Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Just like the first shot, the shot caused them to get their arm to be swollen; top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender; Arm to be red; Arm hard as a rock; Have a dull headache; Now they have a  swollen at the top of the and superior to the clavicle and up into the lower part and base of neck/top of shoulder, and the lower base of her neck became very sore and swollen; It is swollen and very tender,at the base of their neck and superior to the clavicle; lower back ache; the top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender; really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Just like the first shot, the shot caused them to get their arm to be swollen), TENDERNESS (It is swollen and very tender,at the base of their neck and superior to the clavicle), BACK PAIN (lower back ache), NECK PAIN (top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender) and VACCINATION SITE ERYTHEMA (Arm to be red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal disorder. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), HYDROXYCHLOROQUINE, DICLOFENAC, LOSARTAN, METOPROLOL, LEVOTHYROXINE, TIZANIDINE, VITAMIN D NOS and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication. On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced BACK PAIN (lower back ache), CHILLS (really bad chills) and ARTHRALGIA (the top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender). On 06-Nov-2021, the patient experienced TENDERNESS (It is swollen and very tender,at the base of their neck and superior to the clavicle) and VACCINATION SITE SWELLING (Nowthey have a  swollen at the top of the and superior to the clavicle and up into the lower part and base of neck/top of shoulder, and the lower base of her neck became very sore and swollen). On an unknown date, the patient experienced PERIPHERAL SWELLING (Just like the first shot, the shot caused them to get their arm to be swollen), NECK PAIN (top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender), VACCINATION SITE ERYTHEMA (Arm to be red), VACCINATION SITE INDURATION (Arm hard as a rock) and HEADACHE (Have a dull headache). On 05-Nov-2021, BACK PAIN (lower back ache), CHILLS (really bad chills) and ARTHRALGIA (the top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender) had resolved. On 08-Nov-2021, TENDERNESS (It is swollen and very tender,at the base of their neck and superior to the clavicle) and VACCINATION SITE SWELLING (Nowthey have a  swollen at the top of the and superior to the clavicle and up into the lower part and base of neck/top of shoulder, and the lower base of her neck became very sore and swollen) had resolved. At the time of the report, PERIPHERAL SWELLING (Just like the first shot, the shot caused them to get their arm to be swollen), NECK PAIN (top of her  shoulder, and the lower base of her neck became very sore and swollen.Those areas were also very tender), VACCINATION SITE ERYTHEMA (Arm to be red), VACCINATION SITE INDURATION (Arm hard as a rock) and HEADACHE (Have a dull headache) had resolved. Concomitant information was not provided. Treatment information was not provided. Patient's reactions went away completely by 48 hours since they started. Company Comment: This case concerns a 67 year old female with relevant medical history of Spinal cord disease , who experienced non-serious unexpected event of back pain , expected event of chills and arthralgia one day  after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . Two days after vaccination with the 2nd dose , she experienced non-serious unexpected event of swelling ( swollen at the top and superior to the clavicle and up into the lower part and base of the neck and top of neck ) and Tenderness . On an unknown date  patient experienced non-serious expected events of Vaccination site swelling, vaccination site erythema and vaccination site induration. The re-challenge for this case is positive for the event chills since the patient experienced both event for dose 1 and dose 2 , however for the other events it is not applicable since the events occurred after the 2nd dose and no additional doses will be administered. The age of the patient and history of spinal disorder can be considered as a confounder for this case since elderly patient usually experiences joint pains and spinal disorders can manifest as pain. The benefit -risk relationship of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report. This case was downgraded from Serious to Non-serious  since event spinal disorder was removed as an event as assessed by the medical reviewer.This case was linked to MOD-2021-376925 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up contains reporter details, patient information, concomitant drug and adverse events details.; Sender's Comments: This case concerns a 67 year old female with relevant medical history of Spinal cord disease , who experienced non-serious unexpected event of back pain , expected event of chills and arthralgia one day  after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . Two days after vaccination with the 2nd dose , she experienced non-serious unexpected event of swelling ( swollen at the top and superior to the clavicle and up into the lower part and base of the neck and top of neck ) and Tenderness . On an unknown date  patient experienced non-serious expected events of Vaccination site swelling, vaccination site erythema and vaccination site induration. The re-challenge for this case is positive for the event chills since the patient experienced both event for dose 1 and dose 2 , however for the other events it is not applicable since the events occurred after the 2nd dose and no additional doses will be administered. The age of the patient and history of spinal disorder can be considered as a confounder for this case since elderly patient usually experiences joint pains and spinal disorders can manifest as pain. The benefit -risk relationship of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report. This case was downgraded from Serious to Non-serious  since event spinal disorder was removed as an event as assessed by the medical reviewer.