Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Chills, Hypersensitivity, Lip disorder, Lip swelling
Clinical narrative: Having a severe allergic reaction; lymph node swelling; sore throat; chills; lip was swollen and bumps all over; lip was swollen and bumps all over; rash; I feel sleepy; breaking out of the face; Swelling of the face and throat; Swelling of the face and throat; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 13Feb2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 71-years-old). Medical history and concomitant medications included none. The patient experienced having a severe allergic reaction, lymph node swelling, sore throat, chills, lip was swollen and bumps all over, rash, feel sleepy, breaking out of the face, Swelling of the face and throat on 14Feb2021. Investigation assessment included none. Patient asked if it was advisable to go to the hospital and should take the second dose of the vaccine. Patient stated her weight as approximately 190 pounds. Patient took Covid-19 took the first dose or shot on Saturday and having a severe allergic reaction to it. Got the swollen lymph nodes and sore throat, face was breaking out, lip was swollen and bumps all over, everywhere. Start date of events was stated as 14Feb2021 (yesterday, Sunday; not clarified further). Patient stated the events were worsened (not appropriately clarified further, hence ongoing not checked of events). Patient did not receive treatment at the time of this report and that was why she was calling to let Pfizer know that she was experiencing side effect and stated to have care that was part of a Hospital and was thinking to go through them and see if they might be would in a situation like her they would give her something to count or acted on something, something that would just allow her to cope with the situation. Patient was trying to get some relief from the side effects. Consumer was informed that Pfizer medical information was the concerned department for all queries. Consumer denied taking the number and stated that she knew the side effects, had the literature and called Pfizer to know that she was experiencing these severe side effects and was going to the doctor. According to Pfizer literature that had on Covid, if she was experiencing side effects with the first shot, she should not get the second shot. Also, the literature said that if you are experiencing the side effects from the first dose of severe reaction, it says not to get the second shot. It says list of the Pfizer BioNTech COVID-19 vaccine and it says severe reactions like difficulty breathing, swelling of the face and neck, a fast heartbeat, a bad rash all over your body and patient was getting that rash. She was not dizzy and weak but felt sleepy, just didn't feel dizzy. Also, patient was getting the swelling of the face and throat and the rash and was feeling very sleepy. It also said that there was remote chance that Pfizer Covid-19 vaccine can cause a severe allergic reaction, the reaction can happen within 1 minutes to an hour but mine started to happen Sunday (14Feb2021). It also says what patient should do about side effects, it says if you have severe allergic reaction, call 911 and go to the nearest hospital. She was calling to let you Pfizer know that she was experiencing those reaction. Commented that as it was not clarified if consumer was experiencing difficulty breathing and fast heartbeat also, hence these were not captured as events. Clinical outcome of reported events was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.