Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia, Movement disorder, Muscle tightness, Nausea, Pain in extremity
Clinical narrative: headache; arm was hurting quite a bit; felt really sick; High fever/monitoring her temperature and it was 101, 103, 105; Body was shaking uncontrollably; All the muscles in her body were really tight, locked into place, she couldn't move; chills/rigor; Kept waking up, maybe 5 times; felt like she was going to die; nausea; felt paralyzed; couldn't move to get out of bed to turn light on to check temperature or anything; This is a spontaneous report from a contactable pharmacist who reported for herself, a 50-year-old female patient who received BNT162B2 (COMIRNATY, Solution for injection, Lot number: 30155BA), via an unspecified route of administration, administered in right arm on 11Oct2021 at 14:30 (at the age of 50 years old) as dose 3 (booster), 0.3 mL single for COVID-19 immunization. Medical history included ongoing fibromyalgia diagnosed 8 or 9 years ago, and chronic pain. The patient was concomitantly taking a number of medications (unspecified). Historical vaccine included BNT162B2 injections, first dose received on 18Mar2021 (Lot: EP7534) where she felt like she had the flu the first week after vaccination, then second dose received on 08Apr2021 (Lot: ER8731) where she was sick for about 3 days after vaccination; both received at the age of 49 years old, in the right arm at 0.3 mL for COVID-19 immunization. On 11Oct2021, the patient experienced high fever, body was shaking uncontrollably, all the muscles in her body were really tight, locked into place, chills/rigor, kept waking up, maybe 5 times, bad headache at 21:00, felt really sick, and arm was hurting quite a bit at 21:00. On Oct2021, the patient experienced felt like she was going to die, nausea, felt paralyzed, and couldn't move to get out of bed to turn light on to check temperature or anything. The events high fever, body was shaking uncontrollably, "all the muscles in her body were really tight, locked into place", "kept waking up, maybe 5 times", chills/rigor, bad headache, nausea, and "felt like she was going to die" were reported as serious per medically significant by the reporter. The clinical course was reported as follows: The patient had the booster shot on 11Oct2021. She had a high fever, her body was shaking, all the muscles in her body were tight, chills, and nausea. She was concerned because she felt really sick and would not want someone else to experience that. In addition to that, patient said it was the first time that she had her body shaking uncontrollably for several hours. Her whole body was shaking and could not make it stop and there was something going on with her muscle and described it as a different experience with chills. She also mentioned that other people she have spoken to and friends of her have been shaking as well. She was calling to know if other people have reporter similar reaction with the booster dose, and if she can expect her severe reaction from the booster dose, if in case she gets another booster. The patient had to go to urgent care, they didn't have an emergency room, but they did have urgent care. She had the booster Monday afternoon, 11Oct2021. With the booster vaccine, she was having high fevers and her body was shaking uncontrollably plus all the muscles in her body were really tight, like locked into place, she couldn't move. This was Monday night when she was sleeping, it kept waking her up in the night, probably 5 times, she still was feeling chills and stuff. So, the next day, she emailed her doctor and told her the symptoms, plus a bad headache, and she told her to get seen at the urgent care so Tuesday afternoon (12Oct2021), she started monitoring her temperature and it was 101, 103, 105, it was going up and down, like 101 when she got to urgent care about 7:00 Tuesday evening, they just said it was her body's immune response to the shot, but she didn't know if people were calling to report this sort thing.She takes a number of medications (unspecified), she has chronic pain, she has fibromyalgia that they were treating. She didn't know, they might think it might be some of the medications she takes and the vaccine booster, they didn't seem to know. She thought she went to the doctor and they of course gave her a COVID test which was negative, they just said she would have to ride it out, in Mar2021. She has had COVID tests ongoing on and off throughout the pandemic and they all have been negative. What the patient experienced Monday night she has never experienced in her life. She also had nausea, she felt like she was going to die, she didn't know what was on. She had the booster at about 230PM on Monday afternoon 11Oct2021 and that night around 9PM or so she had a bad headache and her arm was hurting quite a bit so she put ice on it, she took 2 extra strength Tylenol and took her other medications that she normally takes at nighttime, the list was kind of long, she woke up with the chills and everything else around, she couldn't move to get out of bed to turn light on to check temperature or anything, She thought she woke up with the symptoms 4 or 5 times. She confirmed all symptoms from third booster shot ended Oct2021 and she has recovered completely. She started when she realized she was running a fever, her son was a teenager and took her temperature Tuesday afternoon when he took her temperature it was 102 then when they checked it again after an hour or two it was 105 when she got to urgent care around 7:00 PM on Tuesday, it was at 101. She felt okay yesterday and today, so she thinks she has recovered. The patient didn't know if she was having seizures or what was going on, but it was an awful feeling, she felt paralyzed she couldn't get out of bed couldn't change positions. The patient contacted her HCP on Tuesday about what her experience was on Monday night. After she emailed her a couple times, her response to her was that the booster was fairly new, they don't know enough information about it yet but did say to go be seen by a doctor. Urgent care said he didn't think she was having seizures; it was called rigor that she had. The outcome of all the events was recovered on Oct2021. The reporter considered the reported events as related to the suspect product, as her symptoms were right after she had the vaccine.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the events Pyrexia, impending doom, tremor, muscle tightness, chills, middle insomnia, headache, nausea, paralysis, malaise, pain in extremity, movement disorder and the suspect drug BNT162B2.   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.