Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Paraesthesia, Periorbital swelling, Poor quality sleep, Product dose omission issue
Clinical narrative: mild feet burning/warmness; with no sleep at "ALL"; Patient hasn't received 2nd dose yet past 35 days/Patient received his 1st dose 16Jul2021. He is scheduled for 2nd dose on 10Sep2021; Anxiety; numbness; feeling hot; Burning from his neck to  legs/paresthesia/stinging  and tiingling of the skin at the neck (top torso) with burning (warmth); Stinging from neck to  legs/ stinging  and tiingling of the skin at the neck (top torso) with; Popping in sinuses; Eyes started to get puffy; Congestion; Pain and discomfort; Shoulder pain; Frontal headache; Little bit of swelling in his arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning from his neck to  legs/paresthesia/stinging  and tiingling of the skin at the neck (top torso) with burning (warmth)), PARAESTHESIA (Stinging from neck to  legs/ stinging  and tiingling of the skin at the neck (top torso) with), SINUS CONGESTION (Popping in sinuses), PERIORBITAL SWELLING (Eyes started to get puffy) and NASAL CONGESTION (Congestion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Previously administered products included for Tetanus: TDAP/Tetanus (Severe chills(full body), bedridden for a day, fatigue, aches, etc.) on 30-Dec-1988, TDAP/Tetanus (Severe chills(full body), bedridden for a day, fatigue, aches and etc.) on 20-Nov-2006. Past adverse reactions to the above products included Chills with TDAP/Tetanus and TDAP/Tetanus. Concurrent medical conditions included Seasonal allergy, GERD, Penicillin allergy (rash, itching (body), arms, etc) since 2006, Drug allergy (lips or mouth swell (during an endoscopic exam at a hospital)) since 2019, Sulfonamide allergy (rash, itching (body), arms, etc) since 2006, Milk allergy (since birth: milk (gastric disorders, mucus, fatigue, gastritis)) since 10-Jun-1968, Pollen allergy (watery eyes, sneezing, and sinus issues), Arthritis (currently seeing a chiropractor), Sinusitis (Simply Saline Spray Mist, nasal sprays, and nasal rinses, and Allegra) and Hypersensitivity. Concomitant products included MONTELUKAST SODIUM from 2021 to an unknown date for Allergy, ESOMEPRAZOLE from 2019 to an unknown date and FAMOTIDINE from 2019 to an unknown date for GERD, FLUTICASONE from 2000 to an unknown date for Sinus congestion, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PARAESTHESIA (Stinging from neck to  legs/ stinging  and tiingling of the skin at the neck (top torso) with), SINUS CONGESTION (Popping in sinuses), PERIORBITAL SWELLING (Eyes started to get puffy), NASAL CONGESTION (Congestion), DISCOMFORT (Pain and discomfort), ARTHRALGIA (Shoulder pain), HEADACHE (Frontal headache) and VACCINATION SITE SWELLING (Little bit of swelling in his arm). On 18-Jul-2021, the patient experienced BURNING SENSATION (Burning from his neck to  legs/paresthesia/stinging  and tiingling of the skin at the neck (top torso) with burning (warmth)), HYPOAESTHESIA (numbness) and FEELING HOT (feeling hot). On 19-Jul-2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced BURNING SENSATION (mild feet burning/warmness), POOR QUALITY SLEEP (with no sleep at "ALL") and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 35 days/Patient received his 1st dose 16Jul2021. He is scheduled for 2nd dose on 10Sep2021). The patient was treated with PARACETAMOL (TYLENOL) on 17-Jul-2021 for Swelling arm, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) (oral) in 2021 for Allergy, at a dose of 180 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 19-Jul-2021 to 21-Jul-2021 at a dose of 25 mg and PREDNISONE (oral) from 21-Jul-2021 to 26-Jul-2021 for Paresthesia, at a dose of 20 mg. On 17-Jul-2021, ARTHRALGIA (Shoulder pain) and VACCINATION SITE SWELLING (Little bit of swelling in his arm) had resolved. On 19-Jul-2021, SINUS CONGESTION (Popping in sinuses), NASAL CONGESTION (Congestion) and HEADACHE (Frontal headache) had resolved. On 26-Jul-2021, BURNING SENSATION (Burning from his neck to  legs/paresthesia/stinging  and tiingling of the skin at the neck (top torso) with burning (warmth)), HYPOAESTHESIA (numbness) and FEELING HOT (feeling hot) had resolved with sequelae. At the time of the report, PARAESTHESIA (Stinging from neck to  legs/ stinging  and tiingling of the skin at the neck (top torso) with) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 35 days/Patient received his 1st dose 16Jul2021. He is scheduled for 2nd dose on 10Sep2021) had resolved, PERIORBITAL SWELLING (Eyes started to get puffy), ANXIETY (Anxiety) and POOR QUALITY SLEEP (with no sleep at "ALL") had not resolved and BURNING SENSATION (mild feet burning/warmness) and DISCOMFORT (Pain and discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 149/86 mmHg (normal) normal. On an unknown date, Body temperature: 37.1 degree Celsius (normal) normal. On an unknown date, Heart rate: 83 (normal) normal. On an unknown date, Respiratory rate: 14 breaths per minute (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient was hospitalized on 19-7-2021  The patient  recovered with residual effects on 30 July 2021 Heart rate was 83 beats per minute   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: No new information. On 02-Sep-2021: Follow up document included concomitant drug added and new event added.