Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oral discomfort, Pain in extremity, Pyrexia, Rhinalgia
Clinical narrative: Heart/Kidneys/PituitaryBrain Tumor/Trigeminal Neuralgia are all activated even worse; Still feel very bad and just so foggy; Trigeminal Neuralgia; Sever leg injury; Face pain, on her bridge nose like a big sore on her whole face is on fire and suffered for the whole weekend; shingles; bradycardia; Spasm like a grape size on her left neck and its scaring her/whole leg spasm; TH3, TH4 and, pituitary is messed up; legs are in pain for 24/7; tachycardia; headache; lump on her legs and neck; Face Burning; Sore spot inside nose; Burning Lip; terrible viral infection; Fever-104 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (bradycardia) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified, Cardiac arrest in April 2020, Pneumonia and Device implant NOS in June 2020. Concurrent medical conditions included Trigeminal nerve disorder, Chronic kidney disease, Brain tumor, Migraine headache and Dementia. Concomitant products included MULTI VITAMIN & MINERAL, PROPRANOLOL, OMEPRAZOLE, DIAZEPAM (VALIUM), CARBAMAZEPINE and ESTRADIOL for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VIRAL INFECTION (terrible viral infection). 22-Feb-2021, the patient experienced PYREXIA (Fever-104 degrees Fahrenheit). On 23-Feb-2021, the patient experienced BURNING SENSATION (Face Burning), NASAL DISCOMFORT (Sore spot inside nose) and ORAL DISCOMFORT (Burning Lip). On 12-Mar-2021, the patient experienced INDURATION (lump on her legs and neck). On 12-May-2021, the patient experienced BRADYCARDIA (bradycardia) (seriousness criterion medically significant), HERPES ZOSTER (shingles), MUSCLE SPASMS (Spasm like a grape size on her left neck and its scaring her/whole leg spasm), HORMONE LEVEL ABNORMAL (TH3, TH4 and, pituitary is messed up), PAIN IN EXTREMITY (legs are in pain for 24/7), TACHYCARDIA (tachycardia) and HEADACHE (headache). On an unknown date, the patient experienced CONDITION AGGRAVATED (Heart/Kidneys/PituitaryBrain Tumor/Trigeminal Neuralgia are all activated even worse), FEELING ABNORMAL (Still feel very bad and just so foggy), TRIGEMINAL NEURALGIA (Trigeminal Neuralgia), LIMB INJURY (Sever leg injury) and FACIAL PAIN (Face pain, on her bridge nose like a big sore on her whole face is on fire and suffered for the whole weekend). The patient was treated with ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for Adverse event, at a dose of 800 mg. At the time of the report, BRADYCARDIA (bradycardia), NASAL DISCOMFORT (Sore spot inside nose), ORAL DISCOMFORT (Burning Lip), CONDITION AGGRAVATED (Heart/Kidneys/PituitaryBrain Tumor/Trigeminal Neuralgia are all activated even worse), HERPES ZOSTER (shingles), INDURATION (lump on her legs and neck), MUSCLE SPASMS (Spasm like a grape size on her left neck and its scaring her/whole leg spasm), HORMONE LEVEL ABNORMAL (TH3, TH4 and, pituitary is messed up), PAIN IN EXTREMITY (legs are in pain for 24/7), TACHYCARDIA (tachycardia) and HEADACHE (headache) outcome was unknown, BURNING SENSATION (Face Burning), TRIGEMINAL NEURALGIA (Trigeminal Neuralgia) and FACIAL PAIN (Face pain, on her bridge nose like a big sore on her whole face is on fire and suffered for the whole weekend) had resolved, VIRAL INFECTION (terrible viral infection), LIMB INJURY (Sever leg injury) and PYREXIA (Fever-104 degrees Fahrenheit) was resolving and FEELING ABNORMAL (Still feel very bad and just so foggy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported additional side effects that had occurred after the 2nd Moderna vaccine:  shingles, fever: 104 degrees Fahrenheit, terrible viral infection. Those injury were completely gone like normal on Thursday and came back. A  lump on her legs and neck, spasm like a grape size on her left neck and its scaring her, headache, on her bridge nose like a big sore on her whole face is on fire and suffered for the whole weekend. TH3, TH4 and, pituitary is messed up, legs are in pain for 24/7, whole leg spasm, tachycardia, bradycardia pituitary tumor was activated, kidney failure and dementia is really bad now. The patient is with seasonal allergy and also reported that she had COVID possibly, but was not tested for it.   This case was linked to US-MODERNATX, INC.-MOD-2021-057199 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant Follow Up case reported additional events On 13-May-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field On 11-Aug-2021: Follow-up information received on 11-Aug-2021 contains non-significant information.; 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. US-MODERNATX, INC.-MOD-2021-057199:crosslinked