chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Moderna COVID-19 Vaccine EUA
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Cough, Dysphonia, Dysstasia
Clinical narrative: Immediate allergic reaction. Itching face first then spread, coughing, wheeze, tight chest, hoarseness.  Extreme pain in vaccinated arm. Severe weakness in both arms, legs, feet, hands. Dragging right foot  ( hx of clonus), excruciating neck pain and back pain, increased numbness and tingling in hands and feet. Lost ability to stand or walk the few steps I could walk before vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Neck pain
Clinical narrative: Immediate allergic reaction. Itching face first then spread, coughing, wheeze, tight chest, hoarseness.  Extreme pain in vaccinated arm. Severe weakness in both arms, legs, feet, hands. Dragging right foot  ( hx of clonus), excruciating neck pain and back pain, increased numbness and tingling in hands and feet. Lost ability to stand or walk the few steps I could walk before vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Wheezing
Clinical narrative: Immediate allergic reaction. Itching face first then spread, coughing, wheeze, tight chest, hoarseness.  Extreme pain in vaccinated arm. Severe weakness in both arms, legs, feet, hands. Dragging right foot  ( hx of clonus), excruciating neck pain and back pain, increased numbness and tingling in hands and feet. Lost ability to stand or walk the few steps I could walk before vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19, Coronavirus test positive
Clinical narrative: COVID-19 positive, requiring admission and oxygen support.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: On 7 June 2021, member received the first dose of Pfizer. On 7 August 2021, member presented to Air Base COVID-19 Vaccination Line to receive a dose of Janssen. Member documented that no prior doses of COVID-19 vaccine was received during patient screening. Upon record reviews conducted on 20 August 2021, it was revealed that member received a dose of Pfizer prior to 13 August.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms, Polymenorrhoea, Sleep disorder, Thrombosis
Clinical narrative: Heaviest period I?ve ever had, early in cycle. Large clots. Extreme cramping. On day 5 and still large clots and cramping that has kept me up all night long almost unbearable. Bleeding through tampons in less than an hour.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Myositis
Clinical narrative: Myositis
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Flatulence, Gastrooesophageal reflux disease, Headache
Clinical narrative: Acid reflux, gas/bloating, pelvic pain, stomach pain and headache since first dose, daily, not resolved. Menstrual period is also 9 days late, never irregular and not pregnant.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pelvic pain
Clinical narrative: Acid reflux, gas/bloating, pelvic pain, stomach pain and headache since first dose, daily, not resolved. Menstrual period is also 9 days late, never irregular and not pregnant.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough infection despite vaccination
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diaphragmalgia, Headache, Hypoaesthesia oral, Musculoskeletal chest pain
Clinical narrative: Headache, body aches, sharp pains along lower ribs/diaphragm into chest, numbness of left lateral lower and upper lip
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache, body aches, sharp pains along lower ribs/diaphragm into chest, numbness of left lateral lower and upper lip
Sex: M
Vaccine: COVID19
Symptoms: Eye symptom, Fatigue, Headache, Myalgia
Clinical narrative: Sore arm; Fatigue; mild headache; worsening of existing eye symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, FATIGUE, HEADACHE, and EYE SYMPTOM in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0403214 and 0183214) for COVID-19 vaccination.     The patient's past medical history included Vision abnormal since an unknown date.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA, FATIGUE, HEADACHE, and EYE SYMPTOM. At the time of the report, MYALGIA, FATIGUE, HEADACHE, and EYE SYMPTOM outcome was unknown. Not Provided.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient reported that he had some vision problem in the past and does the vaccination have anything to do with the worsening of the existing eye symptoms.  No concomitant medications were provided.    No treatments medications were provided.   This case was linked to US-MODERNATX, INC MOD-2021-080482. Sender's Comments:  US-MODERNATX, INC MOD-2021-080482: 1st dose of vaccine.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Erythema nodosum, Pain in extremity, Rash, Vaccination complication
Clinical narrative: She had lower leg pain in both legs; a red painful rash developed where she had the pain for both legs; a red painful rash developed where she had the pain for both legs; erythema nodusum; Immune reaction; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (lower leg pain in both legs), ERYTHEMA, RASH, ERYTHEMA NODOSUM, and VACCINATION COMPLICATION (Immune reaction) in an 18-year-old female patient 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) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ERYTHEMA, RASH, ERYTHEMA NODOSUM, and VACCINATION COMPLICATION. On an unknown date, the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY, ERYTHEMA, RASH, ERYTHEMA NODOSUM, and VACCINATION COMPLICATION (Immune reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Angiogram, Chest pain, Differential white blood cell count, Dyspnoea
Clinical narrative: Right lower leg pain, swelling, warmth, vein varicosities, chest pain, shortness of breath continuing over days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling hot, Fibrin D dimer, Full blood count, Human chorionic gonadotropin
Clinical narrative: Right lower leg pain, swelling, warmth, vein varicosities, chest pain, shortness of breath continuing over days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Metabolic function test, Pain in extremity, Swelling, Troponin
Clinical narrative: Right lower leg pain, swelling, warmth, vein varicosities, chest pain, shortness of breath continuing over days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Urine analysis, Varicose vein
Clinical narrative: Right lower leg pain, swelling, warmth, vein varicosities, chest pain, shortness of breath continuing over days
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Back pain, Blood culture negative, C-reactive protein increased
Clinical narrative: After 2nd shot on 2/22, pt reported onset of muscle pain, joint pain, stiffness, fatigue, decreased mobility, back pain, slight chills, that persisted for months.  Initially tried OTC NSAIDS (Aleve, Ibuprofen) without relief.   After inflammation seen on lab testing & MRI of spine in May, started on Prednisone x 6 wks (15 mg initially, then tapered).   Symptoms significantly improved.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Echocardiogram abnormal, Fatigue, Inflammation, Magnetic resonance imaging spinal abnormal
Clinical narrative: After 2nd shot on 2/22, pt reported onset of muscle pain, joint pain, stiffness, fatigue, decreased mobility, back pain, slight chills, that persisted for months.  Initially tried OTC NSAIDS (Aleve, Ibuprofen) without relief.   After inflammation seen on lab testing & MRI of spine in May, started on Prednisone x 6 wks (15 mg initially, then tapered).   Symptoms significantly improved.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test normal, Mobility decreased, Musculoskeletal stiffness, Myalgia, Pulmonary hypertension
Clinical narrative: After 2nd shot on 2/22, pt reported onset of muscle pain, joint pain, stiffness, fatigue, decreased mobility, back pain, slight chills, that persisted for months.  Initially tried OTC NSAIDS (Aleve, Ibuprofen) without relief.   After inflammation seen on lab testing & MRI of spine in May, started on Prednisone x 6 wks (15 mg initially, then tapered).   Symptoms significantly improved.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: After 2nd shot on 2/22, pt reported onset of muscle pain, joint pain, stiffness, fatigue, decreased mobility, back pain, slight chills, that persisted for months.  Initially tried OTC NSAIDS (Aleve, Ibuprofen) without relief.   After inflammation seen on lab testing & MRI of spine in May, started on Prednisone x 6 wks (15 mg initially, then tapered).   Symptoms significantly improved.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever chills headache and sore muscles. Fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Glomerular filtration rate, Glomerular filtration rate decreased, Laryngeal oedema
Clinical narrative: left side of my neck and face swelled; left side of my neck and face swelled; my glottis closed 85%; GFR was less than 60; blood pressure 87/57; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 14:00 (Batch/Lot Number: EN6206; Expiration Date: Jun2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, allergic bronchitis. There were no concomitant medications. Patient was not pregnant. The patient previously took iodo and experienced drug hypersensitivity. It was reported "When I got home, the left side of my neck and face swelled, my glottis closed 85%. To act quickly. I live alone. I ran and looked for Benadril. Two weeks later my GFR was less than 60. And during the hour of 4:30 am in several days, I woke up and when I took my blood pressure, I had for example 87/57. I had no one to take me to the Emergency Room. I tried to get the cardiologist to see me, but the office told me that there were no appointments available and I had to wait for my regular appointment. At that time my blood pressure was normal". Patient had COVID SARS-COVID-2 Antigen on 09Apr2021 with negative result. Outcome of events was recovered with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling, Swelling face
Clinical narrative: left side of my neck and face swelled; left side of my neck and face swelled; my glottis closed 85%; GFR was less than 60; blood pressure 87/57; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 14:00 (Batch/Lot Number: EN6206; Expiration Date: Jun2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, allergic bronchitis. There were no concomitant medications. Patient was not pregnant. The patient previously took iodo and experienced drug hypersensitivity. It was reported "When I got home, the left side of my neck and face swelled, my glottis closed 85%. To act quickly. I live alone. I ran and looked for Benadril. Two weeks later my GFR was less than 60. And during the hour of 4:30 am in several days, I woke up and when I took my blood pressure, I had for example 87/57. I had no one to take me to the Emergency Room. I tried to get the cardiologist to see me, but the office told me that there were no appointments available and I had to wait for my regular appointment. At that time my blood pressure was normal". Patient had COVID SARS-COVID-2 Antigen on 09Apr2021 with negative result. Outcome of events was recovered with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Eye movement disorder, Hyperhidrosis, Mass
Clinical narrative: dizziness (vertigo), felt the mattress moved, elevated as if it was going to turn to the right and had slight sweating.; dizziness (vertigo), felt the mattress moved, elevated as if it was going to turn to the right and had slight sweating.; my eyes went crossed-eyes momentarily; lump between my buttocks.; Had mild sinus.; mild throat and nose congestion pressure; Could taste medication in the mouth; soar left arm.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Mar2021 at 10:45(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 11:00 the patient experienced mild throat and nose congestion pressure, could taste medication in the mouth and sore left arm. On 30Mar2021 at 08:00 the patient experienced lump between her buttocks and had mild sinus. On 30Mar2021 at 22:30 the patient experienced her eyes went crossed-eyes momentarily. On 31Mar2021 at 08:45 the patient experienced dizziness (vertigo), felt the mattress moved, elevated as if it was going to turn to the right and had slight sweating. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event mild throat and nose congestion pressure, Could taste medication in the mouth, sore left arm, lump between my buttocks, mild sinus, eyes went crossed-eyes momentarily, dizziness (vertigo), slight sweating was recovered with sequelae.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Sinusitis
Clinical narrative: dizziness (vertigo), felt the mattress moved, elevated as if it was going to turn to the right and had slight sweating.; dizziness (vertigo), felt the mattress moved, elevated as if it was going to turn to the right and had slight sweating.; my eyes went crossed-eyes momentarily; lump between my buttocks.; Had mild sinus.; mild throat and nose congestion pressure; Could taste medication in the mouth; soar left arm.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Mar2021 at 10:45(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 11:00 the patient experienced mild throat and nose congestion pressure, could taste medication in the mouth and sore left arm. On 30Mar2021 at 08:00 the patient experienced lump between her buttocks and had mild sinus. On 30Mar2021 at 22:30 the patient experienced her eyes went crossed-eyes momentarily. On 31Mar2021 at 08:45 the patient experienced dizziness (vertigo), felt the mattress moved, elevated as if it was going to turn to the right and had slight sweating. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event mild throat and nose congestion pressure, Could taste medication in the mouth, sore left arm, lump between my buttocks, mild sinus, eyes went crossed-eyes momentarily, dizziness (vertigo), slight sweating was recovered with sequelae.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     codine shellfish.  Concurrent medical conditions included Drug allergy (codine) and Shellfish allergy.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (severe diarrhea). On 23-May-2021, DIARRHOEA (severe diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in both arms and hands; Numbness and tingling in both arms and hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness and tingling in both arms and hands) and PARAESTHESIA (Numbness and tingling in both arms and hands) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced HYPOAESTHESIA (Numbness and tingling in both arms and hands) and PARAESTHESIA (Numbness and tingling in both arms and hands). At the time of the report, HYPOAESTHESIA (Numbness and tingling in both arms and hands) and PARAESTHESIA (Numbness and tingling in both arms and hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by the reporter.   No treatment medications provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the back of my leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the back of my leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the back of my leg). At the time of the report, PAIN IN EXTREMITY (Pain in the back of my leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 27-May-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node in arm pit swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node in arm pit swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node in arm pit swollen). At the time of the report, LYMPHADENOPATHY (Lymph node in arm pit swollen) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ear pain, Headache, Menstrual disorder, Tinnitus
Clinical narrative: Left tympanic pain, tinnitus both ears, sound in ears. Headache, menstrual problems.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Soft tissue swelling, Swollen tongue
Clinical narrative: Soft tissue swelling in hands, lips, orbital area and tongue along with recurrent times over the last three weeks starting 2 days after vaccine, treated with Benadryl , cortisone cream and a metrology dose pack, this am half of my tongue is swollen with difficulty swallowing but not an emergent life threatening . My symptoms have not yet resolved and have been recurring
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; headache; body ache rated as 7 out of 10, 10 being the highest; fever.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Nausea vomiting headache chills fever and pain), HEADACHE (headache), MYALGIA (body ache rated as 7 out of 10, 10 being the highest), PYREXIA (fever.) and VOMITING (Nausea vomiting headache chills fever and pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunosuppression (Sofa clindamycin codeine Supressed immune system) since an unknown date. Concomitant products included CLINDAMYCIN for Immunosuppression, DULOXETINE HYDROCHLORIDE (CYMBALTA), CILNIDIPINE and Garvapetine for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache rated as 7 out of 10, 10 being the highest) and PYREXIA (fever.). On an unknown date, the patient experienced PAIN (Nausea vomiting headache chills fever and pain), VOMITING (Nausea vomiting headache chills fever and pain), NAUSEA (Nausea vomiting headache chills fever and pain) and CHILLS (Nausea vomiting headache chills fever and pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (Nausea vomiting headache chills fever and pain), HEADACHE (headache), PYREXIA (fever.), VOMITING (Nausea vomiting headache chills fever and pain), NAUSEA (Nausea vomiting headache chills fever and pain) and CHILLS (Nausea vomiting headache chills fever and pain) had not resolved and MYALGIA (body ache rated as 7 out of 10, 10 being the highest) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; headache; body ache rated as 7 out of 10, 10 being the highest; fever.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Nausea vomiting headache chills fever and pain), HEADACHE (headache), MYALGIA (body ache rated as 7 out of 10, 10 being the highest), PYREXIA (fever.) and VOMITING (Nausea vomiting headache chills fever and pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunosuppression (Sofa clindamycin codeine Supressed immune system) since an unknown date. Concomitant products included CLINDAMYCIN for Immunosuppression, DULOXETINE HYDROCHLORIDE (CYMBALTA), CILNIDIPINE and Garvapetine for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache rated as 7 out of 10, 10 being the highest) and PYREXIA (fever.). On an unknown date, the patient experienced PAIN (Nausea vomiting headache chills fever and pain), VOMITING (Nausea vomiting headache chills fever and pain), NAUSEA (Nausea vomiting headache chills fever and pain) and CHILLS (Nausea vomiting headache chills fever and pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (Nausea vomiting headache chills fever and pain), HEADACHE (headache), PYREXIA (fever.), VOMITING (Nausea vomiting headache chills fever and pain), NAUSEA (Nausea vomiting headache chills fever and pain) and CHILLS (Nausea vomiting headache chills fever and pain) had not resolved and MYALGIA (body ache rated as 7 out of 10, 10 being the highest) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: No specific follow-up information recorded.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Menstrual disorder, Tinnitus
Clinical narrative: Menstrual problem ,headache, tinitus , dizziness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: At night had chills and headache. Chills resolved after 6hrs but headache continued Arm is sore
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Sleep disorder, Vision blurred
Clinical narrative: Pounding headache which started after being given vaccine. 6:39am on Friday 8/20 head still pounding barely got sleep. Blurred vision started about an hour after injection every so often, comes and goes. Nausea  about an hour after being given vaccine on 8/19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Fever, chills,  nausea , in ability to go about daily activities
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: Patient felt weak and faniting.  She drank water and rest for 30 minutes and was fine.   Asked her if she needs us to call 911 she said no she gets like this all the time whenever she gets vaccine/shot
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: My underpit is swollen and hurts; My underpit is swollen and hurts; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (My underpit is swollen and hurts) and AXILLARY PAIN (My underpit is swollen and hurts) in a 46-year-old female patient 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 25-May-2021, the patient experienced AXILLARY MASS (My underpit is swollen and hurts) and AXILLARY PAIN (My underpit is swollen and hurts). At the time of the report, AXILLARY MASS (My underpit is swollen and hurts) and AXILLARY PAIN (My underpit is swollen and hurts) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Injection site warmth; sore down to hands; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (sore down to hands) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (sore down to hands) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (sore down to hands) and INJECTION SITE ERYTHEMA (Redness at injection site) had not resolved.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache for days since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache for days since vaccination) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     None.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Severe headache for days since vaccination). On 30-May-2021, HEADACHE (Severe headache for days since vaccination) had not resolved.            On 25may2021, post vaccination, the patient reported that she experienced symptoms of severe headache.  No treatment information was provided No conmed information was provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Lymphadenopathy, Myalgia, Night sweats, Pain
Clinical narrative: Heavy metallic taste; Heavy sweating at night; very swollen lymph nodes on right side base of neck and arm pit tender to touch; very swollen lymph nodes on right side base of neck and arm pit, sore to touch; very swollen lymph nodes on right side base of neck and arm pit; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch) and LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) in a 55-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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch), LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) and MYALGIA (Body aches). At the time of the report, DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch), LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) and MYALGIA (Body aches) had not resolved.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Heavy metallic taste; Heavy sweating at night; very swollen lymph nodes on right side base of neck and arm pit tender to touch; very swollen lymph nodes on right side base of neck and arm pit, sore to touch; very swollen lymph nodes on right side base of neck and arm pit; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch) and LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) in a 55-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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch), LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) and MYALGIA (Body aches). At the time of the report, DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch), LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) and MYALGIA (Body aches) had not resolved.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: injection site redness and swelling 2 weeks after injection.; injection site redness and swelling 2 weeks after injection.; injection site started itching; I looked at it 3 hrs later and the site is red and welted; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness and swelling 2 weeks after injection.), INJECTION SITE SWELLING (injection site redness and swelling 2 weeks after injection.), INJECTION SITE PRURITUS (injection site started itching) and INJECTION SITE URTICARIA (I looked at it 3 hrs later and the site is red and welted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no allergies. on medication for diabetes - metforman and glipizide. on anxiety meds - zoloft.  Concurrent medical conditions included Diabetes and Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, GLIPIZIDE, METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE AND GLIPIZIDE) for Diabetes.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 31-May-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness and swelling 2 weeks after injection.), INJECTION SITE SWELLING (injection site redness and swelling 2 weeks after injection.), INJECTION SITE PRURITUS (injection site started itching) and INJECTION SITE URTICARIA (I looked at it 3 hrs later and the site is red and welted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness and swelling 2 weeks after injection.), INJECTION SITE SWELLING (injection site redness and swelling 2 weeks after injection.), INJECTION SITE PRURITUS (injection site started itching) and INJECTION SITE URTICARIA (I looked at it 3 hrs later and the site is red and welted) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Muscular weakness, Myalgia, Palpitations
Clinical narrative: Hand cramps; Persistent, muscle weakness in injection arm; Numbness in injection arm; Occasional, heart palpatations; Severe, persistent leg and muscle pain in left leg( side of injection).; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (Hand cramps), MUSCULAR WEAKNESS (Persistent, muscle weakness in injection arm), HYPOAESTHESIA (Numbness in injection arm), PALPITATIONS (Occasional, heart palpatations) and MYALGIA (Severe, persistent leg and muscle pain in left leg( side of injection).) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Severe, persistent leg and muscle pain in left leg( side of injection).). On an unknown date, the patient experienced MUSCLE SPASMS (Hand cramps), MUSCULAR WEAKNESS (Persistent, muscle weakness in injection arm), HYPOAESTHESIA (Numbness in injection arm) and PALPITATIONS (Occasional, heart palpatations). At the time of the report, MUSCLE SPASMS (Hand cramps), MUSCULAR WEAKNESS (Persistent, muscle weakness in injection arm), HYPOAESTHESIA (Numbness in injection arm), PALPITATIONS (Occasional, heart palpatations) and MYALGIA (Severe, persistent leg and muscle pain in left leg( side of injection).) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product was reported  Concomitant product included for the maintenance for Diabetes and Hypertension
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA; injection site pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021. The most recent information was received on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (injection site pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Ehlers Danlos Syndrome, Arthritis medly.  The patient's past medical history included Ehlers-Danlos syndrome and Arthritis.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter once. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (injection site pain). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) outcome was unknown and INJECTION SITE PAIN (injection site pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported No treatment medication were reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: No specific follow-up information recorded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Tinnitus; clogged ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No concomitant medications reported.  Concurrent medical conditions included Sulfonamide allergy (allergy to sulfa drugs).   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears). The patient was treated with PREDNISONE for Ear feels clogged, at a dose of 1 dosage form and GINKGO BILOBA (GINGKO BILOBA) at a dose of 1 dosage form. At the time of the report, TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.Treatment for the events included sound therapy.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Multiple sclerosis, PCOS, hypothyroidism, hypertension.  Concurrent medical conditions included Multiple sclerosis, Polycystic ovary, Hypothyroidism and Hypertension.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had not resolved.       No concomitant medications were provided by the reporter. The patient is taking an antiviral medication for treatment of Shingles. The treatment is ongoing.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat dry; Loss of appetite; Fatigue; Feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jun-2021 and was forwarded to Moderna on 13-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat dry), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and PYREXIA (Feverish) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat dry), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and PYREXIA (Feverish). At the time of the report, OROPHARYNGEAL PAIN (Sore throat dry), DECREASED APPETITE (Loss of appetite) and PYREXIA (Feverish) was resolving and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Concomitants were not reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-06-2021 included reporter information and updated state.