Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Inflammation, Pruritus, Weight decreased
Clinical narrative: She feels like the burning and itching on her face is flaring up since the second dose.; She feels like the burning and itching on her face is flaring up since the second dose.; Adds her ear is still burning; still has pain in her temple; the streak on the left side of her face is scorched bright red and painful; the streak on the left side of her face is scorched bright red and painful; lost about 15 pounds; I got inflamed; I am still in numbness half of my face is still numb; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9263, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in Left arm on 20Mar2021 09:45 (at the age of 67-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included surgery on an unspecified date in Aug2020, pacemaker and defibrillator placed in on an unspecified date in 2017 and reported that; supposed to get her knee in Apr2021. Concomitant medications included carvedilol (CARVEDILOL) taken for an unspecified indication from 2012 and ongoing; losartan (LOSARTAN) taken for an unspecified heart disorder from 2012 and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication (water pill) from 2017 and ongoing; valaciclovir hydrochloride (VALTREX) taken for herpes zoster from 21Feb2021; prednisone (PREDNISONE) taken for blister from 21Feb2021; gabapentin (GABAPENTIN) taken for an unspecified indication from 21Feb2021. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) administered in Left arm on 20Feb2021 09:30 for covid-19 immunisation and further experienced pain, teeth started hurting went to her temple: (From: 21Feb2021 To: Ongoing), blisters in her mouth on 22Feb2021, loss of hearing: (From: 05Mar2021 To: Ongoing), blisters on face, temple, ear: (From: 23Feb2021 To: 04Mar2021), left side of her face is scorched bright red and painful: (From: 22Feb2021 To: Ongoing), numbness; no feeling in her mouth on the left, cheek, temple: (From: 22Feb2021 To: Ongoing), itchy on the left side of the face: (From: 25Feb2021 To: Ongoing). Ramsay-Hunt syndrome: (From: 05Mar2021 To: Ongoing). Adverse events did not require a visit to Emergency Room but pain and blisters resulted in Physician Office. History of all previous immunization with the pfizer vaccine considered as suspect was none. Additional vaccines administered on Same Date of the Pfizer Suspect were none. The patient did not receive prior vaccinations within four weeks of vaccination. Patient did not have medical History including any illness at time of vaccination. There was no family history and relevant tests were none. Patient received the first dose of the COVID 19 vaccine on 20Feb2021 at 09:30 AM in the left arm. Reports first her teeth started hurting on the left side on Sunday, then the pain went to her temple on the left side of her ear and it is still giving her a lot of pain. She started getting a rash in her mouth, blisters in her mouth and called the dentist who said it was not her teeth. Monday night she started to break out on her lips and her ear and there was a line of rash from her temple to her lips. She saw the dermatologist 25Feb2021 who diagnosed her with shingles and prescribed Valtrex. By then the rash was full blown in her mouth, the left side of her face and her left ear. The dermatologist thought it might also be in her eye and had to go to the eye doctor who said what the dermatologist gave her would help. The Valtrex cleared up the blisters in her mouth and her face. Now she just has some scabs, it took a week. She also saw a primary care nurse practitioner on 04Mar2021, who looked in her ear and saw it down her ear canal and said she needed to see the ENT. So then she called the dermatologist on 05Mar2021 and the dermatologist was able to get her seen by an ENT who then diagnosed Ramsay Hunt syndrome with the shingles in her ear; adds she had lost some hearing in her left ear. The ENT put her back on the Valtrex at half the dose; gave her ear drops to use to dry up the blisters, and some prednisone. All but one of the blisters in her ears have cleared up now. She got the second dose of the vaccine on Saturday 20Mar2021 at 09:45 in the left arm. On an unspecified date in 2021, She felt like the burning and itching on her face is flaring up since the second dose. Adds her ear is still burning, she still has pain in her temple and the streak on the left side of her face is scorched bright red and painful. Consumer reported an AE for the Pfizer COVID 19 vaccine mentioned, she called the ENT and he has increased her Gabapentin. Caller does not see NDC, lot or expiration date on Gabapentin dispensed in pharmacy vial. She has been taking Benadryl over the counter all along for relief from the itching, but it is not doing too much. For the generic for Benadryl that she has been taking she provides the UPC 357896681012; expiration date May2022; and Lot 681F01. It was mentioned that, she has lost about 15 pounds but she needed to. Consumer stated, "I just called to notify Pfizer that I had reactions from the Pfizer COVID Vaccine and she took all the information and I didn't have my vaccine papers with me at the time and there was no way of sending it, then I received the letter of the medicine that I was been given Gabapentin with the problem stating you know you were complaining about, that's nothing to do with that so my problem was after the first vaccine in February next day my feet started hurting, next day I got a rash on my left side of my face and I ended with shingle in my ear, inside of my face, in my mouth, my lips. I had to go the dentist, dermatologist, ENT. I am still numb from my ear down my cheek to my half and my mouth its like I got the Novocaine from the dentist (Clarification unknown) and I got the second shot nobody could give me any information whether or not to get it so I went through the second shot on 20Mar and I got inflamed on an unspecified date in 2021, my face was itchy I 'thought' I could rip it off and half of my face was quite red. I had to go back to get the medication again I have been on and off prednisone gabapentin Valtrex (Clarification unknown) since February 21st and I am still suffering from itchiness and numbness." First time calling Pfizer Drug Safety: Consumer stated, "No, I talked to someone a couple of years ago and they sent me a letter." (Hence checked as follow up report). Consumer stated "My shoulder did hurt that was no different than my regular shoulder (incomplete sentence). I had shoulder surgery before, the next day my 'cheek', my left side where I got my shot, the left side (incomplete sentence)." Consumer added, "I have ear pain inside my ear, my temporal is burning right above it." Other medical conditions: Consumer stated, "I have a pacemaker and a Defibrillators implanted, an AICD." Consumer added, "I just want to know when I got the second shot they explained everything I do have 'stitches' on the face, I send them what I am going through, I am still in numbness half of my face is still numb. I am suffering from 2 months." Consumer stated, still experiencing adverse events and treated with unspecified medications. There were no Investigation assessment. The patient underwent lab tests and procedures which included blood work (blood test) with unknown result on an unspecified date. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.