Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site movement impairment, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Injection arm is extremely swollen), PAIN IN EXTREMITY (Injection arm is extremely painful), VACCINATION SITE WARMTH (Injection arm is very much warm/Area was hot to the touch), ADVERSE REACTION (nasty side effects) and ILLNESS (sick for almost a week after the second dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No adverse event reported. The patient's past medical history included No adverse event (no medical history was reported.). Concomitant products included ATENOLOL for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Doesn't have the strength in her left arm like i do in my right). On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (Injection arm is extremely swollen), PAIN IN EXTREMITY (Injection arm is extremely painful), VACCINATION SITE WARMTH (Injection arm is very much warm/Area was hot to the touch), VACCINATION SITE INDURATION (Noticed a hard node in the injection arm), VACCINATION SITE PRURITUS (Injection site is very itchy), PYREXIA (Fever) and INJECTION SITE ERYTHEMA (Red spot at injection site). 07-Apr-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION COMPLICATION (In bed for 5 days with no mood to do anything), DIARRHOEA (diarrhea), VACCINATION SITE BRUISING (it turned black and blue in the middle of the rash), NAUSEA (Nausea), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Horrible headaches.). On an unknown date, the patient experienced ADVERSE REACTION (nasty side effects) and ILLNESS (sick for almost a week after the second dose). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, Nausea, Chills, Joint pain, Diarrhea and Headache, at a dose of unk,unk and PARACETAMOL (TYLENOL) for Nausea, Chills, Joint pain, Diarrhea, Headache and Fever, at a dose of unk,unk. On 08-Mar-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Doesn't have the strength in her left arm like i do in my right) had resolved. At the time of the report, PERIPHERAL SWELLING (Injection arm is extremely swollen), PAIN IN EXTREMITY (Injection arm is extremely painful), VACCINATION SITE WARMTH (Injection arm is very much warm/Area was hot to the touch), ADVERSE REACTION (nasty side effects), ILLNESS (sick for almost a week after the second dose), VACCINATION SITE INDURATION (Noticed a hard node in the injection arm), VACCINATION SITE PRURITUS (Injection site is very itchy) and INJECTION SITE ERYTHEMA (Red spot at injection site) outcome was unknown, DIZZINESS (Dizziness), DIARRHOEA (diarrhea), VACCINATION SITE BRUISING (it turned black and blue in the middle of the rash), NAUSEA (Nausea), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Horrible headaches.) had not resolved and VACCINATION COMPLICATION (In bed for 5 days with no mood to do anything) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs in followup include :Revemir Insulin , Medicine for GERD. Med Info Agent: Caller states she received a phone call and is returning due to her nasty side effects after her second dose of the Moderna vaccine. She received Moderna for both dose one and two. She says it was so bad she told her son to wait to get Pfizer. She was sick for almost a week after the second dose. No further information obtained. Caller consents for safety to contact via phone. This case was linked to MOD-2021-089896. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: events information was provided. On 19-May-2021: Non-Significant follow-up Appended.