Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Chills, Enlarged uvula, Erythema, Hyperhidrosis, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 50-year-old female patient who received BOOSTRIX (batch number 4SN42, expiry date 23rd March 2019). Co-suspect products included ZOSTAVAX (batch number M039453, expiry date 19th December 2017) and (batch number M034443, expiry date 20th April 2019). Concomitant products included CLARITIN, FLONASE, amlodipine, atenolol, Cetirizine, Montelukast, omeprazole, Hydrochlorothiazide + Triamterene, Venlafaxine and trazodone. On 13th June 2017, the patient received BOOSTRIX (intramuscular) .5 ml and ZOSTAVAX (subcutaneous) .65 ml. On an unknown date, the dose was an unknown dose. In May 2017, less than a week after receiving BOOSTRIX, the patient experienced uvula swelling (serious criteria life threatening and other: As per reporter). On 14th June 2017, the patient experienced rash (serious criteria life threatening and other: As per reporter), hives (serious criteria life threatening and other: As per reporter), skin red (serious criteria life threatening and other: As per reporter), pruritus (serious criteria life threatening and other: As per reporter), vomiting (serious criteria life threatening and other: As per reporter), sweating (serious criteria life threatening and other: As per reporter), chills (serious criteria life threatening and other: As per reporter), throat swelling (serious criteria life threatening and other: As per reporter) and swelling arm (serious criteria life threatening and other: As per reporter). The patient was treated with steroid injection and EPIPEN Tablet. In June 2017, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the rash, hives, skin red, pruritus, sweating, chills, throat swelling and swelling arm were not recovered/not resolved and the outcome of the uvula swelling was unknown. The reporter considered the rash, hives, skin red, pruritus, vomiting, sweating, chills and throat swelling to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the swelling arm and uvula swelling to be related to BOOSTRIX. Additional details were reported as follows: At 12:30 hours, the patient received BOOSTRIX on the left deltoid and ZOSTAVAX on the right arm. About 24 hours after the vaccine administration, the patient started developing a rash and hives. Her skin was beet red and itching. She went to bed and alternated between sweating and chills. Her throat started swelling and she vomited and her arms started swelling as well. The patient went to the emergency room on the reporting date morning and it was seen that her uvula was swollen and hives down her throat. The patient received a steroid injection and a prescription for prednisone. The reporter saw the patient on the reporting date's evening when she came in to pick-up her prednisone prescription. The reporter described the patient had hives from head to toe and she was beet red and sweaty. The patient told that she almost used her husband's EPIPEN before going to the emergency room. The reporter was certain that one of the vaccines caused this reaction, but reporter didn't know which vaccine, as both arms are swollen and covered in hives. The reporter considered the rash, hives, skin red, pruritus, sweating, chills, throat swelling and vomiting to be almost certainly related to ZOSTAVAX. It was unknown if the reporter considered the swelling arm and uvula swelling to be related to ZOSTAVAX.