Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Eye swelling, Hypersensitivity, Swelling of eyelid, Throat irritation
Clinical narrative: feeling groggy; throat is itchy; allergic reaction; right eye began swelling/ both eyes are swollen shut; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via regulatory authority (under reference 00792629).  This case involves a 62 years old female patient who had allergic reaction (hypersensitivity) after receiving QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) and feeling groggy (somnolence), after receiving DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL).  The patient's past vaccination(s) included Influenza vaccine (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was also reported that the patient had several flu shots in the past, probably five flu shots in her lifetime.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 29-Sep-2021 at 10:00AM EST, the patient received a dose of suspect FLUBLOK QIV (Total, lot UJ723AA and expiration date: 30-Jun-2022) via unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect BENADRYL (50 mg, lot number and expiration date were not reported) via unknown route for Hypersensitivity.  On 29-Sep-2021, the patient developed a non-serious allergic reaction (hypersensitivity) and right eye began swelling (eye swelling) on the same day following the administration of vaccine.  On 30-Sep-2021, the patient's both eyes are swollen shut (eye swelling, non-serious) and throat is itchy (throat irritation, non-serious), one day following the administration of vaccine.  On an unknown date, the patient was feeling groggy (somnolence, non-serious) (unknown latency) following the administration of BENADRYL.  It was reported "Caller (patient) reporting allergic reaction to a flu vaccine. Caller states that she does not know which vaccine was administered to her but has the lot number and expiration date and is sure it is a SANOFI product. The caller states the vaccine was administered on 29SEP2021 at 10:00AM EST and shortly after in the parking lot on the way out, the caller's right eye began swelling. Caller states she was able to drive home but on 30SEP201 at time of call both eyes are swollen shut and her throat is itchy. Caller states she has spoken to the clinic where the shot was administered. Patient states that she is calling to let the company know about her reaction and to ask for the name of the flu vaccine that she received. Patient states that she got the lot number and expiration date from her doctor's office. Called Sanofi Pasteur Customer Service and spoke with customer service. Informed the Sanofi Pasteur Customer Service representative of the lot number provided by the patient. Sanofi Pasteur Customer Service representative stated that the product name is FLUBLOK. Relayed the information to the patient that the product name associated with the lot number provided is FLUBLOK. I only saw a small vial with a red top. My daughter also works in the pharmaceutical industry and she said that you all would need to know about my reaction. I am feeling groggy now. That is probably because I have been taking Benadryl every four hours. I can't drive. I can't put my contacts in. After I get off the phone with you and am going to go back and take a nap."  No laboratory data were reported.  Action taken with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) was unknown.  The patient was given 50mg of antihistamine every four hours as a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.