Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Cardio-respiratory arrest, Dizziness, Feeling abnormal, Flushing
Clinical narrative: Intense pain at injection site; Severe throat swelling, code blue, taken to ER, hospitalized; Facial swelling; Rapid heartbeat; Dizziness; Shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included epinephrine for injection site pain, heartbeats increased, throat swelling and facial swelling.   Concurrent medical conditions included hearing aid wearer. Concomitant products included cetirizine hydrochloride (Zyrtec) and famotidine (Pepcid).   On 11th February 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started epinephrine at an unknown dose and frequency. On 11th February 2022, immediately after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization and clinically significant/intervention required), throat swelling (serious criteria hospitalization and clinically significant/intervention required), facial swelling (serious criteria hospitalization and clinically significant/intervention required) and heartbeats increased (serious criteria hospitalization and clinically significant/intervention required). In February 2022, the patient experienced dizziness (serious criteria hospitalization and clinically significant/intervention required) and shortness of breath (serious criteria hospitalization and clinically significant/intervention required). In February 2022, the outcome of the injection site pain, throat swelling and heartbeats increased were recovered/resolved. On an unknown date, the outcome of the facial swelling, dizziness and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, throat swelling, facial swelling, dizziness, shortness of breath and heartbeats increased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR034721  Additional details were provided as follows: The patient self-reported this case. The patient stated that she was now taking Zyrtec, Oral Steroids, Benadryl, and Pepcid. The patient had received a dose of Shingrix and as soon as the vaccine was injected, she experienced intense pain at the injection site and within 10 minutes developed a rapid heartbeat, severe throat swelling, and facial swelling.  The patient stated that a code blue was called, and she was taken to the emergency department and received a dose of Epinephrine and intravenous steroids.  The patient stated she continued to have facial swelling and less than 2 weeks after receiving Shingrix, epinephrine and intravenous steroids, the patient was experiencing dizziness and becomes short of breath walking up stairs. It was unknown if the reporter considered the dizziness and shortness of breath to be related to Epinephrine and intravenous steroids.  The reporter consented to follow-up. The case was linked with case US2022AMR034721, reported by same reporter.