chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: vaccination site erythema; vaccination site swelling; injection site hard to the touch; vaccination site warmth; vaccination site pruritus; lymph nodes that were large and swollen near collar bone; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch) and VACCINATION SITE PRURITUS (vaccination site pruritus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L204A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain). On 12-Jan-2021, the patient experienced LYMPHADENOPATHY (lymph nodes that were large and swollen near collar bone). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus). On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch) and VACCINATION SITE WARMTH (vaccination site warmth). On 09-Jan-2021, VACCINATION SITE PAIN (arm pain) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE WARMTH (vaccination site warmth) and LYMPHADENOPATHY (lymph nodes that were large and swollen near collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Last night (14JAN2021) before going to bed, she noticed her arm near the injection was itching and red. This morning (15JAN2021) the area became round as a softball, hard to the touch, much bigger, itchy, and hot.  No history of concomitant medications were taken by the patient.   Patient was able to get hold of health department who suggested her using heat, cold and ice in the effected area. She has not started following the suggestion which health department gave.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea
Clinical narrative: Arm numbness; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm numbness), NAUSEA (Nausea) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (Arm numbness), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Arm numbness), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects that have lasted ten days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects that have lasted ten days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects that have lasted ten days). At the time of the report, VACCINATION COMPLICATION (side effects that have lasted ten days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Treatment for the event included was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness
Clinical narrative: dizzy and lightheaded; opposite side shoulder he received the vaccine was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy and lightheaded) and ARTHRALGIA (opposite side shoulder he received the vaccine was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (dizzy and lightheaded) and ARTHRALGIA (opposite side shoulder he received the vaccine was sore). On 15-Jan-2021, DIZZINESS (dizzy and lightheaded) and ARTHRALGIA (opposite side shoulder he received the vaccine was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Heat
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE SWELLING (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE PAIN (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE ERYTHEMA (Painful, warm touch, red swollen rump at the site injection) and VACCINATION SITE INDURATION (Painful, warm touch, red swollen rump at the site injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE SWELLING (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE PAIN (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE ERYTHEMA (Painful, warm touch, red swollen rump at the site injection) and VACCINATION SITE INDURATION (Painful, warm touch, red swollen rump at the site injection). At the time of the report, VACCINATION SITE WARMTH (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE SWELLING (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE PAIN (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE ERYTHEMA (Painful, warm touch, red swollen rump at the site injection) and VACCINATION SITE INDURATION (Painful, warm touch, red swollen rump at the site injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient applied ice and hydrocortisone for treatment, but the symptoms persisted.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling and warmness at the injection site, and swelling again at day 8; swelling and warmness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (swelling and warmness at the injection site ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (swelling and warmness at the injection site ). On 10-Jan-2021, VACCINATION SITE WARMTH (swelling and warmness at the injection site ) had resolved.        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.   On 09JAN2021 consumer took first dose of Moderna COVID 19 vaccine last Saturday and she got swelling and warmness at injection site. But it went away on second day but on 16JAN2021 after 8 days her arm is swollen again.    Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Sore arm; it's a little red; there's a welt and now there's a second one; Itching in the area; it's a little hot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (it's a little red), VACCINATION SITE SWELLING (there's a welt and now there's a second one), VACCINATION SITE PRURITUS (Itching in the area) and VACCINATION SITE WARMTH (it's a little hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (it's a little red), VACCINATION SITE SWELLING (there's a welt and now there's a second one), VACCINATION SITE PRURITUS (Itching in the area) and VACCINATION SITE WARMTH (it's a little hot). At the time of the report, VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (it's a little red), VACCINATION SITE SWELLING (there's a welt and now there's a second one), VACCINATION SITE PRURITUS (Itching in the area) and VACCINATION SITE WARMTH (it's a little hot) outcome was unknown.            Treatment for the events were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; Swelling at the injection site; Redness at the injection site; Mild pain and tenderness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (Itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, ATORVASTATIN, LORATADINE, UBIDECARENONE (QUNOL LIQUID COQ10), CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), MULTI VITAMIN ONE A DAY, TRIAMCINOLONE ACETONIDE (NASACORT) and APOAEQUORIN, COLECALCIFEROL (PREVAGEN [APOAEQUORIN;COLECALCIFEROL]) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        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.   Treatment for the events included diphenhydramine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: knot/swelling/swollen lymph node above the L clavicle; Left arm hurt; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Left arm hurt) and LYMPHADENOPATHY (knot/swelling/swollen lymph node above the L clavicle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20(?)) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Left arm hurt). On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (knot/swelling/swollen lymph node above the L clavicle). On 02-Jan-2021, VACCINATION SITE PAIN (Left arm hurt) had resolved. At the time of the report, LYMPHADENOPATHY (knot/swelling/swollen lymph node above the L clavicle) outcome was unknown.        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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Pyrexia
Clinical narrative: injection site swelling; Hurts; Fever; chills; Headache; Feels cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FEELING COLD (Feels cold). At the time of the report, VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FEELING COLD (Feels cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.7 f degree Celsius (High) high.     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.   Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site swelling; Hurts; Fever; chills; Headache; Feels cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FEELING COLD (Feels cold). At the time of the report, VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FEELING COLD (Feels cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.7 f degree Celsius (High) high.     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.   Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Right arm hurts; Right shoulder hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm hurts) and ARTHRALGIA (Right shoulder hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Right arm hurts) and ARTHRALGIA (Right shoulder hurts). At the time of the report, VACCINATION SITE PAIN (Right arm hurts) and ARTHRALGIA (Right shoulder hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported.   No concomitant medication reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Site of injcetion became red that spreads from top of her shoulder to her biceps; Site of injection is itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Site of injcetion became red that spreads from top of her shoulder to her biceps) and VACCINATION SITE PRURITUS (Site of injection is itching) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Site of injcetion became red that spreads from top of her shoulder to her biceps) and VACCINATION SITE PRURITUS (Site of injection is itching). At the time of the report, VACCINATION SITE ERYTHEMA (Site of injcetion became red that spreads from top of her shoulder to her biceps) and VACCINATION SITE PRURITUS (Site of injection is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used Benadryl and cortisone cream for treatment.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: it hurts; it's itchy; My arm is turning red, it appears to be spreading; It's hot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (It's hot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's hot). At the time of the report, VACCINATION SITE WARMTH (It's hot) outcome was unknown.        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.   Patient's primary care physician told him to take Benadryl and put cortisone ointment on the injection site.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swollen tongue, Tongue discomfort, Vaccination site pain
Clinical narrative: swollen tongue,the tongue is a little sore,I woke up with a scalloped tongue; swollen tongue,the tongue is a little sore,I woke up with a scalloped tongue; arm was sore; a slight headache that went on and off for 10 minutes then no more headaches that happened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONGUE DISCOMFORT (swollen tongue,the tongue is a little sore,I woke up with a scalloped tongue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (patient had a swollen tongue when eating spinach and now she has an anaphylaxis reaction to spinach.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced TONGUE DISCOMFORT (swollen tongue,the tongue is a little sore,I woke up with a scalloped tongue). At the time of the report, TONGUE DISCOMFORT (swollen tongue,the tongue is a little sore,I woke up with a scalloped tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided.   Treatment activities for event was done with diphenhydramine.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: heart is beating fast; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart is beating fast) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient is reported to have a  long covid syndrome since he cant breath good for past month.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HEART RATE INCREASED (heart is beating fast). At the time of the report, HEART RATE INCREASED (heart is beating fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided.   Treatment activities for event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site swelling
Clinical narrative: High fever; Chills; Swelling; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Apr-2020. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN, LEVOTHYROXINE, ATORVASTATIN, OLMESARTAN, MELOXICAM (MELOXICAN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching; soreness in right arm similar to flu shot experience; Some small tightness in my throat and rib cage; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Some small tightness in my throat and rib cage), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE PAIN (soreness in right arm similar to flu shot experience) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2O4) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced THROAT TIGHTNESS (Some small tightness in my throat and rib cage). On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in right arm similar to flu shot experience). On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching). On 16-Jan-2021, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE PAIN (soreness in right arm similar to flu shot experience) had resolved. At the time of the report, THROAT TIGHTNESS (Some small tightness in my throat and rib cage) had resolved. The throat tightness lasted for 10 mins      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient drank orange juice for the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: soreness and pain in neck; high fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (soreness and pain in neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (soreness and pain in neck). At the time of the report, NECK PAIN (soreness and pain in neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Swollen glands; Tiredness; Chills; Fever; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with IBUPROFEN (ADVIL 12 HOUR) on 14-Jan-2021 for Fever, at a dose of 500 mg.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.; 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. Further information has been requested
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Sore throat; Swollen glands; Tiredness; Chills; Fever; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with IBUPROFEN (ADVIL 12 HOUR) on 14-Jan-2021 for Fever, at a dose of 500 mg.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.; 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. Further information has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness postural, Fatigue, Nausea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS POSTURAL (Feeling faint when standing up), PAIN IN EXTREMITY (arm soreness), FATIGUE (feeling tired), NAUSEA (nauseous) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Postural orthostatic tachycardia syndrome from 2015 to 2018. Concomitant products included ADRENAL SUPPORT for Adrenal insufficiency, LYSINE for Cold sores, ASCORBIC ACID (VITAMIN C CITRUS) for Combined immunity deficiency, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, ZINC and FISH OIL for Supplementation therapy.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and FATIGUE (feeling tired). On 14-Jan-2021, the patient experienced DIZZINESS POSTURAL (Feeling faint when standing up), NAUSEA (nauseous) and CHILLS (chills). At the time of the report, DIZZINESS POSTURAL (Feeling faint when standing up), PAIN IN EXTREMITY (arm soreness), FATIGUE (feeling tired), NAUSEA (nauseous) and CHILLS (chills) had not resolved.        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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-Significant Follow-up; 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.  The patient's concurrent condition of Postural orthostatic tachycardia syndrome remains a confounder.
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: feeling some discomfort; Slight itchiness; redness around the site of injection and getting bigger; Pain at site of injection/burning sensation; A spontaneous report was received from other health care professional concerning a 76- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced Pain at site of injection/slight burn sensation(injection site pain), redness (Injection site erythema) and slight itchiness (Injection site pruritus) and feeling some discomfort (Injection site discomfort).  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 4-jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  He had pain at the site of injection for 2 days from the day he received it. On 9-jan-2021 he started noticing redness around the site of injection and it seems to be getting bigger. Over the weekend around 16 or 17 of January 2021 he started feeling some discomfort which includes slight burning sensation and itchiness. He had used Benadryl ointment for the affected area since last week, but he still had the symptoms.  No laboratory data was provided.  No treatment drugs were provided.  Action taken with mRNA-1273 in response to the events Pain at site of injection/slight burn sensation (injection site pain), redness (Injection site erythema) and slight itchiness (Injection site pruritus) and feeling some discomfort (Injection site discomfort) was unknown.   On an unknown date, the outcome of the event Pain at site of injection/slight burn sensation(injection site pain) was recovered/resolved and the outcome of the events redness (Injection site erythema) and slight itchiness (Injection site pruritus) and feeling some discomfort (Injection site discomfort) was not recovered/not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site paraesthesia, Vaccination site pruritus
Clinical narrative: Discomfort - Near Injection Site; Itchiness - Near Injection site; Tingling Sensation - Near Injection Site; A spontaneous report was received from other health care professional concerning a 69- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced some discomfort (vaccination site discomfort), itchiness(vaccination site pruritus), and a tingling sensation (vaccination site par aesthesia) near the injection site. The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 15-jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  He reported that his wife received the first dose of the Moderna COVID-19 Vaccine on 15JAN2021 in her Right upper arm. Patient husband reported that her symptoms began the same day on 15JAN2021. These symptoms include some discomfort, itchiness, and a tingling sensation near the injection site.   No laboratory data was provided.  No treatment drugs were provided.  Action taken with mRNA-1273 in response to the events some discomfort (vaccination site discomfort), itchiness (vaccination site pruritus), and a tingling sensation (vaccination site par aesthesia) near the injection site was unknown.   On an unknown date, the outcome of the events some discomfort (vaccination site discomfort), itchiness (vaccination site pruritus), and a tingling sensation (vaccination site par aesthesia) near the injection site was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Developed severe dizziness; A spontaneous report was received from other health care professional concerning a 31- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced severe dizziness.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 14-jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14-jan-2021, patient developed after receiving her first shot of Moderna COVID 19 Vaccine severe dizziness which is still ongoing and would like to know if it is normal.  No laboratory data was provided.  No treatment drugs were provided.  Action taken with mRNA-1273 in response to the event severe dizziness was unknown.   On an unknown date, the outcome of the event severe dizziness was not recovered/not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red rash that was itchy; mild rash 2-3 inch (5-8 cm); A spontaneous report was received from other health care professional concerning a 74- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced red rash that was itchy (rash pruritic) and mild rash 2-3inch (5-8 cm) rash erythematous.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 7-jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection.  Patient said that he got vaccinated with Moderna COVID-19 vaccine on 7-jan-2021 at Lomalinda University and it's all normal no adverse reaction until the 9th day. On 16-jan-2021 he had a red rash on his arm that is about 2-3inch or 5-8CM that is itchy. Said that he did not took any medication to relieve the itchiness but he just scratching it and it is now a little better.   No laboratory data was provided.  Action taken with mRNA-1273 in response to the events red rash that was itchy (rash pruritic) and mild rash 2-3inch (5-8 cm) rash erythematous was unknown.    On an unknown date, the outcome of the events red rash that was itchy (rash pruritic) and mild rash 2-3inch (5-8 cm) rash erythematous was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm pain; red spot on my arm (size of a dime) where they injected the shot (left arm),; little sore; A spontaneous report was received from a consumer concerning a -female patient of unknown age,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm,vaccination site erythema and vaccination site pain. The patient's medical history was not provided.No relevant concomitant medications were reported.   On 7-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection.   On 17-jan-2021,the patient experienced a red spot on arm (size of a dime) where they injected the shot (left arm) and a little sore. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events pain in arm,vaccination site erythema and vaccination site pain was considered as not resolved at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Sore at the site of injection; Redness at the injection site; Warm touch at the injection site; A spontaneous report was received from consumer concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore at the injection site/Pain, Redness at the injection site/Redness and warm touch at the injection site/ Warmth. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On 10 Jan  2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025L20A)  via  unknown route  at unknown location  for prophylaxis of COVID-19 infection.  Patient experienced soreness, redness, and warm to ouch at the injection site on 11 Jan 2021 after taking the first dose of vaccine. Tylenol and Advil were used as treatment medication by the patient. Consent was given for the follow up by the patient. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events injection site pain, Redness at the injection site and injection site warmth was considered unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pain in extremity
Clinical narrative: Cough; sore arm; Headache; A spontaneous report was received from a consumer concerning a 81- year old-male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm,cough and headache.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 15-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch 029L20A) on left arm for prophylaxis of COVID-19 infection.  On 16-jan-2021,the patient developed a cough and experienced a sore arm and a headache.  No laboratory data was provided.Treatment information included,cough syrup was reported. Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events cough,pain in arm and headache was considered as not resolved at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site discolouration, Injection site pain, Injection site swelling, Pain
Clinical narrative: pink; swollen; hurts in the muscle; felt tired; Hurt; A spontaneous report was received from a consumer concerning a 64- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site discolouration,pain,injection site pain,injection site swelling and fatigue.  The patient's medical history was not provided.concomitant medications included,fexofenadine hydrochloride was reported.   On 07-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch unknown) through an unknown route on her arm for prophylaxis of COVID-19 infection.  On 17-jan-2021,the patient got her injection site swollen and pink and it hurts in the muscle.she initially got vaccinated she just felt tired and hurt but she got well until the reaction that appeared tonight.No laboratory data was provided.Treatment information included,ice pack was reported.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events  vaccination site discolouration,pain,injection site pain,injection site swelling and fatigue was considered as unknown at the time of the report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Eye swelling, Feeling abnormal, Palpitations
Clinical narrative: Heart started racing rapidly; Felt dizzy; Eyes felt like swelling; Still feeling bad since the shot; Could not catch her breath; A spontaneous report was received from a consumer concerning herself, a  64-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rapid racing of her heart / palpitation, felt dizzy, eyes felt like swelling, could not catch her breath / dysnopea and was still feeling bad since the shot / feeling abnormal.  The patient's medical history was not reported. Concomitant medications reported included thyroid medications, Escitalopram oxalate, Pravastatin, Trazodone and vitamins.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) in the arm for prophylaxis of COVID-19 infection. The route of administration was not provided.  On 21 Jan 2021, as soon as she was injected her heart started racing rapidly, felt dizzy, her eyes felt like swelling and she could not catch her breath. A nurse at the facility spoke to her and calmed her down but she was still feeling bad since the shot.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, heart started racing rapidly, felt dizzy, her eyes felt like swelling and she could not catch her breath resolved on 21 Jan 2021.  The outcome of the event, feeling bad since the shot was not resolved at the time of report.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit lymph nodes; A spontaneous report was received from a consumer, concerning a male patient of 32 age, who received ModernaCOVID-19 vaccine .  The patient's medical history was not provided. Concomitant product code was  provided as finasteride 1mg. On an 7-jan-2021 ,  the patient received their first of two planned doses of mRNA-1273 at Hospital.(lot number unknown) via unknow route of administration.   Said that 1/15/21 9 days after the vaccination the patient had swollen armpit lymph nodes patient never had any adverse reaction after being vaccinated not until 9 days after.  Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, shingles was considered to be not resolved at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Vomiting
Clinical narrative: Indigestion; Chills; Vomiting; A spontaneous report was received from a consumer concerning an 84-year-old female who experienced indigestion, chills and vomiting.  The patient's medical history was not provided.  Concomitant product use was not provided.  On 16-Jan-2021, approximately 1 day prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 070821) intramuscularly for prophylaxis of COVID-19 infection.  On 17-Jan-2021 patient experienced indigestion, chills, and vomiting.  Treatment for indigestion included self-administered bismuth subsalicylate. Treatment for chills and vomiting was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The events, chills and vomiting were considered recovered/resolved.  The outcome of the event of indigestion was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Myalgia
Clinical narrative: Injection Site hive; The Injection area was a little itchy like a 1 out of 10; little Redness on the injection site; Muscle Pain; A spontaneous report was received from a consumer who was also a 63-years-old male patient who received Moderna's COVID-19 vaccine and experienced redness on the Injection Site, and Muscle Pain, hives began around the injection area looking like little bumps and pink color and the hives were more visible, little itchy. Patient's medical history was not provided, and concomitant medicines taken by the patient, Azithromycin 250mg from January 5th until January 10th (Prescribed by his Physician). 2 days before the vaccination. On 12 JAN 2021, approximately, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient started to experience following redness on the Injection Site, and Muscle Pain, hives began around the injection area looking like little bumps and pink color and the hives were more visible, little itchy.  Treatment included Benadryl By mouth, Famotidine By Mouth, Hydrocortisone 1% Cream by topical route  63 years old male patient calling to report that he had the Moderna COVID-19 Vaccine on 12JAN2021 in the deltoid muscle of the left arm. The next day he had a little Redness on the Injection Site, and Muscle Pain. On 14JAN2021 the redness disappeared. On 15JAN2021 hives began around the injection area looking like little bumps and pink color and the hives were more visible on 16JAN2021. The Injection area was a little itchy like a 1 out of a scale of 1 to 10. Today 17JAN2021 The Injection Site hive is still going on but not as visible. He reported, "I took Benadryl, and acid reflux medicine Famotidine (heard it is good for hives). Applied Hydrocortisone 1% cream on it as per my pharmacist recommendation."  Action taken with mRNA-1273 was not reported. The outcome of the events, redness on the Injection Site, and Muscle Pain, hives began around the injection area looking like little bumps and pink color and the hives were more visible, little itchy, was considered not recovered/resolved