Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Rash, Rash pruritic, Swollen tongue
Clinical narrative: This is an initial report of a serious adverse event, received on 06/Dec/2013, following receipt of FLUBLOK. Subject  a 43 year old, 230 lb, 64 inch, female received FLUBLOK Intramuscular on 03/Dec/2013. She was vaccinated at community hospital and her provider informed her that he/she administered FLUBLOK lot #340503F. The dose of FLUBLOK administered was obtained from another hospital. No information on the method of transport of the vaccine was provided. The patient self-reported the event to the Protein Sciences website. On or about Day 0 of receiving FLUBLOK - 03/Dec/2013 at approximately 7:00 PM -- the subject reported experiencing swelling of the eyes, lips, tongue and throat, a headache, increased blood pressure, rash above the right eye, difficulty breathing and "racing" of the heart. Prior to receiving FLUBLOK, the patient reported that she took two Benadryl capsules to prevent or lessen any allergic reaction she might have. The patient also reported experiencing anxiety and a racing heart prior to receiving the influenza vaccination. The patient reported that this was the first flu vaccine she had ever received, due to the fact that she is "highly allergic" to eggs. Within minutes of receiving the vaccination the patient's tongue felt swollen, a few hours later she developed a headache but continued to work. Near the end of her shift at work she took two Tagamet as recommended by the staff nursing supervisor at her place of employment. After leaving work and arriving at home on 4/Dec/2013, the patient took two more Benadryl and she reports she felt miserable with a racing heart and increased blood pressure. At 3:00 PM on 4/Dec/2013, the patient noticed a rash above her right eye and her eyes, lips and tongue appeared very swollen. She began having difficulty breathing on her way into work on 4/Dec/2013 which caused her to use her inhaler (condition for which the inhaler was prescribed was not reported). Upon her arrival at work, a staff member recommended that she go to the emergency room. In the emergency room the patient received intravenous solumedrol, Zyrtec, a breathing treatment, and intravenous fluid bolus (doses not reported). When her throat improved, she was treated with ibuprofen. At the request of her nursing supervisor, the patient did not go home alone, but stayed in a vacant hospital room overnight for observation. On the morning of 5/Dec/3013, the patient reported that she had improved, but still felt swollen so she returned to the emergency room before returning home. In the emergency room, the patient was given prescriptions for an Epi-pen and prednisone taper. She was instructed to continue taking Zyrtec and to use Benadryl and Tagamet if needed for a flare of the reaction. The patient followed up with her primary healthcare physician on 10/Dec/2013. It was reported at that time all of the events had resolved except that her tongue remained slightly swollen. The primary health care physician prescribed another five day course of prednisone which the patient reports completing on 14/Dec/2013 and 15/Dec/2013. At the time of this report, the patient reported that her tongue remains slightly swollen. She plans to follow-up with her primary healthcare physician. Medical/surgical history reported a severe allergy to eggs. Illnesses at the time of vaccination were not reported. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. The events are considered serious as they are significant medical events that caused the patient to visit an emergency room for symptomatic treatment and unexpected, based on the FLUBLOK Package Insert. Further medical follow-up information is unavailable at the time of this report. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available. The Company's assessment of the causal relationship between these events and FLUBLOK is that there may be a possible relationship. In the context of over 30,000 doses of FLUBLOK having been distributed during this season, many to individuals with significant allergic conditions due to the specific recommendations by ACIP of FLUBLOK for allergic individuals, this case report does not substantively change the known safety profile of FLUBLOK. Additional information was received regarding Subject:  on 14/Jan/2014. It was discovered that the pharmacy at the hospital who administered the vaccine to the subject uses FLUZONE® (manufactured by Sanofi Pasteur) for all patients including those with an egg allergy. The subject reported that at the time of this report she had been on prednisone for a month and was still experiencing symptoms. She reported that her tongue had not gone down any more than previously reported and the rash above both eyes on the eye lids continued to be present. It was suggested that the subject contact her primary care physician to assess the underlying cause for the swelling and rash. Based on the new follow up information received on 14/Jan/2014 stating that the patient received FLUZONE (from another manufacturer); the company's assessment of the causal relationship between the events of swollen tongue, swollen eyes, swollen lips, swollen throat, heart racing, blood pressure increased, headache, difficulty breathing and rash above both eye lids and FLUBLOK are not possibly related. In summary, this case report does not change the known safety profile of FLUBLOK. Additional information was received on 16/Jan/2014 regarding Subject: 2013-023114/LW. It was reported that the subject did receive FLUBLOK at her place of employment who obtained the vaccine from a different institution. A call to the pharmacist at the subject's place of employment reported no information regarding how FLUBLOK was obtained or transported. At the time of this report, the subject continues 06-Oct-2017 15:36 Page 3 of 3 Mfr. / imm. proj. report no. 2013-023224 to report tongue swelling and a severe rash over her right eye and "somewhat" of a rash over her left eye. The subject states that she did in fact receive FLUBLOK (verified by lot number provided previously). Based on the new follow up information received on 16/Jan/2014 stating that the patient received FLUBLOK which was obtained from a different institution; the company's assessment of the causal relationship between the events and FLUBLOK are possibly related Additional information was received on 27/Jan/2014 regarding Subject 2013-023224/LW (previously reported on 17/Jan/2014 as 2013-023114/LW in error). It was reported that FLUBLOK was ordered from Hospital's account in Sept/2013 and received on 15/Nov/2013. On 20/Nov/13 six doses of FLUBLOK were shipped to Hospital Pharmacy. The product was received in a cooler with ice packs to ensure shipping the product at the correct temperature as is the standard practice for the carrier. The contact person stated that there was nothing unusual regarding the storage/shipping of FLUBLOK. No additional details are available. Based on the follow up information received 27/Jan/2014, the company's assessment of the causal relationship between the events and FLUBLOK remain possibly related. On 03/Mar/2014, it was reported that attempts to contact the reporter for additional information regarding these events were made on 20/Feb/2014, 26/Feb/2014 and 27/Feb/2014. No response was received from the reporter. Should the reporter contact the call center, the information will be reported. Additional information is not available at this time. Additional information was received on 04/Mar/2014 regarding Subject 2013-023224/LW. Per the report, the event of tongue swelling is not as severe but still ongoing, rash over the right eye and rash over the left eye almost clears and flares again. The patient also reported that she is no longer taking prednisone. No additional details are available. Based on the follow up information received 04/Mar/2014, the company's assessment of the causal relationship between the events and FLUBLOK remain possibly related. Additional information was received on 07Apr/2014 regarding Subject 2013-023224/LW. Per the report, the rash over eyes has not resolved and still has tongue swelling. The patient reported that symptoms seem like they almost clear up then they flare again. Rash can be extremely itchy so she uses Benadryl cream and sometimes steroid cream. No additional details are reported. Based on the follow up information received 07Apr/2014, the company's assessment of the causal relationship between the events and FLUBLOK remain possibly related. Additional information was received on 07May2014 regarding Subject 2013-023224/LW. Per the report, the patient met with her physician on 18Apr2014 and was prescribed Desowen cream to be applied over both eyes twice daily which helped improve 90% of rash symptoms. Her tongue was still swollen and teeth imprints are visible. The patient also stated that she had her first mammogram which revealed a finding of fluid filled sacs in both breasts. Upon follow up with another physician she was informed that lymph nodes in both her breasts were swollen in response to some type of inflammation. The patient has given verbal consent to contact both physicians. The new event of Swollen Lymph Nodes was added. However, the onset date was not provided. The patient was asked to return for a 6 month repeat of the mammogram. Based on the follow up information received 07May2014, the company's assessment of the causal relationship between the event of Swollen Lymph nodes and Flubok is unlikely related in light of the reported information that the body may possibly be processing some type of inflammation. Addendum 02 Jan 2019: Upon second medical examination of the case during internal review, a significant correction was performed on 02 Jan 2019 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK Trivalent (528).; Sender's Comments: This case concerns a 43 years old patient who experienced with swelling of tongue, eye, lip, throat, heart racing, blood pressure increased, headache, difficulty breathing. Time to onset is compatible. Etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information & considering the allergic history of the patient, the role of the vaccines cannot be assessed.