chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: MUSCLE PAIN IN BOTH LEGS, HIPS, NECK AND BOTH ARMS; NAUSEA; 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 alcohol use. The patient had no known allergies. The patient had no history of drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient was non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced muscle pain in both legs, hips, neck and both arms. On 27-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 27-MAR-2021, and had not recovered from muscle pain in both legs, hips, neck and both arms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; TIRED; 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-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 MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103.5 degree F. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. 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 fever on 26-MAR-2021, and was recovering from tired, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hypersomnia, Injection site erythema, Injection site nodule, Malaise
Clinical narrative: FEVER; SLEPT FOR 2 DAYS; INJECTION SITE PAINFUL HUGE KNOT; FELT VERY SICK; A HUGE BLOOD RED SPOT AT THE INJECTION SITE ABOUT THE SIZE OF A DESSERT PLATE AND EXTREMELY HOT TO THE TOUCH; 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, and batch number were not reported) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported .and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slept for 2 days. On MAR-2021, the subject experienced injection site painful huge knot. On MAR-2021, the subject experienced felt very sick. On MAR-2021, the subject experienced a huge blood red spot at the injection site about the size of a dessert plate and extremely hot to the touch. On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 25-MAR-2021, had not recovered from a huge blood red spot at the injection site about the size of a dessert plate and extremely hot to the touch, and injection site painful huge knot, and the outcome of felt very sick and slept for 2 days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; SLEPT FOR 2 DAYS; INJECTION SITE PAINFUL HUGE KNOT; FELT VERY SICK; A HUGE BLOOD RED SPOT AT THE INJECTION SITE ABOUT THE SIZE OF A DESSERT PLATE AND EXTREMELY HOT TO THE TOUCH; 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, and batch number were not reported) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported .and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slept for 2 days. On MAR-2021, the subject experienced injection site painful huge knot. On MAR-2021, the subject experienced felt very sick. On MAR-2021, the subject experienced a huge blood red spot at the injection site about the size of a dessert plate and extremely hot to the touch. On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 25-MAR-2021, had not recovered from a huge blood red spot at the injection site about the size of a dessert plate and extremely hot to the touch, and injection site painful huge knot, and the outcome of felt very sick and slept for 2 days was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Feeling worse; This spontaneous report received from a patient concerned an adult 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: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch was not reported and has been requested .No concomitant medications were reported. On an unspecified date, the subject experienced feeling worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling worse. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: ARM HURT FOR SEVERAL DAYS; MILDLY FATIGUED; This spontaneous report received from a consumer via a company representative 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 expiry: 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 arm hurt for several days, and mildly fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mildly fatigued and arm hurt for several days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210354397.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: LIGHT-HEADED; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 300 pounds, and height was 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced light-headed, and nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light-headed and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: ARM HURT; MILDLY FATIGUED; 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, once a total administered, start therapy date 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 arm hurt, and mildly fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mildly fatigued and arm hurt was not reported. This report was non-serious.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product administration duration, Product complaint, Product packaging quantity issue
Clinical narrative: PRODUCT COMPLIANT; ADMINISTRATION OF VACCINE FROM VIAL OPEN FOR 17 HOURS; 6 DOSES WITHDRAWN PER VIAL; This spontaneous report received from a health care professional concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced 6 doses withdrawn per vial. On 27-MAR-2021, the subject experienced administration of vaccine from open for 17 hours. On an unspecified date, the subject experienced product compliant. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from open for 17 hours, 6 doses withdrawn per vial and product compliant was not reported. This report was non-serious. This case is a duplicate of 20210354363. This case, from the same reporter is linked to 20210354152. This case is associated with PQC number 90000174514.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination complication
Clinical narrative: SIDE EFFECTS (UNSPECIFIED); NOT FEELING WELL; This spontaneous report received from a consumer 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 24-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 MAR-2021, the subject experienced side effects (unspecified). On MAR-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well and side effects (unspecified) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHES; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headaches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210354213.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT HEADEDNESS; 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, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 13-MAR-2021, the subject experienced light headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210355509.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: CHILLS; FATIGUE; HEADACHE; 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: 1805020,expiry: UNKNOWN) dose was not reported, administered in left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fatigue, and headache. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dyspnoea, Fatigue, Headache
Clinical narrative: FEELING OF "DID NOT WANT TO BE ALONE"; FEELING KIND OF WEAK; GENERAL TIREDNESS; DIFFICULTY BREATHING; SWEATINESS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, tetracycline allergy, and vancomycin allergy. The patient experienced drug allergy when treated with promethazine, carbamazepine, and topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1802068 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced difficulty breathing. On 24-MAR-2021, the subject experienced sweatiness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 25-MAR-2021, the subject experienced feeling of "did not want to be alone". On 25-MAR-2021, the subject experienced feeling kind of weak. On 25-MAR-2021, the subject experienced general tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, sweatiness, feeling of "did not want to be alone", feeling kind of weak, fever, headache, nausea, and general tiredness on 26-MAR-2021. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Psychiatric symptom, Pyrexia
Clinical narrative: FEELING OF "DID NOT WANT TO BE ALONE"; FEELING KIND OF WEAK; GENERAL TIREDNESS; DIFFICULTY BREATHING; SWEATINESS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, tetracycline allergy, and vancomycin allergy. The patient experienced drug allergy when treated with promethazine, carbamazepine, and topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1802068 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced difficulty breathing. On 24-MAR-2021, the subject experienced sweatiness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 25-MAR-2021, the subject experienced feeling of "did not want to be alone". On 25-MAR-2021, the subject experienced feeling kind of weak. On 25-MAR-2021, the subject experienced general tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, sweatiness, feeling of "did not want to be alone", feeling kind of weak, fever, headache, nausea, and general tiredness on 26-MAR-2021. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Pain
Clinical narrative: LUMP AT INJECTION SITE; BODY ACHES; REDNESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 57 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced redness at injection site. On 22-MAR-2021, the subject experienced lump at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site, redness at injection site, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; 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) dose was not reported, administered on 25-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 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210356547.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: MENSTRUAL PERIOD; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced menstrual period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual period was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: SHIVERING; HEADACHE; EXHAUSTED; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included surgery to remove a fibroid tumor from her uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) once a total dose was not reported, administered on 27-MAR-2021 at 10:30 am on right arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced shivering. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivering, and had not recovered from headache, and exhausted. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: DIARRHEA - SEVERAL TIMES; BODY ITCHING; INJECTION SITE SWELLING; INJECTION SITE ITCHINESS; SEVERE HEACHACHE- JACKHAMMER LIKE; FULL BODY MUSCLE ACHES; FATIGUE; FEVER; INJECTION SITE REDNESS; INJECTION SITE PAIN; INTENSE NECK PAIN; LYMPH NODES IN THE NECK SWOLLEN; 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, intramuscular, batch number: 1800185, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced intense neck pain. On 26-MAR-2021, the subject experienced lymph nodes in the neck swollen. On 26-MAR-2021, the subject experienced injection site swelling. On 26-MAR-2021, the subject experienced injection site itchiness. On 26-MAR-2021, the subject experienced severe headache- jackhammer like. On 26-MAR-2021, the subject experienced full body muscle aches. On 26-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced injection site redness. On 26-MAR-2021, the subject experienced injection site pain. On 27-MAR-2021, the subject experienced diarrhea - several times. On 27-MAR-2021, the subject experienced body itching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense neck pain, lymph nodes in the neck swollen, diarrhea - several times, severe headache- jackhammer like, full body muscle aches, and fatigue on 27-MAR-2021, had not recovered from body itching, injection site swelling, injection site redness, injection site pain, and injection site itchiness, and the outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: DIARRHEA - SEVERAL TIMES; BODY ITCHING; INJECTION SITE SWELLING; INJECTION SITE ITCHINESS; SEVERE HEACHACHE- JACKHAMMER LIKE; FULL BODY MUSCLE ACHES; FATIGUE; FEVER; INJECTION SITE REDNESS; INJECTION SITE PAIN; INTENSE NECK PAIN; LYMPH NODES IN THE NECK SWOLLEN; 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, intramuscular, batch number: 1800185, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced intense neck pain. On 26-MAR-2021, the subject experienced lymph nodes in the neck swollen. On 26-MAR-2021, the subject experienced injection site swelling. On 26-MAR-2021, the subject experienced injection site itchiness. On 26-MAR-2021, the subject experienced severe headache- jackhammer like. On 26-MAR-2021, the subject experienced full body muscle aches. On 26-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced injection site redness. On 26-MAR-2021, the subject experienced injection site pain. On 27-MAR-2021, the subject experienced diarrhea - several times. On 27-MAR-2021, the subject experienced body itching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense neck pain, lymph nodes in the neck swollen, diarrhea - several times, severe headache- jackhammer like, full body muscle aches, and fatigue on 27-MAR-2021, had not recovered from body itching, injection site swelling, injection site redness, injection site pain, and injection site itchiness, and the outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pruritus, Pyrexia
Clinical narrative: DIARRHEA - SEVERAL TIMES; BODY ITCHING; INJECTION SITE SWELLING; INJECTION SITE ITCHINESS; SEVERE HEACHACHE- JACKHAMMER LIKE; FULL BODY MUSCLE ACHES; FATIGUE; FEVER; INJECTION SITE REDNESS; INJECTION SITE PAIN; INTENSE NECK PAIN; LYMPH NODES IN THE NECK SWOLLEN; 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, intramuscular, batch number: 1800185, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced intense neck pain. On 26-MAR-2021, the subject experienced lymph nodes in the neck swollen. On 26-MAR-2021, the subject experienced injection site swelling. On 26-MAR-2021, the subject experienced injection site itchiness. On 26-MAR-2021, the subject experienced severe headache- jackhammer like. On 26-MAR-2021, the subject experienced full body muscle aches. On 26-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced injection site redness. On 26-MAR-2021, the subject experienced injection site pain. On 27-MAR-2021, the subject experienced diarrhea - several times. On 27-MAR-2021, the subject experienced body itching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense neck pain, lymph nodes in the neck swollen, diarrhea - several times, severe headache- jackhammer like, full body muscle aches, and fatigue on 27-MAR-2021, had not recovered from body itching, injection site swelling, injection site redness, injection site pain, and injection site itchiness, and the outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Flushing, Nausea
Clinical narrative: SWOLLEN FACE; DIFFICULTIES BREATHING; WEIGHT IN HER CHEST; FLUSHING; HEART PALPITATIONS; CHILLS; NAUSEA; 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced swollen face. On 26-MAR-2021, the subject experienced difficulties breathing. On 26-MAR-2021, the subject experienced weight in her chest. On 26-MAR-2021, the subject experienced flushing. On 26-MAR-2021, the subject experienced heart palpitations. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, swollen face, difficulties breathing, weight in her chest, flushing, nausea and heart palpitations was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Swelling face
Clinical narrative: SWOLLEN FACE; DIFFICULTIES BREATHING; WEIGHT IN HER CHEST; FLUSHING; HEART PALPITATIONS; CHILLS; NAUSEA; 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced swollen face. On 26-MAR-2021, the subject experienced difficulties breathing. On 26-MAR-2021, the subject experienced weight in her chest. On 26-MAR-2021, the subject experienced flushing. On 26-MAR-2021, the subject experienced heart palpitations. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, swollen face, difficulties breathing, weight in her chest, flushing, nausea and heart palpitations was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Head discomfort
Clinical narrative: SORE THROAT; CONGESTED; NIGHT SWEATS; CHILLS; HEADACHE; FEVER; MULTIPLE JOINT PAIN; REALLY TIRED; NAUSEA; HIGHER BODY TEMPERATURE; BODY ACHE; HEAVY HEAD; 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 arthritic pain, penicillline drug allergy and wellbutrin drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 Expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:45 in left arm for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced heavy head. On 24-MAR-2021, the subject experienced multiple joint pain. On 24-MAR-2021, the subject experienced really tired. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced higher body temperature. On 25-MAR-2021, the subject experienced congested. On 25-MAR-2021, the subject experienced night sweats. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 26-MAR-2021, had not recovered from really tired, body ache, chills, sore throat, multiple joint pain, nausea, higher body temperature, and heavy head, and the outcome of night sweats, fever and congested was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Night sweats, Oropharyngeal pain
Clinical narrative: SORE THROAT; CONGESTED; NIGHT SWEATS; CHILLS; HEADACHE; FEVER; MULTIPLE JOINT PAIN; REALLY TIRED; NAUSEA; HIGHER BODY TEMPERATURE; BODY ACHE; HEAVY HEAD; 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 arthritic pain, penicillline drug allergy and wellbutrin drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 Expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:45 in left arm for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced heavy head. On 24-MAR-2021, the subject experienced multiple joint pain. On 24-MAR-2021, the subject experienced really tired. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced higher body temperature. On 25-MAR-2021, the subject experienced congested. On 25-MAR-2021, the subject experienced night sweats. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 26-MAR-2021, had not recovered from really tired, body ache, chills, sore throat, multiple joint pain, nausea, higher body temperature, and heavy head, and the outcome of night sweats, fever and congested was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SORE THROAT; CONGESTED; NIGHT SWEATS; CHILLS; HEADACHE; FEVER; MULTIPLE JOINT PAIN; REALLY TIRED; NAUSEA; HIGHER BODY TEMPERATURE; BODY ACHE; HEAVY HEAD; 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 arthritic pain, penicillline drug allergy and wellbutrin drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 Expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:45 in left arm for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced heavy head. On 24-MAR-2021, the subject experienced multiple joint pain. On 24-MAR-2021, the subject experienced really tired. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced higher body temperature. On 25-MAR-2021, the subject experienced congested. On 25-MAR-2021, the subject experienced night sweats. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 26-MAR-2021, had not recovered from really tired, body ache, chills, sore throat, multiple joint pain, nausea, higher body temperature, and heavy head, and the outcome of night sweats, fever and congested was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: WHEEZING; DIZZINESS; SPINNING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 180 pounds, and height was 73 inches. The patient's pre-existing medical conditions included the patient had no history of medical issues.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802086, and batch number: 1802086 expiry: UNKNOWN) dose was not reported, administered to the left arm, on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced wheezing. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced spinning. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, wheezing, dizziness, spinning, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: WHEEZING; DIZZINESS; SPINNING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 180 pounds, and height was 73 inches. The patient's pre-existing medical conditions included the patient had no history of medical issues.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802086, and batch number: 1802086 expiry: UNKNOWN) dose was not reported, administered to the left arm, on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced wheezing. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced spinning. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, wheezing, dizziness, spinning, and nausea. 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 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, expiry: unknown) dose was not reported, administered on 25-MAR-2021 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 26-MAR-2021. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a 63 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: 1808096, expiry: UNKNOWN) dose was not reported, administered to left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, in evening, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; 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, and batch number were not reported) 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; MUSCLE ACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. 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. The Company is unable to perform follow-up to request batch/lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced headache, muscle ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle ache and fever was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: FLU-LIKE SYMPTOMS; CHILLS; MUSCLE ACHES; This spontaneous report received from a parent concerned a 25 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) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced flu-like symptoms. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle aches, and the outcome of flu-like symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Aggression, Hostility, Irritability
Clinical narrative: IRRITABLE; CONFRONTATIONAL; AGGRESSIVE; 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 was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAR-2021, the subject experienced irritablity. On 28-MAR-2021, the subject experienced confrontational. On 28-MAR-2021, the subject experienced aggression. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the irritablity, confrontational and aggression was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: FEVER; DIZZINESS; 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 past medical history included levofloxacin allergy, midazolam allergy, amoxicillin allergy, and aleve allergy, and concurrent conditions included myelodysplasia, recurrent bladder infection, and sulfa allergy. The patient was previously treated with levofloxacin, midazolam, amoxicillin, and naproxen sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 16:00 for prophylactic vaccination. Concomitant medications included aciclovir for myelodysplasia, and recurrent bladder infections, calcium carbonate for myelodysplasia, and recurrent bladder infections, colecalciferol for myelodysplasia, and recurrent bladder infections, docusate sodium for recurrent bladder infections, and myelodysplasia, fluconazole for recurrent bladder infections, and myelodysplasia, iron for recurrent bladder infections, and myelodysplasia, and nitrofurantoin for recurrent bladder infections, and myelodysplasia. On 18-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 18-MAR-2021, and fever on 25-MAR-2021. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Medication error, Pain in extremity, Underdose
Clinical narrative: FEVER; DIZZINESS; 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 past medical history included levofloxacin allergy, midazolam allergy, amoxicillin allergy, and aleve allergy, and concurrent conditions included myelodysplasia, recurrent bladder infection, and sulfa allergy. The patient was previously treated with levofloxacin, midazolam, amoxicillin, and naproxen sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 16:00 for prophylactic vaccination. Concomitant medications included aciclovir for myelodysplasia, and recurrent bladder infections, calcium carbonate for myelodysplasia, and recurrent bladder infections, colecalciferol for myelodysplasia, and recurrent bladder infections, docusate sodium for recurrent bladder infections, and myelodysplasia, fluconazole for recurrent bladder infections, and myelodysplasia, iron for recurrent bladder infections, and myelodysplasia, and nitrofurantoin for recurrent bladder infections, and myelodysplasia. On 18-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 18-MAR-2021, and fever on 25-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Headache, Hyperhidrosis, Paraesthesia
Clinical narrative: This spontaneous report received from a consumer 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, 1 total, administered on 17-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pins and needles feeling on legs. On MAR-2021, the subject experienced feeling of fire on legs. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, pins and needles feeling on legs, feeling of fire on legs, dizziness and sweating was not reported. This report was non-serious.