Age: 50.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Neurological symptom, Oropharyngeal discomfort, Palpitations, Pyrexia, Sensation of foreign body
Clinical narrative: Serious guillian barré syndrome; Twiching feet, top of feet; Numbness in hands and feet; Vertigo; Joint stiffness; Heart pounding; Vision is blurry; Neurologic symptom; Face, arm and leg tightness; Arthritic symptoms in hands and feet; Chest pain; tightness in throat; lymphedema; neck and glands swelling; Felt like something was in the back of throat; Neck pain; Tongue swelling; malaise; fever, 102 F; weakness; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE SANOFI) (batch number UJ943AA, expiry date unknown) for prophylaxis.   On 10th January 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, the patient received FLUZONE SANOFI (intramuscular) .5 ml. On 10th January 2022, less than a day after receiving Shingrix, the patient experienced malaise, fever, weakness, throat tightness, lymphedema, neck swelling, oropharyngeal discomfort, neck pain and swollen tongue. On 7th November 2022, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), twitching of limbs, numbness of extremities, vertigo, stiff joint, heart pounding, blurred vision, neurological symptom, muscle tightness, arthritis and chest pain. On an unknown date, the outcome of the guillain barre syndrome, weakness, throat tightness, lymphedema, neck swelling, twitching of limbs, numbness of extremities, vertigo, stiff joint, heart pounding, blurred vision, neurological symptom, muscle tightness, arthritis and chest pain were not recovered/not resolved and the outcome of the malaise, fever, oropharyngeal discomfort, neck pain and swollen tongue were recovered/resolved.   The reporter considered the guillain barre syndrome, malaise, fever, weakness, throat tightness, lymphedema, neck swelling, oropharyngeal discomfort, neck pain, swollen tongue, twitching of limbs, numbness of extremities, vertigo, stiff joint, heart pounding, blurred vision, neurological symptom, muscle tightness, arthritis and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Feb-2022. Reporter's Comments:  The patient received a dose of Shingrix and experienced fever, malaise, weakness for 3 to 4 days, tightness in throat, lymphedema, and neck swelling. Consent to follow up was granted.   Follow-up information received on 6-Jan-2023. Reporter's Comments:  On 4th November 2022, 3 days after receiving FLUZONE SANOFI, the patient experienced Guillan barre syndrome, neurologic symptom neurological symptom, twitching joint stiffness, heart pounding palpitations, vision in right eye was blurry  face, arm and leg tightness arthritis symptoms in hands and feet, chest pain On 10th January 2022, the patient received an unknown dose of suspect Shingrix not produced by Sanofi Pasteur lot number not reported in an unknown administration site for immunization. On 10th Jan 2022 the patient developed a non-serious event 102 F fever neck and throat symptoms and stated it felt like something was back of her throat(oropharyngeal discomfort) neck and gland may have been swollen (neck pain) tongue swelling same day following  the administration of Shingrix. The patient saw physician on 13th Jan 2022 symptoms finally went away several months later. On 04th November 2022, the patient received a suspect Influenza quadrival A B vaccine Dose 0.5 ml strength standard batch number UJ943AA via intramuscular route in the left arm. On 07th November 2022 the patient developed a serious event Guillainn barre syndrome Guillain-Barre syndrome e Latency- 3 day On 07th November 2022  the patient developed a non-serious events other neurologic symptom neurological symptom, twitching joint stiffness, heart pounding palpitations, vision in right eye was blurry  face, arm and leg tightness arthritis symptoms in hands and feet, chest pain following the administration of  Influenza quadrival A B vaccine. The reporter stated that relevant laboratory test results included chest X-ray.  On an unknown date physician on 14th Nov 2022,Ear, Eye and Throat physician has had magnetic resonance imaging, eye examination, electrocardiogram ophthalmological examination. An Ear, eye and throat physician PCP had an MRI,eye exam, chest x ray,EKG, no medication and was received corrective treatment for the events. At the time of reporting the outcome was recovered and resolved in 2022 for pyrexia oropharyngeal discomfort, neck pain and swollen tongue and not recovered and not resolved for all other events. Summary of Changes: The lab details, suspect details, event details and narrative were updated.