Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Ear disorder, Epistaxis, Fatigue, Feeling hot
Clinical narrative: short of breath; tension went up/tension was high; blurred vision; drowning in the ear; blood pressure was very high; COVID-19; allergic reaction; Fatigue/tiredness; Joint pain; dizziness/Dizziness; headache/Headaches; Feeling hot; got really sick; Nasal congestion; blood came from my nose/Nose bleeds; I could not stand up for 4 days/couldn't stand up; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), TENSION (tension went up/tension was high), VISION BLURRED (blurred vision), EAR DISORDER (drowning in the ear) and EPISTAXIS (blood came from my nose/Nose bleeds) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy and Nasal congestion. Concomitant products included LORATADINE for Nasal congestion.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced EPISTAXIS (blood came from my nose/Nose bleeds), DYSSTASIA (I could not stand up for 4 days/couldn't stand up), FEELING HOT (Feeling hot), ILLNESS (got really sick), NASAL CONGESTION (Nasal congestion), DIZZINESS (dizziness/Dizziness), HEADACHE (headache/Headaches), FATIGUE (Fatigue/tiredness) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced DYSPNOEA (short of breath), TENSION (tension went up/tension was high), VISION BLURRED (blurred vision), EAR DISORDER (drowning in the ear), HYPERTENSION (blood pressure was very high), COVID-19 (COVID-19) and HYPERSENSITIVITY (allergic reaction). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and NAPROXEN at a dose of naproxen 500. At the time of the report, DYSPNOEA (short of breath), TENSION (tension went up/tension was high), VISION BLURRED (blurred vision), EAR DISORDER (drowning in the ear), EPISTAXIS (blood came from my nose/Nose bleeds), DYSSTASIA (I could not stand up for 4 days/couldn't stand up), HYPERTENSION (blood pressure was very high), FEELING HOT (Feeling hot), ILLNESS (got really sick), NASAL CONGESTION (Nasal congestion), COVID-19 (COVID-19), DIZZINESS (dizziness/Dizziness), HEADACHE (headache/Headaches), HYPERSENSITIVITY (allergic reaction), FATIGUE (Fatigue/tiredness) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: high (High) high. On an unknown date, Blood pressure measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient got COVID on Jan (unspecified). The patient wanted to receive the 2nd dose patient's blood pressure was high. After some time her health care professional advised her to take the 2nd dose since her blood pressure was normal but refused because of fear. The patient had applied the first dose of the vaccine and had an allergic reaction where was short of breath and the tension, had dizziness, blurred vision, drowning in the ear, blood came from nose, headache, could not stop for 4 days. The tension lasted high until the second dose. But since blood pressure was very high, they didn't apply it. The patient went to the doctor and told it was normal.  Company comment: This case concerns a 45-year-old female patient who experienced non-serious unexpected COVID-19 in an unknown temporal relationship to administration of the first dose of mRNA-1273. The patient also experienced numerous non-serious events. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow up information received: New events: (Feeling hot, High blood pressure, sickness, fatigue, Nasal congestion, Covid-19 were added.Concomitant and treatment medications added and narrative updated.; Sender's Comments: This case concerns a 45-year-old female patient who experienced non-serious unexpected COVID-19 in an unknown temporal relationship to administration of the first dose of mRNA-1273. The patient also experienced numerous non-serious events. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.