chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Headache, Oropharyngeal discomfort
Clinical narrative: couldn't move her arm; Joint pain; chills; Fever came fast and gone away fast; really dry mouth; fall feeling throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), DRY MOUTH (really dry mouth), OROPHARYNGEAL DISCOMFORT (fall feeling throat), HEADACHE (headache) and ARTHRALGIA (Joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease since 2000.    On 27-Jan-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (headache). On 27-Jan-2021 at 5:50 PM, the patient experienced DRY MOUTH (really dry mouth) and OROPHARYNGEAL DISCOMFORT (fall feeling throat). On 28-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), ARTHRALGIA (Joint pain), CHILLS (chills) and PYREXIA (Fever came fast and gone away fast). On 27-Jan-2021 at 8:30 PM, DRY MOUTH (really dry mouth) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), OROPHARYNGEAL DISCOMFORT (fall feeling throat) and CHILLS (chills) outcome was unknown, HEADACHE (headache) and ARTHRALGIA (Joint pain) had not resolved and PYREXIA (Fever came fast and gone away fast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medications were not reported.    Treatment for the events included Aspirin next day of the shot on 28 Jan 2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site movement impairment
Clinical narrative: couldn't move her arm; Joint pain; chills; Fever came fast and gone away fast; really dry mouth; fall feeling throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), DRY MOUTH (really dry mouth), OROPHARYNGEAL DISCOMFORT (fall feeling throat), HEADACHE (headache) and ARTHRALGIA (Joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease since 2000.    On 27-Jan-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (headache). On 27-Jan-2021 at 5:50 PM, the patient experienced DRY MOUTH (really dry mouth) and OROPHARYNGEAL DISCOMFORT (fall feeling throat). On 28-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), ARTHRALGIA (Joint pain), CHILLS (chills) and PYREXIA (Fever came fast and gone away fast). On 27-Jan-2021 at 8:30 PM, DRY MOUTH (really dry mouth) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), OROPHARYNGEAL DISCOMFORT (fall feeling throat) and CHILLS (chills) outcome was unknown, HEADACHE (headache) and ARTHRALGIA (Joint pain) had not resolved and PYREXIA (Fever came fast and gone away fast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medications were not reported.    Treatment for the events included Aspirin next day of the shot on 28 Jan 2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: Got the first dose of Moderna vaccine while 19 weeks Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got the first dose of Moderna vaccine while 19 weeks Pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation.    On 01-Feb-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 28-Sep-2020 and the estimated date of delivery was 28-Jun-2021. On 05-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got the first dose of Moderna vaccine while 19 weeks Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 05-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got the first dose of Moderna vaccine while 19 weeks Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Ultrasound antenatal screen normal: normal (normal) Patient is in second trimester & 20 weeks pregnant at the time of reporting..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Exposure via breast milk, Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: throat feels kind of swollen; tongue felt numb and strange when first got it; no trouble breathing; chest feels like esophagus might have swollen; currently breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (no trouble breathing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (no trouble breathing). On 04-Feb-2021, DYSPNOEA (no trouble breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches have been gradual and very intense; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches have been gradual and very intense) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Headaches have been gradual and very intense). At the time of the report, HEADACHE (Headaches have been gradual and very intense) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol and Advil as treatment.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Red, circular /defined borders about 3.5 inches in width and 2.5 in length; Pain around my deltoid; Traveling to my shoulder and scapula; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red, circular /defined borders about 3.5 inches in width and 2.5 in length), VACCINATION SITE PAIN (Pain around my deltoid) and ARTHRALGIA (Traveling to my shoulder and scapula) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Allergy to antibiotic (Allergic to Doxycycline) and Allergy to antibiotic (Allergic to Bactrim).    On 08-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, circular /defined borders about 3.5 inches in width and 2.5 in length), VACCINATION SITE PAIN (Pain around my deltoid) and ARTHRALGIA (Traveling to my shoulder and scapula). At the time of the report, VACCINATION SITE ERYTHEMA (Red, circular /defined borders about 3.5 inches in width and 2.5 in length), VACCINATION SITE PAIN (Pain around my deltoid) and ARTHRALGIA (Traveling to my shoulder and scapula) had not resolved. Not Provided          Concomitant product use included biologics.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: arm pain, tenderness on the arm area, soreness; underneath the injection site there was a slight red area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain, tenderness on the arm area, soreness) and VACCINATION SITE ERYTHEMA (underneath the injection site there was a slight red area) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L50A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain, tenderness on the arm area, soreness) and VACCINATION SITE ERYTHEMA (underneath the injection site there was a slight red area). At the time of the report, VACCINATION SITE PAIN (arm pain, tenderness on the arm area, soreness) and VACCINATION SITE ERYTHEMA (underneath the injection site there was a slight red area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: soreness; warmness; redness around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE WARMTH (warmness) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 75-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) , while the parent received the product for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant product exposures included LEVOTHYROXINE, ATORVASTIN (ATORVASTATIN), BETAXOLOL, HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication.    On 11-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the elderly was diagnosed with VACCINATION SITE PAIN (soreness), VACCINATION SITE WARMTH (warmness) and VACCINATION SITE ERYTHEMA (redness around the injection site). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, VACCINATION SITE PAIN (soreness), VACCINATION SITE WARMTH (warmness) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic, Vaccination site rash
Clinical narrative: rash on the sides of the injectio site; rash itch; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 10-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs provided. In general, she takes medication for her blood pressure and cholesterol, a daily baby aspirin and a water pill. 22Jan2021
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; body temperature; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (body temperature) and PAIN (body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-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 CHILLS (chills), PYREXIA (body temperature) and PAIN (body aches). At the time of the report, CHILLS (chills), PYREXIA (body temperature) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications are provided. No treatment.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: scratched at rash that came back; itchiness inside of hands, leg, arm and thigh; A Spontaneous report was received from consumer concerning a 82-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced itching on right leg, right arm, right thigh and scratched at rash.  The patient's medical history and concomitant medications are unknown.  On 18 JAN 2021, the patient received their first dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the left arm for prophylaxis of COVID-19 infection and on 20 JAN 2021 and started to feel symptoms the night like felt itchiness inside of hands for 45mins and on 21 JAN 2021 itching on right leg, right arm, right thigh and symptoms went away at the afternoon of 21JAN2021. At night of 21JAN2021 consumer scratched at rash that came back After 15 mins rash went away  No laboratory tests were provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events are Resolved/Recovered.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Urticaria
Clinical narrative: dark red rash, itchy; urticaria; dark red rash, itchy; dark red rash, itchy; A spontaneous report was received from a healthcare facility staff member concerning a patient (age and gender unknown) who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urticaria, itching at the injection site/injection site pruritus, and dark red rash at the injection site/injection site rash/injection site erythema.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On an unknown date, approximately one week prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced urticaria and developed an itchy, dark red rash at the injection site approximately one week after receiving vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events urticaria, itching at the injection site, and dark red rash at the injection site were not reported.  Reporter causality for the events was not provided.; Sender's Comments:  MOD-2021-011289:same reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-May-2020 and the estimated date of delivery was 21-Feb-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.  The patient had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Lymphadenopathy, Vaccination site erythema, Vaccination site mass, Vaccination site reaction
Clinical narrative: arm is red at injection site; Arm is swollen at injection site; Little bump; big circle at injection site; hot; Swollen lymph nodes on left side of under armpit and neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site) and FEELING HOT (hot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and BACITRACIN, POLYMYXIN B SULFATE (ANTIBIOTIC [BACITRACIN;POLYMYXIN B SULFATE]) for an unknown indication.    On 09-Jan-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site), FEELING HOT (hot) and LYMPHADENOPATHY (Swollen lymph nodes on left side of under armpit and neck). At the time of the report, VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site), FEELING HOT (hot) and LYMPHADENOPATHY (Swollen lymph nodes on left side of under armpit and neck) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arm is red at injection site; Arm is swollen at injection site; Little bump; big circle at injection site; hot; Swollen lymph nodes on left side of under armpit and neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site) and FEELING HOT (hot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and BACITRACIN, POLYMYXIN B SULFATE (ANTIBIOTIC [BACITRACIN;POLYMYXIN B SULFATE]) for an unknown indication.    On 09-Jan-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site), FEELING HOT (hot) and LYMPHADENOPATHY (Swollen lymph nodes on left side of under armpit and neck). At the time of the report, VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site), FEELING HOT (hot) and LYMPHADENOPATHY (Swollen lymph nodes on left side of under armpit and neck) 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: joint pain; rash; red; swollen; mild arm pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild arm pain near the injection site), ARTHRALGIA (joint pain), VACCINATION SITE RASH (rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033620A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild arm pain near the injection site). On 19-Jan-2021, the patient experienced ARTHRALGIA (joint pain), VACCINATION SITE RASH (rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). On 22-Jan-2021, VACCINATION SITE PAIN (mild arm pain near the injection site), ARTHRALGIA (joint pain), VACCINATION SITE RASH (rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) was resolving. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness; swelling; severe itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (severe itching) 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 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 VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (severe itching). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (severe itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.     Treatment details was not provided.  Event outcome was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fatigue, Headache, Influenza
Clinical narrative: injection site redness; injection site swelling; injection site itching; Injection site which is bruised; Nauseous; Headaches; Fatigue; Diarrhea; Rash on stomach, back , hip, and thigh; Slept for 3 days; Low grade fever; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction).   The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Influenza: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, Skin reaction, Somnolence
Clinical narrative: injection site redness; injection site swelling; injection site itching; Injection site which is bruised; Nauseous; Headaches; Fatigue; Diarrhea; Rash on stomach, back , hip, and thigh; Slept for 3 days; Low grade fever; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction).   The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Influenza: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness; injection site swelling; injection site itching; Injection site which is bruised; Nauseous; Headaches; Fatigue; Diarrhea; Rash on stomach, back , hip, and thigh; Slept for 3 days; Low grade fever; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction).   The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Influenza: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant product use was not provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; Intense body pain; back pain is sharp and burning, from the back of shoulder blades; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MYALGIA (Intense body pain) and ARTHRALGIA (back pain is sharp and burning, from the back of shoulder blades) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), MYALGIA (Intense body pain) and ARTHRALGIA (back pain is sharp and burning, from the back of shoulder blades). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MYALGIA (Intense body pain) and ARTHRALGIA (back pain is sharp and burning, from the back of shoulder blades) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No specific follow-up information recorded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Ultrasound foetal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Knee pain (Right knee pain Knee injection during pregnancy in NOV2020; PrP; no changes) since 2012, Low back pain (No changes) since 2010 and Obesity since 2010. Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Heartburn, PARACETAMOL (TYLENOL) for Knee pain, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, ALUMINIUM CHLORIDE (DRYSOL).    On 03-Feb-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Ultrasound foetal: normal (normal) Fetal anatomy ultrasound was normal. On 13-Jan-2021, Glucose tolerance test: normal (normal) 3 hour glucose tolerance test. On 15-Sep-2021, Ultrasound foetal: normal (normal) Fetal anatomy ultrasound was normal.     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 provided. Patient had history of subfertility with details as follows: No conception after 10 months of trying. HSG (hysterosalpingogram) was performed in JUN2020. No medications needed for conception.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site pain
Clinical narrative: chills; arm  hurts; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (body aches) 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 24-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). At the time of the report, CHILLS (chills) and MYALGIA (body aches) had not resolved. Not Provided          No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Mild arm soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild arm soreness). At the time of the report, VACCINATION SITE PAIN (Mild arm soreness) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Muscle pain in the scapula; Feeling a little fatigue; Shoulder joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling a little fatigue), ARTHRALGIA (Shoulder joint pain) and MYALGIA (Muscle pain in the scapula) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (Feeling a little fatigue) and ARTHRALGIA (Shoulder joint pain). On 18-Jan-2021, the patient experienced MYALGIA (Muscle pain in the scapula). On 17-Jan-2021, FATIGUE (Feeling a little fatigue) had resolved. On 18-Jan-2021, ARTHRALGIA (Shoulder joint pain) had resolved. At the time of the report, MYALGIA (Muscle pain in the scapula) outcome was unknown. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm was Itching; Red around site; Sore for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm was Itching), VACCINATION SITE ERYTHEMA (Red around site) and VACCINATION SITE PAIN (Sore for a couple days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-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 VACCINATION SITE PRURITUS (Arm was Itching), VACCINATION SITE ERYTHEMA (Red around site) and VACCINATION SITE PAIN (Sore for a couple days). At the time of the report, VACCINATION SITE PRURITUS (Arm was Itching), VACCINATION SITE ERYTHEMA (Red around site) and VACCINATION SITE PAIN (Sore for a couple days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It's a little bit warm to the touch; it itches but not painful; Swelling of about 3 inches long at the injection site; hard swelling of about 3 inches long on the COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's a little bit warm to the touch), VACCINATION SITE INDURATION (hard swelling of about 3 inches long on the COVID arm), VACCINATION SITE PRURITUS (it itches but not painful) and VACCINATION SITE SWELLING (Swelling of about 3 inches long at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol total abnormal NOS and Blood triglycerides abnormal. Concomitant products included VALSARTAN and AMLODIPINE for Blood pressure high, PRAVASTATIN for Cholesterol, FENOFIBRATE for Triglycerides abnormal.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard swelling of about 3 inches long on the COVID arm) and VACCINATION SITE SWELLING (Swelling of about 3 inches long at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's a little bit warm to the touch) and VACCINATION SITE PRURITUS (it itches but not painful). On 28-Jan-2021, VACCINATION SITE INDURATION (hard swelling of about 3 inches long on the COVID arm) and VACCINATION SITE SWELLING (Swelling of about 3 inches long at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's a little bit warm to the touch) and VACCINATION SITE PRURITUS (it itches but not painful) 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.   Patient used ice pack as a corrective for swelling.   This case was linked to MOD-2021-214969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event outcome updated. On 09-Jun-2021: Dosing and event details updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Middle ear effusion, Nausea, Vertigo
Clinical narrative: she got her menstrual period which she has not had in 2 1/2 years; headache; fluid in her ear was cloudy; nausea; extreme vertigo; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (she got her menstrual period which she has not had in 2 1/2 years), VERTIGO (extreme vertigo), MIDDLE EAR EFFUSION (fluid in her ear was cloudy), HEADACHE (headache) and NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included AFib. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VERTIGO (extreme vertigo) and NAUSEA (nausea). On 07-Feb-2021, the patient experienced MIDDLE EAR EFFUSION (fluid in her ear was cloudy). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (she got her menstrual period which she has not had in 2 1/2 years) and HEADACHE (headache). At the time of the report, MENSTRUATION IRREGULAR (she got her menstrual period which she has not had in 2 1/2 years), VERTIGO (extreme vertigo), MIDDLE EAR EFFUSION (fluid in her ear was cloudy), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-013852 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on their neck; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on their neck) in a female patient of an unknown age 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node on their neck). At the time of the report, LYMPHADENOPATHY (swollen lymph node on their neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not received any treatment medications.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.