Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Pulmonary pain, Pyrexia, Respiratory tract irritation
Clinical narrative: really really sick - with chemotherapy; blood pressure was slightly elevated; felt unusual; Temperature was 100.4F.; exhausted; pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer; painful in the area of her cancer; difficulty in breathing; lot of discomfort; Second dose administered on 38th day; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT IRRITATION (pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer), PULMONARY PAIN (painful in the area of her cancer) and DYSPNOEA (difficulty in breathing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on 38th day). On 23-Mar-2021, the patient experienced RESPIRATORY TRACT IRRITATION (pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer) (seriousness criterion intervention required), PULMONARY PAIN (painful in the area of her cancer) (seriousness criterion intervention required), DYSPNOEA (difficulty in breathing) (seriousness criterion intervention required) and DISCOMFORT (lot of discomfort). On 27-Mar-2021, the patient experienced ILLNESS (really really sick - with chemotherapy), HYPERTENSION (blood pressure was slightly elevated), MALAISE (felt unusual), PYREXIA (Temperature was 100.4F.) and FATIGUE (exhausted). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on 38th day) had resolved. On 26-Mar-2021, RESPIRATORY TRACT IRRITATION (pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer), PULMONARY PAIN (painful in the area of her cancer), DYSPNOEA (difficulty in breathing) and DISCOMFORT (lot of discomfort) had resolved. On 31-Mar-2021, ILLNESS (really really sick - with chemotherapy), HYPERTENSION (blood pressure was slightly elevated), MALAISE (felt unusual), PYREXIA (Temperature was 100.4F.) and FATIGUE (exhausted) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Because of chemotherapy the patient rescheduled her second shot and so it was delayed. Four days after the second shot she got pressure in the area of her cancer (left lung cancer), it tightened up, she had difficulty in breathing, painful, lot of discomfort, it was like somebody was squeezing her lungs. Few days later (2-3 days) she got really really sick and felt very tired - she was under chemotherapy. This never happened before with the chemotherapy (she has been taking it from several years). Her blood pressure was slightly elevated. Temperature was 100.4F. She felt very unusual and exhausted. All this happened for about for about 4-5 days.  Treatment for the event included acetylsalicylic acid.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, noting the subject's currently chemotherapy may remain as confounder. This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot # 013M20A, with no associated AEs. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, noting the subject's currently chemotherapy may remain as confounder. This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot # 013M20A, with no associated AEs. Further information has been requested.