Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Guillain Barre syndrome; Hypoxic respiratory failure; strep pneumonia; MSSA; Patient was seen in wheelchair today, but she was able to walk with a walker; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. On 03-AUG-2024, the patient received Shingrix. On 01-JUL-2024, the patient received Pneumococcal vaccine. In AUG-2024, less than 2 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), hypoxic respiratory failure (Verbatim: Hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), pneumonia streptococcal (Verbatim: strep pneumonia) (serious criteria hospitalization and GSK medically significant) and methicillin-sensitive staphylococcus aureus infection (Verbatim: MSSA) (serious criteria hospitalization). On an unknown date, the patient experienced walker user (Verbatim: Patient was seen in wheelchair today, but she was able to walk with a walker). The patient was treated with immunoglobulins nos (Immunoglobulin I.V). The outcome of the guillain barre syndrome was resolving and the outcome of the hypoxic respiratory failure was resolved and the outcome of the pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user were not reported. It was unknown if the reporter considered the guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user to be related to Shingrix. It was unknown if the company considered the guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient received Pneumonia vaccine on 01-JUL-2024 in the office and Shingrix on 03-AUG-2024 at the pharmacy. No other products were received by the patient. The patient was in hospital for GBS (guillain barre syndrome) and diagnosed on 12-AUG-2024. Guillain-Barre syndrome-patient called the on-call physician on Sunday August 11th, 2024, for new onset of numbness and tingling in her hands and feet. At that time had no other symptoms. The patient was told to call and schedule a visit the next day on 12th August 2024. Patient was seen the next day in at that time had severe ataxia as well as upper and lower extremity weakness and paresthesia. She was sent to emergency room. She was then transferred to emergency room. She had 4 doses of IVIG then she had 5 doses of plasmapheresis. Patient had received Pneumonia vaccine and followed by Shingles vaccine about 2 weeks prior. Also, she had a recent tick bite. Lumbar puncture showed no white cells and protein and 150. Lyme was negative. She then developed hypoxic respiratory failure requiring endotracheal intubation on 14-AUG-2024. She was transferred to hospital on August 19th until August 31st, 2024. Patient's hospital course was complicated by MSSA (Methicillin-Sensitive Staphylococcus Aureus) and strep pneumonia, autonomic dysfunction and labile blood pressures. She was unable to be weaned from the ventilator and underwent trach (Tracheostomy) or PEG (Percutaneous Endoscopic Gastrostomy) tube on 25-AUG-2024. She was then sent to hospital and for weaning. Patient was finally weaned on 25th-SEP-2024. PEG tube was shortly thereafter discontinued. She was then admitted to hospital on 3rd October 2024 till 4th November 2024 for aggressive physical therapy. She was then sent to subacute rehab for which she stayed from 4th November 2024 until 27th November 2024. She was then discharged to home with home health care as well as occupational therapy and physical therapy. Patient was seen in wheelchair today, but she was able to walk with a walker. She continued have paresthesia's in the hands in the feet she occasionally has back pain and spasms. She denied any dysphagia or dyspnea. Denied any difficulty swallowing. Less than a month, after received Shingrix, the patient experienced pneumonia streptococcal and methicillin-sensitive staphylococcus aureus infection. Between 1 and 2 months, after received Pneumococcal vaccine, the patient experienced guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal and methicillin-sensitive staphylococcus aureus infection. It was unknown if the company considered the guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user to be related to Pneumococcal vaccine.; Sender's Comments: Guillain-Barre syndrome is a listed event which is considered related to a GSK vaccine Shingrix Respiratory failure, Pneumonia streptococcal and Staphylococcal infection are unlisted events which are considered unrelated to GSK vaccine Shingrix
Test Date: 202408; Test Name: Blood pressure; Result Unstructured Data: (Test Result:labile blood pressures,Unit:unknown,Normal Low:,Normal High:); Test Date: 202408; Test Name: Laboratory test; Test Result: Negative ; Test Date: 202408; Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:no white cells,Unit:unknown,Normal Low:,Normal High:); Test Date: 202408; Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:no protein,Unit:unknown,Normal Low:,Normal High:); Test Date: 202408; Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:150,Unit:unknown,Normal Low:,Normal High:)