Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Headache, Hypoaesthesia oral, Vaccination site pain
Clinical narrative: COVID arm (painful, itchy, hot); COVID arm (painful, itchy, hot); COVID arm (painful, itchy, hot); Anaphylactic Reaction/Throat began to swell and could only swallow water/chest discomfort; Lips and Cheeks were numb; Lips and Cheeks were numb; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction/Throat began to swell and could only swallow water/chest discomfort) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic reaction to bee sting (Bees).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction/Throat began to swell and could only swallow water/chest discomfort) (seriousness criterion medically significant), the first episode of HYPOAESTHESIA ORAL (Lips and Cheeks were numb), the second episode of HYPOAESTHESIA ORAL (Lips and Cheeks were numb), CHILLS (Chills) and HEADACHE (Headache). On 25-Apr-2021, the patient experienced VACCINATION SITE WARMTH (COVID arm (painful, itchy, hot)), VACCINATION SITE PRURITUS (COVID arm (painful, itchy, hot)) and VACCINATION SITE PAIN (COVID arm (painful, itchy, hot)). The patient was treated with Physical therapy (Ice wraps) for Anaphylactic reaction. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic Reaction/Throat began to swell and could only swallow water/chest discomfort), the last episode of HYPOAESTHESIA ORAL (Lips and Cheeks were numb), VACCINATION SITE WARMTH (COVID arm (painful, itchy, hot)), VACCINATION SITE PRURITUS (COVID arm (painful, itchy, hot)), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (COVID arm (painful, itchy, hot)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was fine while she was at the facility, but on her way home she had an anaphylactic reaction. Her lips and cheeks became numb. Her throat began to swell and she could not swallow anything but water. She also reports her chest was tight. No breathing difficulties. She stated that she tried to call her physician to get an EpiPen, but he was gone for the day. She stated that she was allergic to bees and that is why she went to a facility who would have a doctor there if she had a reaction. The reaction lasted about 1.5 hours. She used ice wraps and eventually the reaction stopped and she did not go to the emergency room. She also reports that she also had the normal side effects like chills and a headache after receiving the shot. Two days after the vaccination she woke up with COVID arm which was painful, itchy and hot. It lasted over a week, but it finally went away.  The concomitant medications were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events( anaphylactic reaction, hypoesthesia oral, hypoesthesia, chills, headache, vaccination site pain, vaccination site pruritus, vaccination site warmth), a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events( anaphylactic reaction, hypoesthesia oral, hypoesthesia, chills, headache, vaccination site pain, vaccination site pruritus, vaccination site warmth), a causal relationship cannot be excluded.