Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Condition aggravated, Cytomegalovirus infection, Feeling abnormal, Hypoacusis
Clinical narrative: chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine; chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine; chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine; chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine; chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine; These symptoms also worsened after being vaccinated: TMJ arthritis, degenerative disc disease (neuropathy in my right foot) and arthritis in my thumbs and fingers, and shoulders; lost 30% hearing in my hearing ear; These symptoms also worsened after being vaccinated: TMJ arthritis, degenerative disc disease (neuropathy in my right foot) and arthritis in my thumbs and fingers, and shoulders; tinnitus has increased in my non-hearing ear; brain fog; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "CMV", start date: 2003 (unspecified if ongoing), notes: led to the diagnosis of ME/CFS in 2005; "myalgic encephalomyelitis", start date: 2005 (unspecified if ongoing); "Chronic Fatigue syndrome", start date: 2005 (unspecified if ongoing); "Lyme disease", start date: 2007 (unspecified if ongoing); "Epstein-Barr" (unspecified if ongoing), notes: as a teenager; "neurological deafness in my right ear", start date: 2009 (unspecified if ongoing), notes: In 2009, I developed sudden sensory neurological deafness in my right ear; "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: NALTREXONE, start date: Mar2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 27Jan2021, for COVID-19 immunization, reaction(s): "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "These symptoms also worsened after being vaccinated: TMJ arthritis, degenerative disc disease (neuropathy in my right foot) and arthritis in my thumbs and fingers, and shoulders", "These symptoms also worsened after being vaccinated: TMJ arthritis, degenerative disc disease (neuropathy in my right foot) and arthritis in my thumbs and fingers, and shoulders", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "lost 30% hearing in my hearing ear", "tinnitus has increased in my non-hearing ear", "arm soreness", "significant increase in my anxiety and depression", "significant increase in my anxiety and depression"; BNT162b2 (DOSE 2, SINGLE), administration date: 17Feb2021, for COVID-19 immunization, reaction(s): "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "These symptoms also worsened after being vaccinated: TMJ arthritis, degenerative disc disease (neuropathy in my right foot) and arthritis in my thumbs and fingers, and shoulders", "These symptoms also worsened after being vaccinated: TMJ arthritis, degenerative disc disease (neuropathy in my right foot) and arthritis in my thumbs and fingers, and shoulders", "chronic conditions (eg Lyme disease, myalgic encephalomyelitis/Chronic Fatigue syndrome, CMV infection) have been exacerbated after receiving the Pfizer vaccine", "lost 30% hearing in my hearing ear", "tinnitus has increased in my non-hearing ear", "arm soreness", "significant increase in my anxiety and depression", "significant increase in my anxiety and depression". The patient provided a long history of chronic conditions that she attributed to various causes (e.g. Lyme disease, myalgic encephalomyelitis (ME)/Chronic Fatigue syndrome (CFS), cytomegalovirus (CMV) infection) that she was claiming have been exacerbated after receiving the Pfizer vaccine. The patient reported that she could be the poster child for unmet medical needs because of the degree to which her Lyme and ME/CFS symptoms have been aggravated after receiving two Pfizer COVID-19 vaccines and one booster shot. The first vaccine was on 17Jan2021, the second 27Feb2021 with the booster following. In 2003, the patient contracted CMV which led to the diagnosis of ME/CFS in 2005. The patient was also diagnosed with Lyme disease in 2007, which may or may not relate to a bout she had of Epstein-Barr as a teenager. The patient attributed the causation/worsening of arthritic conditions to Lyme. In 2009, the patient developed sudden sensory neurological deafness in her right ear. The patient believed that condition and her muscle weakness can be attributed to either Lyme or ME/CFS. The symptoms have been debilitating enough that by 2009, the patient began receiving SSDI. She had supplemented that income with substitute teaching. Unfortunately, the patient could only manage teaching one day a week followed by a "recovery day" or two. Following her first Pfizer vaccination on 27Jan2021 and her second shot on 17Feb2021, the patient did not initially notice any significant symptoms other than arm sores, although she did experience a significant increase in her anxiety and depression. As the time went on, however, she began noticing that the symptoms of both illnesses were worsening (some seemed to be Lyme specific, others common to both Lyme and ME/CFS). In addition, the patient began experiencing more frequent crashes/post exertional malaise, the debilitating effect of any type of over-exertion related to her ME/CFS. They were debilitating enough that she needed to stop working as a substitute almost entirely - only about five days the entire school year. These symptoms also worsened after being vaccinated: temporomandibular joint arthritis, degenerative disc disease (neuropathy in her right foot) and arthritis in her thumbs and fingers, and shoulders. The tinnitus had increased in her non-hearing ear and had lost 30% hearing in her hearing ear, which would require her to get a hearing aid. At times, her ability to care for herself had been significantly diminished. On some occasions, the patient was not able to drive and get medication or go to the grocery store. As a result, the patient had to cancel various appointments, a visit with her son in another state and many get-togethers with friends; she still could not plan with any degree of certainty. The patient also had to stop her volunteer work with a favorite non-profit since the crashes came too often and were too intense. The patient began low-dose naltrexone in the middle of Mar2022. The patient noticed immediate improvement in her depression, stamina, and brain fog, although it did not prevent a crash. The patient reported that she should still practice pacing. She began at a dosage of 1.5 mg, and had titrated down to 0.1 mg and was now trying to slowly work back up to what she understood was a more therapeutic dose. She was learning that this drug must be adjusted to each individual and required some significant time to determine the correct dosage and time of day to take it. It was her hope that there could be some research to how LDN may help the "long haulers" (those of them with post COVID-19, with ME/CFS, Lyme disease, multiple sclerosis or any other auto immune illnesses). The patient was asking if she could expect to return to her pre-vaccine life, when, and how could Pfizer help. She was also asking for suggestions on what she should do personally to help reverse them symptoms without aggravating her condition any further. The outcome of the events was unknown, except for feeling abnormal (recovering).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200072327 Same patient, different vaccine dose number and different event.;US-PFIZER INC-202201192057 Same patient, different vaccine dose number and different event.;