Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Gastroenteritis viral, Guillain-Barre syndrome, Incentive spirometry, Lung disorder
Clinical narrative: incentive spirometry; lung disorder; muscular weakness; neurological decompensation paraesthesia; productive cough; sputum discoloured; traumatic lumbar puncture; asthenia; gastroenteritis viral; guillain barre syndrome; paraesthesia/pens-and -needles on her arms; pneumonia aspiration; Acute respiratory failure; albumin csf increased; csf protein increased; csf red blood cell count positive; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024SA279533 (Sanofi).  Initial information received on 17Sep2024 regarding an unsolicited valid serious case received from an other health professional.  This case involves an unknown age female patient who experienced acute respiratory failure, sputum discolored, traumatic lumbar puncture, albumin csf increased, csf protein increased, csf red blood cell count positive, asthenia, gastroenteritis viral, viral gastroenteritis, incentive spirometry, lung disorder, muscular weakness, neurological decompensation, paraesthesia, productive cough, aspiration pna, Guillain barre syndrome: presented to the ed on 22Feb with progressive le weakness as a pens and needles on her arms and paraesthesia while receiving vaccine abrysvo and while treated with furosemide, magnesium oxide. levothyroxine sodium, rosuvastatin, famotidine, acetaminophen, lidocaine, sodium chloride [muro 128), docusate, paracetamol, cholecalciferol [d3], warfarin sodium [jantoven] and albuterol sulfate. The patient s past medical included MIRTAZAPINE, GEMTESA, MIRALAX and LORAZEPAM. The patient's past medical history, vaccination(s) and family history were not provided. On an unknown date, the patient stared taking furosemide tablet at strength of 40 mg and at a dose of 1 df qd (once daily) via orally, magnesium oxide tablet a strength of 400 mg and t 1 df qd (once daily) via orally, Levothyroxine sodium tablet at a strength of 75 mcg and at a dose of 1 df qd(once daily) via orally, rosuvastatin tablet at a strength of 5 mg and at a dose of 1 df qd oral, famotidine film-coated tablet at a strength of 20 mg and at a dose of 1 df bid(twice daily) via orally, acetaminophen tablet at a strength of 650 mg and at a dose of 1 df qd(once daily) via orally for pain, lidocaine patch at a strength of 4% topical applied once daily as per needed for pain, muro 128 (sodium chloride) eye drops at a strength of 5% and at a dose of 1 drop qid (four times in a day), docusate capsule 1 df qd(once daily) via orally, paracetamol tablet at a strength of 500mg - 25 mg and at a dose of 2 df qd (once daily) via orally, d3 (cholecalciferol) capsule at a strength of 50 mcg and at a dose of 2 df qd(once daily) via orally. On an unknown date jantoven (warfarin sodium) at a strength of 5 mg was changed to 1 df biw (jantoven (warfarin sodium) tablet 0.5 df 5iw(five times in a week) oral and albuterol sulfate inhalation aerosol at a strength of 90 mcg at a dose of 2 DF inhalation use for Dyspnea. On an unknown date, the patient received a dose of suspect Abrysvo not produced by (company name withheld) lot number not reported. On an unknown date the patient developed a serious paraesthesia, Guillain barre syndrome: presented to the ed on 22Feb with progressive le weakness as pens-and-needles on her arms (Guillain-Barre syndrome), aspiration pna (pneumonia aspiration), productive cough, neurological decompensation paraesthesia (neurological decompensation), muscular weakness, lung disorder, incentive spirometry, viral gastroenteritis (gastroenteritis vital), gastroenteritis viral, asthenia, csf red blood cell count positive, csf protein increased, traumatic lumbar puncture, albumin csf increased, sputum discolored and acute respiratory failure (unknown latency) following the first dose intake and (unknown latency) following the last dose intake (unknown batch number) of furosemide, magnesium oxide, levothyroxine sodium, rosuvastatin, famotidine, acetaminophen, lidocaine, sodium chloride, docusate, paracetamol, cholecalciferol, warfarin sodium and albuterol sulfate. Final diagnosis was (life-threatening) paraesthesia, (life-threatening) Guillain barre syndrome: presented to the ed on 22Feb with progressive le weakness as a pens-and -needles on her arms, (life-threatening) aspiration pna, (life-threatening) productive cough, (life-threatening) neurological decompensation paraesthesia, (life-threatening) muscular weakness, (life-threatening) lung disorder, (life-threatening) incentive spirometry, (life-threatening) viral gastroenteritis, (life-threatening) gastroenteritis viral, (life-threatening) asthenia, (life-threatening) csf red blood cell count positive, (life-threatening) csf protein increased, (life-threatening) albumin csf increased, (Life-threatening) traumatic lumbar puncture, (life-threatening) sputum discolored and (life-threatening) acute respiratory failure Action taken with RSV vaccine Prot subunit PreF2v was not applicable and with rest all suspect drug was unknown. Corrective treatment: not reported for all the events. At time of reporting. the outcome was Unknown for all the events. Seriousness criteria: life-threatening and hospitalization for paraesthesia, Guillain-Barre syndrome, pneumonia aspiration, gastroenteritis viral (hospitalization during 56 days), productive cough, neurological decompensation paraesthesia (neurological decompensation), muscular weakness, lung disorder, incentive spirometry, gastroenteritis viral, asthenia, traumatic lumbar puncture, sputum discolored (hospitalization during 63 days), and medically significant, life threatening and hospitalization (63 days) for csf red blood cell count positive, csf protein increased, albumin csf increased and acute respiratory failure(medically significant, life threatening and hospitalization (27 days)   Sanofi Company Comment: Name withheld company comment dated 01Oct2024: This case involves an unknown age female who experienced acute respiratory failure, sputum discolored, traumatic lumbar puncture. albumin csf increased, csf protein increased, csf red blood cell count positive, asthenia, gastroenteritis viral, viral gastroenteritis, incentive spirometry, lung disorder, muscular weakness, neurological decompensation paraesthesia, productive cough, aspiration pna, Guillain barre syndrome: presented to the ed on 22Feb with progressive le weakness as a pens-and-needles on her arms and paraesthesia while receiving vaccine abrysvo and while treated with furosemide, magnesium oxide, levothyroxine sodium, rosuvastatin, famotidine, acetaminophen, lidocaine, sodium chloride [muro128], docusate, paracetamol, cholecalciferol [d3], warfarin sodium [jantoven] and albuterol sulfate. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be denied. However, lack of information of past medication, pre-existing conditions and medical history any family history precludes comprehensive case assessment.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Guillain-Barre syndrome and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V. As there is limited information in the case provided, the causal association between the events acute respiratory failure sputum discoloured, traumatic lumbar puncture, albumin CSF increased, CSF protein increased, CSF red blood cell count positive, asthenia, gastroenteritis viral, incentive spirometry, lung disorder, muscular weakness, neurological decompensation, productive cough, paraesthesia, and pneumonia aspiration; and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available.  As there is limited information in the case provided, the causal association between the events acute respiratory failure sputum discoloured, traumatic lumbar puncture, albumin CSF increased, CSF protein increased, CSF red blood cell count positive, asthenia, gastroenteritis viral, incentive spirometry, lung disorder, muscular weakness, neurological decompensation, productive cough, Guillain-Barre syndrome, paraesthesia, and pneumonia aspiration; and the suspect drugs FUROSEMIDE, LEVOTHYROXINE SODIUM, and LIDOCAINE HCL cannot be excluded. The case will be reassessed once new information is available.  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.