Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Pyrexia, Suspected transmission of an infectious agent via product
Clinical narrative: This case was reported by a physician (subject) and described the occurrence of red around injection site in a 37-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). Concurrent medications included Vitamins. On 17 September 2013 at 15:00 the subject received a dose of FLUARIX QUADRIVALENT (.5 ml, unknown route, left arm). On 19 September 2013, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced red around injection site, injection site lump, injection site warmth, injection site tenderness. In September 2013, within days after vaccination with FLUARIX QUADRIVALENT, the subject experienced low grade fever, diaphoresis and fatigue. At the time of reporting the events of red around injection site, injection site lump, injection site warmth, low grade fever, diaphoresis, and fatigue were resolved "within 48 to 36 hours after injection." The physician reported that the injection site tenderness was unresolved and "still evident". The physician considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This physician mentioned that this case was also reported to GlaxoSmithKline. See case A1042502A for details on the other case. Follow up was received from physician on 31 October 2013. This prospective pregnancy case was reported by the physician on follow up. The physician reported that on 17 September 2013, she received a primary dose of FLUARIX QUADRIVALENT (intramuscular) and also experienced vaccine exposure during the first trimester of pregnancy. Concurrent medications included prenatal vitamin. The gestational age was calculated to be 3 weeks. The date of last menstrual period was reported as 22 August 2013. The estimated date of delivery was calculated to be 29 May 2014. At the time of reporting, the pregnancy was ongoing. The physician did not consider the events experienced as serious. The physician reported that the events began on 17 September 2013, on the same date as vaccination with FLUARIX QUADRIVALENT. The physician documented that all events were resolved on 20 September 2013. The diagnosis was "localized vaccine relationship." Per the physician the immunization series was not discontinued or delayed. The following information was received on 31 January 2014 via subject who is also a physician. The subject's last menstrual period occurred on 22 August 2013 and estimated date of delivery was 29 May 2014. The pregnancy was by normal conception and consisted of a single fetus. The subject was exposed to FLUARIX at 3 5/7 weeks gestation. At the time of the report the outcome of the pregnancy was ongoing and "healthy pregnancy so far". Follow up was received from the physician on 26 August 2014. The physician documented that the conception was normal. When asked if events were the result of a suspected transmission of an infectious agent via a medicinal product, the physician ticked "yes"; however, the physician also did not consider the events as serious. Attempts to clarify the reason the physician ticked "yes" for the question were unsuccessful. The physician documented that all events had resolved and were related to vaccination with FLUARIX QUADRIVALENT. After 39 weeks gestation (calculated), the subject gave birth to a female live infant with no congenital anomaly. The full-term infant was delivered by cesarean section and weighed 4.3 kilograms and was 22 inches long. The infant head circumference was 14 inches. APGAR score at 1 minute was 8 and at 5 minutes was 9. No further details were provided.