Age: 41.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Injection site pain, Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: experienced arm pain in her left arm where she had the Boostrix administered; Inappropriate age at vaccine administration; sore arm in her right arm where she had the Shingrix administered; fatigue/Tiredness; muscle aches; achy feeling; interfered with her daily activity because she just laid around on the couch; She further explains the sore arm as feeling as if gravity was even hurting her arm when she would stand up; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 41-year-old female patient who received Herpes zoster (Shingrix) (batch number Y7RZ7) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 235D2) for prophylaxis.   Previously administered products included Varicella vaccine (received at an unknow time in the past), Tdap with an associated reaction of injection site pain (received Tdap (brand unspecified) almost 8 years ago and experienced arm pain at the injection site of the Tdap dose), Tdap (received a dose of Tdap (brand unspecified) about 4 years prior to that Tdap dose), Covid with an associated reaction of fatigue (COVID vaccines had caused her to feel fatigue and laid her out in the past), Prevenar with an associated reaction of pain in extremity (Pneumococcal vaccine (Prevnar) caused her arm pain for about 1.5 weeks in the past.) and Influenza vaccine with an associated reaction of no adverse event (Influenza vaccination did not cause her any adverse reactions). Concurrent medical conditions included multiple sclerosis (diagnosed with multiple sclerosis in 2024).   On 23-NOV-2024 12:00, the patient received Shingrix (right arm) and Boostrix (left arm). On 23-NOV-2024, 4 hrs after receiving Shingrix and not applicable after receiving Boostrix, the patient experienced injection site pain (Verbatim: sore arm in her right arm where she had the Shingrix administered), fatigue (Verbatim: fatigue/Tiredness), muscle pain (Verbatim: muscle aches), pain (Verbatim: achy feeling), activities of daily living impaired (Verbatim: interfered with her daily activity because she just laid around on the couch) and arm discomfort (Verbatim: She further explains the sore arm as feeling as if gravity was even hurting her arm when she would stand up). On 23-NOV-2024 12:00, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 24-NOV-2024, the patient experienced injection site pain (Verbatim: experienced arm pain in her left arm where she had the Boostrix administered). The patient was treated with ibuprofen. On 24-NOV-2024, the outcome of the fatigue, muscle pain, pain, activities of daily living impaired and arm discomfort were resolved (duration 1 day). The outcome of the injection site pain and injection site pain were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, pain, activities of daily living impaired and arm discomfort to be related to Shingrix. It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, pain, activities of daily living impaired and arm discomfort to be related to Boostrix.     It was unknown if the company considered the injection site pain, fatigue, muscle pain, pain, activities of daily living impaired and arm discomfort to be related to Shingrix. It was unknown if the company considered the injection site pain, fatigue, muscle pain, pain, activities of daily living impaired and arm discomfort to be related to Boostrix.   Additional Information: GSK receipt date: 25-NOV-2024 Patient was a registered nurse and nurse consultant for state immunization Unit in Public Health. This 41-year-old female patient reported receiving a standard dose of Shingrix in her right arm, and a standard dose of Boostrix in her left arm, once on Saturday, 23-Nov-2024, at around 12:00 pm, as recommended by her neurologist. On 23Nov2024, about 4 hours after her dose of Shingrix, she experienced a sore arm in her right arm where she had the Shingrix administered, fatigue, muscle aches, achy feeling, and was super tired. She further explained the sore arm as feeling as if gravity was even hurting her arm when she would stand up. She started taking ibuprofen after the adverse reactions started, dose unknown, every 6 hours to treat the adverse reactions. She stated that the adverse reactions interfered with her daily activity because she just laid around on the couch the following day. On the evening of 24-Nov-2024, all of the adverse reactions had resolved, except for some arm pain in her right arm when she received the Shingrix dose. On the evening of 24-Nov-2024, about 36 hours after her dose of Boostrix, she experienced arm pain in her left arm where she had the Boostrix administered. As of 25Nov2024, she continues to experience some minimal arm pain in her right arm when she received the Shingrix dose if she pushed on the area and some minimal arm pain in her left arm where she received the Boostrix dose when she pushed on the injection site. She was due for her second dose of Shingrix in about 2 months after her first dose (expected for the end of January, 2025), but must be separated by at least 2 weeks from her monoclonal antibody therapy for multiple sclerosis.  She might take ibuprofen prophylactically prior to her next dose of Shingrix. As patient was diagnosed with multiple sclerosis in 2024, within the last couple of months. She was barely Positive for John Cunningham virus, so she was contraindicated to receive natalizumab.  She was scheduled to start a B-cell depleting monoclonal antibody infusion therapy (OCREVUS (ocrelizumab) or BRIUMVI (ublituximab-xiiy); might be rituximab) in the next few weeks, two loading doses and then one dose every 6 months.  The Neurologist recommended first dose of Shingrix to be administered at least 2 weeks prior to starting therapy with monoclonal antibody therapy. She had never had chicken pox and was varicella titer negative. Patient received Shingrix below the recommended age schedule,which led to inappropriate age at vaccine administration. This was 1 of 3 linked cases , reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR148495:same reporter different patient US-GSK-US2024AMR148540:same reporter different patient