Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Emphysema, Fatigue, Feeling abnormal, Myalgia, Pulmonary function test
Clinical narrative: joint pains/she had arthritis before she took the vaccines but the pains are getting worse; She also had shortness of breath with exertion; she has very mild emphysema; SOB gotten worse after the 1st dose; felt really tired and achy /aches and pains in the muscles of her arms and legs; felt really tired/feels very, very tired and with absolutely no energy; chills/shivering; fever; she did not feel good but it was just mild; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (joint pains/she had arthritis before she took the vaccines but the pains are getting worse), DYSPNOEA EXERTIONAL (She also had shortness of breath with exertion), EMPHYSEMA (she has very mild emphysema), FEELING ABNORMAL (she did not feel good but it was just mild) and DYSPNOEA (SOB gotten worse after the 1st dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 007B21A, 033F21A and 011B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ileostomy in 2002. Concurrent medical conditions included Seasonal allergy, Crohn's disease (Crohn's disease diagnosed way before she got the vaccines), Arthritis and Shortness of breath.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (she did not feel good but it was just mild), CHILLS (chills/shivering), PYREXIA (fever) and FATIGUE (felt really tired/feels very, very tired and with absolutely no energy). On an unknown date, the patient experienced ARTHRITIS (joint pains/she had arthritis before she took the vaccines but the pains are getting worse), DYSPNOEA EXERTIONAL (She also had shortness of breath with exertion), EMPHYSEMA (she has very mild emphysema), DYSPNOEA (SOB gotten worse after the 1st dose) and MYALGIA (felt really tired and achy /aches and pains in the muscles of her arms and legs). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (joint pains/she had arthritis before she took the vaccines but the pains are getting worse), DYSPNOEA EXERTIONAL (She also had shortness of breath with exertion), EMPHYSEMA (she has very mild emphysema), DYSPNOEA (SOB gotten worse after the 1st dose) and MYALGIA (felt really tired and achy /aches and pains in the muscles of her arms and legs) had not resolved, FEELING ABNORMAL (she did not feel good but it was just mild) and FATIGUE (felt really tired/feels very, very tired and with absolutely no energy) outcome was unknown and CHILLS (chills/shivering) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 something. On an unknown date, Pulmonary function test: Inconclusive did not fully show anything, She said she has very mild emphysema..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported.  The patient did not receive other vaccines in the 4 weeks prior to COVID-19 vaccine.  Caller reported that she had numerous problems after getting the Moderna Covid-19 vaccines 4 doses, 2 primary and 2 booster doses. After the 1st dose, she did not feel good but it was just mild.  After the 2nd dose, she had pretty horrible symptoms. She woke up in the middle of the night with chills, shivering and fever (101 something). She had that for 2 days. After the 1st booster dose - she felt really tired and achy and that lasted for a day or two. After the 2nd booster dose, she felt the same symptoms as the ones after she got 1st booster dose. All kinds of test and blood works were done and everything came back normal. Shortness of breath started shortly after the 1st shot. As mentioned she used to have but it had gotten worse after the 1st dose. Patient had experienced symptoms like this before receiving the Moderna COVID-19 vaccine but it had gotten worse. Patient was reporting more the long term symptoms that she is experiencing. She has aches and pains in the muscles of her arms and legs and joint pains. She said that she had arthritis before she took the vaccines but the pains are getting worse. She also had shortness of breath with exertion and feels very, very tired and with absolutely no energy. She lives in a circle and she used to walk around that 7-8 times but now she can barely complete one. There was no history of COVID-19 infection or myocarditis or pericarditis.  Company comment: This spontaneous case concerns a 71-year-old, female patient with medical history of Seasonal allergy, Crohn's disease (Crohn's disease diagnosed way before she got the vaccines), Arthritis and Shortness of breath, who experienced the unexpected non serious of arthritis along with other non-serious events. The patient received 4 doses of Moderna COVID 19 vaccine. The event of Arthritis worsening occurred after the first and second booster dose of mRNA-1273. As reported, after the 1st dose, patient did not feel good but it was just mild. After the 2nd dose, patient woke up in the middle of the night with chills, shivering and fever which had for 2 days. After the 1st booster dose patient felt really tired and achy and this lasted for a day or two. After the 2nd booster dose, she felt the same symptoms as the ones after the 1st booster dose. Patient also experienced the long term symptoms having aches and pains in the muscles of her arms and legs and joint pains. Patient reported that she had arthritis before she took the vaccines but the pains are getting worse. She also had shortness of breath with exertion and feels very, very tired and with absolutely no energy. All kinds of test and blood works were done and everything came back normal, as reported. Patient was also found to have mild emphysema on pulmonary function test. Patient's medical history of Crohn's disease and arthritis are confounders for worsening of arthritis and the pains the patient was experiencing. While history of SOB and allergy is a confounder for dyspnoea. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This spontaneous case concerns a 71-year-old, female patient with medical history of Seasonal allergy, Crohn's disease (Crohn's disease diagnosed way before she got the vaccines), Arthritis and Shortness of breath, who experienced the unexpected non serious of arthritis along with other non serious events. The patient received 4 doses of Moderna COVID 19 vaccine. The event of Arthritis worsening occurred after the first and second booster dose of mRNA-1273. As reported, after the 1st dose, patient did not feel good but it was just mild. After the 2nd dose, patient woke up in the middle of the night with chills, shivering and fever which had for 2 days. After the 1st booster dose patient felt really tired and achy and this lasted for a day or two. After the 2nd booster dose, she felt the same symptoms as the ones after the 1st booster dose. Patient also experienced the long term symptoms having aches and pains in the muscles of her arms and legs and joint pains. Patient reported that she had arthritis before she took the vaccines but the pains are getting worse. She also had shortness of breath with exertion and feels very, very tired and with absolutely no energy. All kinds of test and blood works were done and everything came back normal, as reported. Patient was also found to have mild emphysema on pulmonary function test. Patient's medical history of Crohn's disease and arthritis are confounders for worsening of arthritis and the pains the patient was experiencing. While history of SOB and allergy is a confounder for dyspnoea. The benefit-risk relationship of mRNA-1273 is not affected by this report.