Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastrooesophageal reflux disease, Hernia, Immunisation reaction, Joint swelling, Myalgia
Clinical narrative: Asthma had been getting worse; Coughing a lot and a lot of mucous was coming out; Hernia had been getting bigger; Swelling on ankles; Had serious pain under the right breast; Acid reflux; Sick off the covid vaccine/vaccination related malaise; Swelling of fingers; Swelling on stomach/Swelling abdomen; Hard time passing stool its hard; Muscle pain; Left ear pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma had been getting worse) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Patient had no known allergies.  The patient's past medical history included Knee surgery NOS in 2017. Previously administered products included for Drug use for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Colon cancer stage III since 2017 and Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2022, the patient experienced EAR PAIN (Left ear pain). On an unknown date, the patient experienced ASTHMA (Asthma had been getting worse) (seriousness criteria hospitalization and medically significant), PRODUCTIVE COUGH (Coughing a lot and a lot of mucous was coming out), HERNIA (Hernia had been getting bigger), JOINT SWELLING (Swelling on ankles), PAIN (Had serious pain under the right breast), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), IMMUNISATION REACTION (Sick off the covid vaccine/vaccination related malaise), PERIPHERAL SWELLING (Swelling of fingers), ABDOMINAL DISTENSION (Swelling on stomach/Swelling abdomen), FAECES HARD (Hard time passing stool its hard) and MYALGIA (Muscle pain). At the time of the report, ASTHMA (Asthma had been getting worse), PRODUCTIVE COUGH (Coughing a lot and a lot of mucous was coming out) and HERNIA (Hernia had been getting bigger) had not resolved and EAR PAIN (Left ear pain), JOINT SWELLING (Swelling on ankles), PAIN (Had serious pain under the right breast), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), IMMUNISATION REACTION (Sick off the covid vaccine/vaccination related malaise), PERIPHERAL SWELLING (Swelling of fingers), ABDOMINAL DISTENSION (Swelling on stomach/Swelling abdomen), FAECES HARD (Hard time passing stool its hard) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient had been coughing a lot and a lot of mucous was coming out. Patient  had hard time passing stool, it was hard and clumpy. Patient  also had pain on left side ear which started that morning in Apr 2022. Patient continued swelling on finger, ankles, and stomach. Patient's asthma had been getting worse. Patient's hernia had been getting bigger and believed  coughing had been making the hernia worse.  The reporter's causality for the events of asthma had been getting worse, muscle pain, coughing a lot and a lot of mucous was coming out, left ear pain, hernia had been getting bigger, swelling on ankles, high cholesterol, pain under the right breast, acid reflux, sick off the covid vaccine, swelling on finger and swelling on stomach with Rinvoq (Upadacitinib) was not provided.  No treatment medications were reported. Company comment: This spontaneous case concerns an 80-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant, Hospitalization) event of Asthma. The exact date of administration of a dose of mRNA-1273 and onset of the event was not specified, hence latency could not be assessed. It has been reported that the patient is experiencing productive cough which results in progression of her hernia accompanied by aggravation of Asthma. Details of concomitant medications, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns an 80-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant, Hospitalization) event of Asthma. The exact date of administration of a dose of mRNA-1273 and onset of the event was not specified, hence latency could not be assessed. It has been reported that the patient is experiencing productive cough which results in progression of her hernia accompanied by aggravation of Asthma. Details of concomitant medications, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.