Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Pain, Pruritus
Clinical narrative: I had this itchy sensation over my body; felt lousy; that evening I was very chill, wrapped in a blanket, very very cold and I developed a fever of about 100.5°F during the night; that evening I was very chill, wrapped in a blanket, very very cold and I developed a fever of about 100.5°F during the night; I felt just achy over my whole body; I had a headache; Keeps getting so tired and so weak; Keeps getting so tired and so weak; felt pretty bad; 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 72-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 72 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: Diagnosed several years ago; "Broke her wrist" (unspecified if ongoing), notes: Diagnosed several years ago; "Ovarian cancer", start date: Feb2018 (unspecified if ongoing); "Diabetes" (ongoing), notes: Had been prediabetic; "pain in her knee" (unspecified if ongoing), notes: receives steroid injection; "pain at night in her leg" (unspecified if ongoing); "pain" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for deep vein thrombosis; TYLENOL EXTRA STRENGTH taken for pain in extremity; GABAPENTIN taken for pain. Past drug history included: Reclast, notes: she has had 3 of those done over a period of 3 years; Warfarin for deep vein thrombosis. Vaccination history included: Flu shot (Dose: 1, When I had the first flu shot at 65 years I had a reaction), when the patient was 65 years old, for Immunization; Moderna vaccine (Dose 1), for COVID-19 immunization; Moderna vaccine (Dose 2), for COVID-19 immunization; Moderna vaccine (Dose 3 (Booster)), for COVID-19 immunization; Moderna vaccine (Dose 4 (Booster)), for COVID-19 immunization; Moderna vaccine (Dose 5 (Booster)), administration date: May2023, when the patient was 72 years old, for COVID-19 immunization; Flu vaccine, for immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2023, outcome "unknown", described as "felt pretty bad"; PAIN (non-serious) with onset 16Oct2023, outcome "recovering", described as "I felt just achy over my whole body"; HEADACHE (non-serious) with onset 16Oct2023, outcome "unknown", described as "I had a headache"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 16Oct2023, outcome "unknown" and all described as "Keeps getting so tired and so weak"; CHILLS (non-serious), PYREXIA (non-serious) all with onset 17Oct2023, outcome "unknown" and all described as "that evening I was very chill, wrapped in a blanket, very very cold and I developed a fever of about 100.5°F during the night"; PRURITUS (non-serious) with onset 19Oct2023, outcome "unknown", described as "I had this itchy sensation over my body"; MALAISE (non-serious) with onset 19Oct2023, outcome "unknown", described as "felt lousy". The event "i had this itchy sensation over my body" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: Patient was diagnosed with osteoporosis several years ago, the year she broke her wrist. X-ray showed her bones didn't look so good. Went to their affiliate doctor that is her currently osteoporosis doctor. Would say it's been at least 4 years because her doctor has ordered Reclast infusions for her and she has had 3 of those done over a period of 3 years. Her doctor for osteoporosis measured her and said she shrunk a little, was previously 5ft. Patient had been prediabetic. Then it was about a year that she was not on medication but her A1C test indicated her levels had gone up to the diabetic state. That was about a year and then her doctor had her go to a nutritionist who put her on a diet. Has been on that diet for about a year now and has been able to get it on last A1C test back down so she is prediabetic again. Had gone to her primary care and found she had a problem with her leg and they did a bilateral doppler. She had a deep vein thrombosis on her left leg and a regular blood clot in the right leg. They put her on Warfarin. She was then diagnosed with her ovarian cancer in Feb2018, and then at that point put her on the Eliquis instead of Warfarin. Clarified this is her 5th year of taking Eliquis. States she asked her oncologist how long. Then states she is under the care of the Anticoagulation Clinic. Patient reported that she was with her primary care doctor on 16Oct2023 and he administered the new COVID-19 vaccine for her and she had already had all her other vaccines. Patient reported to have initial COVID-19 vaccines and boosters by Moderna. Patient was then administered with the Pfizer vaccine and said it would be ok and they went ahead with it. As soon as she had it, in the bottom hour, she felt just achy over her whole body. Patient reported that it began about an hour after she had received the injection. They were doing a wellness check and taking, because she's diabetic, blood for an A1C test and checking her feet and various things. Until she got all that done, it was about an hour and she was starting to feel achy. Patient stated she feels pretty good at this point. Until she got home she really felt pretty bad, she had a headache and later that evening she was very chill, wrapped in a blanket, very very cold and she developed a fever of about 100.5 degree F during the night and stated that it probably began into the early hours like after midnight on 17Oct2023 and described that the fever would've developed after when she was still cold and then she checked her temperature and it was 100.5 degrees Fahrenheit maybe like between 1AM-2AM in the morning of 17Oct2023. On the same day of 17Oct2023, Tuesday, she was down just resting and eating lightly. By Wednesday (18Oct2023), she felt pretty good she was up and around, but then on 19Oct2023, she got up again and she had this itchy sensation over her body. It wasn't constant, but felt different parts of her body were itchy, not just her arm and legs. Patient did call her doctors office and he said she must have had some sensitivity to the vaccine and she should drink a lot of water and rest the day. At the time of reporting, patient stated she doesn't feel too badly. An orthopedic doctor saw her the week before, on 09Oct2023, for a problem she had with her knee and he had given her an injection of steroid in her knee. Only thing they told her was they were going to give her a steroid injection but didn't tell her what it was. She had been having pain in her knee and it was radiating into her thigh and hip area. The physician wanted to try the steroid injection before anything else. Realized today that the steroid injection was so close to the Comirnaty, it was only one week apart from the Comirnaty shot. Patient asked, would anything like that have intensified the reaction of the COVID-shot? She did have a booster shot for COVID, it wasn't this new shot, but she did have a Moderna booster shot back in May of this year. She questioned the doctor as to whether she had to have a second shot in the same year. She did have a reaction to the initial vaccines for COVID-19 when she had her first two. This would've been her sixth shot. The other booster shots versus this particular one she never had a bad reaction, but this one really flattened her. She has been on Eliquis for a period of 5 years because she had cancer on 2018. She had a flu shot three weeks before. Facility did not mark this vaccine on her vaccine card. Does not have any NDC/LOT/EXP. On the information sheet she was given, it provides the following information: COVID-19 MRNA-LNP 2023-2024 PF 30mcg/0.3ml. 12 years and older IM Pfizer Comirnaty. It was injected into her left arm, but very high on left arm almost up to the shoulder. Because she had been hearing that the COVID was going to be pretty bad this year and it was a different strain and she had inquired with her doctor and he said he would advise her to certainly to have the injection because she had the pain in her knee that she related to, states she had the pain, which was reason got the steroid injection. Was having pain at night in her leg, but during the day it didn't bother her. She was taking like at bedtime a double dose of Tylenol Extra Strength: 500mg. Clarified she would take 1 Tylenol Extra strength when she went to bed, and then if she had additional pain and couldn't rest, she would take 1 during the night toward the early morning hours. She was then taking, her doctor prescribed at one point, Gabapentin 100mg for her for pain. Clarified she had a prescription for it and she had that refilled. So she was taking that in addition to taking the Tylenol Extra Strength to help her to rest. She didn't have any tests done in relationship to the Comirnaty injection itself. When she had the first flu shot at 65 years she had a reaction. She just kept getting so tired and weak (with Comirnaty). First noticed this from time of the injection except on 18Oct2023 when she got up she felt fine and thought it was all over and felt pretty good that day. But then on 19Oct2023, she kind of felt lousy again. On 19Oct2023, she did have just a slight headache. Pretty much everything else resolved. When she first got up, she had itching, but she didn't have the achiness, just felt tired and weak. When she felt so very cold, even yesterday (19Oct2023) and toward evening she felt kind of like a chilled effect through her body. Not that she needed to bundle up or anything, just felt like she wasn't as warm as she should be. Knows it's getting cold out, but it was not that kind of cold. Had bloodwork done that particular day when she had the injection done because they wanted to have bloodwork done and run an A1C again for her diabetic situation, since it was a wellness check. So she had blood work done that day, after she had the Comirnaty injection, but that would have been the extent of it and it wasn't in relationship to the Comirnaty. She was trying to obtain any information for her well being as to why the fluctuation and not getting over how she's feeling. She had 1 day of feeling bad and then the next day of feeling better, and then not feeling better. Patient is hoping she feels better. It's been kind of been like a whole week of being sick and tired. Patient was querying why would the Pi mention to tell your doctor about any bleeding disorder or are on a blood thinner. What effect would Eliquis have on Comirnaty?   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.