Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Swelling of lymph nodes/lymph node under armpit is huge and worst/patient's lymph nodes under her armpit and on her neck got swollen, and swelling of lymph node under armpit is huge and worst than the one on the neck; Exhaustion; Body ache; Massive headache; Bottom lip still had tingling; Tongue swelled up; Swelling  in her left arm travelling all the way up to her neck; Tingling; Trouble breathing/breathing is still tight; Numbness; Throat Swelling; Swelling of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), PARAESTHESIA ORAL (Bottom lip still had tingling), DYSPNOEA (Trouble breathing/breathing is still tight), HYPOAESTHESIA (Numbness), PHARYNGEAL SWELLING (Throat Swelling), SWELLING FACE (Swelling of face), SWOLLEN TONGUE (Tongue swelled up), SWELLING (Swelling  in her left arm travelling all the way up to her neck), LYMPHADENOPATHY (Swelling of lymph nodes/lymph node under armpit is huge and worst/patient's lymph nodes under her armpit and on her neck got swollen, and swelling of lymph node under armpit is huge and worst than the one on the neck), FATIGUE (Exhaustion), MYALGIA (Body ache) and HEADACHE (Massive headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BUPROPION, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PARAESTHESIA (Tingling) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing/breathing is still tight) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat Swelling) (seriousness criterion medically significant), SWELLING FACE (Swelling of face) (seriousness criterion medically significant) and SWELLING (Swelling  in her left arm travelling all the way up to her neck) (seriousness criterion medically significant). On 30-Aug-2021, the patient experienced SWOLLEN TONGUE (Tongue swelled up) (seriousness criterion medically significant). On 01-Sep-2021, the patient experienced PARAESTHESIA ORAL (Bottom lip still had tingling) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), MYALGIA (Body ache) (seriousness criterion medically significant) and HEADACHE (Massive headache) (seriousness criterion medically significant). On 02-Sep-2021, the patient experienced LYMPHADENOPATHY (Swelling of lymph nodes/lymph node under armpit is huge and worst/patient's lymph nodes under her armpit and on her neck got swollen, and swelling of lymph node under armpit is huge and worst than the one on the neck) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 29-Aug-2021, PHARYNGEAL SWELLING (Throat Swelling), SWELLING FACE (Swelling of face) and SWELLING (Swelling  in her left arm travelling all the way up to her neck) had resolved. At the time of the report, PARAESTHESIA (Tingling), PARAESTHESIA ORAL (Bottom lip still had tingling), DYSPNOEA (Trouble breathing/breathing is still tight) and HYPOAESTHESIA (Numbness) had not resolved, SWOLLEN TONGUE (Tongue swelled up) had resolved and LYMPHADENOPATHY (Swelling of lymph nodes/lymph node under armpit is huge and worst/patient's lymph nodes under her armpit and on her neck got swollen, and swelling of lymph node under armpit is huge and worst than the one on the neck), FATIGUE (Exhaustion), MYALGIA (Body ache) and HEADACHE (Massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included steroids to treat symptoms.  Ten minutes after her first dose, patient started feeling numbness, tingling and swelling in her left arm travelling all the way up to her neck, throat and left side of her face. Patient also started having trouble breathing on the same day.  Patient still had tingling and part of her face was numb. Patient stated that her breathing was still tight and her doctor has prescribed some extra steroids. Patient was advised by her doctor not to get her second dose.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's medical history of asthma is a confounder for the reported events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's medical history of asthma is a confounder for the reported events.