chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hypoaesthesia, Hypokinesia
Clinical narrative: NUMBNESS IN THE ARM AND WHOLE BODY; DIFFICULTY IN BREATHING; CHEST PAIN; FELT LIKE COULDN'T MOVE BODY; COULDN'T MOVE HAND; PRESSURE IN CHEST; SHARP PAIN; This spontaneous report received from a patient via a company representative concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medical history, no known allergies to medications and not taking any medications regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry date: unknown) dose was not reported,1 total, administered in on an unspecified date in JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JUN-2021, after 20-25 minutes of vaccination, the patient experienced difficulty in breathing, numbness, chest pain and felt like he could not move his body. All these events were subsided within 15-20 minutes. On 29-Jun-2021, patient experienced the events again. The patient experienced the numbness in whole body then numbness subsided to the arm. The patient was not able to move his hand and experienced the numbness in his hand. The patient experienced sharp pain. On 29-Jun-2021, the patient was admitted to the hospital. It was reported that by the time of patient admitted to the hospital, sharp pain was slightly improved but still felt numbness. The patient also experienced the pressure on chest and the numbness was improved. The number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sharp pain and numbness in the arm and whole body, and the outcome of felt like could not move body, difficulty in breathing, chest pain, pressure in chest and could not move hand was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210703857-Covid-19 vaccine ad26.cov2.s- Numbness in the arm and whole body, difficulty in breathing, chest pain, felt like couldn't move body, couldn't move hand, pressure in chest, sharp pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: NUMBNESS IN THE ARM AND WHOLE BODY; DIFFICULTY IN BREATHING; CHEST PAIN; FELT LIKE COULDN'T MOVE BODY; COULDN'T MOVE HAND; PRESSURE IN CHEST; SHARP PAIN; This spontaneous report received from a patient via a company representative concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medical history, no known allergies to medications and not taking any medications regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry date: unknown) dose was not reported,1 total, administered in on an unspecified date in JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JUN-2021, after 20-25 minutes of vaccination, the patient experienced difficulty in breathing, numbness, chest pain and felt like he could not move his body. All these events were subsided within 15-20 minutes. On 29-Jun-2021, patient experienced the events again. The patient experienced the numbness in whole body then numbness subsided to the arm. The patient was not able to move his hand and experienced the numbness in his hand. The patient experienced sharp pain. On 29-Jun-2021, the patient was admitted to the hospital. It was reported that by the time of patient admitted to the hospital, sharp pain was slightly improved but still felt numbness. The patient also experienced the pressure on chest and the numbness was improved. The number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sharp pain and numbness in the arm and whole body, and the outcome of felt like could not move body, difficulty in breathing, chest pain, pressure in chest and could not move hand was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210703857-Covid-19 vaccine ad26.cov2.s- Numbness in the arm and whole body, difficulty in breathing, chest pain, felt like couldn't move body, couldn't move hand, pressure in chest, sharp pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Product barcode issue
Clinical narrative: CONFUSED AS OBTAINING DIFFERENT DATES WHEN SCANNING BAR CODE FOR EXPIRY DATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced confused as obtaining different dates when scanning bar code for expiry date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confused as obtaining different dates when scanning bar code for expiry date was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, Injection site pain
Clinical narrative: SPOT ON HER LEFT LEG THAT LOOKED LIKE A VEIN HAD RAISED UP/RED SPOT ON HER LEG; FEELS LIKE ITS MOVING UP AND DOWN; WHOLE BODY HURT; DIZZINESS; FAST HEART RATE; SHORTNESS OF BREATH; ARM PAIN ON INJECTION ARM; PAIN IN ARM WHEN INJECTING; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-smoker, and latex allergy. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced fast heart rate. On 26-JUN-2021, the subject experienced shortness of breath. On 26-JUN-2021, the subject experienced pain in arm when injecting. On 26-JUN-2021, the subject experienced arm pain on injection arm. On 27-JUN-2021, the subject experienced whole body hurt. On 02-JUL-2021, the subject experienced feels like its moving up and down. On an unspecified date, the subject experienced spot on her left leg that looked like a vein had raised up/red spot on her leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate on 30-JUN-2021, and shortness of breath on 01-JUL-2021, had not recovered from whole body hurt, feels like its moving up and down, pain in arm when injecting, and arm pain on injection arm, and the outcome of dizziness and spot on her left leg that looked like a vein had raised up/red spot on her leg was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash papular, Visual impairment
Clinical narrative: SPOT ON HER LEFT LEG THAT LOOKED LIKE A VEIN HAD RAISED UP/RED SPOT ON HER LEG; FEELS LIKE ITS MOVING UP AND DOWN; WHOLE BODY HURT; DIZZINESS; FAST HEART RATE; SHORTNESS OF BREATH; ARM PAIN ON INJECTION ARM; PAIN IN ARM WHEN INJECTING; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-smoker, and latex allergy. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced fast heart rate. On 26-JUN-2021, the subject experienced shortness of breath. On 26-JUN-2021, the subject experienced pain in arm when injecting. On 26-JUN-2021, the subject experienced arm pain on injection arm. On 27-JUN-2021, the subject experienced whole body hurt. On 02-JUL-2021, the subject experienced feels like its moving up and down. On an unspecified date, the subject experienced spot on her left leg that looked like a vein had raised up/red spot on her leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate on 30-JUN-2021, and shortness of breath on 01-JUL-2021, had not recovered from whole body hurt, feels like its moving up and down, pain in arm when injecting, and arm pain on injection arm, and the outcome of dizziness and spot on her left leg that looked like a vein had raised up/red spot on her leg was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Sinus congestion
Clinical narrative: BODY ACHE; BAD CONGESTION; CHILLS; HEADACHE; FEVER/ FELT WARM; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no previous medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUL-2021, the subject experienced body ache. On 02-JUL-2021, the subject experienced bad congestion. On 02-JUL-2021, the subject experienced chills. On 02-JUL-2021, the subject experienced headache. On 02-JUL-2021, the subject experienced fever/ felt warm. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, chills, fever/ felt warm, bad congestion, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Nasopharyngitis, Productive cough
Clinical narrative: COUGHING UP PHLEGM; GENERAL COLD-LIKE SYMPTOMS; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced swelling at injection site. On 02-JUL-2021, the subject experienced coughing up phlegm. On 02-JUL-2021, the subject experienced general cold-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling at injection site, and had not recovered from coughing up phlegm, and general cold-like symptoms. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes virus test, Injection site pain, Therapeutic response unexpected
Clinical narrative: GOING TO BATHROOM FINE SINCE VACCINATION, NO NEED OF TAKING LAXATIVE THAT WERE PRESCRIBED; PAIN IN THE LEFT ARM WHERE SHE HAD THE INJECTION; TIRED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bipolar disorder, bone spurs, migraines, herpes types 1/2, quit smoking prior to vaccination, and grass mold mushrooms allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced going to bathroom fine since vaccination, no need of taking laxative that were prescribed. On 25-JUN-2021, the subject experienced pain in the left arm where she had the injection. On 25-JUN-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Herpes virus test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 26-JUN-2021, and the outcome of pain in the left arm where she had the injection and going to bathroom fine since vaccination, no need of taking laxative that were prescribed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Anaemia, Blood iron, Iron deficiency
Clinical narrative: ANEMIC; IRON NOT AT A NORMAL LEVEL; VACCINE DID SOMETHING / UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included iron level normal.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced anemic, iron not at a normal level, and vaccine did something / unspecified adverse event. Laboratory data (dates unspecified) included: Blood iron (NR: not provided) Abnormal. Treatment medications (dates unspecified) included: iron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anemic, vaccine did something / unspecified adverse event and iron not at a normal level was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dysmenorrhoea, Fatigue, Headache
Clinical narrative: LOSS OF APPETITE; PERIOD DELAYED A WEEK; WORSE CRAMPS THAN USUAL; CHILLS; NAUSEA; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, period delayed a week, worse cramps than usual, chills, nausea, fever, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, period delayed a week, worse cramps than usual, chills, nausea, fever, fatigue, and headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Nausea, Pyrexia
Clinical narrative: LOSS OF APPETITE; PERIOD DELAYED A WEEK; WORSE CRAMPS THAN USUAL; CHILLS; NAUSEA; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, period delayed a week, worse cramps than usual, chills, nausea, fever, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, period delayed a week, worse cramps than usual, chills, nausea, fever, fatigue, and headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PAIN IN THE THIGHS BOTH SIDES; PAIN IN THE ARM AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced pain in the arm at the site of injection. On 13-JUN-2021, the subject experienced pain in the thighs both sides. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the arm at the site of injection on 13-JUN-2021, and had not recovered from pain in the thighs both sides. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Memory impairment, Musculoskeletal discomfort
Clinical narrative: DIFFICULTY SLEEPING; FORGET THINGS; NECK NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 220 pounds, and height was 71 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty sleeping, forget things, neck not feeling good, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of difficulty sleeping, forget things and neck not feeling good was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: LEFT ARM LYMPH NODE SWOLLEN; ARM IS WARM TO THE TOUCH; REDNESS AT INJECTION SITE; TENDERNESS OF LYMPH NODES; FEVER; BODY ACHES; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 01-JUL-2021, the subject experienced arm is warm to the touch. On 01-JUL-2021, the subject experienced tenderness of lymph nodes. On 01-JUL-2021, the subject experienced redness at injection site. On an unspecified date, the subject experienced left arm lymph node swollen. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, sore arm, and fever on 25-JUN-2021, was recovering from tenderness of lymph nodes, and left arm lymph node swollen, and had not recovered from redness at injection site, and arm is warm to the touch. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: LEFT ARM LYMPH NODE SWOLLEN; ARM IS WARM TO THE TOUCH; REDNESS AT INJECTION SITE; TENDERNESS OF LYMPH NODES; FEVER; BODY ACHES; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 01-JUL-2021, the subject experienced arm is warm to the touch. On 01-JUL-2021, the subject experienced tenderness of lymph nodes. On 01-JUL-2021, the subject experienced redness at injection site. On an unspecified date, the subject experienced left arm lymph node swollen. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, sore arm, and fever on 25-JUN-2021, was recovering from tenderness of lymph nodes, and left arm lymph node swollen, and had not recovered from redness at injection site, and arm is warm to the touch. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspepsia, Ear pain, Feeling hot, Headache
Clinical narrative: FEVER; FELT NAUSEATED; FELT REALLY HOT; COLD; COUGH; BILATERAL EAR ACHE; FELT BURNING PAIN ON STOMACH MOSTLY ON THE MIDDLE AREA; SEVERE HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clot, non alcoholic, occasional smoker, penicillin allergy, allergic to amoxicillin, and bee sting allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. Patient's concomitant medication included: cemoxazine100 mg twice a day for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included hydroxyzine for anxiety. On 02-JUL-2021, the subject experienced body ache. On 02-JUL-2021, the subject experienced cold. On 02-JUL-2021, the subject experienced cough. On 02-JUL-2021, the subject experienced bilateral ear ache. On 02-JUL-2021, the subject experienced felt burning pain on stomach mostly on the middle area. On 02-JUL-2021, the subject experienced severe headache. On 03-JUL-2021, the subject experienced felt really hot. On 03-JUL-2021, the subject experienced felt nauseated. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Headache, Body ache and Bilateral ear ache had pain scale of 10/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, body ache, felt really hot, cold, cough, bilateral ear ache, felt burning pain on stomach mostly on the middle area, and felt nauseated, and the outcome of fever was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain, Pain assessment, Pyrexia
Clinical narrative: FEVER; FELT NAUSEATED; FELT REALLY HOT; COLD; COUGH; BILATERAL EAR ACHE; FELT BURNING PAIN ON STOMACH MOSTLY ON THE MIDDLE AREA; SEVERE HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clot, non alcoholic, occasional smoker, penicillin allergy, allergic to amoxicillin, and bee sting allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. Patient's concomitant medication included: cemoxazine100 mg twice a day for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included hydroxyzine for anxiety. On 02-JUL-2021, the subject experienced body ache. On 02-JUL-2021, the subject experienced cold. On 02-JUL-2021, the subject experienced cough. On 02-JUL-2021, the subject experienced bilateral ear ache. On 02-JUL-2021, the subject experienced felt burning pain on stomach mostly on the middle area. On 02-JUL-2021, the subject experienced severe headache. On 03-JUL-2021, the subject experienced felt really hot. On 03-JUL-2021, the subject experienced felt nauseated. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Headache, Body ache and Bilateral ear ache had pain scale of 10/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, body ache, felt really hot, cold, cough, bilateral ear ache, felt burning pain on stomach mostly on the middle area, and felt nauseated, and the outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Neck pain
Clinical narrative: NECK PAIN; ACUTE HEADACHE OR POUNDING HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUL-2021 15:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUL-2021, the subject experienced injection site pain. On 03-JUL-2021, the subject experienced neck pain. On 03-JUL-2021, the subject experienced acute headache or pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 03-JUL-2021, and had not recovered from acute headache or pounding headache, and neck pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS A COUPLE OF HOURS AFTERWARDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills a couple of hours afterwards. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills a couple of hours afterwards. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death, Dizziness, Hot flush
Clinical narrative: Hot flashes; Dizziness; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a female patient of an unknown age 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 20-Apr-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 20-Apr-2021, the patient experienced HOT FLUSH (Hot flashes) and DIZZINESS (Dizziness). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HOT FLUSH (Hot flashes) and DIZZINESS (Dizziness) outcome was unknown.            Concomitant medication use was not provided by reporter.  Treatment information was not provided by reporter.  Very limited information regarding this patient's death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followed up Received on 29-jun-2021 that includes TCR: patient passed away.; Sender's Comments: Very limited information regarding this patient's death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Iodine allergy, Pain in extremity, Rash
Clinical narrative: recently released from Hospital after taking a test; Rash on body, breakout all over my body; Allergic reaction to Iodine; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (recently released from Hospital after taking a test) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 23-Apr-2021, the patient experienced IODINE ALLERGY (Allergic reaction to Iodine). On 25-Apr-2021, the patient experienced RASH (Rash on body, breakout all over my body). On an unknown date, the patient experienced HOSPITALISATION (recently released from Hospital after taking a test) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (recently released from Hospital after taking a test), PAIN IN EXTREMITY (Sore left arm), IODINE ALLERGY (Allergic reaction to Iodine) and RASH (Rash on body, breakout all over my body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On 23-Apr-2021, the patient received an iodine media contrast (type unspecified) which was considered a suspect product.  No concomitants were provided. No treatment was provided.  The patient reported, she had just recently been released from the hospital after taking a test in which they injected iodine for procedure. Up to that time, she had never known that she was allergic to iodine and had a very bad reaction (breakout all over her body).  On 23-Apr-2021, patient underwent a CT scan (unspecified), result unknown.  Company Comment: 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.  however the concomitant use of iodine contrast media could be a confounder. further information has been requested   This case was linked to MOD-2021-245524, MOD-2021-245524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Upgraded case to serious (hospitalization), updated action taken for Moderna vaccine, added event and case details.; 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.  however the concomitant use of iodine contrast media could be a confounder. further information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis was aggravated after receiving the vaccine; 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 RHEUMATOID ARTHRITIS (rheumatoid arthritis was aggravated after receiving the vaccine) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis was aggravated after receiving the vaccine) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis was aggravated after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case pertains to several patients of the rheumatologist who received the Covid-19 vaccine and  were indicating that their rheumatoid arthritis was aggravated after receiving the vaccine.  Concomitant product use was not reported.  No treatment information was provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  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.   This case was linked to MOD-2021-143032 (Patient Link).; 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Heart pain/worsened; headaches after my 2nd dose which would not respond to Tylenol or ibuprofen/non-stop headaches; my vision was weird zigzag moving lines that formed a circle like shape.; ocular migraine; Heart pain; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Allergy to antibiotic (sulfamethoxazole and trimethoprim), Nickel sensitivity, Irritable bowel syndrome, Arthritis and Migraine.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant). 20-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 25-May-2021, the patient experienced OPHTHALMIC MIGRAINE (ocular migraine) and VISUAL IMPAIRMENT (my vision was weird zigzag moving lines that formed a circle like shape.). On an unknown date, the patient experienced CONDITION AGGRAVATED (Heart pain/worsened) and HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen/non-stop headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 25-May-2021, OPHTHALMIC MIGRAINE (ocular migraine) had resolved. At the time of the report, ANGINA PECTORIS (Heart pain) had not resolved and CONDITION AGGRAVATED (Heart pain/worsened), OROPHARYNGEAL PAIN (sore throat), VISUAL IMPAIRMENT (my vision was weird zigzag moving lines that formed a circle like shape.) and HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen/non-stop headaches) outcome was unknown.            Concomitant product use was not provided.  Patient reported she had a history of migraine but nothing like the events experienced.  She had consist headaches after her 2nd dose which would not respond to paracetamol or ibuprofen.  She emailed her physician but did not see in person.   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.   This case was linked to MOD-2021-208995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Added allergies, medical history, vaccine information, and events; event outcomes updated.; 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.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Burning sensation, Muscle spasms, Oedema, Pain in extremity
Clinical narrative: Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib.  Company Comment: 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.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email updated; 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.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib.  Company Comment: 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.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email updated; 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.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dyspnoea, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Slight shortness of breath; I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all; Extreme fatigue\ I Feel exhausted, physically weak; Joint pain; Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Slight shortness of breath), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) and ARTHRALGIA (Joint pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced DYSPNOEA (Slight shortness of breath) (seriousness criterion medically significant), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all) (seriousness criterion medically significant), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.) had resolved. At the time of the report, DYSPNOEA (Slight shortness of breath), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) not find anything out of the ordinary and thus discharged the patient. In 2021, X-ray: normal (normal) not find anything out of the ordinary and thus discharged the patient.         Over-the-counter "stimulants" and "energy drinks" were provided as treatment drug information. 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.; 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.