Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Scan brain
Clinical narrative: tingling in hands and feet; numbness in the left side of face; developed a headache; woozy-weird feeling; tingling in tongue; numbness in feet up toward knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 14May2022 at 10:13 as dose 4 (booster), single (Lot number: FJ4989) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: She has high blood pressure and diabetes; "diabetes" (unspecified if ongoing), notes: She has high blood pressure and diabetes; "obese" (unspecified if ongoing); "undifferentiated connective tissue disorder" (unspecified if ongoing), notes: she does have something they call undifferentiated connective tissue disorder. It manifests like rheumatoid arthritis, joint issues and psoriatic arthritis - it has the same kind of joint issues like joint pains, but she has never been diagnosed with any of those. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot Number: EL9264, Anatomical Location: Left arm, Her first initial Pfizer vaccine 30Jan2021 gave her ocular migraines, one episode.), administration date: 30Jan2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "ocular migraines"; BNT162b2 (Dose 2, Lot Number: EN6198, Anatomical Location: Left arm), administration date: 20Feb2021, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (Dose 3, Lot Number: FF8839, Anatomical Location: Left arm), administration date: 09Oct2021, when the patient was 67-year-old, for Covid-19 Immunization; Flu vaccine (States she took the senior flu vaccine probably sometime in 2020 or 2021. She got weird reactive arthritis that she think some people get from flu vaccines.), for Immunization, reaction(s): "joints started aching", "reactive arthritis". The following information was reported: HYPOAESTHESIA (non-serious) with onset 15May2022, outcome "recovering", described as "numbness in feet up toward knees"; PARAESTHESIA (caused and prolonged hospitalization) with onset 15May2022, outcome "recovering", described as "tingling in hands and feet"; PARAESTHESIA ORAL (non-serious) with onset 16May2022, outcome "not recovered", described as "tingling in tongue"; HEADACHE (non-serious) with onset 18May2022, outcome "not recovered", described as "developed a headache"; FEELING ABNORMAL (non-serious) with onset 18May2022, outcome "not recovered", described as "woozy-weird feeling"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in the left side of face". The patient was hospitalized and prolonged hospitalization for paraesthesia (start date: 15May2022, discharge date: 16May2022, hospitalization duration: 1 day(s)). The events "tingling in hands and feet", "numbness in feet up toward knees" and "tingling in tongue" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (16May2022) Unknown result, notes: she didn't have a stroke; Magnetic resonance imaging head: (16May2022) Unknown result, notes: she didn't have a stroke; Scan brain: (16May2022) Unknown result.  Additional Context: This is a follow up report. Reference number: unknown by caller.Caller received Covid 19 vaccine 4th booster on 14May2022. This is her fourth shot, which is her second booster. She received her first booster in October. She felt that with her preconditions she should get the extra booster. She had the shot on Saturday morning of 14May2022. She didn't seem to have a problem until the next day and all the sudden she got tingling in her hands and feet and it's progressed to numbness and tingling in her feet and legs. States the tingling was still in her hands. She went to the emergency room on Monday. She started to feel some weird effects on Sunday evening and decided to go to emergency room if things didn't get better. While in the emergency room, she was put in the admitting observation area so she could have a MRI and brain scan. She was released yesterday morning and her symptoms did seem to get better. She did have tingling and strange feelings, which are not back to normal, but they didn't say one way or another, it wasn't like she had a stroke because they did the brain imaging. She is still feeling a little weird as far as tingling in her hands and feet and the numbness in the left side of her face. They checked her for stroke and nothing was detected. Caller asked call handler to hold because she doesn't know who is calling and it may be the hospital and call disconnected. First outbound attempt 18May2022 at 12:48 PM, ININ: #. Reporter reached. Caller states that she had just received a follow up call from the emergency room stay. States she told them she is still feeling tingling and a little woozy-weird feeling, but not as bad as she was 2 days ago so hopefully it will disappear soon. She received the vaccine in the neighborhood this past Saturday. Her first initial Pfizer vaccine 30Jan2021 gave her ocular migraines, one episode. The Lot number is EL9264, but the expiration and NDC number are not on the card from the pharmacy. They don't put them down which is not good. She got the first and second vaccine at (Hospital Name Withheld) and the boosters she got in the neighborhood.  Reporter Details: She is retired. HCP details: Her doctor doesn't know about this. She has to tell her and she has a cardiology appointment tomorrow. States at the hospital when they released her they said perhaps she should check with a neurologist as well and she doesn't have one and hopefully her cardiologist can recommend one. HCP permission to contact declined, she will call back in and if she has a neurologist she will report that in to us as that will probably who will, if these things persist, who she will be dealing with. Event Details: Tingling in her tongue didn't happen until today, she had it on Monday and it went away and now it's come back. The numbness in her feet up toward her knees and has to say, which she didn't have before, she developed a headache, she's in the first couple of days for the booster so she assumes things can happen while her system is reacting to the booster. Tingling in hands and feet: It's not as severe and slightly improved. Numbness in feet up toward knees: There is still slight numbness. Tingling tongue: She woke up in the morning and she was fine. Toward mid-morning it was tingling and she had that woozy feeling and it's still doing it now. Products: Indication: Comorbidities for Covid; She has high blood pressure and diabetes, her age and she lives in (Withheld). She felt that she needed to give herself the extra protection which the 4th inoculation would provide. Covid cases are rising in her area and everywhere, and everyone is going around without masks and pretending life is normal. Concomitant: She is taking the same medications she took when she got all the other Pfizer vaccines. Investigations: She had some tests run in the emergency room but doesn't think she has any to report. Treatment: She went to the emergency room Monday, 16May2022, but not really other than doing the brain scans and MRI's. Refence number for previous report filed: She doesn't have it because when she talked to the agent they said if this happens again to call Pfizer and it was a one time thing.  Nothing happened on the second shot and the first booster.  VACCINE SUPPLEMENTAL FORM  1. Patient Details: see report 2. Patient Age at Time of Vaccination in Years: 68 years  3. Pfizer Suspect Vaccine and Vaccination Details, Vaccine Lot Number: FJ4989, Vaccine Lot Expire Date: unknown Time the Vaccination Was Given: appt at 10:13 am, Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm 4. Vaccination Facility Type: Pharmacy/Drug Store; please specify: (Withheld). It looks like 31May2022 on the card, but the pharmacist had terrible handwriting. Caller has a record through (Withheld) App. 5. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Vaccine Name: Pfizer Covid 19 Vaccine - First Lot Number / Expiry Date: EL9264; unknown NDC or expiry, Route, Anatomical Location: Left arm, No. of Previous Doses: none  Date: 30Jan2021, Age at Immunization if date not available: 67 years, Vaccine Name: Pfizer Covid 19 Vaccine - Second Lot Number / Expiry Date: EN6198 OR ENG198; She thinks it is a 6. Expiry unknown, Route, Anatomical Location: Left Arm, No. of Previous Doses: one Date: 20Feb2021, Age at Immunization if date not available: 67 years, Vaccine Name: Pfizer Covid 19 Vaccine - Third, Lot Number / Expiry Date: FF8839; Expiry unknown, Route, Anatomical Location: Left Arm No. of Previous Doses: two, Date: 09Oct2021, Age at Immunization if date not available: 67 years, Given at (Withheld), She thinks she had all of them in the left arm.  6. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None  7. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Tingling in hands and feet Time of Onset: (24-hour clock): She became aware of it on 15May2022 when she tried to go to bed because it was so weird it kept her from falling asleep sometime around 2200. Adverse Event: numbness in feet up toward knees Time of Onset: (24-hour clock): In the morning when she woke up it progressed to numbness moving up her legs more left than on the right. That's what sent me to the emergency room around 1700 on Monday. Adverse Event: tingling in tongue Time of Onset: (24-hour clock): She mentioned it in the emergency room, thinks the morning of 17May2022 when they were going to send her for her brain scan.  8. Additional Information Did any AE(s) require a visit to: Emergency Room? Yes Physician Office? NO, she has a follow up with a cardiologist tomorrow to get recommendation for a neurologist. If Yes, which AE(s)? tingling in hands and feet; numbness in feet up toward knees  If the patient was hospitalized, how many days was the hospital stay? She was on observation and kept overnight. Hospital Name: (Withheld), or it may be (Withheld). 9. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None  10. AE(s) following prior vaccinations: None or Unknown Adverse Event: States she took the senior flu vaccine probably sometime in 2020 or 2021. She got weird reactive arthritis that she think some people get from flu vaccines. Her joints started aching and took a while to resolve so she didn't get a flu vaccine this year and looks like she won't be getting any more Pfizer boosters either. Onset Age: not provided Vaccine/Brand Name: Flu vaccine, Vaccination Date: unknown, 2021 or 2020. Caller does not have NDC/LOT/Expiration of flu vaccine and does not know when she received it. 11. Patient's Medical History (including any illness at time of vaccination)?  Caller guesses she is obese and she does have something they call undifferentiated connective tissue disorder. It manifests like rheumatoid arthritis, joint issues and psoriatic arthritis - it has the same kind of joint issues like joint pains, but she has never been diagnosed with any of those.  12. Family Medical History Relevant to AE(s): No 13. Relevant Tests: Comments: She had an MRI of brain and spine. The results are unknown. She is going to the doctor tomorrow to get the results. They basically released her and said she didn't have a stroke. Caller asks if her symptoms persist for more than a week, should she call back and let Pfizer know what's going on? Instead of being transferred, she states she will take down the reference number and just call back with the reference number if things don't resolve. Caller states there are other people online that have had similar side effects and she hopes that they report them because she thinks it's very important.  No follow-up attempts are possible. No further information is expected.  Follow-Up (24May2022): Follow-up attempts are completed. No further information is expected.