Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site reaction
Clinical narrative: Delayed local reaction; warm; Swollen from arm to fingertips; Painfull arm; Itching; Redness/ Area around site became reddened gradually worsened; lymphadenopathy; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Delayed local reaction), SKIN WARM (warm), PERIPHERAL SWELLING (Swollen from arm to fingertips), PAIN IN EXTREMITY (Painfull arm) and PRURITUS (Itching) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Osteoarthritis, Drug allergy (Valsartan), Drug allergy (Amlodipine), Drug allergy (Normodyne), Allergy to antibiotic (Erythromycin), Allergy to antibiotic (Cipro), Allergy to antibiotic (Amoxicillin), Allergy to antibiotic (Flagyl), Allergy to antibiotic (Besivance), Allergy to antibiotic (Achromycin), Allergy to antibiotic (Keflex), Allergy to antibiotic (Clindamycin), Allergy to antibiotic (Floxin), Drug allergy (Tramadol) and Drug allergy (Codeine). Concomitant products included TRIAMTERENE, METOPROLOL and MELOXICAM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE REACTION (Delayed local reaction), SKIN WARM (warm), PERIPHERAL SWELLING (Swollen from arm to fingertips), PAIN IN EXTREMITY (Painfull arm), PRURITUS (Itching), RASH (Redness/ Area around site became reddened gradually worsened) and LYMPHADENOPATHY (lymphadenopathy). At the time of the report, VACCINATION SITE REACTION (Delayed local reaction), SKIN WARM (warm), PRURITUS (Itching), RASH (Redness/ Area around site became reddened gradually worsened) and LYMPHADENOPATHY (lymphadenopathy) outcome was unknown and PERIPHERAL SWELLING (Swollen from arm to fingertips) and PAIN IN EXTREMITY (Painfull arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE REACTION (Delayed local reaction), SKIN WARM (warm), PERIPHERAL SWELLING (Swollen from arm to fingertips), PAIN IN EXTREMITY (Painfull arm), PRURITUS (Itching), RASH (Redness/ Area around site became reddened gradually worsened) and LYMPHADENOPATHY (lymphadenopathy) to be related.    No treatment medications were provided.  Patient stated that her physician would decide when to administer second vaccine   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up information received on 13 Sep 2021 Added allergy, added event start date, outcome and causality On 13-Sep-2021: Follow-up received contains no new information On 13-Sep-2021: Follow-up information received on 13 Sep 2021 Patient demographics, medical history, vaccine details, vaccine facility information and concomitant medications added On 13-Sep-2021: Follow-up received contains no new information On 13-Sep-2021: Follow-up received contains non significant information- reporter added On 14-Sep-2021: Follow-up received contains non significant information- reporter details updated On 14-Sep-2021: Follow-up information received on 14 Sep 2021,Allergies added, event warm and painful added; Sender's Comments: This case concerns a 86 year-old, female with a history of allergy to multiples medication , who experienced the unexpected events of vaccination site reaction, peripheral swelling, rash, skin warm, pain in extremity, pruritus; and the expected event of lymphadenopathy . The events occurred the same day after the first dose of mRNA-1273 Moderna vaccine.  The event was considered related to the product per the reporter´s assessment. The medical history, of Allergy could be a potentially confounder.  The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.