Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Asthma; She had a telemedicine appointment with her doctor the following week who recommended that she not take an additional dose of the vaccine at at time; Heart beat which was very rapid; Mucous started running; A sore arm; Headaches; Felt tired; Feeling pressure on her chest; Throat was getting smaller/ like it was starting to close up; Throat was starting to burn; Felt is was hard to breathe; Hyperventilating; Felt her blood was bubbling; Stomach started hurting; She had saliva like she needed to spit; Had a headache; Sore arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Feeling pressure on her chest), THROAT TIGHTNESS (Throat was getting smaller/ like it was starting to close up), THROAT IRRITATION (Throat was starting to burn), DYSPNOEA (Felt is was hard to breathe), HYPERVENTILATION (Hyperventilating), BLOOD DISORDER (Felt her blood was bubbling), ABDOMINAL PAIN UPPER (Stomach started hurting), SALIVARY HYPERSECRETION (She had saliva like she needed to spit), ASTHMA (Asthma), TACHYCARDIA (Heart beat which was very rapid), SECRETION DISCHARGE (Mucous started running), PAIN IN EXTREMITY (A sore arm), HEADACHE (Headaches) and the first episode of FATIGUE (Felt tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced CHEST DISCOMFORT (Feeling pressure on her chest) (seriousness criteria medically significant and life threatening), THROAT TIGHTNESS (Throat was getting smaller/ like it was starting to close up) (seriousness criteria medically significant and life threatening), THROAT IRRITATION (Throat was starting to burn) (seriousness criteria medically significant and life threatening), DYSPNOEA (Felt is was hard to breathe) (seriousness criteria medically significant and life threatening), HYPERVENTILATION (Hyperventilating) (seriousness criteria medically significant and life threatening), BLOOD DISORDER (Felt her blood was bubbling) (seriousness criteria medically significant and life threatening), ABDOMINAL PAIN UPPER (Stomach started hurting) (seriousness criteria medically significant and life threatening), SALIVARY HYPERSECRETION (She had saliva like she needed to spit) (seriousness criteria medically significant and life threatening), TACHYCARDIA (Heart beat which was very rapid) (seriousness criteria medically significant and life threatening), SECRETION DISCHARGE (Mucous started running) (seriousness criteria medically significant and life threatening), PAIN IN EXTREMITY (A sore arm) (seriousness criteria medically significant and life threatening), HEADACHE (Headaches) (seriousness criteria medically significant and life threatening) and the first episode of FATIGUE (Felt tired) (seriousness criteria medically significant and life threatening). In 2021, the patient experienced HEADACHE (Had a headache), PAIN IN EXTREMITY (Sore arm) and the second episode of FATIGUE (Felt tired). On an unknown date, the patient experienced ASTHMA (Asthma) (seriousness criteria medically significant and life threatening) and OFF LABEL USE (She had a telemedicine appointment with her doctor the following week who recommended that she not take an additional dose of the vaccine at at time). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 04-Jan-2021, CHEST DISCOMFORT (Feeling pressure on her chest), THROAT TIGHTNESS (Throat was getting smaller/ like it was starting to close up), THROAT IRRITATION (Throat was starting to burn), DYSPNOEA (Felt is was hard to breathe), HYPERVENTILATION (Hyperventilating), BLOOD DISORDER (Felt her blood was bubbling), ABDOMINAL PAIN UPPER (Stomach started hurting), SALIVARY HYPERSECRETION (She had saliva like she needed to spit), TACHYCARDIA (Heart beat which was very rapid) and SECRETION DISCHARGE (Mucous started running) had resolved. On 07-Jan-2021, PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headaches) had resolved. At the time of the report, ASTHMA (Asthma), OFF LABEL USE (She had a telemedicine appointment with her doctor the following week who recommended that she not take an additional dose of the vaccine at at time), HEADACHE (Had a headache), PAIN IN EXTREMITY (Sore arm) and the last episode of FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Within 15-20 minutes after receiving the vaccine the patient's throat was getting smaller and starting to burn, like it was starting to close up. The patient then started feeling pressure on her chest, felt it was hard to breathe and she was hyperventilating, felt her blood was bubbling, her stomach started hurting, mucous started running, she had saliva like she needed to spit, and she had headaches. This lasted for 2-3 hours.  Events Sore arm, Fatigue and Headache are duplicated in the case because they were included in the Structured fields and also reported with unknown start date in the Narrative of the case. Conservatively, both events are included in the case.  Company Comment: This case concerns a 50 year-old female patient with no relevant medical history reported, who experienced the unexpected serious events of Chest discomfort, Throat tightness, Throat irritation, Dyspnoea, Hyperventilation, Blood disorder, Abdominal pain upper, Salivary hypersecretion, Tachycardia, Secretion discharge, Pain in extremity, Asthma and events as Headache and Fatigue, which are considered unlisted because of the seriousness of the case (Medically significant and Life-Threatening). Most events started 15-20 minutes after the first dose of an inappropriate schedule of administration of Moderna Covid-19 vaccine and resolved in 2 to 3 hours after the administration of Benadryl. The event asthma started on an unknown date after the vaccine administration and the outcome is unknown. The rechallenge is unknown for all the events reported, since the patient never received a second dose. The patient was advised by her Health Care Provider not to take the second dose of the vaccine and based on that information, the Non serious event Off label use was added to the case. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 50 year-old female patient with no relevant medical history reported, who experienced the unexpected serious events of Chest discomfort, Throat tightness, Throat irritation, Dyspnoea, Hyperventilation, Blood disorder, Abdominal pain upper, Salivary hypersecretion, Tachycardia, Secretion discharge, Pain in extremity, Asthma and events as Headache and Fatigue, which are considered unlisted because of the seriousness of the case (Medically significant and Life-Threatening). Most events started 15-20 minutes after the first dose of an inappropriate schedule of administration of Moderna Covid-19 vaccine and resolved in 2 to 3 hours after the administration of Benadryl. The event asthma started on an unknown date after the vaccine administration and the outcome is unknown. The rechallenge is unknown for all the events reported, since the patient never received a second dose. The patient was advised by her Health Care Provider not to take the second dose of the vaccine and based on that information, the Non serious event Off label use was added to the case. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.