Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Spacey; It is debilitating for her; Started noticing arm pain at the injection site/pain started getting worse; there is also hardness and some swelling associated with the pain, at the injection site; There is some swelling associated with the pain, at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Spacey), ASTHENIA (It is debilitating for her), VACCINATION SITE PAIN (Started noticing arm pain at the injection site/pain started getting worse), VACCINATION SITE INDURATION (there is also hardness and some swelling associated with the pain, at the injection site) and VACCINATION SITE SWELLING (There is some swelling associated with the pain, at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.    Co-suspect product included non-company product TRAMADOL for an unknown indication.    It was reported that patient has never been diagnosed or tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer (first dose), Pfizer (First booster) and Pfizer (second dose). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Benadryl). Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for Booster, APIXABAN (ELIQUIS), METOPROLOL, FUROSEMIDE (LASIX [FUROSEMIDE]), PREGABALIN (LYRICA) and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 04-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TRAMADOL (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced CONFUSIONAL STATE (Spacey), VACCINATION SITE PAIN (Started noticing arm pain at the injection site/pain started getting worse), VACCINATION SITE INDURATION (there is also hardness and some swelling associated with the pain, at the injection site) and VACCINATION SITE SWELLING (There is some swelling associated with the pain, at the injection site). 05-May-2022, the patient experienced ASTHENIA (It is debilitating for her). At the time of the report, CONFUSIONAL STATE (Spacey), ASTHENIA (It is debilitating for her), VACCINATION SITE PAIN (Started noticing arm pain at the injection site/pain started getting worse), VACCINATION SITE INDURATION (there is also hardness and some swelling associated with the pain, at the injection site) and VACCINATION SITE SWELLING (There is some swelling associated with the pain, at the injection site) had not resolved.            No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient received second booster shot on her right arm. The patient visited her HCP, who put her on Tramadol. After taking Taramadol, patient was spacey which the reporter thinks was from Tramadol and was not from Moderna. It was reported that except for the swelling, patient's symptoms had worsened since they first started, pain in right arm at injection site, hardness were worsened and swelling was stable. Reporter stated that it looks like the patient had something inflammatory going on.  For swelling HCP prescribed Prednisone but patient had not started taking it yet.