Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Sleep deficit
Clinical narrative: BELL'S PALSY; AFFECTING ABILITY TO THINK CLEARLY; DEPRIVATION OF SLEEP; PAIN IN THE BACK; TINGLING SENSATION OVER THE BODY BUT MORE IN THE EXTREMITIES; PERCEPTION OF HEAT AND COLD REVERSED OR DELAYED; MIGRAINE HEADACHES; MUSCLE WEAKNESS IN THIGHS AND LOWER BACK; CONTINUOUSLY EXHAUSTED WHICH IS AFFECTING ABILITY TO THINK CLEARLY; MUSCLES PAIN IN THE THIGHS AND LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 52 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After several weeks of vaccination on an unspecified date, the patient developed muscle pain and muscle weakness in his thighs and lower back, and the pain extended to his back. Patient experienced tingling sensation over the body but more in the extremities. He experienced perception of heat and cold reversed or delayed. The development migraine headaches increased dramatically, but as per reporter it was possible to had consequence of exhaustion from being sleep deprived. While brushing teeth patient discovered that he had partial paralysis of the left side of face and he was unable to spit, purse his lips, whistle, smile, twitch nose, or raise his eyebrow and the face area was mostly numb. Patient went to emergency room and where he had been told that he had Bell's palsy, but they did not know what to think about the non-facial symptoms and asked him to see a neurologist. The patient was prescribed with prednisone and an antiviral. By the end of the same day, he lost most sense of taste. Patient later saw a neurologist who ordered Magnetic resonance imaging (MRIs) of brain, sinuses, and upper spine to look for signs of neuronal demyelination, but there were not any significant findings. During follow up appointment on 15-JUL-2021 with the neurologist, they discussed potential association between vaccine and Guillain barre syndrome. He ordered patient to do nerve conduction test to look for evidence of peripheral nerve damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the back, and muscles pain in the thighs and lower back, had not recovered from deprivation of sleep, tingling sensation over the body but more in the extremities, bell's palsy, lost most sense of taste, continuously exhausted which was affecting ability to think clearly, and muscle weakness in thighs and lower back, and the outcome of perception of heat and cold reversed or delayed and migraine headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210739148-COVID-19 VACCINE AD26.COV2.S -Bell's palsy and affecting ability to think clearly. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.