Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Stomatitis, Tongue erythema
Clinical narrative: mucous membranes inside her nose were burning; headache; soreness in the arm; inside of cheeks were puffy; random itchiness; increased fatigue; Irritation roof of mouth; tongue was raw, red, and puffy; This is a spontaneous report from a contactable consumer or other non hcp.   An 81-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 04Feb2021 13:00 as SINGLE DOSE for COVID-19 immunization. Medical history included restless legs syndrome, multiple allergies, disability (handicapped for 7 years), osteoarthritis, drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took ampicillin and experienced rash, ampicillin and experienced drug hypersensitivity. After 1.5 hours after vaccination, the patient experienced headache, random itchiness, increased fatigue, irritation roof of mouth, tongue was raw, red, and puffy on 04Feb2021, mucous membranes inside her nose were burning, on 05Feb2021. The patient stated some side effects including: the inside of her cheek became puffy, the roof of her mouth became irritated, her tongue became raw and puffy and red, the mucous membranes became irritated, and she had burning inside her nostrils. The roof of her mouth and inside of cheeks is diminished but it is not gone and has been 6 days. The caller stated she has multiple allergies and chemical sensitivities and asked if this is a common side effect in sensitive people. She stated she has not taken any allergy medicine. The caller stated she also had a headache that lasted the rest of the day, soreness in the arm, random itchiness that began an hour and half after and continued to next day then began to disappear, intense fatigue for 3 days, her restless leg was increased through yesterday, for several days she felt out of sorts, didn't feel like herself, she can't put her finger on it but she felt off, she had increased joint and muscle pain a day and a half later, and has heard that whatever side effects you experience they will be more intense after the second dose. The patient stated that the facility didn't give them a vaccine card, NDC/LOT/EXP: Unknown. She says that they gave her some copied pages and a date for her next dose appointment which is 25Feb2021. She says that her first dose was injected in her left arm on 04Feb2021 at 01:00PM. She says that 1.5 hours after her first dose she had a headache and itchiness. She says that the itchiness was random and minor, and went away by the next day with no treatment. She says then she also had increased fatigue that day, which lasted for three days. She says later on Thursday, the day she got the vaccine, the inside of her cheeks were puffy, the roof of her mouth was irritated, and her tongue was raw, red, and puffy. She says she did no treatment for this, though she does have Benadryl in her house, she is so sensitive to Benadryl (UPC/LOT/EXP: Unknown) because she has restless legs syndrome, it makes it worse. Caller says she did not take the Benadryl. Caller says she is handicapped and has difficulty standing with restless legs syndrome. She says that those symptoms diminished, but have not gone, it has been 6 days already which is why she looked at the information from Pfizer. She says that the mucous membranes inside her nose on the following day were like burning, and she couldn't use her regular nasal wash that she uses. No further details provided about nasal wash. She says that was subsiding, and the thing that has been the most aggravating right now are the feelings in her mouth, which are not listed on normal side effects, which is why she called to find out if they could be side effects, and find out if it could be her immune system working. The patient stated she has had previous allergic reactions 7 years ago, when her allergist wanted to immunize her to Ampicillin allergy, which she is allergic to all major antibiotics, and when she had that she had a thick tongue and a puffy roof of her mouth and irritated tongue. She says that her allergist wrote a note saying they felt this was her immune system reacting. She says that the allergist was trying to help her with desensitization for her allergies, and she wanted to know if something like this happens with this COVID-19 vaccine, if a number of sensitive people that are sensitive to medications have reactions like this to it. She says that she thought she would call here before calling her general practitioner. Ampicillin NDC/LOT/EXP: Unknown. She says she is allergic to Ampicillin and Penicillin, she took Ampicillin 30 years ago and had a rash, and is allergic to everything else. She says that she was supposed to have elective surgery, so her doctor wanted to make sure she would be able to take an antibiotic, so her allergist chose Ampicillin. Penicillin NDC/LOT/EXP: Unknown. The patient stated she has not had any other recent vaccinations or started any new medications. She says she has eaten or drank nothing different recently. The patient stated she has so many allergies that she can't tell what they all are, she has multiple allergies and chemical sensitivities that she doesn't know what they are. She says there are inert ingredients in some medications too, she is difficult to prescribe for, as well as some things have multiple fillers but those have never been identified as to what is bothering her, so she just tries different manufacturers to see which don't bother her after she takes them. She says she is an unusual case. The patient says that she is handicapped and has had restless legs syndrome which she has had for a number of years. And handicapped 7 years, and she needs two hip replacements.  She says she has end stage osteoarthritis, documented as provided. She says when her allergies and chemical sensitivities become active, with her restless legs syndrome it is difficult to stand, it makes her restless legs syndrome worse. The outcome of the event random itchiness was recovered and the outcome of all other events was unknown.  Information on the lot/batch number has been requested.