Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Rhinorrhoea
Clinical narrative: I still have no smell; She started struggling with her breathing, out of breath; Runny nose; I still have no taste; Cough; My fingers are cold all the time. My feet are cold all the time; I have absolutely no strength whatsoever; She got sick; I'm numb all the time; My head was just on fire; Gave me the, the shot, it, the er, doctor said it hurt, hit a nerve and it gushed blood out, it squirted blood all over the lady; This spontaneous case was reported by a patient and describes the occurrence of ANOSMIA (I still have no smell), RESPIRATION ABNORMAL (She started struggling with her breathing, out of breath), RHINORRHOEA (Runny nose), AGEUSIA (I still have no taste) and COUGH (Cough) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD (Diagnosed with COPD in 2019) in 2019 and Acute pancreatitis (After this March she has acute pancreatitis, which she never had before.). Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1, Batch no: 004M20A and had no issues after the administration.) on 02-Feb-2021. Past adverse reactions to the above products included No adverse effect with MODERNA COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy, Asthma, Skin cancer (After this March she has skin cancer, which she never had before.), Osteoporosis (After this March she has osteoporosis, which she never had before.) and Restless legs syndrome (After this March she has Restless legs syndrome, which she never had any of those things.).    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE HAEMORRHAGE (Gave me the, the shot, it, the er, doctor said it hurt, hit a nerve and it gushed blood out, it squirted blood all over the lady). On an unknown date, the patient experienced ANOSMIA (I still have no smell), RESPIRATION ABNORMAL (She started struggling with her breathing, out of breath), RHINORRHOEA (Runny nose), AGEUSIA (I still have no taste), COUGH (Cough), PERIPHERAL COLDNESS (My fingers are cold all the time. My feet are cold all the time), ASTHENIA (I have absolutely no strength whatsoever), ILLNESS (She got sick), HYPOAESTHESIA (I'm numb all the time) and HEADACHE (My head was just on fire). At the time of the report, ANOSMIA (I still have no smell), RESPIRATION ABNORMAL (She started struggling with her breathing, out of breath), RHINORRHOEA (Runny nose), AGEUSIA (I still have no taste), COUGH (Cough), PERIPHERAL COLDNESS (My fingers are cold all the time. My feet are cold all the time), ILLNESS (She got sick) and INJECTION SITE HAEMORRHAGE (Gave me the, the shot, it, the er, doctor said it hurt, hit a nerve and it gushed blood out, it squirted blood all over the lady) had not resolved and ASTHENIA (I have absolutely no strength whatsoever), HYPOAESTHESIA (I'm numb all the time) and HEADACHE (My head was just on fire) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Blood work done the week before and there were no signs of any type of trouble or anything according to the patient..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that she was told that the Moderna booster she received was a bad batch and she has had a lot of medical issues from it. She had several 'bars' reports because she had been in and out of the hospital the last three years at least 15 - 20 times for different reasons. Patient went on saying, she had so many different things going on, that she had never been diagnosed with prior to this vaccination. She added that, when they gave her the shot, doctor said it hurt, hit a nerve and it gushed blood out, it squirted blood all over the lady that gave her the shot and then down her arm and everything else. Immediately she had a runny nose, a terrible cough and her head was just on fire. She had a bad back, and ever since then she was going downhill and was out of breath a lot. She had difficulty doing the things that she normally does. She was on oxygen 24/7. She had over 20 things she has been diagnosed with and she was not diagnosed prior to that vaccination. Patient added that she can't work, and she wasn't old enough to collect social security. Patient already talked with her HCP regarding her health issues. She also said that she went through the public health clinic, and it was a drive-through and that's where she got the vaccination. Her arm bled and she got sick, and she took that week off. Then when she came back to work, she started struggling with her breathing. It was like her strength had disappeared. Patient mentioned she got COVID in November, that's when she was put on oxygen. She was being sent to cardiology and was admitted and got the pacemaker kept in 2022. Patient added she was being referred for an appointment in a Nephrology and then she had a Pulmonary appointment but can't get in to see them until September. Patient still had no taste, no smell, absolutely no strength whatsoever. Treatment information was not reported.  Company Comment: This is a spontaneous case concerning a 62-year-old female patient with a history of COPD, who experienced the non-serious unexpected, AESI events of ANOSMIA and AGEUSIA, together with other non-serious events, which occurred on an unknown date after a dose of mRNA-1273 vaccine, received as the second dose of COVID-19 vaccination schedule.  The mentioned medical history remains as a confounder for events RESPIRATION ABNORMAL and COUGH. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-766705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2024: Live follow-up received and added quality complaint number. On 30-Apr-2024: Live follow-up received and updated references.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 62-year-old female patient with a history of COPD, who experienced the non-serious unexpected, AESI events of ANOSMIA and AGEUSIA, together with other non-serious events, which occurred on an unknown date after a dose of mRNA-1273 vaccine, received as the second dose of COVID-19 vaccination schedule.  The mentioned medical history remains as a confounder for events RESPIRATION ABNORMAL and COUGH. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2024-766705:Master Case