Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Gastrooesophageal reflux disease, Heart rate, Hypersensitivity, Mechanical urticaria
Clinical narrative: Dermatographia; Sinus fill up with mucus; scratch her skin (arms and legs); allergic reaction; Hands were swollen/Feet were swollen; Her heart beating fast; Acid reflux; Scalp itched incredibly much/feet itched incredibly much/hands itched incredibly much; getting hives/hives covered all her body/ hives everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (getting hives/hives covered all her body/ hives everywhere), MECHANICAL URTICARIA (Dermatographia), PRURITUS (Scalp itched incredibly much/feet itched incredibly much/hands itched incredibly much), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PERIPHERAL SWELLING (Hands were swollen/Feet were swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 047A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Hypertension, Environmental allergy, Grass allergy, Allergy to plants (Trees allergy), Allergy to feathers, Dust allergy, Allergic to dogs, Cockroach allergy and Vitamin deficiency. Concomitant products included VITAMIN C [ASCORBIC ACID], MULTIVITAMINS [VITAMINS NOS], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN D [VITAMIN D NOS], ZINC and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced URTICARIA (getting hives/hives covered all her body/ hives everywhere). On 05-Nov-2021, the patient experienced PRURITUS (Scalp itched incredibly much/feet itched incredibly much/hands itched incredibly much). On 08-Nov-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). 08-Nov-2021, the patient experienced PALPITATIONS (Her heart beating fast). On 09-Nov-2021, the patient experienced PERIPHERAL SWELLING (Hands were swollen/Feet were swollen). 09-Nov-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). On 17-Nov-2021, the patient experienced SINUS CONGESTION (Sinus fill up with mucus). 17-Nov-2021, the patient experienced SCRATCH (scratch her skin (arms and legs)). On 18-Nov-2021, the patient experienced MECHANICAL URTICARIA (Dermatographia). The patient was treated with DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intramuscular) on 06-Nov-2021 for Hives, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 06-Nov-2021 for Hives, at an unspecified dose and frequency; HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) on 06-Nov-2021 at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL DOSEPAK) on 06-Nov-2021 at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 07-Nov-2021 at an unspecified dose and frequency; PREDNISONE on 07-Nov-2021 at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) on 20-Dec-2021 for Dermatographia, at a dose of UNK, qid. On 09-Nov-2021, PALPITATIONS (Her heart beating fast) had resolved. On 17-Nov-2021, SINUS CONGESTION (Sinus fill up with mucus) had resolved. At the time of the report, URTICARIA (getting hives/hives covered all her body/ hives everywhere), MECHANICAL URTICARIA (Dermatographia), PRURITUS (Scalp itched incredibly much/feet itched incredibly much/hands itched incredibly much), SCRATCH (scratch her skin (arms and legs)) and HYPERSENSITIVITY (allergic reaction) had not resolved and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PERIPHERAL SWELLING (Hands were swollen/Feet were swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2021, Heart rate: high (High) at 10.30 PM, heart began beating and couldn't get the beat under a 120 bpm. On 09-Nov-2021, Electrocardiogram: normal (normal) Did an EKG, and it was fine. On 09-Nov-2021, Heart rate: normal (normal) Around 2 AM it went down.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered URTICARIA (getting hives/hives covered all her body/ hives everywhere), MECHANICAL URTICARIA (Dermatographia), PRURITUS (Scalp itched incredibly much/feet itched incredibly much/hands itched incredibly much), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PERIPHERAL SWELLING (Hands were swollen/Feet were swollen), SINUS CONGESTION (Sinus fill up with mucus), PALPITATIONS (Her heart beating fast), SCRATCH (scratch her skin (arms and legs)) and HYPERSENSITIVITY (allergic reaction) to be not related.    Patient not had COVID-19 before. Concomitant medications include Birth control and high blood pressure medication.  Patient had stated that she went to ER On 06-Nov-2021 at 4 AM. and patient went to urgent care and nothing got better. Doctor added Pepcid, and changed the dose pack of Medrol to Prednisone. On 08-Nov-2021heart began beating and could not get the beat under a 120 bpm. Around 2 am, it  went down patient drank a lot of water. On 09 Nov 2021, patient returned to primary care. Doctors decided to stop all medications because they thought she had an allergic reaction to Medrol or Prednisone. On 17-Nov-2021, patient would scratch her skin arms and legs and histamine overload, like histamine congestion, too much histamine would give her head a cold. This lasted for 2 hours and Patient went to dermatologist on 02 Dec 2021 and diagnosed with dermatographia. The worst parts are ears, face, neck and upper torso. But she had all over her body patient was head to an allergist on 21-Feb-2022. Doctors did not believe the symptoms occurred were due to the vaccine. Doctors said it could be a nickel allergy or allergy to the shampoo. In regards to her fast heart beat, doctors believed it was due to anxiety because she could not stop scratching her skin and also because of all the medication she was taking.