Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Trouble putting on chlotes due to dififculty moving the left arm; Pain at the injection site; Lump at the injection site; Pain; Fluad (TIV) was given to the 64-year-old patient; This is a spontaneous case, initially received from other non-health professional (consumer) via Company (reference number: SEQW20-00318) on 17-Apr-2020, concerning a 64-year-old female patient.  The patient's relevant medical history included breathing problems possibly related to scar tissue or cyst near heart/lung and hypertension.  The patient's historical vaccine included an unspecified flu vaccine on an unspecified date in 2017 which caused patient's arm hurt for 3 months and unspecified flu vaccine on an unspecified date in 2018 which caused patient's arm hurt for 6 months. The patient was taking antidepressants in the past but none of them worked. Genetic test was performed to determine the best anti-depressant and it showed that none would work for the patient.  The patient's concomitant medications included Toprol (metoprolol succinate), lisinopril, Ambien (zolpidem tartrate) and Klonopin (clonazepam), all for unknown indication.  On 18-Aug-2019, the patient was administered with Fluad (TIV) vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 260380, anatomical location: left arm, dose, route of administration and expiration date: not reported] (explicitly coded as 'Inappropriate age at vaccine administration') for an influenza prophylaxis.  On an unspecified date, after vaccination, the patient experienced pain at the injection site.  On 01-Sep-2019, two weeks after vaccination, the patient experienced pain (the type of pain was not specified) and developed a lump at the injection site.   On unspecified date, after vaccination, the patient also started having trouble with putting on her clothes due to difficulty moving the left arm.  It was reported that the patient was seen by physician's assistant that looked at the injection site and left arm and said he had never heard of this before.  On unspecified date in Mar-2020, the patient visited her health care professional (HCP) who said he had never seen anything like that. The patient's pain was not increased or decreased, it was still the same. The patient tried exercising to see if that helped, but it did not.  The outcome for the events of pain, 'mobility decreased', 'vaccination site lump' and 'vaccination site pain' was not resolved.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment to Fluad (TIV).  This case is linked to cases 202003112 and 202003113, due to the same patient.  Follow-up information received from other non-health professional via Company (reference number: SEQW20-00349) on 27-Apr-2020: Difficulty breathing, cyst, fibrosis and hypertension added to medical history. Suspect product recoded form unspecified flu vaccine to Fluad (TIV) and batch number added. Toprol, lisinopril, Ambien and Klonopin added as concomitant medications. New event of inappropriate age at vaccine administration added. Narrative updated accordingly.   Follow-up information received from other non-health professional (consumer) via Company (reference number: SEQW20-00404) on 15-May-2020: Event of 'vaccination site pain' added. Additional reference number added. Narrative updated accordingly.   Case updated on 16-Jun-2021. Correction made to information received on 15-May-2020: Case requires resubmission, since the initial version was submitted to eVAERS as a 5-day report (as marked in FDA.C.1.7.1 Local Criteria Report Type). This case does not contain device malfunction or remedial action, and therefore needs to be resubmitted as a non-expedited report. No changes made in the case or narrative.  Company comment: A 64-year-old female patient was administered Fluad (TIV) and developed pain and vaccination site mass two weeks later. On unspecified date, after vaccination the patient also experienced vaccination site pain and mobility decreased. Chronology needs more clarification for the event mobility decreased and vaccination site pain. Based on provided information, causal role of the suspect product is assessed as possibly related for vaccination site pain, vaccination site mass and mobility decreased. Causality is assessed as unlikely related for pain since concomitant medication may provide alterative aetiology for the event (defaults to ''related'' in the safety database for reporting purposes). Product administered to patient of inappropriate age is not related to the suspect vaccine per company's conventions.; Sender's Comments: A 64-year-old female patient was administered Fluad (TIV) and developed pain and vaccination site mass two weeks later. On unspecified date, after vaccination the patient also experienced vaccination site pain and mobility decreased. Chronology needs more clarification for the event mobility decreased and vaccination site pain. Based on provided information, causal role of the suspect product is assessed as possibly related for vaccination site pain, vaccination site mass and mobility decreased. Causality is assessed as unlikely related for pain since concomitant medication may provide alterative aetiology for the event (defaults to "related" in the safety database for reporting purposes). Product administered to patient of inappropriate age is not related to the suspect vaccine per company's conventions.