE and DROSPIRENONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH PAPULAR (raised rash), RASH PRURITIC (very itchy.), URTICARIA (welt) and RASH (Rash started out on both legs and now her arm). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (raised rash), RASH PRURITIC (very itchy.), URTICARIA (welt) and RASH (Rash started out on both legs and now her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain lower, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: abdominal bloating/it looked like she was pregnant; pain in lower abdomen, almost like vaginal area; pain in lower abdomen, almost like vaginal area; arm pain; felt tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain) and FATIGUE (felt tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Inflammatory bowel disease.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain), FATIGUE (felt tired) and PYREXIA (fever). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 14-Mar-2021, ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain), FATIGUE (felt tired) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-048119 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pain
Clinical narrative: abdominal bloating/it looked like she was pregnant; pain in lower abdomen, almost like vaginal area; pain in lower abdomen, almost like vaginal area; arm pain; felt tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain) and FATIGUE (felt tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Inflammatory bowel disease.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain), FATIGUE (felt tired) and PYREXIA (fever). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 14-Mar-2021, ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain), FATIGUE (felt tired) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-048119 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: feels like getting a cold; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feels like getting a cold) and PAIN IN EXTREMITY (sore arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN IN EXTREMITY (sore arm). On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (feels like getting a cold). At the time of the report, NASOPHARYNGITIS (feels like getting a cold) and PAIN IN EXTREMITY (sore arm) outcome was unknown. 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.   This case was linked to -MOD-2021-048100 (E2B Linked Report).; Sender's Comments:  -MOD-2021-048100:Crosslinked daughter case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm to touch; red spot occur at injection side and then it turn into big round full red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (red spot occur at injection side and then it turn into big round full red patch) 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (red spot occur at injection side and then it turn into big round full red patch). On 22-Feb-2021, VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (red spot occur at injection side and then it turn into big round full red patch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: severe Itchy throat which lasted 2 to 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (severe Itchy throat which lasted 2 to 3 hours) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for an unknown indication.     Concurrent medical conditions included Seasonal allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT IRRITATION (severe Itchy throat which lasted 2 to 3 hours). On 03-Mar-2021, THROAT IRRITATION (severe Itchy throat which lasted 2 to 3 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes antihistamines.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: clumps of hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (clumps of hair loss) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (clumps of hair loss). At the time of the report, ALOPECIA (clumps of hair loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported   No treatment medication reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Throat irritation
Clinical narrative: Burning in throat; Burning in stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Burning in throat) and DYSPEPSIA (Burning in stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 007M20A) for COVID-19 vaccination.     No medical history was provided by reporter. No concomitant medication reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced THROAT IRRITATION (Burning in throat) and DYSPEPSIA (Burning in stomach). At the time of the report, THROAT IRRITATION (Burning in throat) outcome was unknown and DYSPEPSIA (Burning in stomach) had not resolved.        No relevant concomitant medications were reported.  No treatment information was provided
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Fatigue, Gait disturbance
Clinical narrative: Unsteady on her feet; Loss of appetite; Stomach upset; sleeping a lot; Very tired; Headache; Nauseous; Severe pains throughout the body; Pain across shoulder to neck; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset) and SOMNOLENCE (sleeping a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included NITROGLYCERIN 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (Pain across shoulder to neck). On 13-Mar-2021, the patient experienced MYALGIA (Severe pains throughout the body). In March 2021, the patient experienced ILLNESS (Very sick). On 16-Mar-2021, the patient experienced NAUSEA (Nauseous). On 17-Mar-2021, the patient experienced GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), SOMNOLENCE (sleeping a lot), FATIGUE (Very tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ILLNESS (Very sick) had not resolved and GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), SOMNOLENCE (sleeping a lot), FATIGUE (Very tired), MYALGIA (Severe pains throughout the body), NAUSEA (Nauseous), ARTHRALGIA (Pain across shoulder to neck) and HEADACHE (Headache) outcome was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Nausea, Somnolence
Clinical narrative: Unsteady on her feet; Loss of appetite; Stomach upset; sleeping a lot; Very tired; Headache; Nauseous; Severe pains throughout the body; Pain across shoulder to neck; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset) and SOMNOLENCE (sleeping a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included NITROGLYCERIN 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (Pain across shoulder to neck). On 13-Mar-2021, the patient experienced MYALGIA (Severe pains throughout the body). In March 2021, the patient experienced ILLNESS (Very sick). On 16-Mar-2021, the patient experienced NAUSEA (Nauseous). On 17-Mar-2021, the patient experienced GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), SOMNOLENCE (sleeping a lot), FATIGUE (Very tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ILLNESS (Very sick) had not resolved and GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), SOMNOLENCE (sleeping a lot), FATIGUE (Very tired), MYALGIA (Severe pains throughout the body), NAUSEA (Nauseous), ARTHRALGIA (Pain across shoulder to neck) and HEADACHE (Headache) outcome was unknown.