Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor, Vocal cord dysfunction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (After 2nd dose patient felt like her heart was coming out of her body/heart is beating out of her body/her heart does not beat right), DYSPNOEA (She was having trouble breathing, She was panting), PAIN (She was aching), NEURITIS (ER said she was having a nerve attack, Her nerves keep being inflamed over and over/it is affecting her nerves) and DYSPHONIA (Got hoarse and couldn't talk) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was allergic to weed and corn. The patient's past medical history included Toxemia (toxemia in 1965 when her son was born.) in 1965, Renal function abnormal (her renal function was down to 57%) in 1965 and Flu symptoms (ran fever, had runny nose, sore throat and loss of taste and smell) in January 2021. Concurrent medical conditions included Heart disease, unspecified (There was no recent change in status such as improvement or worsening.), Grass allergy (Allergies (medications, food and other products): grass.) and Food allergy (Allergies (medications, food and other products): Corn). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced NEURITIS (ER said she was having a nerve attack, Her nerves keep being inflamed over and over/it is affecting her nerves). On an unknown date, the patient experienced PALPITATIONS (After 2nd dose patient felt like her heart was coming out of her body/heart is beating out of her body/her heart does not beat right), DYSPNOEA (She was having trouble breathing, She was panting), PAIN (She was aching), DYSPHONIA (Got hoarse and couldn't talk), PARAESTHESIA (Whole body tingles and burn, Feels like her whole body was singing or humming. She feels like she's being pricked with little needles), BURNING SENSATION (Whole body tingles and burn), TREMOR (She also shakes), LACRIMATION INCREASED (Her eyes fill up with fluid and run), CHEST DISCOMFORT (Felt like she had an elephant sitting her chest), HYPERTENSION (very high blood pressure (170-180)) and VOCAL CORD DYSFUNCTION (has affected her vocal cords). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (After 2nd dose patient felt like her heart was coming out of her body/heart is beating out of her body/her heart does not beat right), DYSPNOEA (She was having trouble breathing, She was panting), PAIN (She was aching), NEURITIS (ER said she was having a nerve attack, Her nerves keep being inflamed over and over/it is affecting her nerves), DYSPHONIA (Got hoarse and couldn't talk), PARAESTHESIA (Whole body tingles and burn, Feels like her whole body was singing or humming. She feels like she's being pricked with little needles), BURNING SENSATION (Whole body tingles and burn), TREMOR (She also shakes), LACRIMATION INCREASED (Her eyes fill up with fluid and run) and CHEST DISCOMFORT (Felt like she had an elephant sitting her chest) had not resolved and HYPERTENSION (very high blood pressure (170-180)) and VOCAL CORD DYSFUNCTION (has affected her vocal cords) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170-180 (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Prior to getting the vaccine, she also had a heart condition (she does not know exactly what it is but she mentioned that her cardiologist would know). Patient never had COVID positive test. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided by the reporter. Patient reported treatment medication as 1000 g of an unspecified antibiotic. It was unknown whether patient experienced a similar event in the past. Patient was advised by her internist to had the booster dose because of the adverse reactions she had after getting the 2nd dose of the vaccine. It was reported that patient cannot had a pacemaker because the procedure would entail going through her groin and it might affect her kidney function all the more. Patient went to the emergency room on 17-Mar-2021 for the symptoms that she experienced after getting the 2nd dose. She was still having the attacks although not as bad but she was still on medication. Patient was not known if the vaccine had done more damage to her heart but her cardiologist will be able to tell once patient visit to her every 6 month follow-up. It was reported that patient does not know but she was told that her heart does not beat right. Patient carried out all the lab data but all the results were there with her cardiologist. Patient had flu symptoms along with husband and daughter in Jan 2021, her doctor told that she had no Covid but she thought that they had Covid. Patient was not known if she had Myocarditis or pericarditis. This case was linked to MOD-2022-511499 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up received on 17 Mar 2022 contains significant follow up- Reporter information, Historical condition, Lab data, Suspect product details, Events updated.