chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dry mouth, Somnolence, Tongue oedema
Clinical narrative: FELT DIZZY/FELT FAINTING; HEAD SPINNING; HANDS SHAKING; DROWSY; VISION BLURRED; MOUTH DRY; ONE SIDE OF TONGUE WAS HEAVY; WEAKNESS; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included influenza vaccine for prophylactic vaccination, and acetylsalicylic acid.  On 23-MAR-2021, the subject experienced felt dizzy/felt fainting. On 23-MAR-2021, the subject experienced head spinning. On 23-MAR-2021, the subject experienced hands shaking. On 23-MAR-2021, the subject experienced drowsy. On 23-MAR-2021, the subject experienced vision blurred. On 23-MAR-2021, the subject experienced mouth dry. On 23-MAR-2021, the subject experienced one side of tongue was heavy. On 23-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt dizzy/felt fainting, drowsy, vision blurred, mouth dry, one side of tongue was heavy, hands shaking, head spinning, and weakness. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Tremor, Vertigo, Vision blurred
Clinical narrative: FELT DIZZY/FELT FAINTING; HEAD SPINNING; HANDS SHAKING; DROWSY; VISION BLURRED; MOUTH DRY; ONE SIDE OF TONGUE WAS HEAVY; WEAKNESS; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included influenza vaccine for prophylactic vaccination, and acetylsalicylic acid.  On 23-MAR-2021, the subject experienced felt dizzy/felt fainting. On 23-MAR-2021, the subject experienced head spinning. On 23-MAR-2021, the subject experienced hands shaking. On 23-MAR-2021, the subject experienced drowsy. On 23-MAR-2021, the subject experienced vision blurred. On 23-MAR-2021, the subject experienced mouth dry. On 23-MAR-2021, the subject experienced one side of tongue was heavy. On 23-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt dizzy/felt fainting, drowsy, vision blurred, mouth dry, one side of tongue was heavy, hands shaking, head spinning, and weakness. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: IMMUNE DISORDER; This spontaneous report received from a consumer via a company representative concerned a 21 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: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced immune disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune disorder was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE; This spontaneous report received from a pharmacist concerned an adult of multiple patients of unspecified sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: CHILLS; NOT FEELING GOOD; NAUSEA; FEVER; TIREDNESS IN MORNING; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pleurisy, issue with lack of cartilage in knee, and sensitive to medication, and other pre-existing medical conditions included the patient was using oral contraceptive. weight was approx 90 lbs. 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for fever. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced not feeling good. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness in morning. Laboratory data included: Body temperature (NR: not provided) 102.7 F, 98 F, jumped higher to the mid 103's teetering 104 F, between 99.5 to under 101, between 97.8 to 99 F, remained in 97-98 range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, nausea, fever, not feeling good, and tiredness in morning. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS; NOT FEELING GOOD; NAUSEA; FEVER; TIREDNESS IN MORNING; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pleurisy, issue with lack of cartilage in knee, and sensitive to medication, and other pre-existing medical conditions included the patient was using oral contraceptive. weight was approx 90 lbs. 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for fever. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced not feeling good. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness in morning. Laboratory data included: Body temperature (NR: not provided) 102.7 F, 98 F, jumped higher to the mid 103's teetering 104 F, between 99.5 to under 101, between 97.8 to 99 F, remained in 97-98 range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, nausea, fever, not feeling good, and tiredness in morning. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 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 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: FELT LIKE HAVING HEART ATTACK; 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. No concomitant medications were reported. On an unspecified date, the subject experienced felt like having heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like having heart attack was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned multiple patients. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding
Clinical narrative: HEAVIER MENSTRUAL FLOW WITH VISIBLE CLOTTED BLOOD; MENSTRUAL CRAMPING; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heavier menstrual flow with visible clotted blood. On APR-2021, the subject experienced menstrual cramping. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the menstrual cramping, heavier menstrual flow with visible clotted blood and fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Night sweats, Pyrexia
Clinical narrative: INCREASED SHORTNESS OF BREATH; FEELS BAD; FEVER; NIGHT SWEATS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol use, and somker, and other pre-existing medical conditions included the patient no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 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 13-APR-2021, the subject experienced night sweats. On 13-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced feels bad. On 14-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced increased shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels bad, night sweats, headache, and fever, and the outcome of increased shortness of breath was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Headache
Clinical narrative: COUGH; POSSIBLE SHORTNESS OF BREATH; HEADACHES BACK OF HEAD TO EYES; FEVER; NAUSEA; LETHARGY; GENERALIZED ACHING; WEAKNESS; CHILLS; This spontaneous report received from a consumer concerned a 37 year old female. The patient's weight was 145.6 pounds, and height was 63 inches. The patient's concurrent conditions included hypothyroidism, allergy to egg, sulfa allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism.  On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced generalized aching. On 06-APR-2021, the subject experienced weakness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headaches back of head to eyes. On an unspecified date, the subject experienced cough, and possible shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, chills, fever, and nausea on 07-APR-2021, had not recovered from lethargy, weakness, and headaches back of head to eyes, and the outcome of cough and possible shortness of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: COUGH; POSSIBLE SHORTNESS OF BREATH; HEADACHES BACK OF HEAD TO EYES; FEVER; NAUSEA; LETHARGY; GENERALIZED ACHING; WEAKNESS; CHILLS; This spontaneous report received from a consumer concerned a 37 year old female. The patient's weight was 145.6 pounds, and height was 63 inches. The patient's concurrent conditions included hypothyroidism, allergy to egg, sulfa allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism.  On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced generalized aching. On 06-APR-2021, the subject experienced weakness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headaches back of head to eyes. On an unspecified date, the subject experienced cough, and possible shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, chills, fever, and nausea on 07-APR-2021, had not recovered from lethargy, weakness, and headaches back of head to eyes, and the outcome of cough and possible shortness of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: DIFFICULTY BREATHING; 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, Expiry: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Hyperchlorhydria
Clinical narrative: GAS IN THE STOMACH; STOMACH ACIDITY; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included depression, and concurrent conditions included anxiety, and hypertension. 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 07-APR-2021 17:00 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 07-APR-2021, the subject experienced gas in the stomach. On 07-APR-2021, the subject experienced stomach acidity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the gas in the stomach and stomach acidity was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Dyspepsia, Extrasystoles, Fatigue
Clinical narrative: SKIPPED HEART BEATS; HEARTBURN; LACK OF APPETITE; IRRITABILITY; FLU LIKE SYMPTOMS; ACHY; ANXIETY; MALAISE; PAIN IN LEGS; FATIGUE; MUSCLE CRAMPS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 106 pounds, and height was 64 inches. The patient's concurrent conditions included anxiety but its worsen, reactive hypoglycemia, sulfa allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug use. The patient was previously treated with Cefaclor.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced achy. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced muscle cramps. On 08-APR-2021, the subject experienced malaise. On 08-APR-2021, the subject experienced pain in legs. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced irritability. On 10-APR-2021, the subject experienced heartburn. On 10-APR-2021, the subject experienced skipped heart beats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in legs on 10-APR-2021, was recovering from lack of appetite, anxiety, and heartburn, and had not recovered from flu like symptoms, malaise, achy, irritability, muscle cramps, skipped heart beats, and fatigue. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Irritability, Malaise, Muscle spasms, Pain
Clinical narrative: SKIPPED HEART BEATS; HEARTBURN; LACK OF APPETITE; IRRITABILITY; FLU LIKE SYMPTOMS; ACHY; ANXIETY; MALAISE; PAIN IN LEGS; FATIGUE; MUSCLE CRAMPS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 106 pounds, and height was 64 inches. The patient's concurrent conditions included anxiety but its worsen, reactive hypoglycemia, sulfa allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug use. The patient was previously treated with Cefaclor.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced achy. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced muscle cramps. On 08-APR-2021, the subject experienced malaise. On 08-APR-2021, the subject experienced pain in legs. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced irritability. On 10-APR-2021, the subject experienced heartburn. On 10-APR-2021, the subject experienced skipped heart beats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in legs on 10-APR-2021, was recovering from lack of appetite, anxiety, and heartburn, and had not recovered from flu like symptoms, malaise, achy, irritability, muscle cramps, skipped heart beats, and fatigue. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SKIPPED HEART BEATS; HEARTBURN; LACK OF APPETITE; IRRITABILITY; FLU LIKE SYMPTOMS; ACHY; ANXIETY; MALAISE; PAIN IN LEGS; FATIGUE; MUSCLE CRAMPS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 106 pounds, and height was 64 inches. The patient's concurrent conditions included anxiety but its worsen, reactive hypoglycemia, sulfa allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug use. The patient was previously treated with Cefaclor.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced achy. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced muscle cramps. On 08-APR-2021, the subject experienced malaise. On 08-APR-2021, the subject experienced pain in legs. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced irritability. On 10-APR-2021, the subject experienced heartburn. On 10-APR-2021, the subject experienced skipped heart beats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in legs on 10-APR-2021, was recovering from lack of appetite, anxiety, and heartburn, and had not recovered from flu like symptoms, malaise, achy, irritability, muscle cramps, skipped heart beats, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Hyperhidrosis, Pain in extremity
Clinical narrative: SWEATING; CHEST PAIN; SEVERE STOMACH PAIN; LEG PAIN; 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 high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the subject experienced chest pain. On 29-MAR-2021, the subject experienced severe stomach pain. On 29-MAR-2021, the subject experienced leg pain. On an unspecified date, the subject experienced sweating. Treatment medications (dates unspecified) included: pantoprazole sodium sesquihydrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe stomach pain, and the outcome of chest pain, leg pain and sweating 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
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain in extremity
Clinical narrative: TIREDNESS; COLD; ARM WAS A LITTLE TENDER; 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 past medical history included skin cancer, and mastectomy, and concurrent conditions included environmental allergy, and hay fever.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced cold. On 11-APR-2021, the subject experienced arm was a little tender. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold on 12-APR-2021, was recovering from arm was a little tender, and had not recovered from tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent concerned a child of unspecified 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.4 F, 102.7 F. 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Headache, Magnetic resonance imaging head
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a 70 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: unknown) dose was not reported, administered on 13-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 headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and Magnetic resonance imaging brain (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: HORRIBLE BODY ACHES; CHILLS; FEVER; TIRED; WEIRD HEADACHE/PRESSURE ON FRONTAL LOBES; 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: UNKNWON) dose was not reported, administered on 10-APR-2021 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 10-APR-2021, the subject experienced horrible body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced weird headache/pressure on frontal lobes. Laboratory data included: Body temperature (NR: not provided) 104 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible body aches, chills, fever, tired and weird headache/pressure on frontal lobes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HORRIBLE BODY ACHES; CHILLS; FEVER; TIRED; WEIRD HEADACHE/PRESSURE ON FRONTAL LOBES; 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: UNKNWON) dose was not reported, administered on 10-APR-2021 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 10-APR-2021, the subject experienced horrible body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced weird headache/pressure on frontal lobes. Laboratory data included: Body temperature (NR: not provided) 104 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible body aches, chills, fever, tired and weird headache/pressure on frontal lobes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This solicited report received from a patient via RRA-18356: Nurse Navigators concerned a 24 year old male. The patient's weight, height, and medical history were not reported. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose and frequency were not reported from 13-APR-2021 for an unspecified indication. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The patient initiated treatment with 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of sore arm was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and sore arm as possible; and between ustekinumab, and sore arm as possible.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTION NOS; This spontaneous report received from a patient 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) 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 2021, the subject experienced adverse reaction nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction nos was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Fatigue
Clinical narrative: LOSS OF TASTE BUDS BY 1/3 / ONLY 1/2 OF TASTE BUDS WORKED; TIRED; 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 pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be required for this case. No concomitant medications were reported. On an unspecified date, the subject experienced loss of taste buds by 1/3 / only 1/2 of taste buds worked, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste buds by 1/3 / only 1/2 of taste buds worked, and tired. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Injection site pain, Pain in extremity
Clinical narrative: HEADACHE; PAIN DURING INJECTION ON RIGHT ARM; PAIN DOWN RIGHT ARM; STOMACH PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included triple bypass, back surgeries, and neck surgery.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stomach pain. On 31-MAR-2021, the subject experienced pain during injection on right arm. On 31-MAR-2021, the subject experienced pain down right arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from pain during injection on right arm, stomach pain, and pain down right arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Peripheral swelling
Clinical narrative: LEGS BRUISED; LEGS SWOLLEN; IN AGONY; 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, 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 legs bruised, legs swollen, and in agony. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs bruised, legs swollen, and in agony. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORENESS IN ARM; LIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 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 11-APR-2021, the subject experienced light headache. On 12-APR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in arm and light headache was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Headache
Clinical narrative: PAIN IN EYE; DRY EYE; HEADACHE; This spontaneous report received from a patient concerned a 63 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in eye, dry eye, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in eye, headache and dry eye was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Confusional state, Disorientation, Dizziness, Hypoaesthesia
Clinical narrative: NUMB FEELING; MUSCLE ACHE (LOWER BACK/UPPER RIGHT SIDE); PAIN ON RIGHT SIDE; ACHES IN LEGS; CHILLS; DIZZINESS; A LITTLE DISORIENTED; VERY LETHARGIC (ON AND OFF); CONFUSED; This spontaneous report received from a patient concerned a 60 year old of unspecified 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced a little disoriented. On 05-APR-2021, the subject experienced very lethargic (on and off). On 05-APR-2021, the subject experienced confused. On 05-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pain on right side. On 06-APR-2021, the subject experienced aches in legs. On 08-APR-2021, the subject experienced numb feeling. On 08-APR-2021, the subject experienced muscle ache (lower back/upper right side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, a little disoriented, very lethargic (on and off), and confused on 09-APR-2021, and chills on 06-APR-2021, and was recovering from pain on right side, aches in legs, muscle ache (lower back/upper right side), and numb feeling. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pain, Pain in extremity
Clinical narrative: NUMB FEELING; MUSCLE ACHE (LOWER BACK/UPPER RIGHT SIDE); PAIN ON RIGHT SIDE; ACHES IN LEGS; CHILLS; DIZZINESS; A LITTLE DISORIENTED; VERY LETHARGIC (ON AND OFF); CONFUSED; This spontaneous report received from a patient concerned a 60 year old of unspecified 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced a little disoriented. On 05-APR-2021, the subject experienced very lethargic (on and off). On 05-APR-2021, the subject experienced confused. On 05-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pain on right side. On 06-APR-2021, the subject experienced aches in legs. On 08-APR-2021, the subject experienced numb feeling. On 08-APR-2021, the subject experienced muscle ache (lower back/upper right side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, a little disoriented, very lethargic (on and off), and confused on 09-APR-2021, and chills on 06-APR-2021, and was recovering from pain on right side, aches in legs, muscle ache (lower back/upper right side), and numb feeling. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Fatigue, Pain in extremity
Clinical narrative: SORE ARM; TIREDNESS; LYMPH NODE SWELLING OF LEFT BREAST; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced lymph node swelling of left breast. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lymph node swelling of left breast, and the outcome of tiredness and sore arm was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness postural, Fatigue, Headache
Clinical narrative: NO APPETITE; DIZZINESS IF STOOD UP, OFF AND ON; UNBEARABLE MIGRAINE; FEVER; SEVERE HEADACHES; NAUSEA; VERY FATIGUED; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included rare blood disease (porphyria), and concurrent conditions included mild asthma, obese, hypothyroid, psoriasis, and vitamin deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included sulfasalazine for psoriasis, cyanocobalamin for vitamin deficiency, folic acid, and levothyroxine. On 07-APR-2021, the subject experienced severe headaches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced very fatigued. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-APR-2021 22:00, the subject experienced fever. On 07-APR-2021 22:30, the subject experienced unbearable migraine. On 10-APR-2021, the subject experienced dizziness if stood up, off and on. On an unspecified date, the subject experienced no appetite. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever on 08-APR-2021 02:00, and the outcome of severe headaches, nausea, very fatigued, dizziness if stood up, off and on, no appetite and unbearable migraine was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia
Clinical narrative: NO APPETITE; DIZZINESS IF STOOD UP, OFF AND ON; UNBEARABLE MIGRAINE; FEVER; SEVERE HEADACHES; NAUSEA; VERY FATIGUED; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included rare blood disease (porphyria), and concurrent conditions included mild asthma, obese, hypothyroid, psoriasis, and vitamin deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included sulfasalazine for psoriasis, cyanocobalamin for vitamin deficiency, folic acid, and levothyroxine. On 07-APR-2021, the subject experienced severe headaches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced very fatigued. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-APR-2021 22:00, the subject experienced fever. On 07-APR-2021 22:30, the subject experienced unbearable migraine. On 10-APR-2021, the subject experienced dizziness if stood up, off and on. On an unspecified date, the subject experienced no appetite. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever on 08-APR-2021 02:00, and the outcome of severe headaches, nausea, very fatigued, dizziness if stood up, off and on, no appetite and unbearable migraine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECT; 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: Unk) 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 side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Injection site pain, Pain
Clinical narrative: COUGH; CHILLS; INJECTION SITE PAIN; FATIGUE; GENERAL BODY ACHES; 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 pre-existing medical conditions included unknown. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the subject experienced general body aches. On an unspecified date, the subject experienced cough, chills, injection site pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain, general body aches, fatigue, chills and cough was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 34 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: 207A21A, expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 16-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain. This report was non-serious.