Received May 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Flare up of Rheumatoid Arthritis; Electrical shocks running down her arms and legs; Numbness/ Hands felt numb; Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them; Swollen hands and feet; Sick all over; Had no energy; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on unknown date). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira). In FEB-2021, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (Verbatim: Flare up of Rheumatoid Arthritis) (serious criteria GSK medically significant), electric shock sensation (Verbatim: Electrical shocks running down her arms and legs), numbness in hand (Verbatim: Numbness/ Hands felt numb), tremor (Verbatim: Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them), peripheral swelling (Verbatim: Swollen hands and feet), sickness (Verbatim: Sick all over) and loss of energy (Verbatim: Had no energy). The outcome of the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy were resolved. It was unknown if the reporter considered the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix. The company considered the rheumatoid arthritis aggravated to be unrelated to Shingrix. It was unknown if the company considered the electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix. Linked case(s) involving the same patient: US2021253751 Additional Information: GSK Receipt Date: 17-APR-2025 The reporter reported that within 12 hours of receiving the second dose of Shingrix, she began to experience a bad immune response. The second dose of Shingrix was in February, 2021. Shingrix had triggered a flare up of her Rheumatoid Arthritis (RA). The patient experienced electrical shocks running down her arms and legs, her hands felt numb and she had no control over them. Her legs would also shake uncontrollably. Her hands and feet became swollen. The patient also reported she was sick all over, and had no energy. The patient stated it took almost 1 year for her joints to be back to where they were before receiving Shingrix.; Sender's Comments: Rheumatoid arthritis aggravated is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GLAXOSMITHKLINE-US2021253751:same patient saperet case is created due to time gap
Rheumatoid arthritis
HUMIRA