chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Pain, Therapeutic response unexpected, Vomiting
Clinical narrative: MORE ANXIETY; OVERALL PHYSICALLY AND MENTALLY IMPROVEMENT; HEADACHE; BODY ACHE; VOMITING; This spontaneous report received from a parent via a company representative concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and hormonal monthly symptoms.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. 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 body ache, vomiting, more anxiety, overall physically and mentally improvement, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, vomiting, and headache, and the outcome of more anxiety and overall physically and mentally improvement was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; GENERAL FATIGUE; 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 and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced joint pain. On 03-MAY-2021, the subject experienced fever. On 03-MAY-2021, the subject experienced general fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, joint pain, and general fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Flushing, Pyrexia
Clinical narrative: HIGH SUGAR LEVELS POST VACCINATION; FLUSH FEELING ON FACE; FELT LIKE FEVERISH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included 5 blood clots, and concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known allergies and taking lit of anticoagulants for type ii diabetes mellitus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 2058A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included gliclazide for type 2 diabetes, metformin for type 2 diabetes, atorvastatin calcium, and metoprolol. On 03-MAY-2021, the subject experienced high sugar levels post vaccination. On 03-MAY-2021, the subject experienced flush feeling on face. On 03-MAY-2021, the subject experienced felt like feverish. Laboratory data included: Blood sugar increased (NR: not provided) Quite high. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from high sugar levels post vaccination, and the outcome of felt like feverish and flush feeling on face was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea, Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; SHORTNESS OF BREATH; CONSTANT HEADACHES; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of administration 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 APR-2021, the subject experienced urinary tract infection. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced constant headaches. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from constant headaches, nausea, shortness of breath, and urinary tract infection. This report as non-serious. This case, from the same reporter is linked to 20210505784.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Pain, Pain in extremity
Clinical narrative: PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non-alcoholic, and drug allergy, and other pre-existing medical conditions included patient had no significant medical history. 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 03-MAY-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced difficulty sleeping. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, Laboratory data included: Heart rate (NR: not provided) 105-120 bpm, 110 bpm. On 04-MAY-2021 02:00, the subject experienced elevated heart rate. On 04-MAY-2021 02:30, treatment medications included: paracetamol. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on MAY-2021, was recovering from body aches, had not recovered from elevated heart rate, and the outcome of fever and pain in arm was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non-alcoholic, and drug allergy, and other pre-existing medical conditions included patient had no significant medical history. 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 03-MAY-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced difficulty sleeping. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, Laboratory data included: Heart rate (NR: not provided) 105-120 bpm, 110 bpm. On 04-MAY-2021 02:00, the subject experienced elevated heart rate. On 04-MAY-2021 02:30, treatment medications included: paracetamol. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on MAY-2021, was recovering from body aches, had not recovered from elevated heart rate, and the outcome of fever and pain in arm was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: FEVERISH AND FEVER LIKE SYMPTOMS; SHAKING; SWEATING; FELT COLD; POUNDING HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included prothrombin gene mutation - increased risk for blood clot (predisposition), amoxicillin allergy, occasional alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) .5 ml, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced feverish and fever like symptoms. On 03-MAY-2021, the subject experienced shaking. On 03-MAY-2021, the subject experienced sweating. On 03-MAY-2021, the subject experienced felt cold. On 03-MAY-2021, the subject experienced pounding headache. On 03-MAY-2021, the subject experienced felt tired. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish and fever like symptoms, shaking, sweating, felt cold, pounding headache, and felt tired on 04-MAY-2021. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FEVERISH AND FEVER LIKE SYMPTOMS; SHAKING; SWEATING; FELT COLD; POUNDING HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included prothrombin gene mutation - increased risk for blood clot (predisposition), amoxicillin allergy, occasional alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) .5 ml, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced feverish and fever like symptoms. On 03-MAY-2021, the subject experienced shaking. On 03-MAY-2021, the subject experienced sweating. On 03-MAY-2021, the subject experienced felt cold. On 03-MAY-2021, the subject experienced pounding headache. On 03-MAY-2021, the subject experienced felt tired. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish and fever like symptoms, shaking, sweating, felt cold, pounding headache, and felt tired on 04-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: TEMPORARY REACTION; 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. No concomitant medications were reported. On an unspecified date, the subject experienced temporary reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporary reaction. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; 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 not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-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 an unspecified date, the subject experienced body aches, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills and headache was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body ache. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, chills, headache, body ache and nausea was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Breast mass, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: KNOT ON THE BREAST; MOOD SHIFTING; HEART RACING; FELT SICK; VARICOSE VEINS AGGRAVATED; SLUGGISH; FELT HOT; SWEATING; DIZZY; SORENESS IN EXTREMITIES; HEAVINESS IN EXTREMITIES; COLLAR BONE PAIN; 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 varicose veins, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. breast cancer runs heavy in the family. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced collar bone pain. On 01-APR-2021, the subject experienced soreness in extremities. On 01-APR-2021, the subject experienced heaviness in extremities. On 02-APR-2021, the subject experienced varicose veins aggravated. On 02-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced felt hot. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced felt sick. On 03-APR-2021, the subject experienced heart racing. On 17-APR-2021, the subject experienced mood shifting. On 03-MAY-2021, the subject experienced knot on the breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, sweating, dizzy, and heart racing on 2021, was recovering from sluggish, and varicose veins aggravated, had not recovered from soreness in extremities, knot on the breast, and heaviness in extremities, and the outcome of mood shifting, collar bone pain and felt sick was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Mood altered, Pain in extremity, Palpitations
Clinical narrative: KNOT ON THE BREAST; MOOD SHIFTING; HEART RACING; FELT SICK; VARICOSE VEINS AGGRAVATED; SLUGGISH; FELT HOT; SWEATING; DIZZY; SORENESS IN EXTREMITIES; HEAVINESS IN EXTREMITIES; COLLAR BONE PAIN; 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 varicose veins, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. breast cancer runs heavy in the family. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced collar bone pain. On 01-APR-2021, the subject experienced soreness in extremities. On 01-APR-2021, the subject experienced heaviness in extremities. On 02-APR-2021, the subject experienced varicose veins aggravated. On 02-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced felt hot. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced felt sick. On 03-APR-2021, the subject experienced heart racing. On 17-APR-2021, the subject experienced mood shifting. On 03-MAY-2021, the subject experienced knot on the breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, sweating, dizzy, and heart racing on 2021, was recovering from sluggish, and varicose veins aggravated, had not recovered from soreness in extremities, knot on the breast, and heaviness in extremities, and the outcome of mood shifting, collar bone pain and felt sick was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Varicose vein
Clinical narrative: KNOT ON THE BREAST; MOOD SHIFTING; HEART RACING; FELT SICK; VARICOSE VEINS AGGRAVATED; SLUGGISH; FELT HOT; SWEATING; DIZZY; SORENESS IN EXTREMITIES; HEAVINESS IN EXTREMITIES; COLLAR BONE PAIN; 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 varicose veins, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. breast cancer runs heavy in the family. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced collar bone pain. On 01-APR-2021, the subject experienced soreness in extremities. On 01-APR-2021, the subject experienced heaviness in extremities. On 02-APR-2021, the subject experienced varicose veins aggravated. On 02-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced felt hot. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced felt sick. On 03-APR-2021, the subject experienced heart racing. On 17-APR-2021, the subject experienced mood shifting. On 03-MAY-2021, the subject experienced knot on the breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, sweating, dizzy, and heart racing on 2021, was recovering from sluggish, and varicose veins aggravated, had not recovered from soreness in extremities, knot on the breast, and heaviness in extremities, and the outcome of mood shifting, collar bone pain and felt sick was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: COULD NOT SLEEP AS TOSSING AND TURNING ALL NIGHT; BODY ACHES; BODY SHAKING; CHILLS AND SHIVERING; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 33 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 16:10 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021 23:30, the subject experienced could not sleep as tossing and turning all night. On 03-MAY-2021 23:30, the subject experienced body aches. On 03-MAY-2021 23:30, the subject experienced body shaking. On 03-MAY-2021 23:30, the subject experienced chills and shivering. On 03-MAY-2021 23:30, the subject experienced headache. On 03-MAY-2021 23:30, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep as tossing and turning all night, body shaking, and chills and shivering on 04-MAY-2021, and had not recovered from fever, body aches, and headache. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: COULD NOT SLEEP AS TOSSING AND TURNING ALL NIGHT; BODY ACHES; BODY SHAKING; CHILLS AND SHIVERING; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 33 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 16:10 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021 23:30, the subject experienced could not sleep as tossing and turning all night. On 03-MAY-2021 23:30, the subject experienced body aches. On 03-MAY-2021 23:30, the subject experienced body shaking. On 03-MAY-2021 23:30, the subject experienced chills and shivering. On 03-MAY-2021 23:30, the subject experienced headache. On 03-MAY-2021 23:30, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep as tossing and turning all night, body shaking, and chills and shivering on 04-MAY-2021, and had not recovered from fever, body aches, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEAD HURT; LITTLE FEVER; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced head hurt, and little fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head hurt, and little fever. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: MEDICATION ERROR; PATIENT RECEIVED VACCINE OUT OF  THE RECOMMENDED TEMPERATURE  RANGE; This spontaneous report received from a pharmacist concerned a 22 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: 1808978 and  expiry: 13-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced medication error. On 03-MAY-2021, the subject experienced subject received vaccine out of the recommended temperature range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and patient received vaccine out of the recommended temperature range was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: COUGH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-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 APR-2021, the subject experienced cough. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Sensory disturbance
Clinical narrative: DIFFICULTY BREATHING; FELT LIKE KNIVES IN LUNGS.; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included lung problems.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 2021 for covid-19 vaccination. Concomitant medications included risankizumab for chronic plaque psoriasis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced felt like knives in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty breathing and felt like knives in lungs. was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Muscle spasms, Musculoskeletal chest pain, Pain
Clinical narrative: SEVERE BODY ACHES ON LEFT SIDE; MUSCLE SPASMS ON LEFT SIDE LEG EYE ARM AND CRAMPING ON RIGHT SIDE; PRESSURE BEHIND LEFT EYE; CRAMPING AND RIB PAIN ON RIGHT SIDE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underline health problems. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced pressure behind left eye. On 2021, the subject experienced cramping and rib pain on right side. On 30-APR-2021, the subject experienced severe body aches on left side. On 30-APR-2021, the subject experienced muscle spasms on left side leg eye arm and cramping on right side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from severe body aches on left side, muscle spasms on left side leg eye arm and cramping on right side, pressure behind left eye, and cramping and rib pain on right side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE FEELING AT INJECTED SITE; This spontaneous report received via social media 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  (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 sore feeling at injected site. The action taken with covid-19 vaccine  was not applicable. The outcome of sore feeling at injected site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210506606.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent 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  (suspension for injection, route of administration 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 suspected covid-19 infection. The action taken with covid-19 vaccine  was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: A LITTLE CHILLS; TIRED; This spontaneous report received from a patient via a social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (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 a little chills, and tired. The action taken with covid-19 vaccine  was not applicable. The outcome of the a little chills and tired was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 48 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, intramuscular, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. 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 2021, the subject experienced chills. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test, Uveitis, White blood cell count
Clinical narrative: UVEITIS/IRITIS; SORE ARM; TIRED; This spontaneous report was received from a 58-year-old, White, not Hispanic/Latino female patient. 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 administration was not reported, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered at approximately 10:00 on left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  After vaccination, the patient waited to 30 minutes and nothing happened. On 06-MAR-2021, the patient was tired and her arm was a little sore. On 08-MAR-2021, the patient recovered from the arm soreness and tiredness and was fine. On 22-MAR-2021, the patient woke up with blood in the left eye, her vision was deteriorating and had foggy vision. The patient visited an ophthalmologist 3 times after which she started treatment with prednisone acetate, Cyclogyl (cyclopentolate hydrochloride), and Prolensa (bromfenac sodium) (dates unspecified). Later, on 05-APR-2021, the patient went to the retinal specialist who was unsure when the patient's vision would return and thought the diagnosis was uveitis/iritis. The patient's doctor thought that the patient got the shot and then her immune system kicked and was fighting the shot or the coronavirus disease (COVID-19). The patient was tested negative for COVID-19 two times and her and her white blood cell (WBC) count was "through the roof" (result unspecified) (test dates unspecified). It was reported that the patient would be seeing a specialist regarding the diagnosis of uveitis/iritis on 25-JUN-2021 The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and tired on 08-MAR-2021, and had not recovered from uveitis/iritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210507327-covid-19 vaccine ad26.cov2.-Uveitis. 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: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VIAL WAS PUNCTURED AND LEFT OUTSIDE OF THE FRIDGE FOR MORE THAN 2 HOURS; ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vial was punctured and left outside of the fridge for more than 2 hours, and administration error. The action taken with covid-19 vaccine  was not applicable. The outcome of the vial was punctured and left outside of the fridge for more than 2 hours and administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210506594 and 20210507453.
Sex: U
Vaccine: COVID19
Symptoms: Facial pain, Paraesthesia
Clinical narrative: PAIN IN SIDE OF FACE; TINGLING; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in side of face, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in side of face and tingling was not reported. This report was non-serious.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: OVERWHELMING METAL TASTE IN MOUTH; This spontaneous report received from a patient concerned a 40 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: 207AZ1A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced overwhelming metal taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overwhelming metal taste in mouth. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Injection site pain
Clinical narrative: NOSE BLEEDS; PAIN AT SITE OF INJECTION; SHARP PAIN IN THE HEAD/HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 0428218, and expiry: unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at site of injection. On APR-2021, the subject experienced sharp pain in the head. On 21-APR-2021, the subject experienced nose bleeds. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain at site of injection on 2021, and had not recovered from nose bleeds, and sharp pain in the head. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: HEART RATE INCREASED; 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  (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 heart rate increased. The action taken with covid-19 vaccine  was not applicable. The outcome of heart rate increased was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: FEW LITTLE PAIN IN ARM; 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  (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 few little pain in arm. The action taken with covid-19 vaccine  was not applicable. The outcome of few little pain in arm was not reported. This report was non-serious. This case was linked to 20210503720 as reported by the same reporter.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Paranasal sinus discomfort, Pyrexia
Clinical narrative: UPSET STOMACH ON AND OFF; SLIGHT SINUS HEADACHE; SOME PRESSURE IN SINUS CAVITY; CHILLS; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced upset stomach on and off. On 05-MAY-2021, the subject experienced slight sinus headache. On 05-MAY-2021, the subject experienced some pressure in sinus cavity. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.1 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills on MAY-2021, and the outcome of upset stomach on and off, fever, slight sinus headache and some pressure in sinus cavity was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: UPSET STOMACH ON AND OFF; SLIGHT SINUS HEADACHE; SOME PRESSURE IN SINUS CAVITY; CHILLS; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced upset stomach on and off. On 05-MAY-2021, the subject experienced slight sinus headache. On 05-MAY-2021, the subject experienced some pressure in sinus cavity. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.1 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills on MAY-2021, and the outcome of upset stomach on and off, fever, slight sinus headache and some pressure in sinus cavity was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Headache, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING SENSATION; PAIN IN ONE LEG; HEADACHE ON AND OFF; BRUISING; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 04-MAY-2021, the subject experienced bruising. On an unspecified date, the subject experienced tingling sensation, pain in one leg, and headache on and off. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache on and off, pain in one leg, tingling sensation and bruising was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: SEVERE BACK PAIN; This spontaneous report received from a consumer concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-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 2021, the subject experienced severe back pain. The action taken with covid-19 vaccine was not applicable. The outcome of severe back pain was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Laboratory test
Clinical narrative: RIGHT ARM PAIN AROUND INJECTION SITE (PAIN LEVEL 8); This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included pacemaker stent in right artery, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, Laboratory data included: Laboratory test (NR: not provided) unknown. On 27-MAR-2021, the subject experienced right arm pain around injection site (pain level 8). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from r arm pain around injection site (pain level 8). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Vaginal haemorrhage
Clinical narrative: VAGINA BLEEDING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibroids, penicillin allergic, smoker, post-menopause, and anal cancer. The patient received covid-19 vaccine  (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 28-APR-2021, the subject experienced vagina bleeding. Laboratory data (dates unspecified) included: Complete blood count (NR: not provided) Unspecified. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from vagina bleeding. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error, Underdose
Clinical narrative: MUCH OF THE FLUID LEAKED OUT OF ARM; INCORRECT ADMINISTRATION; INCOMPLETE ADMINISTRATION; This spontaneous report received from a health care professional via a company representative concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast cell activation syndrome, fibromyalgia, gastroparesis, and seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced much of the fluid leaked out of arm. On 17-MAR-2021, the subject experienced incorrect administration. On 17-MAR-2021, the subject experienced incomplete administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the much of the fluid leaked out of arm, incorrect administration and incomplete administration was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: RIGHT SHOULDER BLADE PAIN WHICH SPREAD TO NECK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205a21a, expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced right shoulder blade pain which spread to neck. The action taken with covid-19 vaccine  was not applicable. The patient recovered from right shoulder blade pain which spread to neck on 05-MAY-2021. This report was non-serious.