Age: 78.0
Sex: F
Vaccine: FLUR4
Symptoms: Anaphylactic shock, Chest discomfort, Hypersensitivity, Lip swelling, Pharyngeal swelling
Clinical narrative: anaphylactic shock; lip swelling; throat swelling; chest tightness; severe allergic reaction/minimal allergic reaction; Initial information received on 20-Oct-2023 regarding an unsolicited valid  serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves 78 years female patient who experienced anaphylactic shock, lip swelling, throat swelling, chest tightness and severe allergic reaction/minimal allergic reaction after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy to antibiotic, Allergy to chemicals, Reaction to preservatives and Drug allergy. Notes: naming a few are penicillin, sulfas, sulfides, phosphates, iodine , probiotics and lidocaine  Concomitant medications included Levothyroxine Sodium (Synthroid) for Thyroid disorder and and her allergy medicine is Cloro-Trimeton which is over the counter.  On an unknown date in 2022, the patient received 0.5 ml total (1 X) of suspect Influenza Quadrivalent Recombinant Vaccine (With an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed events of anaphylactic shock, lip swelling, serious throat swelling (pharyngeal swelling), chest tightness (chest discomfort) and allergic reaction/minimal allergic reaction (hypersensitivity) (unknown latency).  It was reported, Caller is calling us back about the FLUZONE and FLUBLOK vaccines. Caller spoke to someone here about FLUBLOK and was transferred to CR to ask about availability in her area. She was told by CR a shipment was sent out in August, but nothing after that because it was "not ready in time", and now she is terribly upset that she did not get one and said that if she does not get one, she will not be able to leave her house all fall and winter. She has now called us back to ask what the difference is between the FLUBLOK and FLUZONE because she needs something similar to the FLUBLOK desperately. She said she is just shocked that she cannot find the FLUBLOK to get. MIA told the caller the main difference is the egg content, to which she said she can have eggs, she is just allergic to antibiotics and her doctor told her they use antibiotics in chickens so she should only use the FLUBLOK. She is now asking if that is the only difference and if that means she can use the FLUZONE, or if not, she is asking again where she can get the FLUBLOK. What flu vaccine should I get! The caller rapidly gave a large volume of AE information for vaccines and drugs, including the J&J Covid vaccine, a "Fluvaxil" vaccine, Fluzone (uspecified exact formula), preservatives, and antibiotics. What is the difference between Fluzone QIV, Fluzone HD QIV, and Flublok! Which ones are preservative-free! Is the main reason people take Flublok because of egg allergies! Should I take Flublok since I only had lip swelling, throat swelling, and chest tightness when I took it last year, but no anaphylaxis! Which of the flu vaccines has the most ingredient in it that people react to! How can I get the right flu vaccine for me if my doctor does not have it! Can allergy skin testing be done with the different flu vaccines to see which one I react to.The 78-year-old caller stated that she has allergies to preservatives and chemicals. She stated that last year she received Flublok and had an allergic reaction that was not anaphylaxis. She described the reaction as lip swelling, chest tightness, and throat swelling. She took an allergy pill prior to receiving Flublok last year. She says, "it was sort of ok. They just monitor me for 3 hours." She believes she may have had more of a problem with a Fluzone vaccine in the past. She does not know the particular Fluzone vaccine with which she may have had more trouble. She was asked and she does not believe it was the high-dose Fluzone. She believes it was many years ago that she had Fluzone and she may have had anaphylaxis with it. She is not sure. She may have had Fluzone that was drawn from a multi-dose vial, but she is unsure of that too. Additional AE information that she reported is: --She had lip swelling, chest tightness, and throat swelling when she received the J&J Covid vaccine. --She stated, "I took 'Fluvaxil' a couple years ago and felt so sick from i. The patient called to inquire if we change any composition/component of FLUBLOK as she has anaphylactic shock and severe allergic reaction but was able to take the FLUBLOK vaccine last year and just had minimal allergic reaction. She wants to know because she want to have this year's flu vaccine and wanted to use FLUBLOK again if possible. Caller also wanted to know what is the nearest pharmacy or facility near her home who can inject her with the FLUBLOK vaccine. The patient also mentioned that she has a lot of allergies to chemicals and preservatives, naming a few are penicillin, sulfas, sulfides, phosphates, iodine , probiotics and lidocaine. She also mentioned that she is on Synthroid every single day for her thyroid problem and her allergy medicine is Cloro-Trimeton which is over the counter. The patient also asked if in case she gets allergic reaction to FLUBLOK what pill should she take aside from her usual allergic pill.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the reported events.  Outcome: Recovered / Resolved on an unknown date for the event lip swelling, was Recovered / Resolved on an unknown date for the event throat swelling, was Recovered / Resolved on an unknown date for the event chest tightness, was Unknown for the event anaphylactic shock and was Unknown for the event severe allergic reaction/minimal allergic reaction.; Sender's Comments: Sanofi company comment dated 25-Oct-2023: This case involves 78 years female patient who experienced anaphylactic shock, lip swelling, throat swelling, chest tightness and severe allergic reaction/minimal allergic reaction after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv]. The time to onset was compatible with the role of vaccine. Furthermore, information regarding condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.