Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Arm swollen; Arm rock hard; Lymph nodes swollen; vomiting; I had serious reaction to dose 1; Backpain; Dizziness for a whole month; Weakness; Tinnitus; Felt terrible; Nausea; Chills; Severe headache; Joint pain; Muscle pain; Mild fever; Tenderness at the injection site; Swelling at the injection site; redness at the injection site; it feels as though you're about to have a stroke or anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (it feels as though you're about to have a stroke or anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunodeficiency (she has an immunodeficiency as well and is general very sensitive and overreacts to any vaccine or medications at baseline.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (I had serious reaction to dose 1), BACK PAIN (Backpain), DIZZINESS (Dizziness for a whole month), ASTHENIA (Weakness), TINNITUS (Tinnitus), FEELING ABNORMAL (Felt terrible), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Severe headache), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Mild fever), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 16-Feb-2021, the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (it feels as though you're about to have a stroke or anaphylactic reaction) (seriousness criterion disability), PERIPHERAL SWELLING (Arm swollen), VACCINATION SITE INDURATION (Arm rock hard) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, ANAPHYLACTIC REACTION (it feels as though you're about to have a stroke or anaphylactic reaction), VACCINATION COMPLICATION (I had serious reaction to dose 1), BACK PAIN (Backpain), DIZZINESS (Dizziness for a whole month), ASTHENIA (Weakness), TINNITUS (Tinnitus), FEELING ABNORMAL (Felt terrible), PERIPHERAL SWELLING (Arm swollen), VACCINATION SITE INDURATION (Arm rock hard), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Severe headache), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Mild fever), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VOMITING (vomiting) and LYMPHADENOPATHY (Lymph nodes swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a 58 Y/O F with serious expected anaphylactic reaction and NS unexpected vaccination complication, dizziness, asthenia, feeling abnormal, tinnitus, back pain, peripheral swelling, and other expected events both systemic and at the vaccination site. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081696, US-MODERNATX, INC.-MOD-2021-081725 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received included Moderna vaccine start date updated, additional events included (it feels as though you're about to have a stroke or anaphylactic reaction, arm swollen, arm rock hard, lymph nodes swollen); Sender's Comments: This case concerns a 58 Y/O F with serious expected anaphylactic reaction and NS unexpected vaccination complication, dizziness, asthenia, feeling abnormal, tinnitus, back pain, peripheral swelling, and other expected events both systemic and at the vaccination site. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081696:cross linked; wife case US-MODERNATX, INC.-MOD-2021-081725:Cross linked; wife case