Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes), BURNING SENSATION (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Mild fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (Allergy to Amoxicillin), Latex allergy, Cosmetic allergy (Allergic to Cosmetic items) and Blood pressure high since 2008. Concomitant products included LISINOPRIL for Blood pressure high, VITAMIN D [VITAMIN D NOS] for Supplementation therapy. On 27-Apr-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021 at 1:15 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine was received by patient after 42 days from first dose administration). On 08-Jun-2021 at 3:05 PM, the patient experienced ABDOMINAL DISCOMFORT (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes) and BURNING SENSATION (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes). In 2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain), PYREXIA (Mild fever) and FATIGUE (Tiredness). On 08-Jun-2021 at 1:15 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine was received by patient after 42 days from first dose administration) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes) and BURNING SENSATION (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes) had not resolved and VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain), PYREXIA (Mild fever) and FATIGUE (Tiredness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL DISCOMFORT (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes) and BURNING SENSATION (Burning sensation within minutes of injection starting in stomach and abdomen through the back and down both legs and toes) to be related. No further causality assessments were provided for VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain), PYREXIA (Mild fever), FATIGUE (Tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine was received by patient after 42 days from first dose administration). No treatment medication was provided by the reporter. The patient had never been diagnosed or tested positive for COVID-19. This case was linked to MOD-2021-106680, MOD-2022-452274 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow up received, No New Information updated. On 21-Jan-2022: Significant follow up information included updated patient demographic details and new events added (burning sensation in abdomen and burning sensation in legs).