Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vulvovaginal mycotic infection
Clinical narrative: vaginal yeast infection; diarrhea; condition worsened; nausea; fever; chills; aches; fatigue; headache; delayed cutaneous hypersensitivity; deep bruising; felt suddenly faint at about 10 minutes post vaccine; oral numbness beginning 5 minutes shot; back of throat numbness, by 10min; lips tingling; facial tingling cheeks and nose) about 15 minutes; arm soreness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt suddenly faint at about 10 minutes post vaccine), HYPOAESTHESIA ORAL (oral numbness beginning 5 minutes shot), VULVOVAGINAL MYCOTIC INFECTION (vaginal yeast infection), PHARYNGEAL HYPOAESTHESIA (back of throat numbness, by 10min) and PARAESTHESIA ORAL (lips tingling) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Codeine,severe reaction,uncontrolled vomiting for 24-72 hours post exposure), Drug allergy (Allergy to tramadol, severe reaction,uncontrolled vomiting for 24-72 hours post exposure) and Drug allergy (Allergy to morphine, derivatives or compound: severe reaction,uncontrolled vomiting for 24-72 hours).   On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced DIZZINESS (felt suddenly faint at about 10 minutes post vaccine), HYPOAESTHESIA ORAL (oral numbness beginning 5 minutes shot), PHARYNGEAL HYPOAESTHESIA (back of throat numbness, by 10min), PARAESTHESIA ORAL (lips tingling), PARAESTHESIA (facial tingling cheeks and nose) about 15 minutes), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (injection site redness). On 07-Apr-2021, the patient experienced DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity) and VACCINATION SITE BRUISING (deep bruising). On an unknown date, the patient experienced VULVOVAGINAL MYCOTIC INFECTION (vaginal yeast infection), DIARRHOEA (diarrhea), CONDITION AGGRAVATED (condition worsened), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills), MYALGIA (aches), FATIGUE (fatigue) and HEADACHE (headache). On 04-Apr-2021, DIZZINESS (felt suddenly faint at about 10 minutes post vaccine) had resolved. At the time of the report, HYPOAESTHESIA ORAL (oral numbness beginning 5 minutes shot), VULVOVAGINAL MYCOTIC INFECTION (vaginal yeast infection), PHARYNGEAL HYPOAESTHESIA (back of throat numbness, by 10min), PARAESTHESIA ORAL (lips tingling), PARAESTHESIA (facial tingling cheeks and nose) about 15 minutes), DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), VACCINATION SITE BRUISING (deep bruising), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (arm soreness), VACCINATION SITE ERYTHEMA (injection site redness), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills), MYALGIA (aches), FATIGUE (fatigue) and HEADACHE (headache) was resolving.            After the second vaccination, the patient let them know she would be staying for an hour for observation, and they collectively kept an eye on her back in the pharmacy area. She let them know about the numbness but also let them know that her breathing was not becoming compromised.  The patient did not seek additional medical attention post second vaccine since her breathing did not become obstructed.  The patient stated "Other side effects gradually diminished, or I was able to treat at home with otc meds." Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current Available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-038253 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Narrative updated: outcomes of several events updated to recovering/resolving. On 03-May-2021: Follow-up received on 03 May 2021 included no new information; Sender's Comments: Based on the current Available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-038253:1st dose