Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19, FLUX, COVID19, FLU4
Symptoms: Guillain-Barre syndrome, Vaccination site pain
Clinical narrative: He has Guillain Barre Syndrome; Severe, severe pain in both deltoid arms where he got the injections/still experiencing pain in both deltoids; This spontaneous case was reported by a physician and describes the occurrence of GUILLAIN-BARRE SYNDROME (He has Guillain Barre Syndrome) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient had no allergies reported.  Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, METOPROLOL and IRBESARTAN (AVAPRO) for Hypertension.   On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 10-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (Severe, severe pain in both deltoid arms where he got the injections/still experiencing pain in both deltoids). On 17-Oct-2022, the patient experienced GUILLAIN-BARRE SYNDROME (He has Guillain Barre Syndrome) (seriousness criteria hospitalization and medically significant). The patient was treated with PREGABALIN (LYRICA) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Rehabilitation therapy for Guillain-Barre syndrome. At the time of the report, GUILLAIN-BARRE SYNDROME (He has Guillain Barre Syndrome) and VACCINATION SITE PAIN (Severe, severe pain in both deltoid arms where he got the injections/still experiencing pain in both deltoids) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Magnetic resonance imaging: Nothing conclusive was found. On 17-Oct-2022, Lumbar puncture: Result showed Protein and confirmed the Guillain Barre Syndrome.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient previously had Moderna vaccines First dose on 28-Dec-2022, 2nd dose on 27-Jan-2021, then First booster on 10-Sep-2021 and 2nd Booster dose on 22-Mar-2022.   A physician calls in to report an adverse reaction he experienced after getting the Moderna Covid-19 vaccine. Two weeks later, 10Oct2022 he developed "severe, severe pain" in both deltoid arms where he got the injections. It lasted for days until on 13Oct2022, he felt so sick that he drove back home from work. He noticed that he was having symptoms of imbalance the symptoms went to his legs and he had difficulty in walking. He went to the emergency room where they checked everything. On 17Oct2022, his symptoms progressed so he went to another ER where they did a spinal tap. He was admitted and he had plasmapheresis for 6 days. He was now in an acute rehabilitation facility and his weakness was improving. His neurologist thinks the GBS was from the flu shot. After the plasmapheresis, he was still experiencing the pain in both deltoid - the right deltoid where the flu shot was administered is 10 percent more painful. He states that the pain was on and off, it was shooting and it feels like somebody poking him. No medications have given the pain any relief he was given pain patch, warm and cold compresses to no avail.   Patient had not experienced similar events in the past.  Reported symptoms were ongoing at the time of reporting.  Company Comment :This is a spontaneous case concerning  a  72-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant and hospitalization) event of Guillain-Barre syndrome and expected non-serious event of Vaccination site pain. The events occurred 18 days after the fifth dose of mRNA-1273.222 Vaccine. While event  Guillain-Barre syndrome  occurred 25 days after the fifth dose of mRNA-1273.222 Vaccine. Pate  It was reported a physician calls in to report an adverse reaction he experienced after getting the Moderna Covid-19 vaccine. Two weeks later, he developed "severe, severe pain" in both deltoid arms where he got the injections. It lasted for days until, he felt so sick that he drove back home from work. He noticed that he was having symptoms of imbalance the symptoms went to his legs and he had difficulty in walking. He went to the emergency room where they checked everything. His symptoms progressed so he went to another ER where they did a spinal tap. He was admitted and he had plasmapheresis for 6 days. He was now in an acute rehabilitation facility and his weakness was improving. His neurologist thinks the GBS was from the flu shot. After the plasmapheresis, he was still experiencing the pain in both deltoid - the right deltoid where the flu shot was administered is 10 percent more painful. He states that the pain was on and off, it was shooting and it feels like somebody poking him.  . The patient was treated with Pregabalin at an unspecified dose and frequency; Paracetamol at an unspecified dose and frequency and Rehabilitation therapy for Guillain-Barre syndrome. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273.222 Vaccine, is not affected by this report.     This case was linked to MOD-2022-667768 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  72-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant and hospitalization) event of Guillain-Barre syndrome and expected non-serious event of Vaccination site pain. The events occurred 18 days after the fifth dose of mRNA-1273.222 Vaccine. While event  Guillain-Barre syndrome  occurred 25 days after the fifth dose of mRNA-1273.222 Vaccine. Pate  It was reported a physician calls in to report an adverse reaction he experienced after getting the Moderna Covid-19 vaccine. Two weeks later, he developed "severe, severe pain" in both deltoid arms where he got the injections. It lasted for days until, he felt so sick that he drove back home from work. He noticed that he was having symptoms of imbalance the symptoms went to his legs and he had difficulty in walking. He went to the emergency room where they checked everything. His symptoms progressed so he went to another ER where they did a spinal tap. He was admitted and he had plasmapheresis for 6 days. He was now in an acute rehabilitation facility and his weakness was improving. His neurologist thinks the GBS was from the flu shot. After the plasmapheresis, he was still experiencing the pain in both deltoid - the right deltoid where the flu shot was administered is 10 percent more painful. He states that the pain was on and off, it was shooting and it feels like somebody poking him.  . The patient was treated with Pregabalin at an unspecified dose and frequency; Paracetamol at an unspecified dose and frequency and Rehabilitation therapy for Guillain-Barre syndrome. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273.222 Vaccine, is not affected by this report.