Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Dysphonia, Episcleritis, Headache
Clinical narrative: Axillary lymph nodes enlarged; Blisters; Cold symptoms; Episcleritis; Headache; Immune system disorder; Injection site redness; Injection site tenderness; Injection site warmth; Joint pain; Muscle pain; Radiating pain; Sickness; Voice disturbance; A spontaneous report was received from a nurse concerning herself the patient, a 43 year old female who developed warmth and redness at the injection site which was very firm to the touch and pain radiating on the right side from the base of the skull through her neck through her shoulders to her elbows. The first two days post receiving the injection she reported experiencing a headache bordering on a migraine. She also reported joint pain and muscle pain for 3 days. She stated she was sick for 5 days and her immune system crashed. Seven days post injection she reports her voice is scratchy, cold symptoms described as cough, running nose and sore throat. On 29-dec-2020 she reported an inflammation in her "lymphs", subclavian and axillary. She noted it was the lymph nodes right above the collar bones and arm pits. The patient states they are swollen and painful.  The patient's medical history included an unspecified inflammatory issue and chronic bronchitis at least three times a year. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 lot number 039K20A in her right arm for prophylaxis of Covid -19. The described events began right after receiving the vaccination and some reported events continued to develop for the next 5 days.  On 29-dec-2020 the patent, a nurse left a voicemail with the following information. She requested a call back. She received the mRNA 1273 vaccination in her right arm on 23-dec-2020. Within 2 hours of the vaccination she reported warmth and redness at the injection site for 2 days afterwards. The site was very warm to the touch. Two hours post injection she reported pain radiating on the right side from the base of her skull through her neck, through her shoulders to her elbows. On days 1 and 2 post vaccination she reported a headache bordering on a migraine. The patient reported she was sick for 5 days and symptomatic for 5 days. She stated her immune system crashed. On 30-dec-2020 the patient reported her voice is scratchy, cold symptoms of cough, running nose and a sore throat. She stated that she thought she was doing better until reporting on 29-dec-2020 that she developed an inflammation in her "lymphs's": subclavian and axillary. On the night of 28-dec-2020 she woke up and reported pain in her neck and shoulder due to the lymph node inflammation. The patient reported she had not been able to sleep on her right side where she got the injection. The patient also noted that little scratches on her hand from cleaning on the morning of 24-dec-2020 immediately turned red at the edges and were inflamed. She stated it was "not a normal healing process for her." The patient stated she alternately took Tylenol; and Ibuprofen (does and frequency unknown). The patient took Mucinex (dose and frequency unknown) and reported taking additional supplements such as Vitamin C and D#. The patient also reported taking Tumeric for inflammation., The patient stated she wanted to document her experience as she noticed there was not a lot of clinical information on immunocompromised patients.  The patient who is also a nurse also asked questions regarding issues specific to vaccine administration guidelines to provide to other vaccine administrator. This question was escalated to medical affairs.  Action taken with the second planned dose of mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s) was not reported.  A follow up was received on 06 Mar 2021, patient states that she decided not to receive her second dose.  Medical history included 27 for antibodies at 6 weeks.  Treatment for the events was unknown.  On an unspecified date, patient experienced episcleritis in her right eye and water blisters on her back and arms.  The outcome of the events were unknown.  Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.