Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Magnetic resonance imaging, Nausea, Pain in extremity
Clinical narrative: extreme dizziness; vertigo; Dry heave; slight nausea; her arm was only slightly sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood thinner" (unspecified if ongoing); "bad shoulders and bad knees" (unspecified if ongoing); "bad shoulders and bad knees" (unspecified if ongoing); "breast cancer survivor" (unspecified if ongoing); "lymphedema" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "DVTs" (unspecified if ongoing); "clots" (unspecified if ongoing); "hip surgery" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for anticoagulant therapy; METFORMIN taken for diabetes mellitus; TYLENOL taken for arthralgia. The following information was reported: DIZZINESS (non-serious) with onset 13Feb2021, outcome "recovering", described as "extreme dizziness"; VERTIGO (non-serious) with onset 13Feb2021, outcome "recovering", described as "vertigo"; PAIN IN EXTREMITY (non-serious) with onset 09Feb2021, outcome "recovered" (2021), described as "her arm was only slightly sore"; RETCHING (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "Dry heave"; NAUSEA (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "slight nausea". The events "extreme dizziness", "vertigo", "her arm was only slightly sore", "dry heave" and "slight nausea" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, vertigo.  Additional Information: Patient stated she does not like the sleepiness that meclizine produced for her. Is there a longer time frame that she can wait for her second COVID vaccine and it still be effective with her first COVID vaccine. Reaction/event as reported by primary source: She was told to cancel the 01Mar2021 vaccine date and give herself two more weeks before the second dose. Results of tests and procedures for investigation of the patient: Date: 13Feb2021 Test: CAT scan Result: didn't show any abnormalities. Results of tests and procedures for investigation of the patient: Date: 13Feb2021 Test: MRI Result: didn't show any abnormalities. Characterization of drug role: Concomitant: Tylenol 650 mg 4 times spread out over the day. Concomitant Products Warfarin, Metformin and Tylenol she has been taking since she was 60, Tylenol for bad shoulders and bad knees. Patient says that she had her first COVID vaccine on 09Feb2021 and then 4 days later she was in the ER with extreme dizziness and vertigo and of course they sent her home. Confirmed with patient that she was in the ER on Saturday 13Feb2021. She has been dealing with this for 4 weeks now. She has an appointment to get her second COVID vaccine on 15Mar2021 and the (Name) said that was the furthest time that her second COVID vaccine could be extended to. She has had vertigo and severe dizziness since Saturday after the COVID vaccination, 13Feb2021. On Saturday, 13Feb2021, she went to the ER alone and they kept her there and did a CAT scan and an MRI. From those, they didn't see anything and she was sent home with meclizine to help with the dizziness but it only made it worse and they gave her a nausea pill. In the ER she had dry heaves because she hadn't ate anything and she had slight nausea. She has a rolling walker and has been using a cane. Luckily she hasn't fallen and killed herself while using these. She has her next appointment scheduled for 15Mar2021. The one she had scheduled before she developed the vertigo and dizziness was supposed to be on Monday, 01Mar2021. But she had called to the # help line and whoever she spoke with suggested for the patient to wait 2 more weeks. So then she was scheduled to have her second COVID vaccine on Monday, 15Mar2021. She is calling to report what she experienced because she was told to report this when she had talked to someone from the help line. Whoever she spoke with there had told the patient to cancel the 01Mar2021 vaccine date and give herself two more weeks before the second dose. The person the patient spoke to said that is the furthest window between the two doses and that the patient should just wait and see what happens. She asks, has anyone else had major dizziness or vertigo after their second COVID vaccine. Patient asks if this agent can pass on her information to the medical information department for them to contact her with the answer to her question. She says she will not wait for a long time to be transferred to the department. She is soon to be 80 years old. She thinks that she has height shrunk, confirmed that this occurred before she received her COVID vaccine. So far, when the patient went in once to see her provider they didn't do much. Her provider said that the patient hadn't experienced an allergic reaction and confirmed that it was a side effect to the COVID vaccine. She has been on her own since then. She declined to provide further information for her Healthcare professional. Patient received her COVID vaccine in the afternoon around 2 PM on 09Mar2021. 4 days later, on early Saturday morning, 13Feb2021, she had woken up about 3:30 AM and she about fell out of her bed. She was home alone so she called an ambulance because she couldn't get any other relatives to answer their phones. Then 3 ambulances showed up and 6 men came into her house, it was weird. They helped her downstairs because she couldn't stand up and they put her on the gurney and took her to ER. That was around 3:30 AM and she was there until about 3:30 PM or 4:00 PM later that same day. She didn't stay overnight and left 13Feb2021. They gave her nausea medication and meclizine and sent her home. They had no idea what happened and didn't connect what she had experienced with the COVID vaccine. They didn't even say if she had an allergic reaction. She says that her extreme dizziness and vertigo has lessened somewhat. Her son has left and was now taking care of her, since he can do so much of his work online. She would say that she has slightly improved. She has been using a rolling walker and a cane to get around, but she hardly ever uses the cane by herself but she was starting to a little bit. She was worried about what will happen with the second COVID vaccine on 15Mar2021. What response will that be like? She didn't have any eggs or anything before the vaccine. She has bad knees and she takes Tylenol 650 mg 4 times spread out over the day so that she doesn't overdose on it. She didn't feel the COVID vaccine shot, her arm was only slightly sore, but she that was nothing and she thought she was home free, but she was wrong.  Her arm was slightly sore: This began on 09Feb2021 and she confirmed that she has recovered completely. It was nothing really that day or the next day since she takes Tylenol every 4 to 5 hours because she has bad shoulders and bad knees, the dizziness if her main problem. Confirmed that the bad shoulder and knees occurred prior to the COVID vaccine and it was from years before from her skiing. Dry heave and slight nausea: These occurred on 13Feb2021. She has a nausea medication but she never had to use it. She did try to use the meclizine but it didn't really stop the imbalance or the vertigo. It just didn't stop it. At times she has been sick to her stomach but she doesn't take the medication because it makes her sleepy and then she doesn't want to move so she stopped taking it. Caller says she was unsure of an exact date when these stopped but maybe one other afternoon she had the dry heaves and other than that she didn't have it anymore. She confirms that she has recovered completely from both of these. She received her COVID vaccine in her left arm because she was a breast cancer survivor and has lymphedema on her right arm from nodes they took out under her arms. She confirms that the breast cancer and the lymphedema occurred in about 1997, prior to her COVID vaccine. Indication: Because she was older and she was diabetic but that was under control, her doctor said that she didn't need to check her blood sugar every day like she was doing. She was on a blood thinner, warfarin, and she has had a different number of DVTs and the other one that was on surface, a clot. She has never had any trouble in the past with DVTs or clots, even when she had a hip surgery, she never had problems but she still takes the warfarin. She watches what she eats. Is there a Product Complaint: Yes, Dscription of Product Complaint: Description of complaint: Caller reporting AEs after her COVID vaccine mentioned that she was sent home from the ER with meclizine but it didn't really stop the imbalance or the vertigo. History/ Investigations: She says no because she has already told this agent the two prescriptions that she takes and there is nothing different. Confirmed her medications to be Warfarin and Metformin. She has been taking them and the Tylenol since she was 60 and she is still taking them to today. She provides her dose for the Metformin and Warfarin as that these are things that she takes daily. No further details provided. She had no idea that what she had experience and the COVID vaccine were even connected until she went to see her nurse practitioner and she had told the caller that of course the caller didn't have an allergic reaction because it would of happened on the first day after her COVID vaccine or so. Since this had came on later, it sounds like a side effect to the COVID vaccine. The nurse practitioner gave the caller the company number with some print outs. The caller had talked to her other doctors about this too. She is petrified to take the second COVID vaccine that is scheduled for next Monday, 15Mar2021. Her nurse practitioner told the caller to go ahead and get her second COVID vaccine on her original scheduled date of 01Mar2021, and the caller said nope she can't do that so she called and talked to whoever she spoke with there said that she would wait and that the caller has another 2 weeks that she is able to wait. Apparently there's a 5 week window that is able to be had between the two doses. The caller decided to wait but now she is petrified to get the second COVID vaccine. She does not want anything else to happen. What she has experienced is enough. It just didn't stop it. Meclizine: Probed for lot number, NDC number, and expiry date and caller says that she doesn't have this to provide. She is not going to take another trip to get that with how she feels. Patient confirms that the diabetes, DVTs, clots, and hip surgery all occurred prior to COVID, she says way before she thinks in either 2005 or 2007.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.