Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Blood triglycerides, Bone densitometry, Cerebrovascular accident, High density lipoprotein, Low density lipoprotein
Clinical narrative: she had a stroke; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 77-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: Maybe a year ago, took Fosamax; "Antianxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO oral taken for anxiety, start date: 2017; FOSAMAX oral taken for osteoporosis, start date: 2022, stop date: Sep2023; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; FISH OIL. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 17Sep2023, outcome "recovered" (2023), described as "she had a stroke". The patient was hospitalized for cerebrovascular accident (start date: 17Sep2023, discharge date: 19Sep2023, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (15Sep2023) perfect, notes: on Friday 15Sep and all her bloodwork was perfect; Blood triglycerides (normal high range 150): (06Sep2023) 74 mL, notes: supposed to be under 150, thinks units is mL, so not elevated; Bone densitometry: (unspecified date) osteoporosis; High density lipoprotein: (06Sep2023) 52 mL; Low density lipoprotein (normal high range 130): (06Sep2023) 119 mL, notes: supposed to be under 130, so not elevated. Thinks units is mL.The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received. Clinical course: Patient states she has been in perfect health most of her life. She went to have a wellness physical on Friday 15Sep and all her bloodwork was perfect.  She doesn't have diabetes, she doesn't have high blood pressure, she doesn't have high cholesterol.  She doesn't take any medications. Her doctor highly recommended that she take the Prevnar 20 because of her age. She doesn't take vaccines, she never has. She never took the Covid vaccine, she just doesn't take vaccines.  Her doctor was just so insistent, she took the shot, and 36 hours later she had a stroke.  Physician felt at patient's age caller should get in case caller ever got pneumonia, it would protect from severe forms of it, caller said okay, caller doesn't take vaccines, didn't even take the COVID vaccine. Patient doesn't take medication for anything other than osteoporosis which caller took Fosamax for. Osteoporosis: Never had a broken bone, doesn't believe has osteoporosis, has fallen a lot so says has osteoporosis, the DEXA scan said caller does. Has taken some pretty good falls but never broken a bone, caller doesn't think caller has a severe case of osteoporosis. Taking self off of Lexapro too since getting out of hospital, doesn't like taking medicine, doesn't need anymore. Caller is weening herself off of Lexapro currently. Takes a lot of supplements, like vitamin C, vitamin D, fish oil, but nothing prescribed, just all over the counter. No additional information provided.  The information on the batch/lot number for [PREVNAR 20], has been requested and will be submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event stroke related to the suspect product event most likely due to patient underlying contributory factors  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.