Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dry mouth, Dyskinesia, Facial pain, Fatigue
Clinical narrative: Hard time opening mouth and I was in a lot of pain where jaw comes together; Hard time opening mouth and I was in a lot of pain where jaw comes together; Swelling on both sides of my face; Much pain on both sides of my face; Flu symptoms; Tenderness in the glands in my neck and around my ears/significant swelling like I had the mumps, much worse on the left the side, it was very puffy and painful; Tenderness in the glands in my neck and around my ears/significant swelling like I had the mumps, much worse on the left the side, it was very puffy and painful; Tenderness in the glands in my neck and around my ears/significant swelling like I had the mumps, much worse on the left the side, it was very puffy and painful; Chills; Fatigue; Dry mouth; This spontaneous case was received on 05-Oct-2020 with additional document (being processed together) on 07-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-02929) and concerned a 70-year-old female patient.  The patient's medical history included migraines and osteoporosis. The patient's had flu shots for many years, after which she experienced usual side effects, reported as flu symptoms, chills and fatigue. The patient's concomitant medications included Imitrex (sumatriptan) for migraines.  On 02-Oct-2020, at 14:00 pm, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml (reported as one dose), route of administration reported as injection and anatomical location: left arm) for an influenza prevention. The batch number reported was 276580, expiration date: 30-Jun-2021.  On 03-Oct-2020, one day after vaccination, the patient started developing mild flu symptoms, chills and fatigue like she normally did, as reported. The patient did not run a fever at all during that event. On the same night, the patient noticed some tenderness in the glands in her neck and around ears, just below her left ear in the glandular area, and it woke her up at 03:00 am. On the same day, the patient developed significant swelling and much pain on both side of her face, like she had the mumps, much worse on the left side (which was the side where the shot was given), which was very puffy and painful.  On 04-Oct-2020, on Sunday, two days after vaccination, when the patient woke up, she had a hard time opening her mouth and she was in a lot of pain where her jaw came together.   On an unspecified date in Oct-2020, the patient developed dry mouth. The patient did not take any treatments for events.  On an unspecified date in Oct-2020, 3-4 days from flu reaction as reported,  the patient recovered from all the events and no longer had concerns.  The reporter assessed all events as related to Afluria Quadrivalent as reporter stated that she had an odd reaction to Afluria shot.  The reporter assessed this case as non-serious.   The event of 'flu symptoms' was considered to be serious due to the criterion of medical significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked with the case 202004939 (the same patient).  Additional information received on 22-Jan-2021 from other non-health professional: The stop dates for all events were provided and outcome was changed from resolving to resolved. The narrative was amended accordingly.  Company comment: A 70-year-old patient was vaccinated with Afluria Quadrivalent. One day after vaccination, the patient started developing mild flu symptoms, chills, fatigue, lymphadenopathy, tenderness, pain upon movement, pain in jaw, swelling face, facial pain, dry mouth and suspected mumps. Mumps is assessed as not related, due to biological implausibility. For remaining events, causal role of the suspect vaccine cannot be excluded due to plausible temporal relationship. Although reported symptoms were rather consistent with influenza-like-illness, reported influenza (flu symptoms) is assessed as not related.; Reporter's Comments: She had an odd reaction to Afluria shot.; Sender's Comments: A 70-year-old patient was vaccinated with Afluria Quadrivalent. One day after vaccination, the patient started developing mild flu symptoms, chills, fatigue, lymphadenopathy, tenderness, pain upon movement, pain in jaw, swelling face, facial pain, dry mouth and suspected mumps. Mumps is assessed as not related, due to biological implausibility. For remaining events, causal role of the suspect vaccine cannot be excluded due to plausible temporal relationship. Although reported symptoms were rather consistent with influenza-like-illness, reported influenza (flu symptoms) is assessed as not related.