Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: His whole arm feels like it's bruised, heavily bruised; Over a period of a year, the pain traveled down on his arm making it all painful and then up into his face; Mild pain/A lot more or a huge increase of pain; Over a period of a year, the pain traveled down on his arm making it all painful and then up into his face and then down on his left-hand side resulting to a very sensitive to pressure on his whole left-hand side.; He might be allergic to the formula as well as the first shot might sensitized him in the second shot and messed up a bit.; A lot of pain in his shoulder; Neuropathy; He is very sensitive to pressure that makes him very difficult to sleep and having a lot of insomnia; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Allergy to plants (Trees) and Allergy (Flowers).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), INSOMNIA (He is very sensitive to pressure that makes him very difficult to sleep and having a lot of insomnia), FACIAL PAIN (Over a period of a year, the pain traveled down on his arm making it all painful and then up into his face), PAIN (Mild pain/A lot more or a huge increase of pain), PAIN IN EXTREMITY (Over a period of a year, the pain traveled down on his arm making it all painful and then up into his face and then down on his left-hand side resulting to a very sensitive to pressure on his whole left-hand side.), HYPERSENSITIVITY (He might be allergic to the formula as well as the first shot might sensitized him in the second shot and messed up a bit.) and ARTHRALGIA (A lot of pain in his shoulder). On an unknown date, the patient experienced CONTUSION (His whole arm feels like it's bruised, heavily bruised). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), INSOMNIA (He is very sensitive to pressure that makes him very difficult to sleep and having a lot of insomnia), CONTUSION (His whole arm feels like it's bruised, heavily bruised), FACIAL PAIN (Over a period of a year, the pain traveled down on his arm making it all painful and then up into his face), PAIN (Mild pain/A lot more or a huge increase of pain), PAIN IN EXTREMITY (Over a period of a year, the pain traveled down on his arm making it all painful and then up into his face and then down on his left-hand side resulting to a very sensitive to pressure on his whole left-hand side.), HYPERSENSITIVITY (He might be allergic to the formula as well as the first shot might sensitized him in the second shot and messed up a bit.) and ARTHRALGIA (A lot of pain in his shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Reporter stated that the second dose of Moderna created a lot of pain in his shoulder and over a period of a year, the pain traveled down on his arm making it all painful and then up into his face and then down on his left-hand side resulting to a very sensitive to pressure on his whole left-hand side. Patient also stated that he was very sensitive to pressure that makes him very difficult to sleep and having a lot of insomnia and also stated his keyword was neuropathy. Second shot made him experience a lot more or a huge increase of pain. He also thought that he might be allergic to the formula as well as the first shot might sensitized him in the second shot and messed up a bit.  Reporter stated that he won't be calling if he was recovered. Patient stated that he was waiting for the result of biopsy, MRI and laboratory works. Treatment information was not reported.  COMPANY COMMENT:  This is an spontaneous case concerning a 60-year-old male patient with medical history of several allergies who experienced  the unexpected seriousness criteria medically significant unexpected event of neuropathy peripheral; the unexpected events of insomnia, contusion, facial pain, pain, pain in extremity, and other expected events beginning the same year after 1st. dose of mRNA-1273 vaccine. The patient received the 2 first doses in an appropriate schedule. He reported that after the first shot experiencing mild pain, and after the 2nd. one experiencing a huge increase of it, facial, shoulder and arm pain, insomnia, "neuropathy", bruised arm and he thought that he might be allergic to Moderna vaccine formula. Concomitant medication nor Treatment details were reported. At the time of the report, the events had not resolved. The medical history of allergies are contributors for hypersensitivity event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2024: Live follow-up received and added second dose detail, added new events of neuropathy, insomnia, contusion, facial pain, pain in extremity, arthralgia and updated narrative.