Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bell's palsy, Chest pain, Diplopia, Headache
Clinical narrative: eye styes; chest pain; numbness in big toes; bells palsy; double vision; severe headache; left sided back pain; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose 0.5 ml of Shingrix in right arm intramuscularly and had no adverse event.).   On 11th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th February 2022, 3 days after receiving Shingrix, the patient experienced headache (serious criteria hospitalization) and back pain (serious criteria hospitalization). On 25th February 2022, the patient experienced double vision (serious criteria hospitalization). On 7th March 2022, the patient experienced bell's palsy (serious criteria hospitalization and GSK medically significant). On 10th March 2022, the patient experienced numbness in toes (serious criteria hospitalization). On 29th March 2022, the patient experienced chest pain (serious criteria hospitalization). On an unknown date, the patient experienced stye (serious criteria hospitalization). On 5th March 2022, the outcome of the double vision was recovered/resolved. On an unknown date, the outcome of the headache and chest pain were recovered/resolved and the outcome of the back pain, bell's palsy, numbness in toes and stye were not recovered/not resolved.   It was unknown if the reporter considered the headache, back pain, double vision, bell's palsy, numbness in toes, stye and chest pain to be related to Shingrix.     Additional Information: GSK receipt date: 18-Apr-2022 Reporter's comment: The patient self-reported this case. The patient had both of her Shingrix vaccines.   On 11th February 2022, the patient received her second vaccine and then 3 days after vaccination, she started with a severe headache and left sided back pain.  On 25th February 2022, 14 days after vaccination, the patient then started with double vision. On 7th March 2022, 24 days after vaccination, the patient started with bells palsy. On 10th March 2022, 27 days after vaccination, the patient started numbness in her big toes.  Less than 3 months after vaccination, now the patient had has eye styes she could not get rid of.   On 29th March 2022, 46 days after vaccination, the patient also had chest pain that she went to the emergency room for and was now resolved.  On 5th March 2022, the patient's double vision resolved. The patient headaches had resolved, but she continues to had left sided back pain. Her bells palsy was getting better, but continues to had big toe numbness.  From the time she started with symptoms, she stated that she had 2 emergency room visits and 2 hospital stays that lasted about 6 days each.   The patient had no further information in regards to the lot or expiration of the vaccines. Emergency room visit required. The reporter did not consent to follow-up. No health care professional for follow up. Note: As permission denied for the follow-up and reported that patient had  2 emergency room visits and 2 hospital stays that lasted about 6 days each so conservatively hospitalization and emergency room visit was ticked for all the events.