Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Skin disorder
Clinical narrative: little purple spot; administered subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable Other HCP (nurse reporting for herself) communicated to Pfizer-sponsored program. A 68 year-old female patient of an at the age of 68 years received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Lot number: FA7484), dose 2 via subcutaneous route of administration, administered in Deltoid Left (deltoid area of the left arm) on 30Jul2021 14:00, as DOSE 2, SINGLE for covid-19 immunisation. The Relevant medical history included: "rectal cancer" (unspecified if ongoing), notes: Verbatim: rectal cancer. The patient's concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Lot number: FA6780), via an unspecified route of administration on 08Jul2021, as single dose for covid-19 immunisation. The patient reported that she was concerned with her second dose because she believed that her second dose that was given on the deltoid area of the left arm was administered subcutaneously instead of intramuscularly. Patient reports it look like there was a little purple spot right at the site of the injection. Patient states she didn't look, she couldn't really see she just happened to be in a bright sunny area. Confirms patient saw it Aug2021. She confirms seriousness is not serious. She wanted to know immunity results or efficacy of the vaccine when administered via subcutaneous instead of intramuscularly and if there are any recommendations for revaccination. Pfizer has not specifically evaluated the pharmacokinetics, safety, or efficacy of the vaccine when administered by any route other than intramuscularly. Pfizer does not suggest or recommend the use of the vaccine in any manner other than described in the EUA Prescribing Information. The Company has released interim clinical considerations for the use of COVID-19 vaccines. The interim clinical considerations state the following regarding incorrect administration routes (e.g., subcutaneous): Incorrect route (e.g., subcutaneous): Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events. If the dose given in error is the first dose, a second dose should be administered at the recommended interval (21 days [Pfizer-BioNTech] or 28 days [Moderna]). If this dose is the second dose, the series is complete, and no additional doses are needed. The patient reported that she has a suggestion that you put a very simple administration guideline into your packaging in addition to saying that it needs to be given IM, put in capital letters, do not pinch tissue. Use appropriate size needle with a little graph. You know, so at least the Regulatory Authority has a very nice graph, but it doesn't list specifically do not pinch the tissue. You have a lot of stupid people giving the vaccines now and it would hurt to tell people what not to do as well as what to do. It would be very simple to add one line, do not pinch tissue and follow guidelines on length of needle for IM administration. You must tell them what not to do and what to do because if it's not written down right in front of their nose, they won't believe it. A lot of people with different backgrounds are giving the vaccines and they don't get the picture. Patient reports she was not taking any medications at all, she had cancer, which hopefully was not active at the moment, she was sort of in the first few years after being treated for rectal cancer, she could not say she did not have it, but when she had a checkup a year ago things were okay. The outcome of the event Skin disorder and Incorrect route of product administration was unknown at the time of report  Information about lot/batch number has been requested.  Follow-up(13Aug2021):This is a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable female Nurse (patient) reported for herself that: The reporter is the patient.  Updated information: Patient details updated. Relevant medical history updated. Lot number updated. "little purple spot" updated as new event.  Follow-up attempts are completed. No further information is expected.