Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; While the first dose of the injection was administered she felt a burning really bad in her arm/burning more; Panic attacks; Depression; Anxiety; Rash that has continued since receiving the vaccine covering her face, neck, and arms; This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (Panic attacks), DEPRESSION (Depression), ANXIETY (Anxiety), RASH (Rash that has continued since receiving the vaccine covering her face, neck, and arms) and PRURITUS (Itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DIOMZOA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021 at 1:38 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced BURNING SENSATION (While the first dose of the injection was administered she felt a burning really bad in her arm/burning more). In 2021, the patient experienced PANIC ATTACK (Panic attacks), DEPRESSION (Depression), ANXIETY (Anxiety) and RASH (Rash that has continued since receiving the vaccine covering her face, neck, and arms). On an unknown date, the patient experienced PRURITUS (Itching). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency; GABAPENTIN at a dose of 300 milligram three times a day; CITALOPRAM at a dose of 40 milligram once a day; LOSARTAN for Blood pressure high, at a dose of 50 milligram once a day; LORAZEPAM at a dose of 5 milligram twice a day; BUSPIRONE at a dose of 15 milligram twice a day; HYDROXYZINE at an unspecified dose and frequency; PENICILLIN [PENICILLIN NOS] at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (Panic attacks), DEPRESSION (Depression), ANXIETY (Anxiety) and RASH (Rash that has continued since receiving the vaccine covering her face, neck, and arms) had not resolved, PRURITUS (Itching) outcome was unknown and BURNING SENSATION (While the first dose of the injection was administered she felt a burning really bad in her arm/burning more) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported at the time of reporting burning had went away. Patient had spoken to her primary care doctor and a dermatologist. She had been taking multiple medications as well as oral steroids, the strongest creams.  It was also reported that She last saw her dermatologist two weeks ago, and was due to see them again on the 17th. Patient could not go outside for any amount of time without itching and burning more.  Patient did not have any allergy , previous long standing health condition and patient did not ever been diagnosed with/tested positive for COVID-19, did not prescribes OTC medications or herbal remedies being taken at the time of vaccination and/or Adverse event. At the time of vaccination and up to 1 month before patient did not have any acute illness.  Patient began to experienced anxiety, panic attack, depression and a rash. It was treated for anxiety and depression in June 2021. It did not respond to treatment and rash would come to go. Lorazepam was given. February 2021, returned to a different doctor for rash, anxiety, panic Attack and depression. It was treated. No response to treatment.  It returned to another doctor in May 2021, for rash, anxiety, panic Attack, depression and anxiety. It was treated with topical steroid. High Blood pressure was identified, and losartan given. No response to treatment. It developed a worse rash along with may be shingle in June.  It was reported that patient was given Penicillin, gabapentin in addition to everything else and got No response.  Shingle effects lasted months as rash, panic attacks, depression, anxiety got worse. Can not tolerate the outdoors. In October it finally got into a dermatologist Treated with Topical steroids, It was still seen that both doctors and No response to medications was observed.   This case was linked to MODERNATX, INC.-MOD-2022-670481 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2022: Live-Follow-up included new event itching was added and narrative was updated. On 23-Nov-2022: Follow up received that contains significant information includes Updated Patient information, Updated Reporter information, Added Treatment Medications, Updated Event outcome, event details and Narrative updated. Sender's Comments:  MODERNATX, INC.-MOD-2022-670481:Dose 2