Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: loss of hearing; Walking pneumonia; swelling around the injection site; soreness around the injection site; ear infection; bronchitis; dry skin; wrinkling skin; 2nd dose not yet received; shingles on the left leg above the knee;  This serious case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and did not receive 2nd dose of Shingrix. In JUL-2020, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the left leg above the knee). On an unknown date, the patient experienced hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant), walking pneumonia (Verbatim: Walking pneumonia) (serious criteria GSK medically significant), injection site swelling (Verbatim: swelling around the injection site), injection site pain (Verbatim: soreness around the injection site), ear infection (Verbatim: ear infection), bronchitis (Verbatim: bronchitis), dry skin (Verbatim: dry skin), skin wrinkling (Verbatim: wrinkling skin) and incomplete course of vaccination (Verbatim: 2nd dose not yet received). The outcome of the hearing loss, injection site swelling, injection site pain, shingles, ear infection, bronchitis and dry skin were resolved and the outcome of the walking pneumonia was not reported and the outcome of the skin wrinkling was not resolved and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the hearing loss, walking pneumonia, injection site swelling, injection site pain, shingles, ear infection, bronchitis, dry skin and skin wrinkling to be related to Shingrix.     The company considered the hearing loss and walking pneumonia to be unrelated to Shingrix. It was unknown if the company considered the injection site swelling, injection site pain, shingles, ear infection, bronchitis, dry skin and skin wrinkling to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-DEC-2020 The reporter reported that the patient received the first dose of Shingrix vaccine on 10-DEC-2019 and had not received the second dose yet (Inappropriate schedule of vaccine).  Patient reported the day after receiving the vaccine she was achy, had a headache, was exhausted, had soreness around the injection site, had chills, had swelling around the injection site, diarrhea, shivering, and muscle pain. Patient reported these events lasted 3 to 4 days and then resolved.  Patient reported she was diagnosed with shingles in July 2020.  Patient reported shingles on the left leg above the knee, had itching, redness, and pain around the area of shingles.  Patient reported dry skin, wrinkling skin, and peeling skin around the area of shingles.  Patient reported these events lasted a couple of weeks with the exception of the wrinkling skin which was still ongoing at this time.  Patient reported her doctor prescribed an antiviral medication for the shingles.  Patient reported she had bronchitis and an ear infection in January 2020 and these have resolved.  Patient reported she was prescribed steroids for the bronchitis.  Patient reported she had a loss of hearing around January 2020 that lasted for 30 days and resolved.    Follow up information received on: 22-JUL-2025 The reporter states she received her first dose of Shingrix vaccine in January or February of 2020.  Consumer states she was never informed that she needed to have a second dose administered, therefore, she did not have the second dose of Shingrix vaccine (missed dose.)  Consumer states she had a small case of shingles after having the first dose (date not disclosed / lack of effect.) The consumer states after having the first dose of Shingrix she was lethargic, achy, and had a fever.  The consumer stated that there was no record of her having had the first dose administered as the doctor's office where the vaccine was administered failed to record/report the injection.  During the call the consumer stated she will speak with her doctor about having the second dose administered but was worried about the potential adverse events she may have and worried about efficacy.  The consumer states that she has recently been diagnosed with walking pneumonia. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. Summary of changes: Patient tab, product tab, event details and narrative were updated.; Sender's Comments: A case of Deafness and Atypical pneumonia, an unknown time after receiving Shingrix, in a 68-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GLAXOSMITHKLINE-US2020239776:same reporter