chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Muscle tightness, Nausea, Pyrexia, Tremor
Clinical narrative: HEADACHE; SHORTNESS OF BREATH; NAUSEOUS; MUSCLE TENSE; SEVERE MIGRAINES; SWEATING; SHAKING; CHILLS; ELEVATED HEART RATE; FEVER; This spontaneous report received from a patient concerned a 25 year old male. The patient's weight was 200 pounds, and height was 66 inches. The patient's past medical history included childhood asthma, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known vaccine, food or drug allergies and no history of drug abuse. the patient had no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced elevated heart rate. On 19-MAR-2021, the subject experienced sweating. On 19-MAR-2021, the subject experienced shaking. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:00, the subject experienced severe migraines. On 20-MAR-2021, the subject experienced muscle tense. On 20-MAR-2021, the subject experienced nauseous. On 20-MAR-2021 02:00, the subject experienced shortness of breath. On 20-MAR-2021 07:00, the subject experienced headache.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate, severe migraines, sweating, shaking, chills, headache, nauseous, and fever on 20-MAR-2021, was recovering from muscle tense, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V2: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Pyrexia, Somnolence
Clinical narrative: ADVERSE DRUG REACTION; FELT THE NEED TO SLEEP; CHILLS; LOW FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the subject experienced adverse drug reaction. On 30-MAR-2021, the subject experienced felt the need to sleep. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse drug reaction, chills, low fever and felt the need to sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heavy menstrual bleeding, Menstrual disorder, Polymenorrhoea
Clinical narrative: HEAVY BLEEDING WATERY BROWN DISCHARGE; HEAVY BLEEDING WATERY BROWN DISCHARGE; PERIOD IS NOT EXPECTED TILL ANOTHER 2 WEEK; SKIN FEELS HOT TO THE TOUCH; CHILLS; HEAD IS CONSTANTLY HURTING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient did not have any medical history, patient had no known allergies, patient did not have any drug abuse/illicit drug use, patient has regular periods. 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 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 03-APR-2021 03:00, the subject experienced heavy bleeding watery brown discharge. On 03-APR-2021 03:00, the subject experienced heavy bleeding watery brown discharge. On 03-APR-2021 03:00, the subject experienced period is not expected till another 2 week. On 03-APR-2021 03:00, the subject experienced skin feels hot to the touch. On 03-APR-2021 03:00, the subject experienced chills. On 03-APR-2021 03:00, the subject experienced head is constantly hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and the outcome of skin feels hot to the touch, head is constantly hurting, heavy bleeding watery brown discharge, period is not expected till another 2 week and heavy bleeding watery brown discharge was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: HEAVY BLEEDING WATERY BROWN DISCHARGE; HEAVY BLEEDING WATERY BROWN DISCHARGE; PERIOD IS NOT EXPECTED TILL ANOTHER 2 WEEK; SKIN FEELS HOT TO THE TOUCH; CHILLS; HEAD IS CONSTANTLY HURTING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient did not have any medical history, patient had no known allergies, patient did not have any drug abuse/illicit drug use, patient has regular periods. 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 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 03-APR-2021 03:00, the subject experienced heavy bleeding watery brown discharge. On 03-APR-2021 03:00, the subject experienced heavy bleeding watery brown discharge. On 03-APR-2021 03:00, the subject experienced period is not expected till another 2 week. On 03-APR-2021 03:00, the subject experienced skin feels hot to the touch. On 03-APR-2021 03:00, the subject experienced chills. On 03-APR-2021 03:00, the subject experienced head is constantly hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and the outcome of skin feels hot to the touch, head is constantly hurting, heavy bleeding watery brown discharge, period is not expected till another 2 week and heavy bleeding watery brown discharge was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Headache, Hypokinesia, Muscle spasms
Clinical narrative: UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included ptsd, and concurrent conditions included osteoporosis, gluten allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: cannabidiol, and paracetamol. On 17-MAR-2021, the subject experienced unable to lift with left arm. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced muscle spasm. On 17-MAR-2021, the subject experienced difficulty concentrating. On 17-MAR-2021, the subject experienced severe left arm pain. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Described pain 12/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, and headache on 26-MAR-2021, was recovering from body aches, muscle spasm, and difficulty concentrating, had not recovered from severe left arm pain, and the outcome of unable to lift with left arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Pain in extremity, Pyrexia
Clinical narrative: UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included ptsd, and concurrent conditions included osteoporosis, gluten allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: cannabidiol, and paracetamol. On 17-MAR-2021, the subject experienced unable to lift with left arm. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced muscle spasm. On 17-MAR-2021, the subject experienced difficulty concentrating. On 17-MAR-2021, the subject experienced severe left arm pain. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Described pain 12/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, and headache on 26-MAR-2021, was recovering from body aches, muscle spasm, and difficulty concentrating, had not recovered from severe left arm pain, and the outcome of unable to lift with left arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Fatigue, Feeling abnormal
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; BRAIN FOG; JOINT PAIN; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 56 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced brain fog. On 23-MAR-2021, the subject experienced joint pain. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced pain at injection site. On 23-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced muscle aches. On 28-MAR-2021, the subject experienced loss of smell. On 28-MAR-2021, the subject experienced loss of taste. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, pain at injection site, fatigue, and muscle aches on 25-MAR-2021, and fever, and had not recovered from joint pain, loss of taste, loss of smell, and brain fog. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; BRAIN FOG; JOINT PAIN; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 56 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced brain fog. On 23-MAR-2021, the subject experienced joint pain. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced pain at injection site. On 23-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced muscle aches. On 28-MAR-2021, the subject experienced loss of smell. On 28-MAR-2021, the subject experienced loss of taste. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, pain at injection site, fatigue, and muscle aches on 25-MAR-2021, and fever, and had not recovered from joint pain, loss of taste, loss of smell, and brain fog. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: PATIENT RECEIVED JANSSEN VACCINE  BUT IT WAS LATER DISCOVERED HE  HAD ALREADY RECEIVED MODERNA  VACCINE; This spontaneous report received from a physician concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced additional vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of additional vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Myalgia, Polymerase chain reaction
Clinical narrative: HIGH PULSE RATE; CHEST MUSCLE ACHE; THROWING UP; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bactrim allergy. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, Laboratory data included: Polymerase chain reaction (NR: not provided) Negative. On 05-APR-2021, the subject experienced high pulse rate. On 05-APR-2021, the subject experienced chest muscle ache. On 05-APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F, and Pulse rate (NR: not provided) 120 beats per minute (bpm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, high pulse rate, throwing up, and chest muscle ache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: HIGH PULSE RATE; CHEST MUSCLE ACHE; THROWING UP; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bactrim allergy. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, Laboratory data included: Polymerase chain reaction (NR: not provided) Negative. On 05-APR-2021, the subject experienced high pulse rate. On 05-APR-2021, the subject experienced chest muscle ache. On 05-APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F, and Pulse rate (NR: not provided) 120 beats per minute (bpm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, high pulse rate, throwing up, and chest muscle ache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Exposure during pregnancy
Clinical narrative: DRUG EXPOSURE DURING PREGNANCY; PAIN IN LEFT EAR, THROBBING AND POUNDING IN EAR; This spontaneous pregnancy report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient was gravida 1, para 0.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A421, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in left ear, throbbing and pounding in ear. On 04-APR-2021, the subject experienced drug exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug exposure during pregnancy and pain in left ear, throbbing and pounding in ear was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling jittery, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: HEART PALPATIONS (FELT LIKE HEART WAS GOING TO BURST); FEELING JITTERY; POSSIBLE SWEATING; CHILLS; FEVER; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On AUG-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the subject experienced heart palpations (felt like heart was going to burst), feeling jittery, possible sweating, chills, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpations (felt like heart was going to burst), possible sweating, chills, and fever, and had not recovered from feeling jittery. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: HEART PALPATIONS (FELT LIKE HEART WAS GOING TO BURST); FEELING JITTERY; POSSIBLE SWEATING; CHILLS; FEVER; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On AUG-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the subject experienced heart palpations (felt like heart was going to burst), feeling jittery, possible sweating, chills, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpations (felt like heart was going to burst), possible sweating, chills, and fever, and had not recovered from feeling jittery. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pyrexia
Clinical narrative: FEELING COLD; HIGH FEVER/ SWEATING FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced high fever/ sweating fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever/ sweating fever, and the outcome of feeling cold was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM STILL HURTING; 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: 1805025 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced arm still hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurting. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Palpitations, Pyrexia
Clinical narrative: AWAKE ALL NIGHT; EXTREME HEART PALPITATION / RAPID HEART RATE; FEVER 102; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The batch number was not reported and has been requested. The patient's concurrent conditions included corn allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021 18:00, the subject experienced fever 102. On an unspecified date, the subject experienced insomnia, and extreme heart palpitation / rapid heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102, insomnia and extreme heart palpitation / rapid heart rate was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-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 chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea
Clinical narrative: DIZZINESS; CHILLS; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 dizziness, chills, fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, nausea, dizziness and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: INJECTION SITE REDNESS; PAIN IN THE INJECTION SITE; TIREDNESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 04-APR-2021 on unspecified anatomical site for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 04-APR-2021, the subject experienced injection site redness. On 04-APR-2021, the subject experienced pain in the injection site. On 04-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the injection site, injection site redness and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: SWEATING; COLD; LOSS OF TASTE; FATIGUE; POSSIBLE FEVER; HEADACHE; RAPID HEARTBEAT; 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 18:00-19:00, the subject experienced rapid heartbeat. On 06-APR-2021 08:30, the subject experienced headache. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced loss of taste. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced possible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, and headache on 07-APR-2021, and sweating, cold, loss of taste, and fatigue on 08-APR-2021, and the outcome of possible fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: SWEATING; COLD; LOSS OF TASTE; FATIGUE; POSSIBLE FEVER; HEADACHE; RAPID HEARTBEAT; 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 18:00-19:00, the subject experienced rapid heartbeat. On 06-APR-2021 08:30, the subject experienced headache. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced loss of taste. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced possible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, and headache on 07-APR-2021, and sweating, cold, loss of taste, and fatigue on 08-APR-2021, and the outcome of possible fever was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Feeling of body temperature change, Headache
Clinical narrative: NECK AND JAW ACHING; LEFT ARM ACHE; HEADACHE; DIARRHEA; FEELING HOT AND COLD FEVER; TINGLING FINGERS; JOINT ACHES; CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 175 pounds, and height was 60 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no know allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced feeling hot and cold fever. On 07-APR-2021, the subject experienced tingling fingers. On 07-APR-2021, the subject experienced joint aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021 17:00, the subject experienced left arm ache. On 07-APR-2021 17:00, the subject experienced headache. On 07-APR-2021 21:00, the subject experienced neck and jaw aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, neck and jaw aching, and tingling fingers on 08-APR-2021, was recovering from left arm ache, and had not recovered from headache, joint aches, chills, and feeling hot and cold fever. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: NECK AND JAW ACHING; LEFT ARM ACHE; HEADACHE; DIARRHEA; FEELING HOT AND COLD FEVER; TINGLING FINGERS; JOINT ACHES; CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 175 pounds, and height was 60 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no know allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced feeling hot and cold fever. On 07-APR-2021, the subject experienced tingling fingers. On 07-APR-2021, the subject experienced joint aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021 17:00, the subject experienced left arm ache. On 07-APR-2021 17:00, the subject experienced headache. On 07-APR-2021 21:00, the subject experienced neck and jaw aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, neck and jaw aching, and tingling fingers on 08-APR-2021, was recovering from left arm ache, and had not recovered from headache, joint aches, chills, and feeling hot and cold fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: EXPIRED VACCINE USED; INCORRECT STORAGE OF VIAL; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 08-APR-2021, the subject experienced expired vaccine used. On 08-APR-2021, the subject experienced incorrect storage of vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and incorrect storage of vial was not reported. This report was non-serious. This case is a duplicate of 20210416048 and 20210416868.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pain, Pyrexia
Clinical narrative: FEELING COLD; BODY ACHES; FEVER ABOVE 100 F; This spontaneous report received from a consumer concerned a 27 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medical history and no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced feeling cold. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced fever above 100 f. Laboratory data included: Body temperature (NR: not provided) above 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever above 100 f, feeling cold, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: ARMS HURT SO MUCH THAT JUST A SLIGHT MOVEMENT SENDS SEARING PAIN UP IN ARMS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 arms hurt so much that just a slight movement sends searing pain up in arms, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and arms hurt so much that just a slight movement sends searing pain up in arms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413906.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Injection site pain
Clinical narrative: ARMPIT PAIN; INJECTION SITE PAIN; TIREDNESS; 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, the batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers, expiry date: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain, armpit pain and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Injury, Joint stiffness
Clinical narrative: INJURIES IN DIFFERENT PART OF BODY; CRAB FINGERS; JOINT PAIN  IN HANDS, KNEES, WRIST AND FINGERS; NAUSEA; JOINT STIFFNESS IN ANKLES, KNEES, WRIST AND FINGERS; SINUS HEADACHE; SLIGHT CHILLS; FEVER OF 100.1F; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported.  The patient's past medical history included dental work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sinus headache. On 07-APR-2021, the subject experienced slight chills. On 07-APR-2021, the subject experienced fever of 100.1f. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 08-APR-2021, the subject experienced joint stiffness in ankles, knees, wrist and fingers. On 08-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced injuries in different part of body, crab fingers, and joint pain in hands, knees, wrist and fingers.  Treatment medications (dates unspecified) included: paracetamol, acetylsalicylic acid, tramadol, and fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus headache on 08-APR-2021, was recovering from fever of 100.1f, had not recovered from slight chills, nausea, and joint pain in hands, knees, wrist and fingers, and the outcome of joint stiffness in ankles, knees, wrist and fingers, injuries in different part of body and crab fingers was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, Sinus headache
Clinical narrative: INJURIES IN DIFFERENT PART OF BODY; CRAB FINGERS; JOINT PAIN  IN HANDS, KNEES, WRIST AND FINGERS; NAUSEA; JOINT STIFFNESS IN ANKLES, KNEES, WRIST AND FINGERS; SINUS HEADACHE; SLIGHT CHILLS; FEVER OF 100.1F; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported.  The patient's past medical history included dental work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sinus headache. On 07-APR-2021, the subject experienced slight chills. On 07-APR-2021, the subject experienced fever of 100.1f. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 08-APR-2021, the subject experienced joint stiffness in ankles, knees, wrist and fingers. On 08-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced injuries in different part of body, crab fingers, and joint pain in hands, knees, wrist and fingers.  Treatment medications (dates unspecified) included: paracetamol, acetylsalicylic acid, tramadol, and fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus headache on 08-APR-2021, was recovering from fever of 100.1f, had not recovered from slight chills, nausea, and joint pain in hands, knees, wrist and fingers, and the outcome of joint stiffness in ankles, knees, wrist and fingers, injuries in different part of body and crab fingers was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included significant seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced aches. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches on 07-APR-2021, and chills, and fever on APR-2021. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: INTENSE DIARRHEA; This spontaneous report received from a patient concerned a 78 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: 638H8, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced intense diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense diarrhea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 36 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 and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and headache on 08-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: ARM HOT FOR ABOUT 2 SECONDS; ARM HURTS,SORENESS OF ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced arm hot for about 2 seconds. On 07-APR-2021, the subject experienced arm hurts, soreness of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hot for about 2 seconds on 07-APR-2021, and was recovering from arm hurts, soreness of arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; 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 ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever and chills was not reported. This report was non-serious.