Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Loss of personal independence in daily activities, Myalgia, Off label use, Pain
Clinical narrative: off label use; interchange of vaccine products; booster; excruciating pain in every muscle, joint, and long bone in her body; excruciating pain in every muscle, joint, and long bone in her body; Every single bone from her hips to her toes- literally her toe bones and everything were extremely painful/from her armpits down to her fingertips and then back was in pain; excruciating pain in every muscle, joint, and long bone in her body; she couldn't function; She couldn't sleep; The pain at the injection site and arm isn't bad; She does have swelling, redness, rash around the injection site; She does have swelling, redness, rash around the injection site; She does have swelling, redness, rash around the injection site; Itching at the injection site; her stomach was pretty much the only area that didn't have a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 09:30 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mitochondrial cytopathy" (unspecified if ongoing), notes: Verbatim: Mitochondrial cytopathy; "high risk" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna (1st dose), administration date: 09Mar2021, for covid-19 immunisation; Moderna (2nd dose, Her psoriasis may have typically been half of a dime size and it was going to 4 inches in diameter. Her psoriasis was being intense all the time, it was like flea bites over the top.), administration date: 21Apr2021, for covid-19 immunisation, reaction(s): "psoriasis"; Shringix vaccine (1st dose), administration date: 05Apr2019; Shringix vaccine (2nd dose), administration date: 09Aug2019.  The following information was reported: OFF LABEL USE (non-serious) with onset 11Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "booster"; MYALGIA (non-serious) with onset 11Dec2021, outcome "unknown", BONE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 11Dec2021, outcome "recovered" (12Dec2021) and all described as "excruciating pain in every muscle, joint, and long bone in her body"; PAIN (non-serious) with onset 11Dec2021, outcome "recovered" (12Dec2021), described as "Every single bone from her hips to her toes- literally her toe bones and everything were extremely painful/from her armpits down to her fingertips and then back was in pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 11Dec2021, outcome "unknown", described as "she couldn't function"; INSOMNIA (non-serious) with onset 11Dec2021, outcome "unknown", described as "She couldn't sleep"; VACCINATION SITE PAIN (non-serious) with onset 11Dec2021, outcome "not recovered", described as "The pain at the injection site and arm isn't bad"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 11Dec2021, outcome "not recovered" and all described as "She does have swelling, redness, rash around the injection site"; VACCINATION SITE IRRITATION (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Itching at the injection site"; ABDOMINAL PAIN UPPER (non-serious) with onset 11Dec2021, outcome "recovered" (12Dec2021), described as "her stomach was pretty much the only area that didn't have a lot of pain".  Additional information:  Prior vaccination within 4 weeks was reported as none. Additional vaccine administered on same day was reported as none.  The reporter explains she was guessing the timeline because her symptoms started in the middle of the night and she didn't look at the clock. She was guessing about 18 hours post injection, she woke up during the night with excruciating pain in every muscle, joint, and long bone in her body. Every single bone from her hips to her toes- literally her toe bones and everything were extremely painful. Then, from her armpits down to her fingertips and then back was in pain. She states her stomach was pretty much the only area that didn't have a lot of pain. She explains this side effect lasted until that following night. She clarifies this excruciating pain stopped the night of 12Dec2021. She finally took one Tylenol at about 19:00pm on 12Dec 2021. Prior to that, she hadn't taken anything because she wanted the vaccines to have the best immune response that they can have and since they don't really know if painkillers can affect that or stuff, she really tried not to take any. However, at that point, she had to take one because she couldn't function. She couldn't sleep. She tried to go to sleep but because she was in so much pain, she couldn't sleep either. The reporter clarifies the only thing she was experiencing now was what some sites are calling COVID arm. The pain at the injection site and arm isn't bad. She does have swelling, redness, rash around the injection site and it itches like there was no tomorrow. This was something she had not experienced before either. The reporter states itching was actually worse. The rash, redness and swelling has stayed about the same, but the itching has increased. She had not actually looked at her arm at the injection site so she don't know when it first began, but she can tell that the itching portion started when she muscle and bone pain subsided. She had a longer period of time between her Moderna doses. It was 6 weeks between doses instead of 4 weeks because she had really severe side effects with the Moderna vaccine. Her and her doctor discussed that it was better to wait a couple of extra weeks in between the first and second doses in hopes that the side effects wouldn't be so bad she would have to be hospitalized. Her doctor was worried her side effects may be so severe she would be hospitalized. This was another reason she decided to try Pfizer for the booster, in hopes she wouldn't have such intense side effects from it as she did with the Moderna vaccines. She has not started any new prescriptions. With over-the-counter stuff, like supplements, she can't think of anything new there either. The patient was administered the vaccine in a pharmacy. She has a rare underlying condition. The adverse events did not require emergency or physician's room visit.   The reporter explains with the Moderna vaccines, they were expected adverse effects but were just extremely intense. She had the chills. She had her thermostat set in the 80's and she was under a blanket/comforter and still was literally shaking and her teeth were clattering. She still had the chills like this 5 days later after the injection, it was really intense. She had about 6 months worth of extremely intense skin issues. Her psoriasis may have typically been half of a dime size and it was going to 4 inches in diameter. Her psoriasis was being intense all the time, it was like flea bites over the top. She mentions she previously had her Shringix vaccine a couple years before and she got shingles again. She had massive amounts of skin issues for like about 6 months. Until the vaccine antibodies seem to be going away, that's when her skin issues went away, so she was pretty sure they were related. She had a rare condition called Mitochondrial cytopathy. She clarifies it was a neural metabolic disorder. She explains medications drains right through her. Something that may supposedly last 4-6 hours, may last an hour with her because the effects are out of her system. She had surgery where she had a block done and she should not have been able to move her legs. When the surgery was done and she just scooted herself onto the gurney. All of the medical stuff were shocked and flipped out because of the amount of medication she was given for her size, she should not have been able to do that. Her body metabolizes so much quicker that these types of scenarios happen with all sorts of different medication.    The lot number for bnt162b2 was not provided and will be requested during follow up.