Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain, Peripheral swelling
Clinical narrative: Frustrated for not feeling well for a month; Feeling sick, felt horrible/not feeling well for a month; The patient is really concern/scared; The arm she had the shot swelled, got red all the way to the elbow/ on the bicep and tricep; The arm she had the shot swelled, got red all the way to the elbow/ on the bicep and tricep; Chills; Horrible body aches; This spontaneous case was received on 26-Oct-2020 from other non-health professional (consumer) with additional information (being processed together) received on the same day via Health Authority (reference number: SEQW20-04299) and concerned a 66-year-old female patient.  The patient's concurrent conditions included hypertension. The patient's concomitant medication included progesterone for unreported indication.  On 24-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: arm, dose: 0.5 ml and route of administration: intramuscular) for flu prevention. The batch number reported was 279790, expiration date: 25-May-2021.  On the same day, the patient was vaccinated with non-company co-suspects Pneumovax 23 (pneumococcal vaccine polysacch 23v; dose, route of administration, anatomical location, indication and batch number: not reported).  On 25-Sep-2020, one day after receiving Fluad Quadrivalent and Pneumovax 23, the patient had chills and horrible body aches. The arm where the patient had the shot swelled and got red all the way to the elbow, on the bicep and triceps and this lasted for three to four days before it ran away.  On an unspecified date in Sep-2020, the patient recovered from the events 'localised erythema' and 'swollen arm'.  On 22-Oct-2020, reported as last Thursday, the patient went to urgent care because she was feeling sick, felt horrible. The patient did the COVID test, which revealed negative.  On 23-Oct-2020, reported as last Friday, the patient started treatment with Zihtromax (Z-Pak) (azithromycin).  On an unknown date in Oct-2020, the patient was really concerned and frustrated for not feeling well for a month.   At the time of initial reporting on 26-Oct-2020, the patient had not recovered from events. The patient was scared, as she was still feeling horrible.   The case was assessed as non-serious.  The reporter did not provide causality assessment.  Case updated on 14-Dec-2020: Correction made to information received on 26-Oct-2020: Company comment amended per correction request.   Company comment: Pain (reported as 'horrible body aches'), frustration tolerance decreased, erythema, anxiety, peripheral swelling, malaise and chills were associated with the use of Fluad Quadrivalent given on the same day along with another co-suspect product, Pneumovax 23. Pain, peripheral swelling, chills and erythema of reported event occurred on the same day after administration of both products, making chronology suggestive. Chronology is unclarified for frustration tolerance decreased, while for malaise and anxiety seems unsuggestive. The patient's concurrent conditions included hypertension while concomitant medication included progesterone for unreported indication. Based on preseted information, pain and chills are assessed as possibly related, peripheral swelling and erythema are unassessable since anatomical location was not provided (for arm and for both vaccines), anxiety and frustration tolerance decreased are result of the patient overall state - not related to the product itself. Malaise is general state of unwell being, therefore assessed as unlikely related to the product due to presented confounder. (unlikely related defaults to related for reporting purposes).; Sender's Comments: Pain (reported as 'horrible body aches'), frustration tolerance decreased, erythema, anxiety, peripheral swelling, malaise and chills were associated with the use of Fluad Quadrivalent given on the same day along with another co-suspect product, Pneumovax 23. Pain, peripheral swelling, chills and erythema of reported event occurred on the same day after administration of both products, making chronology suggestive. Chronology is unclarified for frustration tolerance decreased, while for malaise and anxiety seems unsuggestive. The patient's concurrent conditions included hypertension while concomitant medication included progesterone for unreported indication. Based on preseted information, pain and chills are assessed as possibly related, peripheral swelling and erythema are unassessable since anatomical location was not provided (for arm and for both vaccines), anxiety and frustration tolerance decreased are result of the patient overall state - not related to the product itself. Malaise is general state of unwell being, therefore assessed as unlikely related to the product due to presented confounder. (unlikely related defaults to related for reporting purposes)