Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Fatigue, Feeling abnormal, Fibromyalgia, Headache
Clinical narrative: week later she felt terrible like the flu/sometimes she feels like she has a fever/ Patient started feeling bad; she had brain fog; loss of appetite; patient has a little bronchitis; exhaustion; experienced muscle and joints, aches; chills; she had fibromyalgia/she has headaches; experienced muscle and joints, aches; Patient received "an extra dose" a long time ago; she had fibromyalgia/she has headaches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (week later she felt terrible like the flu/sometimes she feels like she has a fever/ Patient started feeling bad), BRAIN FOG (she had brain fog), DECREASED APPETITE (loss of appetite), FIBROMYALGIA (she had fibromyalgia/she has headaches) and BRONCHITIS (patient has a little bronchitis) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71848) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FIBROMYALGIA (she had fibromyalgia/she has headaches). On an unknown date, the patient experienced FEELING ABNORMAL (week later she felt terrible like the flu/sometimes she feels like she has a fever/ Patient started feeling bad), BRAIN FOG (she had brain fog), DECREASED APPETITE (loss of appetite), BRONCHITIS (patient has a little bronchitis), FATIGUE (exhaustion), MYALGIA (experienced muscle and joints, aches), CHILLS (chills), HEADACHE (she had fibromyalgia/she has headaches), ARTHRALGIA (experienced muscle and joints, aches) and EXTRA DOSE ADMINISTERED (Patient received "an extra dose" a long time ago). At the time of the report, FEELING ABNORMAL (week later she felt terrible like the flu/sometimes she feels like she has a fever/ Patient started feeling bad), BRAIN FOG (she had brain fog), DECREASED APPETITE (loss of appetite), FIBROMYALGIA (she had fibromyalgia/she has headaches), BRONCHITIS (patient has a little bronchitis), FATIGUE (exhaustion), MYALGIA (experienced muscle and joints, aches), CHILLS (chills) and ARTHRALGIA (experienced muscle and joints, aches) had not resolved and HEADACHE (she had fibromyalgia/she has headaches) and EXTRA DOSE ADMINISTERED (Patient received "an extra dose" a long time ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative. On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medications were reported. The patient did not have fever, patient did not take the temperature, patient could not work, she was moving slowly but she said she did not have nothing major.  It was reported that patient went to ER on Friday last week and was told had fibromyalgia. Probably 6 months ago had another vaccination and did not have the same reaction. Patient was not able to specify how many doses received 5 or 6 because she could not recall. Patient received and an extra dose a long time ago and does not have the original vaccination card and was not able to provide information about the vaccination process as patient did not remember facts about it the 1st dose was in Jan on the same year of the release of the vaccine.  It was reported that patient started experiencing symptoms a week after receiving the vaccine the symptoms were ongoing but little better.     No treatment medications were reported.  Company Comment: This spontaneous case concerns a 79-year-old female patient with no medical history reported, who experienced the non-serious, unexpected AESI of Fibromyalgia. The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received a dose of mRNA-1273.222 (BA.4/BA.5). It was reported that 2 and a half weeks ago and a week later she felt terrible like the flu, experienced a big reaction on her arm, chills, did not have fever, but did not take the temperature, experienced muscle and joints aches, headaches, loss of appetite, exhaustion, could not work. She was moving slowly but she said she did not have nothing mayor. Patient went to Emergency room on last week and was told she had fibromyalgia. She was tested for flu and COVID and the tests came back negative for both. Probably 6 months ago had another vaccination and did not have the same reaction. She had brain fog. She had received 5 or 6 doses of COVID-19 vaccines but was not able to specify how many because she did not recall. Patient started feeling bad, sometimes she feels like she has a fever, has a little bronchitis or "something". Patient received "an extra dose" a long time ago. Patient does not have the original vaccination card and was not able to provide information about her vaccination process. Extra dose administered was considered as an additional event. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with no medical history reported, who experienced the non-serious, unexpected AESI of Fibromyalgia. The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received a dose of mRNA-1273.222 (BA.4/BA.5). It was reported that 2 and a half weeks ago and a week later she felt terrible like the flu, experienced a big reaction on her arm, chills, did not have fever, but did not take the temperature, experienced muscle and joints aches, headaches, loss of appetite, exhaustion, could not work. She was moving slowly but she said she did not have nothing mayor. Patient went to Emergency room on last week and was told she had fibromyalgia. She was tested for flu and COVID and the tests came back negative for both. Probably 6 months ago had another vaccination and did not have the same reaction. She had brain fog. She had received 5 or 6 doses of COVID-19 vaccines but was not able to specify how many because she did not recall. Patient started feeling bad, sometimes she feels like she has a fever, has a little bronchitis or "something". Patient received "an extra dose" a long time ago. Patient does not have the original vaccination card and was not able to provide information about her vaccination process. Extra dose administered was considered as an additional event. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.