Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: non-specific report of vaccination site reaction; Intercostal muscle pain; limitation of movement side to side; Numbness; Abdominal cramping; feeling hot; Use of respiratory accessory muscles; difficulty breathing; intervertibral muscle pain; Light Nausea; Day 42 following her 1st dose; Hypersensitivity reaction; unable to bend or twist/couldn't sit to use the bathroom; could not live with that kind of pain/excruciating pain; chest crushing; Back pain; Painful black knot at the site of injection; Painful black knot at the site of injection; Fatigue; Large hematoma; Difficulty rising from sitting position without aid/non functional; tightness/Chest tightness; excruciating chest pains; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (chest crushing), BACK PAIN (Back pain), VACCINATION SITE REACTION (non-specific report of vaccination site reaction), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty rising from sitting position without aid/non functional) and CHEST DISCOMFORT (tightness/Chest tightness) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve replacement in 2013. Concurrent medical conditions included Drug allergy and Hypothyroidism since 1970. Concomitant products included LEVOTHYROXINE from 30-Jun-1970 to an unknown date for Hypothyroidism, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) from 10-Sep-2005 to an unknown date for Macular degeneration, ACETYLSALICYLIC ACID (ECOTRIN 650) from 02-Aug-2013 to an unknown date and COLECALCIFEROL (VITAMIN D3 1000) from 04-Jan-2019 to an unknown date for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HAEMATOMA (Large hematoma). On 10-Apr-2021, the patient experienced CHEST PAIN (chest crushing) and BACK PAIN (Back pain). 10-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Painful black knot at the site of injection), VACCINATION SITE PAIN (Painful black knot at the site of injection) and FATIGUE (Fatigue). On 11-Apr-2021, the patient experienced PAIN (could not live with that kind of pain/excruciating pain) and MOBILITY DECREASED (unable to bend or twist/couldn't sit to use the bathroom). 11-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). In April 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty rising from sitting position without aid/non functional), CHEST DISCOMFORT (tightness/Chest tightness) and CHEST PAIN (excruciating chest pains). On 19-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Day 42 following her 1st dose). On an unknown date, the patient experienced VACCINATION SITE REACTION (non-specific report of vaccination site reaction), MYALGIA INTERCOSTAL (Intercostal muscle pain), HYPOKINESIA (limitation of movement side to side), DYSPNOEA (difficulty breathing), HYPOAESTHESIA (Numbness), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (feeling hot), USE OF ACCESSORY RESPIRATORY MUSCLES (Use of respiratory accessory muscles), MYALGIA (intervertibral muscle pain) and NAUSEA (Light Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and ALPRAZOLAM (XANAX) at an unspecified dose and frequency. In April 2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty rising from sitting position without aid/non functional), CHEST DISCOMFORT (tightness/Chest tightness) and CHEST PAIN (excruciating chest pains) had not resolved. On 27-Apr-2021, CHEST PAIN (chest crushing), BACK PAIN (Back pain), PAIN (could not live with that kind of pain/excruciating pain) and MOBILITY DECREASED (unable to bend or twist/couldn't sit to use the bathroom) had resolved. On 07-May-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. On 18-May-2021, HAEMATOMA (Large hematoma) had resolved. At the time of the report, VACCINATION SITE REACTION (non-specific report of vaccination site reaction), DYSPNOEA (difficulty breathing), INTENTIONAL PRODUCT USE ISSUE (Day 42 following her 1st dose), HYPOAESTHESIA (Numbness), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (feeling hot) and USE OF ACCESSORY RESPIRATORY MUSCLES (Use of respiratory accessory muscles) outcome was unknown, MYALGIA INTERCOSTAL (Intercostal muscle pain), HYPOKINESIA (limitation of movement side to side), MYALGIA (intervertibral muscle pain) and NAUSEA (Light Nausea) had not resolved and VACCINATION SITE INDURATION (Painful black knot at the site of injection), VACCINATION SITE PAIN (Painful black knot at the site of injection) and FATIGUE (Fatigue) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: patient demographics were added , vaccine facility information were added , events were added, for conmeds dose ,units were added and date is updated, for vaccine route were added.