Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria, Vaccination failure
Clinical narrative: Diagnosed with Pneumonia/ she is still having breathing difficulty due to the pneumonia; Had COVID after receiving the vaccine/ had a very mild case of COVID; Had COVID after receiving the vaccine/ had a very mild case of COVID; Felt like I was allergic to my own sweat /she has become allergic to absolutely / allergic to absolutely everything/ She usually does not get sick but now is reacting to everything; Rash; Body "went bananas"/ hives and welts all over her body; Diagnosed her with autoimmune dermographia/ Intense itching that started in her scalp/ hair was super itchy/ itching then started occurring in the rest of her body including back, legs, and arms; Started to lose her hair; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Diagnosed with Pneumonia/ she is still having breathing difficulty due to the pneumonia), MECHANICAL URTICARIA (Diagnosed her with autoimmune dermographia/ Intense itching that started in her scalp/ hair was super itchy/ itching then started occurring in the rest of her body including back, legs, and arms), ALOPECIA (Started to lose her hair), COVID-19 (Had COVID after receiving the vaccine/ had a very mild case of COVID) and HYPERSENSITIVITY (Felt like I was allergic to my own sweat /she has become allergic to absolutely / allergic to absolutely everything/ She usually does not get sick but now is reacting to everything) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product AZITHROMYCIN for Pneumonia.    The patient had no allergies prior to taking the Moderna COVID-19 vaccine.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient started AZITHROMYCIN (unknown route) at an unspecified dose. On 16-Aug-2021, the patient experienced MECHANICAL URTICARIA (Diagnosed her with autoimmune dermographia/ Intense itching that started in her scalp/ hair was super itchy/ itching then started occurring in the rest of her body including back, legs, and arms), ALOPECIA (Started to lose her hair), HYPERSENSITIVITY (Felt like I was allergic to my own sweat /she has become allergic to absolutely / allergic to absolutely everything/ She usually does not get sick but now is reacting to everything), RASH (Rash) and URTICARIA (Body "went bananas"/ hives and welts all over her body). On 29-Dec-2021, the patient experienced COVID-19 (Had COVID after receiving the vaccine/ had a very mild case of COVID) and VACCINATION FAILURE (Had COVID after receiving the vaccine/ had a very mild case of COVID). In May 2022, the patient experienced PNEUMONIA (Diagnosed with Pneumonia/ she is still having breathing difficulty due to the pneumonia). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in August 2021 for Itching, Welts and Hives, at a dose of Zyrtec in the morning and HYDROXYZINE in August 2021 for Itching, Welts and Hives, at a dose of Hydroxyzine at night. At the time of the report, PNEUMONIA (Diagnosed with Pneumonia/ she is still having breathing difficulty due to the pneumonia), RASH (Rash) and URTICARIA (Body "went bananas"/ hives and welts all over her body) had resolved with sequelae, MECHANICAL URTICARIA (Diagnosed her with autoimmune dermographia/ Intense itching that started in her scalp/ hair was super itchy/ itching then started occurring in the rest of her body including back, legs, and arms) and HYPERSENSITIVITY (Felt like I was allergic to my own sweat /she has become allergic to absolutely / allergic to absolutely everything/ She usually does not get sick but now is reacting to everything) had not resolved, ALOPECIA (Started to lose her hair) and VACCINATION FAILURE (Had COVID after receiving the vaccine/ had a very mild case of COVID) outcome was unknown and COVID-19 (Had COVID after receiving the vaccine/ had a very mild case of COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.    Patient was not on any concomitant medications. The patient had no medical history related to AE and both acute and chronic illnesses at the time of vaccination.  The patient stated that prior to receiving the vaccine, she was an extremely active and healthy person, often a boring and did not have any health related issues. She then started to lose her hair for 5-6 months before she saw a doctor for her symptoms. The itching then started occurring in the rest of her body including back, legs, and arms. She was seen by a dermatologist who diagnosed her with autoimmune dermographia and Pneumonia for which she was put on Azithromycin. She stated that she still had breathing difficulty due to the pneumonia. She was put on a 5 day course of antibiotics. However, on day 3 of taking the Azithromycin, her body went bananas. The patient started getting hives and welts all over her body. The patient had to stop taking the antibiotic and was put on steroid to stop the reactions. The patient did not have any allergies or was on any medications prior to this. The patient has been on Zyrtec and Hydroxyzine for the last 9 months, which helped to keep the itching away. The patient says that if she does not take her medications, the itching comes right back. The patient was very frustrated because of what has happened after receiving the Moderna vaccine and it seemed to have allergies to absolutely everything. The patient felt like the vaccine has changed her DNA makeup and that is the reason for these reactions. The patient had urgent care for rash. Patient stated that she had a very mild case of COVID and quarantined herself for 4 days. Patient took Zyrtec in the morning and Hydroxyzine at night. Patient stated that it keeps the itching, welts, and hives at bay. Steroid for rash due to Azithromycin.  Company Comment: This is a spontaneous case concerning a 46-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 4 months after the second dose of mRNA-1273 vaccine. The patient reported to had a very mild case of COVID, quarantine for 4 days and recovered. Clinical course and treatment details were not provided in the case. Vaccination failure was also reported as an additional event. It should be noted that the two doses of mRNA-1273 were administered in a 28-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-573843 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 46-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 4 months after the second dose of mRNA-1273 vaccine. The patient reported to had a very mild case of COVID, quarantine for 4 days and recovered. Clinical course and treatment details were not provided in the case. Vaccination failure was also reported as an additional event. It should be noted that the two doses of mRNA-1273 were administered in a 28-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.