"Introduction
The vaccines against SARS-CoV-2 have saved many lives, but adverse events have been reported. The Centers for Disease Control and Prevention notes the possibility of rare complications, including anaphylaxis, thrombosis with thrombocytopenia syndrome (specifically after viral vector vaccines), Guillain-Barré Syndrome (specifically after viral vector vaccines), and myocarditis and pericarditis. These complications were not reported in the vaccine clinical trials, emphasizing the limitations of these studies in capturing rare adverse events and highlighting the critical role of post-market surveillance...
Methods
Study Design: ... The LISTEN study began recruiting participants who reported PVS [post-vaccination syndrome] in May 2022. PVS was defined by self-report in response to whether the individual thought the vaccine had injured them. We summarized these individuals’ symptoms, diagnoses, treatments, and experiences...
Results
Study Sample: The study population comprised 241 individuals with self-reported PVS. Among the participants reporting PVS, 127 (55%) were those who had taken the Pfizer-BioNTech vaccine, followed by 86 (37%) who had taken the Moderna vaccine...
Participants reported numerous challenges in their daily lives. In the week before survey completion, 221 (93%) reported feeling unease at least once, 194 (82%) felt fearful, 192 (81%) felt overwhelmed by worries, and 180 (76%) struggled with anxiety. Furthermore, 190 (80%) felt helpless, 182 (76%) depressed, 171 (72%) hopeless, and 116 (49%) worthless at least once in the week before survey completion. Additionally, 233 (98%) felt rundown and 216 (91%) reported sleep problems. Pain interfered with the daily activities of 204 (86%) participants.
Regarding social support, 98 (41%) had two or fewer supportive individuals to rely on for help... Loneliness was prevalent...
Timing of Symptom Onset Following Vaccination: The median time from vaccination to the onset of any symptoms was 3 days (IQR: 1 to 8 days)...
Symptom Severity: When asked to quantify symptom severity on their worst days (0 representing a trivial illness and 100 for an unbearable condition), participants reported a median severity of 80...
Symptom Characteristics: ... The median number of symptoms attributed to PVS was 22 (IQR: 13 to 35). The most common symptoms were exercise intolerance reported by 170 (71%) participants, excessive fatigue by 167 (69%), numbness by 153 (63%), brain fog by 151 (63%), neuropathy by 151 (63%), insomnia by 148 (61%), palpitations by 145 (60%), myalgia by 132 (55%), tinnitus or humming in ears by 131 (54%), headache by 128 (53%), burning sensations by 121 (50%), and dizziness by 121 (50%).
Discussion
This study is the largest to describe people who report a severe, debilitating chronic condition following covid-19 vaccination. This chronic condition began soon after covid-19 vaccination and persisted in many people for a year or more. The symptoms reported are diverse and severe...
PVS could be caused by several potential mechanisms, including a mechanism related to the vaccination or manufacturing process. It may represent a rare response to vaccines in susceptible individuals. Some investigators have concluded, based on their self-referred case series, that vaccines may cause immune system dysfunction. They focused on people with neuropathy after vaccination and could not identify other causes. In 2 of 5 participants, the cerebrospinal fluid had oligoclonal bands, and they found immune complexes in some skin biopsies. Nevertheless, the syndrome could be unrelated to the vaccination, occurring by chance during the vaccination period. However, the temporal relationship with clustering of symptom onset within the first 1–18 days from the index vaccine suggests a potential relationship."
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