Sex: U
Vaccine: HEP, HEPA, PPV, TDAP, TYP
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Swollen tongue, Tongue disorder
Clinical narrative: Initial unsolicited report received from literature on 22 June 2018. Background. The 13 valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged 65 years. The study examines adults 65 years for risk of adverse events (AEs) requiring medical attention following vaccination with PCV13 as compared with vaccination with PPSV23, a long-standing vaccine with a satisfactory safety profile. Methods. The cohort study included 6 Vaccine Safety Datalink sites. The exposed person-time included follow-up time of the first PCV13 received by subjects age 65 years from January 1 to August 15, 2015. The comparator person-time included follow-up time after the first PPSV23 received by subjects of the same age during January 1 to August 15 of each year of 2011-2015. The prespecified AEs included cardiovascular events, Bell's palsy, Guillain-Barre syndrome, syncope, erythema multiforme, thrombocytopenia, cellulitis and infection, allergic reaction, and anaphylaxis. Inverse probability of treatment weighting-adjusted Poisson regression models was used to estimate the relative risk (RR) of each AE. Results. A total of 313,136 doses of PCV13 and 232,591 doses of PPSV23 were included. The adjusted RRs comparing the incidence of AEs following PCV13 vs PPSV23 were all less than 1, except for anaphylaxis, which was insignificant with an RR of 1.32 (95 percentage confidence interval, 0.30-5.79). Only 1 patient who received PCV13 and 4 other vaccines concomitantly was confirmed by medical chart review as having experienced anaphylaxis after vaccination. Conclusions. These data do not support an increased rate of adverse events following PCV13 administration in elders compared with PPSV23 and should provide reassurance regarding continued use of PCV13. This case involves Adult patient who experienced anaphylaxis, while he/she received vaccines HEPATITIS B VACCINE, HEPATITIS A and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and while treated with PNEUMOCOCCAL VACCINE CONJ and Typhoid vaccines. The patient had a history of anaphylaxis to other agents such as eggs and intravenous contrast and experienced the same symptoms. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (with an unknown batch number, expiry date, route and site of administration). On an unknown date, the patient received a dose of suspect Typhoid VACCINE produced by unknown manufacturer (with an unknown batch number, expiry date, route and site of administration). On an unknown date, the patient started taking PNEUMOCOCCAL CONJUGATE VACCINE dosage unknown (with an unknown batch number, expiry date, route and site of administration) for Immunisation. On an unknown date, the patient received a dose of suspect HEPATITIS A not produced by Sanofi Pasteur (with an unknown batch number, expiry date, route and site of administration). On an unknown date, the patient received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur (with an unknown batch number, expiry date, route and site of administration). On an unknown date, fifteen minutes following the vaccination patient developed a serious anaphylaxis, felt the tongue swollen/thick, mild difficulty in breathing and swallowing. Event anaphylaxis assessed as Medical significant. Other relevant tests included no lab data. Final diagnosis was anaphylaxis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for anaphylaxis, as Unknown for patient felt the tongue swollen/thick, as Unknown for mild difficulty in breathing and swallowing and as Unknown for mild difficulty in breathing and swallowing. Sender's Comments: This case concerns an adult patient who received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS vaccine (unknown manufacturer), TYPHOID VACCINE (unknown manufacturer), PNEUMOCOCCAL CONJUGATE VACCINE, HEPATITIS A VACCINE and HEPATITIS B VACCINE and presented with anaphylaxis 15 minutes post vaccination. Time to onset is compatible with the role of vaccine. However, patient has a history of anaphylaxis to egg and intravenous contrast. Based upon the reported information, considering the allergic history of the patient and involvement of multiple vaccines, the role of the vaccine cannot be assessed individually.