Sex: M
Vaccine: PNC20
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Influenza virus test negative, Intensive care, Laboratory test
Clinical narrative: developed a respiratory illness; Guillain Barre Syndrome; mild viral illness; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is a physician specializing in family medicine.  A 69-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Dec2022 as dose number unknown, 0.5ml single (Lot number: GF7610, Expiration Date: 30Mar2024) intramuscular, in left deltoid for immunisation; PAXLOVID, since 12Nov2022 for covid-19 treatment. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Allergy Allergic to Penicillin" (unspecified if ongoing), notes: Allergy Allergic to Penicillin. There were no concomitant medications. The patient had covid in the middle of Nov2022 and for that caller said that he gave the patient Paxlovid on 12Nov2022, the patient got over the covid very rapidly, felt fine, tolerated Paxlovid well and had minor symptoms like the after taste but did okay. The following information was reported: VIRAL INFECTION (non-serious) with onset 29Dec2022, outcome "unknown", described as "mild viral illness "; GUILLAIN-BARRE SYNDROME (caused and prolonged hospitalization, life threatening) with onset 02Jan2023, outcome "not recovered", described as "Guillain Barre Syndrome"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "developed a respiratory illness". The patient did develop a mild viral illness that started 29Dec2022 or so, but he was negative for covid and flu, it resolved, then 2 days after that is when he came down with Guillain-Barre syndrome. It was also reported that the viral ill was 2-3 days, the patient fine by the 29Dec2022, the patient was good for 48 hours on Saturday and Sunday the patient was fine, the patient was ill on 27Dec2022 and 28Dec2022, they got over the viral disease in 1-2 days. The patient was doing better then they had Guillain-Barre syndrome on 02Jan2023. The patient was hospitalized and prolonged hospitalization for guillain-barre syndrome (start date: 02Jan2023). The patient underwent the following laboratory tests and procedures: Influenza virus test: Negative; Tests: Unknown results, notes: He is sure there are tons of tests that the patient has but it is all in the hospital; SARS-CoV-2 test: Negative. The action taken for ritonavir was unknown. Therapeutic measures were taken as a result of guillain-barre syndrome. Guillain Barre syndrome Seriousness Criteria: Life Threatening as the Patient is in ICU and is intubated. In his literature there was not anything with Paxlovid or Prevnar 20 associated with Guillain-Barre syndrome and that is why he called and asked. Caller states that he is not saying the medications are related to the Guillain-Barre syndrome but there could be a spatial relation. Investigations: He is sure there are tons of tests that the patient has but it is all in the hospital. Prior to disconnecting caller states that this is all unknown, the Guillain Barre syndrome is hard to figure out, it happened in recent history.; Sender's Comments: Based on the information currently provided, viral infection with respiratory illness represents intercurrent infectious condition; the antecedent viral infection might trigger the onset of Guillain-Barre syndrome.  All events are considered as unrelated to PREVNAR 20 and Paxlovid use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate