Age: 66.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site swelling, Lymph gland infection, Malaise, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016400773) on 31 August 2016. This case involves a 67-year-old female patient who was vaccinated with a dose of Flu shot and PREVNAR 13 possibly given in late afternoon (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) unspecified date in September 2015. The patients' ongoing medical history included asthma, moderate emphysema, allergy (Had all her life. Allergies to mold and other things.), heart (nos), and celiac disease (Since she was 50 years old). Family Medical History relevant to AE was reported as none. No illness at time of vaccination. Concomitant medications included VENTOLIN 2 puffs as needed (Been taking all her life), QVAR 40mg 2 puffs twice a day (Been taking about 5 to 6 years), ADVAIR HFA 230/71 20mg, 2 puffs in the morning (Been taking about 4 months). She is not getting that same effect that she use to. Lot:6ZP5402 exp:Sep2017), Montelukast 10mg tablet once a day by mouth for allergy, baby aspirin 81mg pill by mouth once a day. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine included Shingles vaccine in her right arm on an unspecified date in August 2015. It was reported that patient received Swine Flu Shot in her 20s in 1974, 1975 or 1976 and developed fever and chills. On an unspecified date, post vaccination, patient experienced injection site was sore, red and puffy. On 19 August 2016, unspecified duration post vaccination, patient got sick experienced sore throat. On 20 August 2016, patient experienced sweating and clammy, coughing up phlegm, was freezing and had a temperature of 100.1 Fahrenheit. On 22 August 2016, patient developed lymph node infection part of pneumonia diagnosis. On the same day, patient went to the clinic and was diagnosed with pneumonia. It was reported that patient received Flu shot vaccine every year since it became available. Laboratory investigations were not reported. Patient was treated with gargled with warm salt water and used cough drops for sore throat. Patient received Ibuprofen 250 mg tablet by mouth every 5 hours for fever, Doxycycline hyclate 100 mg tablet by mouth twice a day for 5 days for pneumonia. It was reported that if patient would not better in 5 days, then she will go back to the doctor. On 21 August 2016, patient's temperature came down to 98 degrees Fahrenheit and the patient recovered. On the same day, patient was recovered from event sweating and clammy, Sore throat. The patient was recovering from coughing up phlegm. The outcome of events Lymph node infection part of pneumonia diagnosis and pneumonia were persisting. The outcome of event weakness and freezing was not reported. Upon internal review, the company decided to consider the event serious because of important medical event pneumonia. List of documents held by sender: none. Sender's Comments: Pneumonia is reported after administration of influenza (unknown manufacturer) and PNEUMOCOCCAL POLYSACCHARIDE VACCINE (other company). Time to onset is too long and not compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine simultaneously hence role of the particular vaccine cannot be assessed.