Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Guillain-Barre syndrome, Muscular weakness, Pain in extremity, Rash erythematous
Clinical narrative: checking him for Gillian-Barre Syndrome; collapsed, fainted; feet ache, & his legs ache/he can't get out of a car; weakness in his arms & legs that has turned to pain/muscle issues; lost total control; a red rash that itches like crazy, has almost covered one side of his stomach, and the spot on his head has been there since right after the 2nd dose; The rash starts as a small spot then itches, you scratch it, and it goes from there; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (checking him for Gillian-Barre Syndrome), SYNCOPE (collapsed, fainted), RASH ERYTHEMATOUS (a red rash that itches like crazy, has almost covered one side of his stomach, and the spot on his head has been there since right after the 2nd dose), RASH PRURITIC (The rash starts as a small spot then itches, you scratch it, and it goes from there) and PAIN IN EXTREMITY (feet ache, & his legs ache/he can't get out of a car) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH ERYTHEMATOUS (a red rash that itches like crazy, has almost covered one side of his stomach, and the spot on his head has been there since right after the 2nd dose) and RASH PRURITIC (The rash starts as a small spot then itches, you scratch it, and it goes from there). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (checking him for Gillian-Barre Syndrome), SYNCOPE (collapsed, fainted), PAIN IN EXTREMITY (feet ache, & his legs ache/he can't get out of a car), MUSCULAR WEAKNESS (weakness in his arms & legs that has turned to pain/muscle issues) and BALANCE DISORDER (lost total control). At the time of the report, GUILLAIN-BARRE SYNDROME (checking him for Gillian-Barre Syndrome), SYNCOPE (collapsed, fainted), PAIN IN EXTREMITY (feet ache, & his legs ache/he can't get out of a car), MUSCULAR WEAKNESS (weakness in his arms & legs that has turned to pain/muscle issues) and BALANCE DISORDER (lost total control) outcome was unknown and RASH ERYTHEMATOUS (a red rash that itches like crazy, has almost covered one side of his stomach, and the spot on his head has been there since right after the 2nd dose) and RASH PRURITIC (The rash starts as a small spot then itches, you scratch it, and it goes from there) had not resolved.            No concomitant medications were reported.  Patient reported his experiences after receiving 2 doses (2nd dose lot # 004F21A on 24Aug2021) of the Moderna Covid-19 Vaccine.  He cannot make out the lot # or date of administration for his 1st dose due to a sticker & folding of the card, but he did get it in July of 2021. Patient had a red rash that itches like crazy, has almost covered one side of his stomach, and the spot on his head been there since right after the 2nd dose. The rash starts as a small spot then itches, you scratch it, and it goes from there. Patient used Triamcinolone Acetonide 0.1% Cream on it but it didn't do much for it. Patient also had muscle issues. His feet and his legs ache, he can't get out of a car. Patient had weakness in his arms & legs that has turned to pain. He's also collapsed, fainted, & lost total control. He's had 8 episodes of that & has taken some licks to his head. They were checking him for Gillian-Barre Syndrome.  This is a spontaneous case concerning a 73-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of Guillain-Barre syndrome and other non-serious events. The event occurred within unknown period after the second dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of Guillain-Barre syndrome and other non-serious events. The event occurred within unknown period after the second dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.