Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Neuralgia, Pain in extremity
Clinical narrative: heaviness/tightness in my chest; pain in her lower extremities; extreme fatigue; tightness in throat area; Chest pain; Nerve pain/ felt more like heaviness or tightness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (heaviness/tightness in my chest), PAIN IN EXTREMITY (pain in her lower extremities) and FATIGUE (extreme fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and C36A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy partial in 1984. Concurrent medical conditions included Asthma since 1987, Blood pressure high since 2021 and Allergy. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, METOPROLOL for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy partial, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for an unknown indication.   On 09-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced THROAT TIGHTNESS (tightness in throat area), CHEST PAIN (Chest pain) and NEURALGIA (Nerve pain/ felt more like heaviness or tightness). On 20-Apr-2021, the patient experienced CHEST DISCOMFORT (heaviness/tightness in my chest) (seriousness criterion hospitalization), PAIN IN EXTREMITY (pain in her lower extremities) (seriousness criterion hospitalization) and FATIGUE (extreme fatigue) (seriousness criterion hospitalization). The patient was hospitalized on 11-Jun-2021 due to CHEST DISCOMFORT, FATIGUE and PAIN IN EXTREMITY. At the time of the report, CHEST DISCOMFORT (heaviness/tightness in my chest) and THROAT TIGHTNESS (tightness in throat area) had not resolved and PAIN IN EXTREMITY (pain in her lower extremities), FATIGUE (extreme fatigue), CHEST PAIN (Chest pain) and NEURALGIA (Nerve pain/ felt more like heaviness or tightness) had resolved.            No concomitant medications was provided by the reporter.  No treatment was provided by the reporter.  Patient was taken Shingles vaccine  of two dose respectively on 21-OCT-2020 and 08-FEB-2021.  Company Comment: This case concerns a 70 year old female patient with medical history of asthma and hypertension who experienced serious unexpected events of chest discomfort, pain in extremity and fatigue after second dose of mRNA-1273. The events occurred 15 days after second dose of mRNA-1273. The re-challenge is not applicable since the patient experienced AEs after second dose. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Followup information received which contains significant information: seriousness upgraded from non serious to serious (hospitalization), patient's demographics,medical history, suspect drug details (anatomical location),concomitant medications updated and narrative updated.; Sender's Comments: This case concerns a 70 year old female patient with medical history of asthma and hypertension who experienced serious unexpected events of chest discomfort, pain in extremity and fatigue after second dose of mRNA-1273. The events occurred 15 days after second dose of mRNA-1273. The re-challenge is not applicable since the patient experienced AEs after second dose. The benefit-risk relationship of Spikevax in not affected by this report.