chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: HEADACHE; MUSCLE ACHE; CHILLS; FEVER; PULSE RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 17:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced pulse rate increased. Laboratory data included: Fever (NR: not provided) 99-102.7 F. Laboratory data (dates unspecified) included: Pulse increased (NR: not provided) 130 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle ache, chills, fever and pulse rate increased was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Myalgia
Clinical narrative: CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. 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 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. 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 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Paraesthesia, Pyrexia, Spinal pain
Clinical narrative: BACK PAIN/SPINE PAIN SECOND TO LAST VERTEBRAE PAIN; TINGLING IN THE LEG; PAIN IN LEG; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the subject experienced back pain/spine pain second to last vertebrae pain. On 01-APR-2021, the subject experienced tingling in the leg. On 01-APR-2021, the subject experienced pain in leg. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103. 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 fever, back pain/spine pain second to last vertebrae pain, tingling in the leg, and pain in leg. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, SARS-CoV-2 test
Clinical narrative: A LITTLE BIT OF LIGHT PINK INFLAMMATION RIGHT BELOW THE INJECTION SITE IN MORNING; SORENESS AT INJECTION SITE; SWELLING RIGHT BELOW THE INJECTION SITE IN MORNING; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 approximately at 17:15 on left arm for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive COVID-19 Test. On MAR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 19-MAR-2021, the subject experienced a little bit of light pink inflammation right below the injection site in morning. On 19-MAR-2021, the subject experienced soreness at injection site. On 19-MAR-2021, the subject experienced swelling right below the injection site in morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a little bit of light pink inflammation right below the injection site in morning, soreness at injection site, and swelling right below the injection site in morning on 20-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Paraesthesia
Clinical narrative: SKIN HURTS WHEN TOUCHED; TINGLING INCLUDING BACK OF HER NECK; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced skin hurts when touched. On 02-APR-2021, the subject experienced tingling including back of her neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin hurts when touched, and tingling including back of her neck. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age (reporting on himself). The patient's weight, height, and medical history were not 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 an unspecified site in 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash
Clinical narrative: RED RASH UNDER BOTH EYES; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 22 year old male.The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had 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: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced red rash under both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue on 02-APR-2021, and had not recovered from red rash under both eyes. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: CHILLS; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and chills was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus headache
Clinical narrative: VERY MILD SINUS HEADACHE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus headache regularly throughout the year. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043421A,expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced very mild sinus headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very mild sinus headache. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Lethargy, Product colour issue
Clinical narrative: DIZZY; TEMPERATURE 99; LETHARGIC; DID NOT FEEL LIKE EATING; VACCINE WAS AMBER TO LIGHT BROWN IN COLOR; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced temperature 99. On 25-MAR-2021, the subject experienced did not feel like eating. On 25-MAR-2021, the subject experienced vaccine was amber to light brown in color. On 25-MAR-2021, the subject experienced lethargic. Laboratory data included: Body temperature (NR: not provided) 99 Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temperature 99, did not feel like eating and vaccine was amber to light brown in color was not reported. This report was non-serious. This report was associated with product quality complaint:90000175219.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature regulation disorder
Clinical narrative: DIZZY; TEMPERATURE 99; LETHARGIC; DID NOT FEEL LIKE EATING; VACCINE WAS AMBER TO LIGHT BROWN IN COLOR; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced temperature 99. On 25-MAR-2021, the subject experienced did not feel like eating. On 25-MAR-2021, the subject experienced vaccine was amber to light brown in color. On 25-MAR-2021, the subject experienced lethargic. Laboratory data included: Body temperature (NR: not provided) 99 Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temperature 99, did not feel like eating and vaccine was amber to light brown in color was not reported. This report was non-serious. This report was associated with product quality complaint:90000175219.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZY; TEMPERATURE 99; LETHARGIC; DID NOT FEEL LIKE EATING; VACCINE WAS AMBER TO LIGHT BROWN IN COLOR; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced temperature 99. On 25-MAR-2021, the subject experienced did not feel like eating. On 25-MAR-2021, the subject experienced vaccine was amber to light brown in color. On 25-MAR-2021, the subject experienced lethargic. Laboratory data included: Body temperature (NR: not provided) 99 Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temperature 99, did not feel like eating and vaccine was amber to light brown in color was not reported. This report was non-serious. This report was associated with product quality complaint:90000175219.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Lethargy, Product colour issue
Clinical narrative: DIZZY; LETHARGIC; DON'T FEEL LIKE EATING; PRODUCT COLOUR ISSUE; TEMP 99; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced lethargic. On 25-MAR-2021, the subject experienced don't feel like eating. On 25-MAR-2021, the subject experienced product colour issue. On 25-MAR-2021, the subject experienced temp 99. Laboratory data included: Body temperature (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temp 99, don't feel like eating and product colour issue was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature regulation disorder
Clinical narrative: DIZZY; LETHARGIC; DON'T FEEL LIKE EATING; PRODUCT COLOUR ISSUE; TEMP 99; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced lethargic. On 25-MAR-2021, the subject experienced don't feel like eating. On 25-MAR-2021, the subject experienced product colour issue. On 25-MAR-2021, the subject experienced temp 99. Laboratory data included: Body temperature (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temp 99, don't feel like eating and product colour issue was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZY; LETHARGIC; DON'T FEEL LIKE EATING; PRODUCT COLOUR ISSUE; TEMP 99; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced lethargic. On 25-MAR-2021, the subject experienced don't feel like eating. On 25-MAR-2021, the subject experienced product colour issue. On 25-MAR-2021, the subject experienced temp 99. Laboratory data included: Body temperature (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temp 99, don't feel like eating and product colour issue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Extra dose administered
Clinical narrative: GOT DOUBLE VACCINE; VACCINE BROKE INTO MY MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced got double vaccine, and vaccine broke into my muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got double vaccine and vaccine broke into my muscle was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-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 01-APR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and shortness of breath. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dehydration, Dry throat
Clinical narrative: SWEATING; DRY THROAT; DEHYDRATED; HANDS WRINKLY; WEAKNESS; TIREDNESS; HORRIBLE HEADACHE; FEVER; CHILLS; BODY ACHES ALL OVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 30-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced body aches all over. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced horrible headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced sweating, dry throat, dehydrated, hands wrinkly, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches all over, chills, horrible headache, weakness, tiredness, sweating, dry throat, dehydrated, and hands wrinkly, and the outcome of fever was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: SWEATING; DRY THROAT; DEHYDRATED; HANDS WRINKLY; WEAKNESS; TIREDNESS; HORRIBLE HEADACHE; FEVER; CHILLS; BODY ACHES ALL OVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 30-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced body aches all over. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced horrible headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced sweating, dry throat, dehydrated, hands wrinkly, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches all over, chills, horrible headache, weakness, tiredness, sweating, dry throat, dehydrated, and hands wrinkly, and the outcome of fever was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: SWEATING; DRY THROAT; DEHYDRATED; HANDS WRINKLY; WEAKNESS; TIREDNESS; HORRIBLE HEADACHE; FEVER; CHILLS; BODY ACHES ALL OVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 30-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced body aches all over. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced horrible headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced sweating, dry throat, dehydrated, hands wrinkly, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches all over, chills, horrible headache, weakness, tiredness, sweating, dry throat, dehydrated, and hands wrinkly, and the outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: PAIN IN THE JOINTS; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 17-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced pain in the joints. On 18-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the joints, and chills. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE SEEM TO BE WORSENING; INCREASED BODY TEMP ABOUT 98; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included history of chronic fatigue, and shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021, vaccinated at right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced increased body temp about 98. Laboratory data included: Body temperature increased (NR: not provided) about 98. On 17-MAR-2021, the subject experienced sore arm. On 17-MAR-2021, the subject experienced fatigue seem to be worsening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 21-MAR-2021, and increased body temp about 98 on 10-MAR-2021, and had not recovered from fatigue seem to be worsening. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: SKIN FALLING OFF; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 skin falling off. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of skin falling off was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: ACHE; SORE ARM; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On 2021, the subject experienced sore arm. On 2021, the subject experienced tired. On 2021, the subject experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, tired and ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 at unspecified site for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea, Pyrexia
Clinical narrative: HIGH HEART BEAT; SICK IN THE STOMACH; FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021 15:00, the subject experienced fever. On an unspecified date, the subject experienced high heart beat, and sick in the stomach. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) HIGH. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of high heart beat and sick in the stomach was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021 10:30 pm, the subject experienced flu like symptoms. On 03-APR-2021 10:30 pm, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and headache was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Ache; Tiredness; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient had right shoulder surgery and concurrent conditions included patient had atherosclerosis, and non-smoker, and other pre-existing medical conditions included has sling shoulder and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 12:30 for prophylactic vaccination at right deltoid. Concomitant medications included acetylsalicylic acid, and rosuvastatin. On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache, and tiredness. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: LEFT EYE SWELLING; LEFT EYE REDNESS; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 46 year old female. The patient's weight, height, and medical history were not 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 25-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced left eye swelling. On 25-MAR-2021, the subject experienced left eye redness. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye swelling, left eye redness, body aches, chills, and fever on 01-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Spinal pain, Toothache
Clinical narrative: TRIGGER FINGER  PAIN; NECK PAIN; LOWER 5 VERTEBRAE PAIN; DULL TOOTHACHE TYPE PAIN; BOTH HAND PAIN; BOTH ANKLE PAIN, LEFT KNEE PAIN, HIP PAIN AND RIGHT SHOULDER PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent condition included pain. The patient had all complaint areas were previous medical trauma issues from 1972 forward. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced trigger finger pain. On 02-APR-2021, the patient experienced neck pain. On 02-APR-2021, the patient experienced lower 5 vertebrae pain. On 02-APR-2021, the patient experienced dull toothache type pain. On 02-APR-2021, the patient experienced both hand pain. On 02-APR-2021, the patient  experienced both ankle pain, left knee pain, hip pain and right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, lower 5 vertebrae pain, both ankle pain, left knee pain, hip pain and right shoulder pain. on 02-APR-2021, was recovering from both hand pain, and trigger finger pain, and the outcome of dull toothache type pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Trigger finger
Clinical narrative: TRIGGER FINGER  PAIN; NECK PAIN; LOWER 5 VERTEBRAE PAIN; DULL TOOTHACHE TYPE PAIN; BOTH HAND PAIN; BOTH ANKLE PAIN, LEFT KNEE PAIN, HIP PAIN AND RIGHT SHOULDER PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent condition included pain. The patient had all complaint areas were previous medical trauma issues from 1972 forward. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced trigger finger pain. On 02-APR-2021, the patient experienced neck pain. On 02-APR-2021, the patient experienced lower 5 vertebrae pain. On 02-APR-2021, the patient experienced dull toothache type pain. On 02-APR-2021, the patient experienced both hand pain. On 02-APR-2021, the patient  experienced both ankle pain, left knee pain, hip pain and right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, lower 5 vertebrae pain, both ankle pain, left knee pain, hip pain and right shoulder pain. on 02-APR-2021, was recovering from both hand pain, and trigger finger pain, and the outcome of dull toothache type pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: RASH ON INJECTION SITE, BIGGER RASH; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rash on injection site, bigger rash. On 31-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on injection site, bigger rash, and sore arm. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: EXTREME SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced extreme shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; EXTREME FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210407180.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Hot flush, Pyrexia
Clinical narrative: LOW BACK PAIN; HOT FLASHES; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced low back pain. On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-APR-2021, had not recovered from low back pain, and the outcome of hot flashes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Influenza like illness, Nausea
Clinical narrative: FLU LIKE SYMPTOMS; DIZZINESS; APPETITE LOST; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, dizziness, appetite lost, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the flu like symptoms, dizziness, nausea and appetite lost was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: SKIN BLOTCHES/LEGS BLOTCHES; ITCHY; RASH ON ARM/RASH ON LEGS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609,  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 vaccinated to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced skin blotches/legs blotches. On 01-APR-2021, the subject experienced itchy. On 01-APR-2021, the subject experienced rash on arm/rash on legs. Treatment medications included: diphenhydramine hydrochloride. On 02-APR-2021, treatment medications included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy on APR-2021, and was recovering from rash on arm/rash on legs, and skin blotches/legs blotches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain
Clinical narrative: BURNING ON SHOULDER; FELT PAIN; This spontaneous report received from a patient concerned a 93 year old female. The patient's height, and weight were not reported. The patient's past medical history included shingles. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 25-MAR-2021, the subject experienced burning on shoulder. On 25-MAR-2021, the subject experienced felt pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt pain, and burning on shoulder. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Fatigue, Feeling cold, Feeling hot
Clinical narrative: ARM FEELS LIKE HIT BY BASEBALL BAT; JUST ABOUT PASSED OUT; FELT FEELING HOT; DEVELOPED LACE TYPE RASH; PHYSICALLY EXHAUSTED, TIRED, FATIGUE; FEVER; FELT FREEZING COLD; SEIZURE LIKE TREMORS UNCONTROLLED; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included genetic liver mutation, and other pre-existing medical conditions included the patient had sensitivity to blood thinner product. 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 30-MAR-2021 16:00 on Right Arm 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 22-MAR-2021, Laboratory data included: Blood test (NR: not provided) negative. On 30-MAR-2021, the subject experienced pain at injection site. On 31-MAR-2021, the subject experienced seizure like tremors uncontrolled. On 31-MAR-2021, the subject experienced felt freezing cold. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2. On 01-APR-2021, the subject experienced felt feeling hot. On 01-APR-2021, the subject experienced developed lace type rash. On 01-APR-2021, the subject experienced physically exhausted, tired, fatigue. Laboratory data included: Body temperature (NR: not provided) 97.1. On 01-APR-2021 12:18, the subject experienced just about passed out. On 02-APR-2021, the subject experienced arm feels like hit by baseball bat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure like tremors uncontrolled, and fever on 2021, and developed lace type rash on APR-2021, had not recovered from pain at injection site, and physically exhausted, tired, fatigue, and the outcome of just about passed out, felt freezing cold, felt feeling hot and arm feels like hit by baseball bat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.