Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract oedema, Swelling, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Swelling of upper airway (lips,tongue, throat, uvula, or larynx); Swelling of upper airway (lips,tongue, throat, uvula, or larynx); Swelling of upper airway (lips,tongue, throat, uvula, or larynx); Swelling of upper airway (lips,tongue, throat, uvula, or larynx); Swelling of upper airway (lips,tongue, throat, uvula, or larynx); Swelling of arm, shoulder; Swelling of neck; Swelling of jaw; Sensation of throat closing; Difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT OEDEMA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)) and LARYNGEAL OEDEMA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: LISINOPRIL on 15-Jun-2019. Past adverse reactions to the above products included Swelling face with LISINOPRIL. Concurrent medical conditions included Chronic kidney disease since 15-May-2018, Hay fever, Acid reflux (esophageal) since 15-Feb-2017, Blood pressure high since 10-May-2019 and Vitamin D deficiency since 12-Aug-2019. Concomitant products included OMEPRAZOLE from 15-Feb-2017 to an unknown date for Acid reflux (esophageal), LOSARTAN from 10-May-2019 to an unknown date for Blood pressure high, VITAMIN D NOS from 12-Aug-2019 to an unknown date for Vitamin D deficiency.   On 10-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021 at 2:00 AM, the patient experienced RESPIRATORY TRACT OEDEMA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)) (seriousness criterion medically significant), LARYNGEAL OEDEMA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)) (seriousness criterion medically significant), LIP SWELLING (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), SWOLLEN TONGUE (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), ENLARGED UVULA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), PERIPHERAL SWELLING (Swelling of arm, shoulder), SWELLING (Swelling of neck), SWELLING FACE (Swelling of jaw), THROAT TIGHTNESS (Sensation of throat closing) and DYSPHAGIA (Difficulty swallowing). At the time of the report, RESPIRATORY TRACT OEDEMA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), LARYNGEAL OEDEMA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), LIP SWELLING (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), SWOLLEN TONGUE (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), ENLARGED UVULA (Swelling of upper airway (lips,tongue, throat, uvula, or larynx)), PERIPHERAL SWELLING (Swelling of arm, shoulder), SWELLING (Swelling of neck), SWELLING FACE (Swelling of jaw), THROAT TIGHTNESS (Sensation of throat closing) and DYSPHAGIA (Difficulty swallowing) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient visited emergency department on 01-AUG-2021. Patient had been suffering from time of 1st dose and still had all the symptoms. No treatment information was provided.  Company comment: This is a spontaneous case concerning a 58-year-old female patient with medical history of Seasonal allergy, previous reaction (swelling face) to lisinopril, Gastrooesophageal reflux disease, Hypertension, Vitamin D deficiency and Chronic kidney disease, who experienced unexpected serious events of Respiratory tract oedema and Laryngeal oedema and unexpected non-serious events of Lip swelling, Swollen tongue, Enlarged uvula, Peripheral swelling, Swelling, Swelling face, Throat tightness and Dysphagia. The events occurred on the same day after the first dose of mRNA-1273 vaccine. The outcome of the events was not recovered. The patient received also the second and the third dose of mRNA-1273 vaccine. The patient did not check angioedema as one of the developed events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-422897 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with medical history of Seasonal allergy, previous reaction (swelling face) to lisinopril, Gastrooesophageal reflux disease, Hypertension, Vitamin D deficiency and Chronic kidney disease, who experienced unexpected serious events of Respiratory tract oedema and Laryngeal oedema and unexpected non-serious events of Lip swelling, Swollen tongue, Enlarged uvula, Peripheral swelling, Swelling, Swelling face, Throat tightness and Dysphagia. The events occurred on the same day after the first dose of mRNA-1273 vaccine. The outcome of the events was not recovered. The patient received also the second and the third dose of mRNA-1273 vaccine. The patient did not check angioedema as one of the developed events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.