Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vaccination site discolouration, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Respiratory infection/green mucus coming out of her nose; The pain is like sinus infection; She states that the bones on her face hurt.; She states that underneath her eyes were raw and red.; Her Left Arm injection site was swollen Black and Blue with a nod under arm; Erratic Crying/erratic behavior/ lost control of her emotions/crying spells for five hours in one day; Tingling inner arm; She has lumps in her inner left arm; Her Left Arm injection site was swollen Black and Blue with a nod under arm; left arm injection site was killing her and it was all sore/there is tenderness; She was overly Fatigue; she had a fever (not measured); Head was pounding; Compare my arms and showed my doctor, there is Redness, there is Lumps, and there is tenderness.; She has lumps in her inner left arm, it is tingling and pain going down her nerves down her entire inner left arm; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory infection/green mucus coming out of her nose), SINUSITIS (The pain is like sinus infection), FACIAL PAIN (She states that the bones on her face hurt.), ERYTHEMA OF EYELID (She states that underneath her eyes were raw and red.) and VACCINATION SITE DISCOLOURATION (Her Left Arm injection site was swollen Black and Blue with a nod under arm) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:LUPUS, High Blood Pressure, Rheumatoid.  The patient's past medical history included COVID-19 (First time was in DEC 2021 and it lasted 2 weeks, does not remember the 2nd time. And the third time with COVID disease was in SEP 2023.) in December 2021. Previously administered products included for COVID-19 prophylaxis: J&J COVID-19 Vaccine (first dose) on 08-Apr-2021, Moderna COVID-19 Vaccine (Second dose) on 30-Oct-2021 and Pfizer COVID-19 Vaccine (Third dose) on 18-Oct-2022; for Product used for unknown indication: Flu shot in October 2023. Past adverse reactions to the above products included No adverse event with Flu shot, J&J COVID-19 Vaccine, Moderna COVID-19 Vaccine and Pfizer COVID-19 Vaccine. Concurrent medical conditions included Lupus erythematosus, Blood pressure high and Rheumatoid arthritis.    On 05-Jan-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Jan-2024, the patient experienced SINUSITIS (The pain is like sinus infection), FACIAL PAIN (She states that the bones on her face hurt.), ERYTHEMA OF EYELID (She states that underneath her eyes were raw and red.), VACCINATION SITE DISCOLOURATION (Her Left Arm injection site was swollen Black and Blue with a nod under arm), MOOD SWINGS (Erratic Crying/erratic behavior/ lost control of her emotions/crying spells for five hours in one day), PARAESTHESIA (Tingling inner arm), VACCINATION SITE MASS (She has lumps in her inner left arm), VACCINATION SITE SWELLING (Her Left Arm injection site was swollen Black and Blue with a nod under arm), VACCINATION SITE PAIN (left arm injection site was killing her and it was all sore/there is tenderness), FATIGUE (She was overly Fatigue) and PYREXIA (she had a fever (not measured)). In January 2024, the patient experienced PAIN (She has lumps in her inner left arm, it is tingling and pain going down her nerves down her entire inner left arm), HEADACHE (Head was pounding) and VACCINATION SITE ERYTHEMA (Compare my arms and showed my doctor, there is Redness, there is Lumps, and there is tenderness.). On 20-Jan-2024, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory infection/green mucus coming out of her nose). The patient was treated with IBUPROFEN in January 2024 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) in January 2024 at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) from January 2024 to 23-Jan-2024 at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory infection/green mucus coming out of her nose), SINUSITIS (The pain is like sinus infection), FACIAL PAIN (She states that the bones on her face hurt.), ERYTHEMA OF EYELID (She states that underneath her eyes were raw and red.), VACCINATION SITE DISCOLOURATION (Her Left Arm injection site was swollen Black and Blue with a nod under arm), MOOD SWINGS (Erratic Crying/erratic behavior/ lost control of her emotions/crying spells for five hours in one day), PAIN (She has lumps in her inner left arm, it is tingling and pain going down her nerves down her entire inner left arm), PARAESTHESIA (Tingling inner arm), VACCINATION SITE MASS (She has lumps in her inner left arm), VACCINATION SITE SWELLING (Her Left Arm injection site was swollen Black and Blue with a nod under arm), VACCINATION SITE PAIN (left arm injection site was killing her and it was all sore/there is tenderness), FATIGUE (She was overly Fatigue), PYREXIA (she had a fever (not measured)), HEADACHE (Head was pounding) and VACCINATION SITE ERYTHEMA (Compare my arms and showed my doctor, there is Redness, there is Lumps, and there is tenderness.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2024, Blood pressure measurement: 190/100 mmHg.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient was having adverse reactions for nearly three weeks.  The patient also had Shingles vaccine on OCT2023  The patient had a 2nd Shingle shot in the right arm on 05JAN2024.  The patient was taking anxiety medication. The patient was not on any medications for HBP for 5 years prior to COVID-19 vaccination and BP was under control. The new Spikevax made her Blood pressure rise again.  The patient had bizarre reactions after receiving the new Spikevax. She states that with the past COVID vaccinations, the reaction happened immediately, or the next day. Past reactions were similar to this time but not as intense. With previous COVID-19 vaccines, she was in bed for about two weeks, with body aches and Pain. With the new Spikevax, the reaction happened 5 days later.  These reactions were still going on.  The patient finished the Levaquin but her nose started with green Mucus again after Levaquin stopped.. On, 23JAN2024, three weeks later, the patient still had the same black and blue mark on her left arm injection site and it is swollen. The Black and Blue on the left arm, did not go away, nor did it fade. The doctor examined the left arm and noticed that there was lumps, lumps ere in inner left arm, it was tingling and pain going down her nerves down her entire inner left arm. It is just such weird and different reaction. The reactions were still ongoing.  The patient was put on high blood pressure medication. The patient had new symptoms keep on popping up.   This case was linked to MOD-2024-758250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2024: Live follow up received on 24-Jan-2024, reference number added.