Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Throat burning; Felt voice is hoarse; Felt like losing voice; Head pressure; Ears felt like they were popping; Worried about breathing; Pain in arm of the injection; Hotness; Itchiness; Giant mass on arm; Twitching and tingling; Spasms in right arm; Much heavier bleeding and blood clots during menstrual cycle; Tightness in chest; Hives on lower abdomen; Chest pain; Rash; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (Throat burning), DYSPHONIA (Felt voice is hoarse), APHONIA (Felt like losing voice), HEAD DISCOMFORT (Head pressure) and EAR DISCOMFORT (Ears felt like they were popping) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced THROAT IRRITATION (Throat burning), DYSPHONIA (Felt voice is hoarse), APHONIA (Felt like losing voice), HEAD DISCOMFORT (Head pressure), EAR DISCOMFORT (Ears felt like they were popping), DYSPNOEA (Worried about breathing), VACCINATION SITE PAIN (Pain in arm of the injection), VACCINATION SITE WARMTH (Hotness), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE MASS (Giant mass on arm), MUSCLE TWITCHING (Twitching and tingling), MUSCLE SPASMS (Spasms in right arm), HEAVY MENSTRUAL BLEEDING (Much heavier bleeding and blood clots during menstrual cycle), CHEST DISCOMFORT (Tightness in chest), URTICARIA (Hives on lower abdomen), CHEST PAIN (Chest pain), RASH (Rash) and NAUSEA (Nausea). At the time of the report, THROAT IRRITATION (Throat burning), DYSPHONIA (Felt voice is hoarse), APHONIA (Felt like losing voice), HEAD DISCOMFORT (Head pressure), EAR DISCOMFORT (Ears felt like they were popping), DYSPNOEA (Worried about breathing), VACCINATION SITE PAIN (Pain in arm of the injection), VACCINATION SITE WARMTH (Hotness), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE MASS (Giant mass on arm), MUSCLE TWITCHING (Twitching and tingling), MUSCLE SPASMS (Spasms in right arm), HEAVY MENSTRUAL BLEEDING (Much heavier bleeding and blood clots during menstrual cycle), CHEST DISCOMFORT (Tightness in chest), URTICARIA (Hives on lower abdomen), CHEST PAIN (Chest pain), RASH (Rash) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment details were provided.  The experiencing throat burning , felt voice is hoarse, losing voice, head pressure, ears felt like popping, trouble breathing, no hx of anaphylaxis, pain in arm of the injection, hot and itchy, twitching, muscle spams, huge flare up lasting 14 days, hives on different sites of the body, giant mass on arm, rash, chest pain and tightness, nausea and much heavier bleeding and blood clots during menstrual cycle. Patient felt like she experienced an anaphylactic shock. The patient wanted to know what to do about the symptoms. Patient reached out to her allergist, OBGYN and primary care. Patient does not want to provide information about HCP. The patient reported that it took her 2 to 3 weeks to recover. The patient had not been able to find out information from her HCP and wanted to know what the side effects are and if she should take the second dose.  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.