Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Urticaria, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of Consciousness), OESOPHAGEAL SPASM (nut cracker esophagus), PRURITUS (minor itching on arms hands - still have all over body moves around/Itching/pruritus- Generalized), ERYTHEMA (Redness/erythema Generalized/red inflamed) and URTICARIA (Hives) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypersensitivity reaction since an unknown date, Hay fever, Hives and Menopause flushing (same comes and goes) on 01-Jan-2016. Previously administered products included for COVID-19 vaccination: Moderna shots (all three shots - HIVES ALL BODY); for an unreported indication: FLU on 13-Sep-2021. Past adverse reactions to the above products included Hives with Moderna shots. Concurrent medical conditions included Drug allergy (sulfa drug, delayed hives 5 days.), Drug allergy (Meloxicam delayed swelling of lips and face.), Allergy to vitamin B12 (B12 injection site issue and headaches) and Histamine intolerance (HIVES worse with booster, vaccines) since 01-Apr-2020. Concomitant products included DESLORATADINE (CLARINEX [DESLORATADINE]) from 07-Jan-2022 to an unknown date, FLUTICASONE PROPIONATE (FLOVENT), COLECALCIFEROL (VIT D [COLECALCIFEROL]), ENZYMES NOS and DIAMINE OXIDASE for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of Consciousness), PRURITUS (minor itching on arms hands  - still have all over body moves around/Itching/pruritus- Generalized), ERYTHEMA (Redness/erythema Generalized/red inflamed), URTICARIA (Hives), DYSPHAGIA (Difficulty swallowing), PALPITATIONS (Irregular heart rate/palpitations), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), OCULAR HYPERAEMIA (Red/itchy eyes), EYE PRURITUS (itchy eyes), CHEST DISCOMFORT (Chest tightness), FEELING HOT (Feeling hot), ABDOMINAL PAIN (Abdominal cramping), VOMITING (Vomiting), NAUSEA (Nausea), RASH (body rash-Rash Generalized) and HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced OESOPHAGEAL SPASM (nut cracker esophagus), SWELLING (neck swelling), OROPHARYNGEAL PAIN (sore throat), NECK MASS (lump on the side of my neck), MALAISE (general malaise), LYMPHADENOPATHY (lots of swollen lymph nodes), HEADACHE (headaches), ARTHRALGIA (shoulder pain) and RASH (body rash). The patient was treated with DESLORATADINE (CLARINEX [DESLORATADINE]) on 07-Jan-2022 at a dose of 5 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Jan-2022 at a dose of UNK, max per day; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 07-Jan-2022 at a dose of UNK, max per day and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) on 07-Jan-2022 at a dose of UNK, max per day. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of Consciousness), PRURITUS (minor itching on arms hands  - still have all over body moves around/Itching/pruritus- Generalized), ERYTHEMA (Redness/erythema Generalized/red inflamed), DYSPHAGIA (Difficulty swallowing), PALPITATIONS (Irregular heart rate/palpitations), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), OCULAR HYPERAEMIA (Red/itchy eyes), EYE PRURITUS (itchy eyes), CHEST DISCOMFORT (Chest tightness), FEELING HOT (Feeling hot), ABDOMINAL PAIN (Abdominal cramping), VOMITING (Vomiting), NAUSEA (Nausea), RASH (body rash-Rash Generalized) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved, OESOPHAGEAL SPASM (nut cracker esophagus) and RASH (body rash) outcome was unknown, URTICARIA (Hives), OROPHARYNGEAL PAIN (sore throat), MALAISE (general malaise), LYMPHADENOPATHY (lots of swollen lymph nodes), HEADACHE (headaches) and ARTHRALGIA (shoulder pain) was resolving and SWELLING (neck swelling) and NECK MASS (lump on the side of my neck) had resolved. Patient reported that she got booster shot on 28 Dec 2021 and had shoulder pain neck swelling and general malaise for 2 days, headaches, lots of swollen lymph nodes and sore throat for next few days, then started to improve. On 8 day 6 Jan 2022 started noticing itching like hives before, next day full blown all over body. HIVES were way worse this time. Patient reported that she had lots of medical testing done to make sure it was not a heart attack, stomach paralysis or Gallbladder issues etc. Patient reported that she soaked in cool tub for hours to try and help for beat red inflamed and itchy welds that run together and tried a lot of antihistamines that did not help much. Now on day 11 of the hives and they were getting less severe and frequent. Patient had a lump on the side of my neck that started 2 days ago and reminds of the pain from the first 2 shots that lasted for months until patient got Covid-19, then disappeared. Patient hope this doesn't stick around as it is causes pain doing daily activities and sleeping is difficult. Company comment: This case concerns a 54-year-old female patient with relevant medical history of hypersensitivity reaction, hay fever and hives, who experienced non-serious unexpected AESI of heart rate irregular and non-serious unexpected event of depressed level of consciousness, that occurred approximately 9 days after the booster dose of the mRNA-1273.  Reportedly, the patient had a hypersensitivity reaction with initial symptom of minor itching of hands. The rechallenge was not applicable due to occurrence after the booster dose. The patient's relevant medical history is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event of depressed level of consciousness was assessed as non-serious based on provided information and medical judgement (the patient did not seek medical care, was not hospitalized or had an emergency room visit, patient referring to general malaise). This case was linked to MOD-2021-066057, MOD-2022-454715 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Significant follow-up - Events added. Sender's Comments: This case concerns a 54-year-old female patient with relevant medical history of hypersensitivity reaction, hay fever and hives, who experienced non-serious unexpected AESI of heart rate irregular and non-serious unexpected event of depressed level of consciousness, that occurred approximately 9 days after the booster dose of the mRNA-1273.  Reportedly, the patient had a hypersensitivity reaction with initial symptom of minor itching of hands. The rechallenge was not applicable due to occurrence after the booster dose. The patient's relevant medical history is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event of depressed level of consciousness was assessed as non-serious based on provided information and medical judgement (the patient did not seek medical care, was not hospitalized or had an emergency room  visit, patient referring to general malaise).