Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: visual changes; Visual disturbance/her vision was weird/couldn't see right; got dizzy; like the information was coming from different places to her brain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 10Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset Feb2022, outcome "unknown", described as "Visual disturbance/her vision was weird/couldn't see right"; DIZZINESS (non-serious) with onset Feb2022, outcome "unknown", described as "got dizzy"; FEELING ABNORMAL (non-serious) with onset Feb2022, outcome "unknown", described as "like the information was coming from different places to her brain"; OCULAR DISCOMFORT (non-serious) with onset Feb2022, outcome "unknown", described as "visual changes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:This is a spontaneous follow-up report received from a contactable consumer. This consumer (patient) reported that:Updated Information: Reporter Information, Patient DOB, Height, Weight, Lab data, New Event Visual disturbance, Dizzy, Feeling abnormal, Event onset date. Is report related to a study or programme? NoSelected Report Type: Initial.Patient Ethnicity: (Ethnicity withheld),Is the patient also the reporter?: Yes Reporter type: Consumer or other non health professional.Reason for no lot number: of Prevnar 13: Other: was given at doctor's office during annual wellness exam.Other Products: No Additional Context: Transfer with consumer calling about Prevnar 13 shot that said she believes she is having side effects. Age: Caller clarified that her visual disturbance occurred in Feb2022 the first time, age adverse event started updated to 65, caller is currently 66.Email Address: Caller says she doesn't have one.Provider Email Address: Queried, not provided.   Caller says her side effect was visual disturbance where suddenly it was like her eyes couldn't see right, like the information was coming from different places to her brain and she couldn't see. She says she got dizzy, her and her vision was weird. She says the visual disturbance started a week after she got the vaccine, in February, and then she had a second episode 05May.  AE Treatment: Caller says that it lasted about 5 minutes, which she didn't time it, this is something she had never had happen before in her life, she was bumfuzzled by it. She says the second one she did time and it lasted 5 minutes and she did a few things, like putting one hand over one eye then she could see fine with no weird effects and she wasn't dizzy anymore. She says then when she uncovered the eye it came back. She says it was all the same for the opposite eye, she did the same thing and with that eye covered she could see fine, when she uncovered it she had a problem again. She says her eyes looked normal when she looked in the mirror. Caller clarifies that as long as one eye was covered she could see fine and wasn't dizzy or anything, she wouldn't know she had a problem until she uncovered the eye, which happened with both eyes, there would be a problem again with one eye uncovered. She says as long as one eye was covered there was no problem or distortion, with either eye uncovered for both eyes then things were haywire.  Historical AE/Other Medical Conditions: Caller says back in Dec2021 she passed out while driving and went to the ER after she came to and they did a head scan, a CT scan of her head and all kinds of blood work. She says after all the testing because she could have died if she didn't go have it done after what happened because she thought what if she was having a stroke, and testing surely would have found out. She says during testing she was taking Pravastatin, and found out a side effect was that she could pass out while driving so she quit taking Pravastatin in late December. She says month or so later she had no issues at all, the feeling lightheaded was totally gone, and she figured out that nothing else has changed, she had no new meds she is taking since then so she figured the visual disturbance must be from the Prevnar 13.  Pravastatin NDC/LOT/EXP: Unknown, product dispensed in an orange pharmacy bottle. Caller says she was sent another bottle after she told them she was not taking it anymore. She says she didn't take any of this bottle, then clarifies this is the bottle that she had taken some from, she gave it to her boyfriend since he takes some Pravastatin too. Caller says that the expiry from what she was taking says use by 17Oct2022. She says she sees L2 below 91-20. She says the Pravastatin dosage was 20mg, and she had started taking Pravastatin probably Feb2021. She clarifies the Pravastatin probably wasn't started until March, after blood work was done in Feb2021. Caller declines to do a report on her boyfriend taking her Pravastatin she was prescribed, and clarifies that he has his own Pravastatin and hasn't taken any from her bottle.  AE Outcome: Caller says that she has not had any visual disturbances since 05May. She says that brings up her question, since she also saw when she looked it up it is listed in side effects, visual changes side effects, so she wanted to know if it could happen again. She says if she was driving and didn't know to cover her eye, she might have an accident, so she wants to know if other people reported experiencing this, and how long this might keep happening.   No follow-up attempts are possible. information about lot/batch number cannot be obtained, No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.