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Write-up: GUILLEN BARRE SYNDROME; BELLS PALSY/FACE DROOPING; CHILLS; HEADACHES/EXCRUCIATING HEADACHES; FEVER; This spontaneous report was received from a consumer and concerned a 55 year old male. The patient''s height and weight were not reported. The patient''s concurrent conditions included drug allergy. Other relevant history included general good health and a marathon runner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced fever, chills and headaches. On 14-APR-2021, patient thought he had eaten something that had burned his lip. On 18-APR-2021, the patient experienced bells palsy/face drooping. His "lip going numb" then "face started drooping". He went to the emergency room. The doctors proceeded with an MRI and "all sorts of bloodwork." Patient also had "leg started to have twitching" and then started to have excruciating headaches ", "back started hurting on around the 22nd or 23rd of April" and "his legs and feet were numb" and "just couldn''t get his utensils", "body weakness and headaches." He went to a neurologist and had a nerve conducting study and "it looked like it was GBS and chronic inflammatory." On 27-MAY-2021, Guillen Barre syndrome was diagnosed. Treatment medications included: ibuprofen, gabapentin, sodium chloride, paracetamol, naproxen, and plasma infusions to help with GBS. At the neurologist, the patient had 5 treatments of plasma. He was having reactions with the infusion including "light headedness or headaches." He was given saline and the doctors told him to "stay hydrated and also was suggested acetaminophen and ibuprofen." He was also having "extreme weakness" with the plasma therapy. The neurologist was looking into the diagnosis and determined as it "is a reaction to the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillen Barre syndrome was not reported. The patient recovered from Bells Palsy/face drooping on 23-APR-2021, and fever and chills on an unspecified date, and had not recovered from headaches/excruciating headaches. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210726629.; Sender''s Comments: V0: This spontaneous report received from a consumer concerns a 55 year old male, who was noted to have bell''s palsy and diagnosed with Guillain-Barre syndrome (GBS) 32 and 71 days, respectively, after receiving the Janssen Covid-19 vaccine. Patient''s height and weight were not reported. The patient''s past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information on smoking history, illicit drug use and alcohol abuse were not provided. Patient has drug allergy, unspecified. Patient had fever, chills and headache one day after receiving the vaccine. Thirty-two (32) days post vaccine, the patient''s face started to droop and was noted to have bells palsy. He sought consult at the emergency room and was worked up on. No results provided. Patient started experiencing twitching of his legs, excruciating headaches and back pains. Later, his legs and feet started to get numb, described as not being able to get his utensils. His body started to get weak and he still was experiencing headaches. He went to a neurologist and had a nerve conducting study. Seventy-one (71) days after receiving the vaccine, patient was diagnosed with Guillain-Barre Syndrome (GBS). Treatment medications included: ibuprofen, gabapentin, sodium chloride, paracetamol, naproxen, and plasma infusions. Information regarding other potential etiologies was insufficient, and the occurrence of Bells Palsy and GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
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