chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Vision blurred, Visual impairment
Clinical narrative: POOR VISION; DOUBLE VISION; BLURRED VISION; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataract surgery on left eye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination.  On 12-MAR-2021, the subject experienced poor vision. On 12-MAR-2021, the subject experienced double vision. On 12-MAR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor vision, double vision, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Therapeutic response unexpected
Clinical narrative: SHOULDER PAIN, SMELL AND TASTE AGAIN; BODY ACHE; ACHY; FEVER; HEADACHE; NAUSEA; 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 past medical history included runny nose, and congestion, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and there was no history of drug abuse/illicit drug use. 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 10-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced nausea. On an unspecified date, the subject experienced shoulder pain, smell and taste again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, achy, fever, headache, nausea, and shoulder pain, smell and taste again on 12-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: HEAT PATCH; SWELLING AT INJECTION SITE; ITCHINESS AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS AT INJECTION SITE; 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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced soreness at injection site. On 18-MAR-2021, the subject experienced itchiness at injection site. On 18-MAR-2021, the subject experienced redness at injection site. On 19-MAR-2021, the subject experienced swelling at injection site. On 20-MAR-2021, the subject experienced heat patch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, redness at injection site, swelling at injection site, and heat patch, and the outcome of itchiness at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; HEADACHE; RIGHT ARM SORENESS (INJECTION SITE); 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 20-MAR-2021 (vaccinated in right arm) for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced right arm soreness (injection site). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and right arm soreness (injection site), and the outcome of body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower
Clinical narrative: LEFT LOWER ABDOMINAL PAIN DISCOMFORT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diverticulosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced left lower abdominal pain discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left lower abdominal pain discomfort. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Malaise, Pain
Clinical narrative: BODY ACHES; SWEATING; MALAISE; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned an 18 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 13:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, sweating, malaise, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, fatigue, sweating, headache and malaise was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pain, Pyrexia
Clinical narrative: ACHES; FLU-LIKE SYMPTOMS; LOW GRADE FEVER UP TO ABOUT 101 DEGREES; This spontaneous report received from a patient concerned a 51 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced aches. On 21-MAR-2021, the subject experienced flu-like symptoms. On 21-MAR-2021, the subject experienced low grade fever up to about 101 degrees. Laboratory data included: Body temperature (NR: not provided) up to about 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever up to about 101 degrees, aches, and flu-like symptoms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: SEVERE CHILLS; FEVER; 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, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 20-MAR-2021, the subject experienced severe chills. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, fever, and nausea on 21-MAR-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Influenza like illness, Pain, Pyrexia
Clinical narrative: ACHES; FLU LIKE SYMPTOMS; FEVER; This spontaneous report received from a consumer concerned a 55 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 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced aches. On 21-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature increased (NR: not provided) 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, aches, and flu like symptoms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate increased, Injection site pain, Insomnia
Clinical narrative: COULDN'T SLEEP FROM PAIN AND TINGLING IN ANKLES AND SHIN; INCREASED HEART RATE; ELEVATED BLOOD PRESSURE; ARM PAIN AT THE INJECTION SITE; BOTH LOWER ANKLE AND SHIN AREA FELT BURNING AND TINGLING; BOTH LOWER ANKLE AND SHIN AREA FELT PAINFUL/ PAIN IN ANKLE AND SHIN WAS GOING UP TOWARDS THE THIGH REGION; FEELING STICKY ON HANDS AND ARMS/ BODY FELT STICKY; 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, intramuscular, batch number: 18050301, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 at Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced feeling sticky on hands and arms/ body felt sticky. On 15-MAR-2021, the subject experienced both lower ankle and shin area felt burning and tingling. On 15-MAR-2021, the subject experienced both lower ankle and shin area felt painful/ pain in ankle and shin was going up towards the thigh region. On 19-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 148/75 mmHg. On 19-MAR-2021 02:00, the subject experienced couldn't sleep from pain and tingling in ankles and shin. On 19-MAR-2021 02:00, the subject experienced increased heart rate. On 19-MAR-2021 02:00, the subject experienced elevated blood pressure. On 19-MAR-2021 02:00, the subject experienced arm pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate on 19-MAR-2021, was recovering from elevated blood pressure, and feeling sticky on hands and arms/ body felt sticky, had not recovered from both lower ankle and shin area felt painful/ pain in ankle and shin was going up towards the thigh region, couldn't sleep from pain and tingling in ankles and shin, and both lower ankle and shin area felt burning and tingling, and the outcome of arm pain at the injection site 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: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Sticky skin
Clinical narrative: COULDN'T SLEEP FROM PAIN AND TINGLING IN ANKLES AND SHIN; INCREASED HEART RATE; ELEVATED BLOOD PRESSURE; ARM PAIN AT THE INJECTION SITE; BOTH LOWER ANKLE AND SHIN AREA FELT BURNING AND TINGLING; BOTH LOWER ANKLE AND SHIN AREA FELT PAINFUL/ PAIN IN ANKLE AND SHIN WAS GOING UP TOWARDS THE THIGH REGION; FEELING STICKY ON HANDS AND ARMS/ BODY FELT STICKY; 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, intramuscular, batch number: 18050301, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 at Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced feeling sticky on hands and arms/ body felt sticky. On 15-MAR-2021, the subject experienced both lower ankle and shin area felt burning and tingling. On 15-MAR-2021, the subject experienced both lower ankle and shin area felt painful/ pain in ankle and shin was going up towards the thigh region. On 19-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 148/75 mmHg. On 19-MAR-2021 02:00, the subject experienced couldn't sleep from pain and tingling in ankles and shin. On 19-MAR-2021 02:00, the subject experienced increased heart rate. On 19-MAR-2021 02:00, the subject experienced elevated blood pressure. On 19-MAR-2021 02:00, the subject experienced arm pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate on 19-MAR-2021, was recovering from elevated blood pressure, and feeling sticky on hands and arms/ body felt sticky, had not recovered from both lower ankle and shin area felt painful/ pain in ankle and shin was going up towards the thigh region, couldn't sleep from pain and tingling in ankles and shin, and both lower ankle and shin area felt burning and tingling, and the outcome of arm pain at the injection site 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: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; FATIGUE; 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, 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 flu like symptoms, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: ACHY; FEELING WEAK; CHILLS; HEADACHE; FEVER; NAUSEA; RAPID HEARTBEAT OF 120; 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 (form of admin, route of admin, and batch number were not reported and has been requested) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced rapid heart rate. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 92. On 13-MAR-2021, the subject experienced achy. On 13-MAR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate, chills, headache, fever, and nausea on 13-MAR-2021, and achy, and feeling weak on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: ACHY; FEELING WEAK; CHILLS; HEADACHE; FEVER; NAUSEA; RAPID HEARTBEAT OF 120; 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 (form of admin, route of admin, and batch number were not reported and has been requested) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced rapid heart rate. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 92. On 13-MAR-2021, the subject experienced achy. On 13-MAR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate, chills, headache, fever, and nausea on 13-MAR-2021, and achy, and feeling weak on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: FEELING DIZZINESS THE WHOLE WEEK; 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced feeling dizziness the whole week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizziness the whole week. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: HEADACHE; 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, vaccinated on left deltoid, batch number: BA43LC, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FEELING TIRED; 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: Unk) dose was not reported, administered on 12-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 feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Illness, Malaise
Clinical narrative: FEELING UNWELL; SEVERE ADVERSE REACTIONS; SICK; This spontaneous report received from a  a company representative concerned multiple patients (40 patient) of unspecified gender and 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 and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling unwell. On MAR-2021, the subject experienced severe adverse reactions. On MAR-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe adverse reactions, feeling unwell and sick was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: LOSING SLEEP; This spontaneous report received from a patient concerned a 68 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 05-MAR-2021 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 losing sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from losing sleep. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea, Influenza like illness, Nasopharyngitis
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; COLD SYMPTOMS; FLU-LIKE EFFECTS; HAVING DIFFICULTY TAKING FULL BREATHS; 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 past medical history included exposure to covid-19.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 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 loss of taste. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced cold symptoms. On MAR-2021, the subject experienced flu-like effects. On MAR-2021, the subject experienced having difficulty taking full breaths. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like effects, had not recovered from loss of taste, and loss of smell, and the outcome of cold symptoms and having difficulty taking full breaths was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345873.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; COLD SYMPTOMS; FLU-LIKE EFFECTS; HAVING DIFFICULTY TAKING FULL BREATHS; 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 past medical history included exposure to covid-19.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 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 loss of taste. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced cold symptoms. On MAR-2021, the subject experienced flu-like effects. On MAR-2021, the subject experienced having difficulty taking full breaths. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like effects, had not recovered from loss of taste, and loss of smell, and the outcome of cold symptoms and having difficulty taking full breaths was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345873.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Injection site pain, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; MILD HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a vaccine facility concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced mild headache. On 14-MAR-2021, the subject experienced soreness at injection site. On 21-MAR-2021 13:35, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 21-MAR-2021 22:41, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache on 14-MAR-2021, and soreness at injection site on MAR-2021, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Rash macular
Clinical narrative: BODY ACHE; SEVERE CHILLS; HEADACHE; YELLOW BLOTCH ON INJECTION SITE, DISCOLORATION; 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 not reported) dose was not reported, administered on 07-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced yellow blotch on injection site, discoloration. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced severe chills. On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, severe chills, and headache, and had not recovered from yellow blotch on injection site, discoloration. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Body temperature increased, Chills
Clinical narrative: STOMACH PAIN; TOP/MIDDLE OF BACK HURT ALL DAY YESTERDAY; HEADACHE; RIGHT ARM SWELLING; INJECTION SITE REDNESS- SIZE OF SILVER DOLLAR; TEMP OF 98.6; FATIGUE; CHILLS; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced temp of 98.6. Laboratory data included: Body temperature (NR: not provided) 98.6 F. On 21-MAR-2021, the subject experienced injection site redness- size of silver dollar. On 21-MAR-2021, the subject experienced right arm swelling. On an unspecified date, the subject experienced stomach pain, top/middle of back hurt all day yesterday, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, injection site redness- size of silver dollar, right arm swelling, headache, stomach pain, top/middle of back hurt all day yesterday, fatigue and temp of 98.6 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: STOMACH PAIN; TOP/MIDDLE OF BACK HURT ALL DAY YESTERDAY; HEADACHE; RIGHT ARM SWELLING; INJECTION SITE REDNESS- SIZE OF SILVER DOLLAR; TEMP OF 98.6; FATIGUE; CHILLS; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced temp of 98.6. Laboratory data included: Body temperature (NR: not provided) 98.6 F. On 21-MAR-2021, the subject experienced injection site redness- size of silver dollar. On 21-MAR-2021, the subject experienced right arm swelling. On an unspecified date, the subject experienced stomach pain, top/middle of back hurt all day yesterday, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, injection site redness- size of silver dollar, right arm swelling, headache, stomach pain, top/middle of back hurt all day yesterday, fatigue and temp of 98.6 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient 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) 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Insomnia, Pain
Clinical narrative: DIZZINESS; TROUBLE SLEEPING; ARM SORENESS; CHILLS; FEVER; HEART PALPITATIONS; BODYACHES; TERRIBLE HEADACHE; 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 past medical history included asthma, and high cholesterol, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 21-MAR-2021 (vaccinated on left arm at 15:30 p.m.) for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced terrible headache. On 21-MAR-2021 22:00, the subject experienced heart palpitations. On 21-MAR-2021 22:00, the subject experienced bodyaches. On 21-MAR-2021 22:00, the subject experienced arm soreness. On 21-MAR-2021 22:00, the subject experienced chills. On 21-MAR-2021 22:00, the subject experienced fever. On 21-MAR-2021 23:00, the subject experienced dizziness. On 21-MAR-2021 23:00, the subject experienced trouble sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, arm soreness, fever, dizziness, bodyaches, terrible headache, trouble sleeping, and heart palpitations. This report was non-serious. Additional information was received on 22/Mar/2021. The following information was updated and incorporated into the case narrative: (Patient name spelling was changed and mail address was corrected). No new information available.; 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: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: DIZZINESS; TROUBLE SLEEPING; ARM SORENESS; CHILLS; FEVER; HEART PALPITATIONS; BODYACHES; TERRIBLE HEADACHE; 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 past medical history included asthma, and high cholesterol, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 21-MAR-2021 (vaccinated on left arm at 15:30 p.m.) for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced terrible headache. On 21-MAR-2021 22:00, the subject experienced heart palpitations. On 21-MAR-2021 22:00, the subject experienced bodyaches. On 21-MAR-2021 22:00, the subject experienced arm soreness. On 21-MAR-2021 22:00, the subject experienced chills. On 21-MAR-2021 22:00, the subject experienced fever. On 21-MAR-2021 23:00, the subject experienced dizziness. On 21-MAR-2021 23:00, the subject experienced trouble sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, arm soreness, fever, dizziness, bodyaches, terrible headache, trouble sleeping, and heart palpitations. This report was non-serious. Additional information was received on 22/Mar/2021. The following information was updated and incorporated into the case narrative: (Patient name spelling was changed and mail address was corrected). No new information available.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER WITH TEMP. 99.3 AND 99.6; 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 blood donation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F, 99.6 F. On 21-MAR-2021 04:00, the subject experienced chills. On 21-MAR-2021 04:00, the subject experienced fever with temp. 99.3 and 99.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever with temp. 99.3 and 99.6 and chills was not reported. This report was non-serious.   Additional information was received on 22/Mar/2021: The following information was updated and incorporated into the case: Product batch number updated.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: MILD BODY ACHES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included reactions (headache and mild body ache) after flu shot some years. 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 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced mild body aches, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild body aches, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Pain
Clinical narrative: TIRED; BODY ACHE; CHILLS; RAISED BODY TEMPERATURE; SORE ARM; This spontaneous report received from a patient concerned a 34 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and bronchitis. 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 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 sore arm. Laboratory data included: Body temperature (NR: not provided) 101.6. On 20-MAR-2021, the subject experienced raised body temperature. On 20-MAR-2021 22:30, the subject experienced chills. On 21-MAR-2021 18:00, the subject experienced tired. On 21-MAR-2021 18:00, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, raised body temperature, tired, and body ache on MAR-2021, and had not recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: TIRED; BODY ACHE; CHILLS; RAISED BODY TEMPERATURE; SORE ARM; This spontaneous report received from a patient concerned a 34 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and bronchitis. 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 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 sore arm. Laboratory data included: Body temperature (NR: not provided) 101.6. On 20-MAR-2021, the subject experienced raised body temperature. On 20-MAR-2021 22:30, the subject experienced chills. On 21-MAR-2021 18:00, the subject experienced tired. On 21-MAR-2021 18:00, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, raised body temperature, tired, and body ache on MAR-2021, and had not recovered from sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Constipation, Diarrhoea, Formication
Clinical narrative: CONSTIPATION; DIARRHEA EVERY 45 MINUTES FOR 10 HOURS; STOOL FREQUENCY INCREASED; CHILLS; HEADACHE; CRAWL OUT OF SKIN IN THE MIDDLE OF NIGHT; FEVER UPTO 100 ON AND OFF; PAINFUL FEET AND RIGHT LEG; INSOMNIA; 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 lupus.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on the left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced insomnia. On 16-MAR-2021, the subject experienced painful feet and right leg. On 16-MAR-2021, the subject experienced fever up to 100 on and off. Laboratory data included: Body temperature (NR: not provided) Up to 100 F. On 17-MAR-2021, the subject experienced crawl out of skin in the middle of night. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced diarrhea every 45 minutes for 10 hours. On 18-MAR-2021, the subject experienced stool frequency increased. On 20-MAR-2021, the subject experienced constipation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawl out of skin in the middle of night, insomnia, painful feet and right leg, and headache on 17-MAR-2021, constipation on 21-MAR-2021, and chills on 18-MAR-2021, was recovering from diarrhea every 45 minutes for 10 hours, and stool frequency increased, and had not recovered from fever up to 100 on and off. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Headache, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: CONSTIPATION; DIARRHEA EVERY 45 MINUTES FOR 10 HOURS; STOOL FREQUENCY INCREASED; CHILLS; HEADACHE; CRAWL OUT OF SKIN IN THE MIDDLE OF NIGHT; FEVER UPTO 100 ON AND OFF; PAINFUL FEET AND RIGHT LEG; INSOMNIA; 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 lupus.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on the left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced insomnia. On 16-MAR-2021, the subject experienced painful feet and right leg. On 16-MAR-2021, the subject experienced fever up to 100 on and off. Laboratory data included: Body temperature (NR: not provided) Up to 100 F. On 17-MAR-2021, the subject experienced crawl out of skin in the middle of night. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced diarrhea every 45 minutes for 10 hours. On 18-MAR-2021, the subject experienced stool frequency increased. On 20-MAR-2021, the subject experienced constipation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawl out of skin in the middle of night, insomnia, painful feet and right leg, and headache on 17-MAR-2021, constipation on 21-MAR-2021, and chills on 18-MAR-2021, was recovering from diarrhea every 45 minutes for 10 hours, and stool frequency increased, and had not recovered from fever up to 100 on and off. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: QUEASY STOMACH; 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: 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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced queasy stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of queasy stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Hypersensitivity
Clinical narrative: ALLERGIC REACTION; DOWN FOR THREE DAYS; 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, 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 allergic reaction, and down for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and down for three days was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: FELT REALLY BAD; BREAKING OUT IN SWEATS; A LITTLE WINDED; LEGS ARE HURTING; HEADACHE; NAUSEA; FATIGUE; 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 20-MAR-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced felt really bad, breaking out in sweats, a little winded, legs are hurting, headache, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and had not recovered from felt really bad, breaking out in sweats, headache, a little winded, legs are hurting, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: FELT REALLY BAD; BREAKING OUT IN SWEATS; A LITTLE WINDED; LEGS ARE HURTING; HEADACHE; NAUSEA; FATIGUE; 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 20-MAR-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced felt really bad, breaking out in sweats, a little winded, legs are hurting, headache, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and had not recovered from felt really bad, breaking out in sweats, headache, a little winded, legs are hurting, and fatigue. This report was non-serious.