Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Condition aggravated, Drug ineffective, Ephelides
Clinical narrative: brown freckles on arm/brown freckles on legs/brown freckles covering  body; joint pain in neck; difficulty eating; arm pain; joint pain in arm/joint pain in shoulder; ulcer that got worse post vaccination; lack of efficacy; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of EPHELIDES (brown freckles on arm/brown freckles on legs/brown freckles covering  body), NECK PAIN (joint pain in neck), FEEDING DISORDER (difficulty eating), COVID-19 (Covid-19) and PAIN IN EXTREMITY (arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 031M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Prostate cancer. Previously administered products included for Ulcer: Sifrol (Sifrol Double twice a day for 10 days). Past adverse reactions to the above products included No adverse event with Sifrol. Concurrent medical conditions included Ulcer and Penicillin allergy. Concomitant products included OMEPRAZOLE for Ulcer.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of efficacy). On an unknown date, the patient experienced EPHELIDES (brown freckles on arm/brown freckles on legs/brown freckles covering  body), NECK PAIN (joint pain in neck), FEEDING DISORDER (difficulty eating), PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain in arm/joint pain in shoulder) and CONDITION AGGRAVATED (ulcer that got worse post vaccination). At the time of the report, EPHELIDES (brown freckles on arm/brown freckles on legs/brown freckles covering  body), NECK PAIN (joint pain in neck), FEEDING DISORDER (difficulty eating), COVID-19 (Covid-19), PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain in arm/joint pain in shoulder), CONDITION AGGRAVATED (ulcer that got worse post vaccination) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) tested positive for Covid-19 3 weeks ago.         Patient height was reported as 6. On 03-Dec-2021, Patient received first booster dose of Moderna COVID-19 Vaccine. Treatment details were not reported by the reporter. Company comment: This spontaneous case concerns an 80-year-old male patient with medical history of Prostate cancer, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). Additionally, Drug ineffective was also reported. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed. The initial two doses were given approximately 9 months prior, the interval between the two doses is 28 days. The patient's medical history of Prostate cancer could be a confounder to the event. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-565213, MOD-2022-565257 (Patient Link).; Sender's Comments: This spontaneous case concerns an 80-year-old male patient with medical history of Prostate cancer, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). Additionally, Drug ineffective was also reported. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed. The initial two doses were given approximately 9 months prior, the interval between the two doses is 28 days. The patient's medical history of Prostate cancer could be a confounder to the event. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.