Age: 72.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pain, Periorbital swelling, Pruritus, Skin warm, Suspected COVID-19
Clinical narrative: she woke up with hives in her eyes (eyes almost swollen, puffy) and ears; palms of the hands were red hot; palms of the hands were red hot and very deeply itchy, armpit inside the elbow, and groin area, it spread on the body in the ventral surface and noticed little bumps; eyes almost swollen, puffy; Body aches; chills; unusual headache; Fatigue/felt exhausted; felt like having COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (felt like having COVID), URTICARIA (she woke up with hives in her eyes (eyes almost swollen, puffy) and ears), ERYTHEMA (palms of the hands were red hot), PRURITUS (palms of the hands were red hot and very deeply itchy, armpit inside the elbow, and groin area, it spread on the body in the ventral surface and noticed little bumps) and EYE SWELLING (eyes almost swollen, puffy) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product EPINEPHRINE (EPIPEN JR) for Anaphylaxis.    The patient's past medical history included COVID-19, Anaphylaxis and Surgery. Previously administered products included for Product used for unknown indication: RSV (shot 4 weeks ago) in 2023, Flu vaccine (shot 4 weeks ago) in 2023, Fasenra and Celebrex (occasionally due to 4 previous back surgeries); for product used for unknown indication: Lyrica (occasionally due to 4 previous back surgeries); for COVID-19 prophylaxis: Pfizer COVID-19 Vaccine (3 shots and did not remember the dates). Past adverse reactions to the above products included No adverse event with Celebrex, Fasenra, Flu vaccine, Lyrica, Pfizer COVID-19 Vaccine and RSV. Concurrent medical conditions included Asthma and Hypersensitivity.   On 02-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started EPINEPHRINE (EPIPEN JR) (unknown route) at an unspecified dose. On 02-Oct-2023, the patient experienced SUSPECTED COVID-19 (felt like having COVID), MYALGIA (Body aches), CHILLS (chills), HEADACHE (unusual headache ) and FATIGUE (Fatigue/felt exhausted). On 03-Oct-2023, the patient experienced URTICARIA (she woke up with hives in her eyes (eyes almost swollen, puffy) and ears), ERYTHEMA (palms of the hands were red hot), PRURITUS (palms of the hands were red hot and very deeply itchy, armpit inside the elbow, and groin area, it spread on the body in the ventral surface and noticed little bumps) and EYE SWELLING (eyes almost swollen, puffy). The patient was treated with PARACETAMOL (ACETAMINOPHEN) at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (felt like having COVID), URTICARIA (she woke up with hives in her eyes (eyes almost swollen, puffy) and ears), ERYTHEMA (palms of the hands were red hot), PRURITUS (palms of the hands were red hot and very deeply itchy, armpit inside the elbow, and groin area, it spread on the body in the ventral surface and noticed little bumps), MYALGIA (Body aches), CHILLS (chills), HEADACHE (unusual headache ) and FATIGUE (Fatigue/felt exhausted) had not resolved and EYE SWELLING (eyes almost swollen, puffy) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient was a retired respiratory and physical therapist stated in the past she only received Pfizer COVID-19 Vaccine (3  shots, did not remember the dates) but the last 4th dose she received was Spikevax on 2-Oct-2023. With Pfizer she did not experienced any AEs, but with Spikevax 6 hours later she felt like having COVID, with body aches, chills, unusual headache and fatigue, this happened within 24 hours, and because she had asthma she needed to use her rescue inhaler, felt exhausted and take a nap during 2 hours and a half and she did not feel that bad until midnight when she woke up with hives in her eyes (eyes almost swollen, puffy) and ears, and palms of the hands were red hot and very deeply itchy, armpit inside the elbow, and groin area, it spread on the body in the ventral surface and noticed little bumps, she got breathing issues, she had anaphylaxis and was administered with EpiPen at home (since she was an HCP she did not need to go to the hospital) and took Acetaminophen PM 1 pill and when symptoms stopped she went to bed, but after a while she woke up again to took another Acetaminophen pill. Next day she still had body aches on the afternoon. Currently she was still tight from COVID shot but was not bad, but she was concerned about this reaction because it was not immediately after the vaccine was given, but she never had this before.