Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Erythema of eyelid, Eyelid rash, Gastrointestinal pain, Headache
Clinical narrative: Rash is on her back; Cheek [on that side started] swelling/bumps; Stye/eye swollen; Red, [itchy] rash; Itchy rash; Bad headache; Gut pain; Fluid in cheek [are dissipating but not resolved completely. Patient also mentions] a weird smell like oily substance such as oil in a fast food fryer/the fluid moved down to her cheek; Loose bowels; This is a spontaneous case, reported by other non-health professional on 20-Dec-2018, concerning a 65-year-old, elderly female patient.  On an unspecified date (reported as last year), the patient received Fluad and didn't experience any adverse reaction. The patient's current conditions included cold sores, allergies like hay fever. It was reported that cold sores, allergies and hay fever started a years ago before flu vaccines and were continuous. The concomitant medications included Zyrtec (cetirizine hydrochloride), Vit C (ascorbic acid), Eye Bright (euphrasia officinalis leaf) and Lyzine (lysozyme chloride) for cold sores.  On 11-Oct-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On 13-Oct-2018, two days after vaccination, the patient experienced worst headache with resolved itself in 4 hours. Reported as that afternoon, the patient developed gut pain and loose bowels which resolved untreated in 5-6 days. Then on 14-Oct-2018, three days after vaccination, the patient developed rash on her face which were red with white pustules in the center. The red itchy rash spread to the patient's hairline and one came up on her eyelid. It had red bumps with a white pinpoint area in the middle of her eyelid. On an unspecified date in Oct-2018 (reported as used immediately after bumps started), the patient had applied Retin A 1 percent (tretinoin) to the majority if the rash and it dried up but the one in the eye had got bigger. It was reported that, the patient stopped Retin A, 3 days after bumps started to dissipate. The patient went to her primary care physician (PCP) and was told that it was possibly an allergic reaction to the vaccine.  On 08-Nov-2018 patient had her annual wellness appointment with her doctor. On 30-Nov-2018 patient's doctor referred her to dermatologist for face, chest and back breakout, but she didn't go because of the spot that was on her eye. On 10-Dec-2018 patient visited doctor, who told the patient to apply warm compresses to her eyelid. Overnight, it errupted and she went to see her eye doctor. The doctor told the patient that it was a stye and that if it did not get better that he would put her on an antibiotic and said to continue doing hot compresses for 20 minutes three times a day. It was reported that took about a week and then cleared up. On an unspecified date the patient developed swelling on the cheek on the side as she was taking hot compress. It was reported that patient had a weird smell like oily substance such as oil in a fast food fryer.  The reporter believes that bump on eyelid resolved from compresses, the fluid moved down to her cheek. The patient had been drinking lots of water to try and flush this out of her system. Neither her PCP or the eye doctor had told the patient what to do about the rash. The patient had not taken any over the counter or prescription meds for that part of it. The first night the patient applied ice which seemed to help but had been doing warm compresses since seeing her PCP. It was reported that, her PCP did not discuss anything with her prior to giving vaccine to her. On an unspecified date, the patient developed rash on her back, and no longer on her arm. It was reported that, patient had spent a lot of money going to the doctors and for medications. The patient confirmed that she provided all information and did not want to be followed up. The patient reported that would never get another flu shot unless had no choice.   The patient was recovering from stye (reported as just a little bit of residual problem), red and itchy rash. The outcome of the events cheek swelling, and fluid discharge was not recovered. The outcome of the event rash was not reported.  The reporter assessed the case as non-serious.  Follow up received from other non-health professional on 22-Jan-2019: The historical vaccine Fluad was added in the patient tab (with no adverse event). The event rash was added and the outcome of the event hordeolum was changed from not reported' to recovering' in the events tab. Med info number (SEQ19-00421) was updated in the additional information tab. The narrative and case comment were amended accordingly.  Follow-up reported by other non-health professional and retrieved on 18-APR-2019 and 23-APR-2019 (both the follow-up documents processed together): The patient's initials were updated in the patient information tab. Start date of cold sores, allergies, and hay fever was updated in the patient tab. The patient's historical condition cold sores were changed to current condition'. The indication of concomitant product Lyzine (lysozyme chloride) was updated as cold sores in the product tab. The start date (Oct-2018) of the event swelling was updated in the event tab. The events swelling of eyelid and redness of eyelid was added in the event tab. The events swelling of eyelid, rash pustular and redness of eyelid were mapped as a symptom under diagnosis Stye. The outcome of the event swelling was updated from not reported' to not recovered'. The narrative and case comment were amended accordingly.  Significant case amendment (18-Apr-2019): The determined causality of the event loose bowels' was corrected from unassessable to related. The LLT of the event swelling face was corrected from swelling to cheek swelling.  The event fluid discharge was added. The case comment was amended accordingly.  Non-significant follow up report received by reporter (medcom) on 19-Jun-2019: Med info number (SEQ19-01504) was updated in the additional information tab. No new information received, so no changes were made in the narrative.  Significant follow-up received from other non-health professional on 13-Aug-2019: The date of administration Fluad vaccine was changed, accordingly the start date of events rash erythematous and rash pruritic were changed.  The start date of event headache and stye was changed. Symptoms swelling of eyelid, rash pustular and redness of eyelid were removed from events as they were mapped as a symptom under diagnosis Stye. Additional event 'gut' provided. The narrative was amended accordingly.  Non-significant follow-up received from other non-health professional on 10-Sep-2019: The patient reported that did not want to be followed up and would never get another flu shot. The narrative was amended accordingly.  Company Comment: The patient experienced discharge, headache, rash erythematous, rash pruritic, diarrhoea, rash, swelling face, hordeolum and gastrointestinal pain after vaccination with the suspect product Fluad (TIV) (influenza vaccine). Chronology is plausible. Medical history of cold sores, allergies and advanced age (65) may have contributed to development of the events. Causality was also confounded by therapy with concomitant medications, Zyrtec (cetirizine hydrochloride), Eye Bright (euphrasia officinalis leaf) and Lyzine (lysozyme chloride). Considering all the above mentioned, causal relationship between the suspect product and the events is assessed as related.; Reporter's Comments: The patient experienced discharge, headache, rash erythematous, rash pruritic, diarrhoea, rash, swelling face, hordeolum and gastrointestinal pain after vaccination with the suspect product Fluad (TIV) (influenza vaccine). Chronology is plausible. Medical history of cold sores, allergies and advanced age (65) may have contributed to development of the events. Causality was also confounded by therapy with concomitant medications, Zyrtec (cetirizine hydrochloride), Eye Bright (euphrasia officinalis leaf) and Lyzine (lysozyme chloride). Considering all the above mentioned, causal relationship between the suspect product and the events is assessed as related.