chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Visual impairment
Clinical narrative: DARKENED VISION; LIGHT HEADED; COLD SWEATS; JOINT ACHE; CHILLS; MUSCLE ACHE; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 21 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: not reported) dose was not reported, administered on 06-APR-2021 13:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021 18:45, the subject experienced darkened vision. On 06-APR-2021 18:45, the subject experienced light headed. On 06-APR-2021 18:45, the subject experienced cold sweats. On 06-APR-2021 18:45, the subject experienced joint ache. On 06-APR-2021 18:45, the subject experienced chills. On 06-APR-2021 18:45, the subject experienced muscle ache. On 06-APR-2021 18:45, the subject experienced nausea. On 06-APR-2021 18:45, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkened vision, light headed, cold sweats, joint ache, chills, muscle ache, nausea, and headache on 07-APR-2021 13:00. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING IN RIGHT LEG AND FOOT; NUMBNESS ON RIGHT LEG AND FOOT; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced tingling in right leg and foot. On 06-APR-2021, the subject experienced numbness on right leg and foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in right leg and foot, and numbness on right leg and foot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Viral test
Clinical narrative: Confirmed COVID-19 INFECTION; 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 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 08-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: Viral swab (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection 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: Bradycardia, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: BRADYCARDIA; DIAPHORETIC; PALE; HYPOTENSIVE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered 1 total on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  Health care professional reported that, on 07-APR-2021, after vaccination, while being observed the patients were diaphoretic, pale, hypotensive and bradycardia. EMS (Emergency medical service) was called and patients were evaluated. Patients decided against transport and were discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diaphoretic, pale, hypotensive and bradycardia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210418457, 20210417209, 20210417256, 20210417456, 20210417469, 20210417550 and 20210417620; Sender's Comments: V0: 20210417122-covid-19 vaccine ad26.cov2.s -Bradycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Feeling abnormal, Pyrexia, Vomiting
Clinical narrative: FEELS HORRIBLE; THROWING UP; FEVER; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received macitentan (tablet, route of admin not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. 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 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 feels horrible, throwing up, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with macitentan was not reported. The outcome of the feels horrible, throwing up and fever was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Headache, Hypertension, Nausea
Clinical narrative: BLURRING EYES IN BOTH EYES BUT WORSE IN THE RIGHT SIDE/ RIGHT EYE BLURRINESS AND NOT ABLE TO SEE FOR 15 MIN; VOMITTED MANY TIMES; BLOOD PRESSURE IS SO HIGH RIGHT NOW 189/98; CHILLS; SEVERE HEADACHE ON THE LEFT SIDE WHEN SHE MOVES; FEELING NAUSEOUS; This spontaneous report received from a consumer concerned a 51 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 141/90. On 08-APR-2021, the subject experienced blurring eyes in both eyes but worse in the right side/ right eye blurriness and not able to see for 15 min. On 08-APR-2021, the subject experienced vomitted many times. On 08-APR-2021, the subject experienced blood pressure is so high right now 189/98. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache on the left side when she moves. On 08-APR-2021, the subject experienced feeling nauseous. Laboratory data included: Blood pressure (NR: not provided) 189/98, and Pain scale (NR: not provided) 9/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache on the left side when she moves, blurring eyes in both eyes but worse in the right side/ right eye blurriness and not able to see for 15 min, vomitted many times, feeling nauseous, chills, and blood pressure is so high right now 189/98. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Vision blurred, Vomiting
Clinical narrative: BLURRING EYES IN BOTH EYES BUT WORSE IN THE RIGHT SIDE/ RIGHT EYE BLURRINESS AND NOT ABLE TO SEE FOR 15 MIN; VOMITTED MANY TIMES; BLOOD PRESSURE IS SO HIGH RIGHT NOW 189/98; CHILLS; SEVERE HEADACHE ON THE LEFT SIDE WHEN SHE MOVES; FEELING NAUSEOUS; This spontaneous report received from a consumer concerned a 51 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 141/90. On 08-APR-2021, the subject experienced blurring eyes in both eyes but worse in the right side/ right eye blurriness and not able to see for 15 min. On 08-APR-2021, the subject experienced vomitted many times. On 08-APR-2021, the subject experienced blood pressure is so high right now 189/98. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache on the left side when she moves. On 08-APR-2021, the subject experienced feeling nauseous. Laboratory data included: Blood pressure (NR: not provided) 189/98, and Pain scale (NR: not provided) 9/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache on the left side when she moves, blurring eyes in both eyes but worse in the right side/ right eye blurriness and not able to see for 15 min, vomitted many times, feeling nauseous, chills, and blood pressure is so high right now 189/98. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Breast pain, Headache, Malaise, Myalgia
Clinical narrative: HEADACHE(RING AROUND BRAIN); BEHIND BREAST ON BACK IS SUPER SORE; NOT FEELING VERY GOOD; WEAKNESS; MUSCLE SORENESS UP AND DOWN SPINE; TINGLING IN LEFT HAND; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient was previously treated with sumatriptan for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: not reported) dose was not reported, administered on 07-APR-2021 14:05 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced tingling in left hand. On 08-APR-2021 08:00, the subject experienced behind breast on back is super sore. On 08-APR-2021 08:00, the subject experienced not feeling very good. On 08-APR-2021 08:00, the subject experienced weakness. On 08-APR-2021 08:00, the subject experienced muscle soreness up and down spine. On an unspecified date, the subject experienced headache (ring around brain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in left hand on 07-APR-2021, was recovering from headache(ring around brain), and had not recovered from weakness, behind breast on back is super sore, muscle soreness up and down spine, and not feeling very good. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: HEADACHE(RING AROUND BRAIN); BEHIND BREAST ON BACK IS SUPER SORE; NOT FEELING VERY GOOD; WEAKNESS; MUSCLE SORENESS UP AND DOWN SPINE; TINGLING IN LEFT HAND; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient was previously treated with sumatriptan for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: not reported) dose was not reported, administered on 07-APR-2021 14:05 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced tingling in left hand. On 08-APR-2021 08:00, the subject experienced behind breast on back is super sore. On 08-APR-2021 08:00, the subject experienced not feeling very good. On 08-APR-2021 08:00, the subject experienced weakness. On 08-APR-2021 08:00, the subject experienced muscle soreness up and down spine. On an unspecified date, the subject experienced headache (ring around brain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in left hand on 07-APR-2021, was recovering from headache(ring around brain), and had not recovered from weakness, behind breast on back is super sore, muscle soreness up and down spine, and not feeling very good. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: CHILLS; HEADACHE; MUSCLE ACHE; FATIGUE; 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 Covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on APR-2021, had not recovered from fatigue, and the outcome of muscle ache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421333.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse Reactions; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Chills, Dysphagia
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate abnormal, Heart rate increased, Hypertension, Muscle spasms
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Paraesthesia oral, Pruritus, Pyrexia, Rash
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, SARS-CoV-2 test negative, Stomatitis, Throat irritation, Tongue discomfort
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Chills, Eyelids pruritus, Full blood count
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Lip pruritus, Myalgia, Pain in extremity
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus, Pyrexia
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Sleep disorder, Stomatitis, Throat tightness, Urticaria
Clinical narrative: NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. 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 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vertigo
Clinical narrative: VERTIGO; FATIGUE; PAIN; 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced pain. On 20-MAR-2021, the subject experienced fatigue. On 22-MAR-2021, the subject experienced vertigo. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and fatigue on 22-MAR-2021, and pain on 21-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210417746.; Sender's Comments: V0:- Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL ADMINISTRATION OF VACCINE; This spontaneous report received from a pharmacist 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: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced partial administration of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial administration of vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: NUMB SKIN; KICKING BUTT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced kicking butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of kicking butt was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: MIGRAINE LIKE HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine like headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine like headache, and fever. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: VOMITING; CHILLS; This spontaneous report received from a parent concerned a 19 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: 205A21A, 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 vomiting. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and chills. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Fatigue, Fear, Feeling abnormal
Clinical narrative: HUNGRY; VERY ANXIOUS; FEELING UNSAFE TO WALK BY HERSELF; FEELING TRAPPED; BAD HEADACHE; FEELING TIRED; SORE ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bipolar, no alcohol use, cigarette smoker and too stressed to take care of herself. The patient experienced drug abuse when treated with metamfetamine, and drug allergy when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for bipolar disorder. On 02-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced very anxious. On 08-APR-2021, the subject experienced feeling unsafe to walk by herself. On 08-APR-2021, the subject experienced feeling trapped. On 08-APR-2021, the subject experienced bad headache. On 08-APR-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced hungry. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very anxious, and feeling unsafe to walk by herself on 09-APR-2021, and feeling trapped, and sore arm on APR-2021, and was recovering from feeling tired, bad headache, and hungry. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hunger, Pain in extremity
Clinical narrative: HUNGRY; VERY ANXIOUS; FEELING UNSAFE TO WALK BY HERSELF; FEELING TRAPPED; BAD HEADACHE; FEELING TIRED; SORE ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bipolar, no alcohol use, cigarette smoker and too stressed to take care of herself. The patient experienced drug abuse when treated with metamfetamine, and drug allergy when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for bipolar disorder. On 02-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced very anxious. On 08-APR-2021, the subject experienced feeling unsafe to walk by herself. On 08-APR-2021, the subject experienced feeling trapped. On 08-APR-2021, the subject experienced bad headache. On 08-APR-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced hungry. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very anxious, and feeling unsafe to walk by herself on 09-APR-2021, and feeling trapped, and sore arm on APR-2021, and was recovering from feeling tired, bad headache, and hungry. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: NEW FOOD ALLERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the subject experienced new food allergy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of new food allergy was not reported. This report was non-serious.