Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Dyspnoea, Headache, Pain
Clinical narrative: BREATHING DIFFICULTY; BODY ACHE; BACK ACHE; CHILLS; FEVER; HEADACHE; ARM REMAINED A LITTLE SORE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for corona virus disease. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient was not pregnant at the time of reporting. The patient had no known allergies to vaccines, drug or food. The patient was previously treated with influenza vaccine for prophylactic vaccination. She stated that there was no past history of a similar event or any adverse event after a previous vaccination. The had no illness at the time of the vaccination. The reporter stated that there was no pre-existing acute illness 30 days prior to the COVID-19 vaccine and no history of hospitalization in the last 30 days. The patient does not have a past history of headaches.  The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number: unknown) unit dose not reported, 1 total, administered on 06-MAR-2021 to her left arm for prophylactic vaccination. The batch number was not reported and has been requested. No other vaccines were administered along with the COVID-19 vaccine. No concomitant medications were reported. On 06-MAR-2021, the patient experienced breathing difficulty and requested breathing treatment. She was directed to call emergency services. On 06-MAR-2021, the patient also experienced headache, body ache, chills, fever, and back ache. The patient had an emergency room visit for the events. The patient did not take her temperature. The adverse events lasted for about a day, mostly body aches but the headache was still there on the day of reporting. On MAR-2021, the patient's arm remained a little sore. No corona virus disease test and flu test was performed recently.  The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from breathing difficulty, body ache, chills, fever, and back ache on MAR-2021, had not recovered from headache, and the outcome of arm remained a little sore was not reported. The reporter causality between COVID-19 vaccine Ad26.COV2.S headache, breathing difficulty, body ache, chills and fever was related. The reporter causality between COVID-19 vaccine Ad26.COV2.S and back ache  and arm remained a little sore  was not possible. Company causality between COVID-19 vaccine Ad26.COV2.S breathing difficulty, body ache, chills, fever, headache and arm remained a little sore was possible. This report was serious (Other Medically Important Condition). Additional information was received from patient on 10-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (age, age group), Vaccination site of suspect vaccine added (her left arm), Past condition added (tested positive for corona virus disease), Event added (arm remained a little sore), Outcome, action taken. Narrative updated. The batch number was not reported and has been requested. Upon review following information was amended:  Emergency room visit checked for events breathing difficulty, body ache, chills, fever and headache. Reporter causality entered as related for the events headache, breathing difficulty, body ache, chills and fever. Narrative changes made.; Sender's Comments: V1: Follow up information received was regarding addition of non serious event (arm remained a little sore), Patient demographic details (age, age group), Vaccination site of suspect vaccine added (her left arm), Past condition (tested positive for corona virus disease), Outcome, action taken. This updated information does not alter prior causality assessment of reported events. Headache, body ache, chills, fever, back ache and breathing difficulty. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.    .