Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Euphoric mood, Exaggerated startle response, Fatigue, Feeling abnormal
Clinical narrative: nervous; easily startled with any quick noise; she has awoken with a very bad startle in the night; depressed; Feeling jittery; woke up on 09Apr2021 around 7 AM, she was on some kind of a high; tiredness/body was tired; head felt a little different, fuzzy; couldn't sleep that well at night; headache; This is a spontaneous report from a contactable consumer reported for herself. A 93-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via an unspecified route of administration in the left upper arm on 08Apr2021 14:00 at single dose  for COVID-19 immunization. Medical history included ongoing acid reflux which was bad enough that she would upchuck in the morning, light stroke from 2019 that she did not need to go to rehab and made a complete recovery, ongoing thyroid problem diagnosed 10 years ago, low on vitamin D which was brought up to normal with a special medication and then she was advised to take vitamin D every day, ongoing chronic urinary tract infections hospitalized and with treatments. Concomitant medications included omeprazole from a couple of years ago and ongoing for acid reflux, levothyroxine ongoing from maybe 8 years ago for thyroid problem, vitamin D3 ongoing for low on vitamin D, sulfamethoxazole/trimethoprim (SMZ-TMP) ongoing from at least 12 years ago for chronic urinary tract infections as prophylaxis, atorvastatin ongoing for a light stroke, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing for a light stroke. The patient reported that she took SMZ-TMP for her chronic urinary tract infections as prophylaxis. Her physician had informed her that your body builds up immunity to the antibiotics and you can still get urinary tract infections. Caller reported that when she gets a urinary tract infection while taking the SMZ-TMP, she has to take something different and then switch back to it. The patient was recently on a different kind of antibiotic for a urinary tract infection, but she cannot remember the name. That evening the patient went to bed and stated "my head felt a little different, fuzzy, I couldn't sleep that well at night on 09Apr2021. I woke up the next morning and felt high as a kite." She stated this lasted all day and said, "my body was tired but I couldn't sleep and take my normal nap. I couldn't sleep at night, I woke with a jerk and a start." This happened 3 times that night. On 10Apr2021 she started to feel very depressed and she had a headache. A couple days ago, the depression lifted but then she felt jittery/nervous and easily startled with any quick noise. She stated that she remained easily startled and wanted to know what the vaccine was doing to her body that would cause this side effect? She reported she had been to her MD and they did not recommend anything. The patient been taking store brand Extra Strength Pain Reliever Acetaminophen 500 mg tablets for her headache. She had been taking 2 or 3 tablets per day. The patient stated she wasn't sure about getting the second dose of the vaccine with her side effects from the first. The patient had a very bad reaction to the 1st dose, that it's a week later and she's still not completely over her reaction. The patient reported that she got the Covid-19 vaccine, came home and felt fine during the evening on 08Apr2021. Right before she went to bed around 9 PM on 08Apr2021, her head didn't feel quite right and felt kind of fuzzy. The patient reported that everybody and all of her friends had been tired the next day following the Covid-19 vaccine so the caller thought that maybe the tiredness was starting. Details not provided for her friends that felt tired. The patient reported that she didn't sleep too well the night of 08Apr2021 but it wasn't anything outstanding.  When she woke up on 09Apr2021 around 7 AM, she was on some kind of a high. She was flying high like a kite instead of being tired after sleeping poorly the night before. The flying high feeling went on and on. The patient reported that her schedule was to have lunch around noon, at 1 PM sit in her chair and read for a bit, and then take a nap. She never had any trouble and she was always ready  for a nap. On 09Apr2021 she sat in her chair and was wide awake. She thought there was no way that she could go to sleep and she gave up taking a nap. The patient reported that she was flying high all day. She went to bed on 09Apr2021 and thought to herself that she was very tired and that she would surly get a good night's sleep. She did not sleep well, that her body was tired but her mind was fully alert and wide awake. She didn't get sleep at all, except that her body was so tired that the patient would doze off and wake up with a start. She didn't usually wake up with a start and a jerk. After she awoke with a start on the night of 09Apr2021, she thought that she had slept for an hour. She looked at the clock and she had only dozed off for 5 minutes. She laid in bed and tried to relax. Her body was tired but her mind was full speed ahead. She dozed off again on the night of 09Apr2021 and that the same thing happened, the patient dozed off for 5 minutes and then jerked awake. The patient reported that she had 3 episodes on the night of 09Apr2021 of falling asleep and then jerking awake. She finally fell asleep around 4 in the morning on 10Apr2021 until 6 AM when she was awake again. She woke up and realized that she had plunged into a very bad depression. This was very troublesome as she was a person with very good spirits that other people mention. She was in a deep depression and was just very concerned about that. The depression went on through the day and it just lasted and lasted. The depression finally seemed to get a little better but not right away. She thought it was almost 2 days that the depression lasted. Because of all of these side effects, it had bothered her mind so much that she can't really keep track of days and times so well. The last 2 days, when she felt like her spirits were coming up but not quite back up to the top yet, she got the jitters. She had just a very nervous feeling of jitters that as still kind of with her. The last 2 nights (13Apr2021 and 14Apr2021), she had awoken with a very bad startle in the night. Last night, 14Apr2021, she experienced a very bad startle again. She was not over the jitters because she never woke up with a jerk and startle and just frightened. She was very concerned and there was no way she can get the second dose of the Covid-19 vaccine. She hadn't even gotten past the depression yet into the jitters. She made an appointment with her doctor and that her doctor kind of blew it off  in a way that they're really pushing for all of them to get the vaccination. The patient reported that she called Pfizer when she had the high and crash into depression. She going to cancel the appointment for her second dose of the Pfizer Covid-19 vaccine. The patient reported that she has never taken an illegal drug in her life, but she had heard stories of what a drug high felt like. She had heard details of what it felt like to get really high and then the crash and to have cravings for the drug. The patient reported that there as apparently some kind of medication in the Covid-19 vaccination that affected her like some kind of not very good drug. The patient reported that she didn't feel quite so nervous and jittery at time of call on 15Apr2021. The jitters were better but still occurring. The depressed feeling was still present a little, but it was a lot better than it was. She was not sure that her spirits were right up to the tip top as usual. The patient reported that given a little time, maybe in a day or two her spirits will be up at the top again. The patient reported that the jittery feeling caused her to startle at unexpected noises. She had been startled quickly and easily and having quite the startle reaction. That's not like her to startle so easily. The patient reported that the headache hadn't been extreme but it's been there. At the time of reporting she felt like her headache was a lot better than it was. She was pretty sure that she reported this AE to the first Pfizer agent that she spoke with. The patient had 2 heart tests done and that everything came back fine and that she was in good health. She was concerned that the vaccine may have affected her brain, heart, or organs. Before she got the Covid-19 vaccine, she was feeling so good. The patient inquired if she had this bad of a reaction maybe it's doing something to her inside organs that no one knows about, how would she know. Outcome of the event Feeling jittery was recovered on 11Apr2021, of the event depressed Was recovering, of the other events was unknown.   No follow-up attempts are needed. No further information is expected.