Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Feeling pretty lousy; Feeling unsteady on and off during walk; Shortness of breath; Extreme fatigue; Dizzy; Fever; Brain fog; Feeling hot; Widespread feeling of inflammation; Felt hot; One hive under my hair at left center of skull 3cm in diameter and raised; Headache; Intermittent pins and needles on trunk, arms and feet; Flu-like symptoms; Itching; A spontaneous report was received from a regulatory authority concerning an 65-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced shortness of breath, intermittent pins and needles on trunk, arms and feet, flu-like symptoms, felt hot, one hive under my hair at left center of skull 3cm in diameter and raised, feeling unsteady on and off during walk, brain fog, widespread feeling of inflammation, feeling hot, itching, dizzy, feeling pretty lousy, headache, fever and extreme fatigue.  The patient's medical history included moderate asthma and consistent idiopathic urticaria. Products known to have been used by the patient, within two weeks prior to the event, included omalizumab.  On 01 Feb 2021, less than one hour prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch# 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the evening of 01 Feb 2021, the patient experienced flu like symptoms, generalized mild itching on the entire body without hives, and intermittent pins and needles on her trunk, arms, and feet for 5 days. Treatment included diphenhydramine with enough improvement that she could sleep.  On 02 Feb 2021, itching was diminished but continued off and on. The patient felt hot and had a headache. Treatment included naproxen for what the patient described as a widespread feeling of inflammation. The patient reported that there was one hive under her hair at left center of skull that was 3 cm in diameter and raised. Treatment included two doses of steroid cream triamcinolone acetonide 0.1% with improvement.  On 03 Feb 2021, the hive was gone. The patient felt hot and had a temperature of 99.2 °F. Treatment included acetaminophen. Itching and dizziness continued off and on. The patient checked her pulse ox and oxygen saturation was 98% and pulse was 78. The patient reported that she was unable to work for 2 days due to brain fog.  On 04 Feb 2021, the patient reportedly felt better but still foggy.  On 05 Feb 2021, the patient was able to work and walked for 20 minutes.  On 06 Feb 2021, the patient still felt very tired/extreme fatigue but was able to do some housework. She took a longer (30 min) walk but was feeling unsteady and dizzy enough on and off that she had stop and grab something during the walk. The patient experienced shortness of breath and used her rescue inhaler.  On 07 Feb 2021, the patient felt exhausted, short of breath, and dizzy. She reported that her blood pressure was 119/58 mmHg which was low for her (her typical result at ~ 130/65 mmHg). She reported that her pulse ox was fine with oxygen saturation of 98 and pulse of 73. The patient reported that it was hard for her to think, her blood pressure was 120/55 mmHg.  She mentioned that the weather was the "type that provokes asthma attack" in her", and she used her rescue inhaler twice daily.  On 08 Feb 2021, the patient reported that she "still feeling pretty lousy".  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, hive was considered resolved on 03 Feb 2021. The outcome of the event, intermittent pins and needles on her trunk, arms and feet, was considered resolved on 05 Feb 2021.  The outcome of the events, felt exhausted, felt lousy, felt hot, shortness of breath, itching on the entire body, flu-like symptoms, headache, dizzy, unsteady on and off during walk, difficulty brain fog, fever, and a widespread feeling of inflammation, were unknown.; Reporter's Comments: This case concerns a 65 year old female patient, with medical history of asthma and idiopathic urticaria, who experienced a non-serious unexpected event of dyspnoea and paraesthesia, among others, after receiving first dose mRNA- 1273 (Lot# 004M20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.