Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Fatigue, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: Delayed allergic reaction; Bad headaches; Nausea; Hand went numb; Arm hurting; Itching all over; Rash on her stomach; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that the 52-year-old female patient received first dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included multiple allergies from an unknown date and unknown if ongoing Multiple allergies , fibromyalgia from an unknown date and unknown if ongoing Fibromyalgia, cystitis interstitial from an unknown date and unknown if ongoing Interstitial cystitis six years ago that caused her to become a lot more sensitive to medications. The patient's concomitant medications were not reported.  Past drug event included she took hydroxyzine 50 mg before the first dose of the Pfizer Covid-19 vaccine initially but also stated that she took Benadryl as well. The patient experienced delayed allergic reaction on 2021 with outcome of unknown, bad headaches on 2021 with outcome of unknown , nausea on 2021 with outcome of unknown, hand went numb on 2021 with outcome of unknown , arm hurting on 2021 with outcome of unknown, itching all over on 2021 with outcome of unknown , rash on her stomach on 2021 with outcome of unknown.  Therapeutic measures were taken as a result of delayed allergic reaction, bad headaches, nausea, hand went numb, arm hurting , itching all over, rash on her stomach. Seriousness criteria of the events was medically significant.  The clinical course was reported as follows: Caller is a 52 year old female who received the first dose of the Pfizer Covid-19 vaccine on 02Jul2021 and had a delayed allergic reaction and possibly phlebitis (attempted to clarify with Caller but she stated that it was a delayed allergic reaction when asked). Caller has a medical history of multiple allergies (did not specify what they are), does not take the flu shot due to adverse reactions years ago (did not specify date or year), fibromyalgia, interstitial cystitis six years ago that caused her to become a lot more sensitive to medications. Caller started to have complaints of really bad headaches, nausea, hand went numb, arm hurting, itching all over, and rash on her stomach. Caller stated that she has consulted the CDC and her HCP's about the above reactions. After the first dose of the Pfizer Covid-19 vaccine, the Caller's HCP prescribed her Biaxin, Zofran (which kept her awake per Caller), and Phenergan. Caller also stated that she covered her body with ice packs and frozen vegetables bags.  Caller stated that she took hydroxyzine 50 mg before the first dose of the Pfizer Covid-19 vaccine initially but also stated that she took Benadryl as well.  Caller stated that the ingredients listed for the Pfizer Covid-19 vaccine on the FACT SHEET FOR RECIPIENTS AND CAREGIVERS LAB-1451-9.0 Revised: 01 Sep 2021 are not cut and dry-not a breakdown of what are the ingredients in the vaccine. Caller wanted to know what to do with her adverse events (specifically treatment recommendations) with INT-331457. Caller is asking how or when she will know to get the second dose of the Pfizer Covid-19 vaccine?  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.