Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Goitre, Headache, Illness, Loss of personal independence in daily activities
Clinical narrative: Didn't go to work; Headache; Fatigue; Achy; Diagnosed with Rocky Mount spotted fever; Felt she had a sore throat near her Adams Apple and it got worse; Thyroid nodules were enlarged; Was sick for about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ROCKY MOUNTAIN SPOTTED FEVER (Diagnosed with Rocky Mount spotted fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced ROCKY MOUNTAIN SPOTTED FEVER (Diagnosed with Rocky Mount spotted fever) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Felt she had a sore throat near her Adams Apple and it got worse), GOITRE (Thyroid nodules were enlarged) and ILLNESS (Was sick for about 3 weeks). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't go to work), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Achy). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, ROCKY MOUNTAIN SPOTTED FEVER (Diagnosed with Rocky Mount spotted fever), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't go to work), OROPHARYNGEAL PAIN (Felt she had a sore throat near her Adams Apple and it got worse), GOITRE (Thyroid nodules were enlarged), ILLNESS (Was sick for about 3 weeks), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Achy) outcome was unknown.            No concomitant medication was reported.  Company Comment: This spontaneous case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected, serious event of Rocky mountain spotted fever and other unexpected and expected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. After vaccination, the patient experienced headache, fatigue, myalgia, and she wasn't able to go to work. By the end of Jun2021, the patient felt like she had a sore throat near the Adam's apple and it got worse. Her thyroid nodules were enlarged, however, she had nodules in the past before getting the vaccine. She was then diagnosed with Rocky Mount spotted fever and was sick for about 3 weeks. She was prescribed with Doxycycline (unspecified dose, frequency and duration). The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2021-418198 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected, serious event of Rocky mountain spotted fever and other unexpected and expected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. After vaccination, the patient experienced headache, fatigue, myalgia, and she wasn't able to go to work. By the end of Jun2021, the patient felt like she had a sore throat near the Adam's apple and it got worse. Her thyroid nodules were enlarged, however, she had nodules in the past before getting the vaccine. She was then diagnosed with Rocky Mount spotted fever and was sick for about 3 weeks. She was prescribed with Doxycycline (unspecified dose, frequency and duration). The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.