Age: 76.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Guillain-Barre like syndrome, symptoms were like GBS, taken to ER; Fever (101.7F); Nausea; Unstable; Needed about 3 people to help him walk, taken to ER; Chills; Weak, energy and strength have not been fully regained; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   Previously administered products included FLUZONE with an associated reaction of guillain-barre syndrome (received FLUZONE about a year ago from reporting date and experienced guillain barre syndrome, fever, nausea, unsteadiness and walking difficulty, chills and weakness.), PNEUMOVAX with an associated reaction of guillain-barre syndrome (received PNEUMOVAX about a year ago from reporting date and experienced guillain barre syndrome, fever, nausea, unsteadiness and walking difficulty, chills and weakness.) and COVID-19 VACCINE UNKNOWN with an associated reaction of pain in extremity. Concurrent medical conditions included diabetes. Concomitant products included INFLUENZA VACCINE.   On 28th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of COVID-19 VACCINE UNKNOWN. On 28th October 2021, less than a day after receiving Shingrix, the patient experienced chills and weakness. On 29th October 2021, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), fever, nausea, unsteadiness and walking difficulty. On an unknown date, the patient experienced pain in arm. On 2nd November 2021, the outcome of the walking difficulty was recovered/resolved. On an unknown date, the outcome of the guillain barre syndrome and pain in arm were unknown and the outcome of the chills, fever, nausea and unsteadiness were recovered/resolved and the outcome of the weakness was recovering/resolving.   It was unknown if the reporter considered the guillain barre syndrome, chills, weakness, fever, nausea, unsteadiness, walking difficulty and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's sister. On 14th October 2021, 2 weeks prior to Shingrix vaccine, the patient received flu shot, but no adverse reactions.  The patient received 2nd dose of Shingrix on left deltoid at the local pharmacy and experienced chills and felt weak later that day.  Next day the patient had additional symptoms fever (101.7 degree F), nausea, difficulty walking, unstable, and Guillain-Barre like syndrome. Guillain-Barre syndrome (GBS) had not been diagnosed, but the reporter thought that symptoms were like GBS.  The reporter mentioned that the patient had difficulty walking the patient needed about 3 people to help him walk.  On 29th October 2021 around 4 pm, the patient was taken to emergency room (ER) and at the ER, blood work and head scan were done, no signs of stroke or blood reports were normal, and the patient was discharged from ER on same day around 9:30 pm.  However, it took patient 2 days to walk without assistance.  As per reporter, the patient was able to move fully without assistance on 2nd November 2021.  Furthermore, the reporter stated that all the symptoms had been resolved and However, his energy and strength had not been fully regained.  As per reporter, the patient was still improving day by day.  The reporter also mentioned that the patient had similar reaction/symptoms when he received fluzone and pneumovax about a year ago from the date of reporting.  Advised the reporter to call the respective companies that manufactures fluzone and pneumovax to report adverse reaction.  The reporter also mentioned that the patient received COVID shots (1st and 2nd dose), but no major reaction other than sore arm.  The reporter did not have lot/expiry date or dosage. However, reporter had NDC (National Drug Code) number. It was unknown if the reporter considered the pain in arm to be related to COVID shot. The reporter gave a consent to follow-up with health care professional. However, she did not have the name of the facility, fax number, or an email address. The reporter consented to follow-up.