Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Skin disorder/Right/left arm was achy and little bumps that came and go; achiness in the morning; Pain in upper extremities/pain in hands upon waking; return of achiness to joints/knee pain; Neck pain upon waking; Kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Swollen joints (swollen joints of hands, upper arms, shoulders), Joint tenderness (tender joints of hands, upper arms, shoulders), Joint stiffness (stiff joints of hands, upper arms, shoulders), Activities of daily living impaired, Pain and Rheumatoid arthritis (Moderate to severe). Concomitant products included PREDNISONE from an unknown date to 30-Nov-2020 for an unknown indication.   On 19-Jun-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free., ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. In 2020, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant). In January 2021, the patient experienced NECK PAIN (Neck pain upon waking). In April 2021, the patient experienced ARTHRALGIA (return of achiness to joints/knee pain). On an unknown date, the patient experienced SKIN DISORDER (Skin disorder/Right/left arm was achy and little bumps that came and go), PAIN (achiness in the morning) and PAIN IN EXTREMITY (Pain in upper extremities/pain in hands upon waking). At the time of the report, NEPHROLITHIASIS (Kidney stones), SKIN DISORDER (Skin disorder/Right/left arm was achy and little bumps that came and go), NECK PAIN (Neck pain upon waking), PAIN (achiness in the morning) and PAIN IN EXTREMITY (Pain in upper extremities/pain in hands upon waking) outcome was unknown and ARTHRALGIA (return of achiness to joints/knee pain) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of skin disorder, pain in extremity and nephrolithiasis was not provided with HUMIRA(ADALIMUMAB). The reporter's causality for the events Arthralgia, neck pain and pain was no reasonable possibility with HUMIRA(ADALIMUMAB).   No treatment drug was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 70 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Nephrolithiasis, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounding to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Nephrolithiasis, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounding to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.