chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 13 months ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 13 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the first dose of the Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reported VARES details pertains to 1st dose.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered dose three; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B244, expiry date 20th March 2023) and (batch number 5P9DR, expiry date 20th March 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX) and ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 12th October 2021, the patient received the 3rd dose of Shingrix. On 12th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: On 22nd May 2021, the patient received 1st dose of Shingrix, vial one lot number PN2L, expiration date 7th November 2022 and vial two lot number 7P934, expiration date 7th November 2022. On 22nd July 2021, the patient received 2nd dose of Shingrix, vial one lot number FS(or 5)TT2, expiration date 4th February 2023 and vial two lot number Z9AD5, expiration date 4th February 2023. The patient came in requesting second dose of Shingrix vaccine, stating she had only received one dose of Shingrix previously.  The pharmacist administered a dose on 12th October 2021, but then discovered in the computer system that the patient had already 2 doses previously, which led to extra dose administered. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose which expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HAV (Havrix) (batch number 3hr79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was medical assistant and stated that, a dose of Havrix which expired on 16th September 2021 was administered the day before reporting day, which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Pain
Clinical narrative: CHILLS; BODY ACHE; FATIGUE; HEADACHE; WELTS ON LEFT ARM; SMALL COUGH; RASH ON LEFT ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no known allergies and no 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, batch number: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced small cough. On OCT-2021, the patient experienced rash on left arm. On OCT-2021, the patient experienced welts on left arm. On 07-OCT-2021, the patient experienced fatigue. On 07-OCT-2021, the patient experienced headache. On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, small cough, chills, fatigue, headache, and welts on left arm on OCT-2021, and had not recovered from rash on left arm. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: CHILLS; BODY ACHE; FATIGUE; HEADACHE; WELTS ON LEFT ARM; SMALL COUGH; RASH ON LEFT ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no known allergies and no 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, batch number: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced small cough. On OCT-2021, the patient experienced rash on left arm. On OCT-2021, the patient experienced welts on left arm. On 07-OCT-2021, the patient experienced fatigue. On 07-OCT-2021, the patient experienced headache. On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, small cough, chills, fatigue, headache, and welts on left arm on OCT-2021, and had not recovered from rash on left arm. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Bladder pain, Chest pain, Diplopia
Clinical narrative: DOUBLE VISION; LEG SWELLING; ABDOMINAL PAIN; BACK OF TONGUE SWOLLEN; BLADDER PAIN GOT WORSE; VISION GETTING WORSE; LITERALLY DYING; PAINFUL LEG; FEELS WEAK; CHEST PAIN GETTING WORSE; MIGRAINES; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known allergies and drug abuse or illicit drug usage. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced migraines. On an unspecified date, the patient experienced chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, vision getting worse, painful leg, feels weak, and literally dying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, migraines, feels weak, vision getting worse, painful leg, and literally dying. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Pain in extremity, Peripheral swelling, Tongue oedema
Clinical narrative: DOUBLE VISION; LEG SWELLING; ABDOMINAL PAIN; BACK OF TONGUE SWOLLEN; BLADDER PAIN GOT WORSE; VISION GETTING WORSE; LITERALLY DYING; PAINFUL LEG; FEELS WEAK; CHEST PAIN GETTING WORSE; MIGRAINES; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known allergies and drug abuse or illicit drug usage. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced migraines. On an unspecified date, the patient experienced chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, vision getting worse, painful leg, feels weak, and literally dying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, migraines, feels weak, vision getting worse, painful leg, and literally dying. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: DOUBLE VISION; LEG SWELLING; ABDOMINAL PAIN; BACK OF TONGUE SWOLLEN; BLADDER PAIN GOT WORSE; VISION GETTING WORSE; LITERALLY DYING; PAINFUL LEG; FEELS WEAK; CHEST PAIN GETTING WORSE; MIGRAINES; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known allergies and drug abuse or illicit drug usage. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced migraines. On an unspecified date, the patient experienced chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, vision getting worse, painful leg, feels weak, and literally dying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, migraines, feels weak, vision getting worse, painful leg, and literally dying. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Heart rate, Heart rate increased
Clinical narrative: STOMACH ACHE THAT FELT LIKE CRAMP IN STOMACH; INCREASED HEART RATE; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was 57.7 kilograms, and height was not reported. The patient's concurrent conditions included: secondary pulmonary hypertension. The patient received selexipag (tablet, oral, batch number: 1223186, and batch number: 1223186 expiry: 31-JUL-2022) 800 ug, 2 times every 1 day from 07-SEP-2021 to 07-OCT-2021 for secondary pulmonary hypertension. 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 OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for drug used for unknown indication, and sildenafil citrate for drug used for unknown indication. On OCT-2021, the patient experienced increased heart rate. Laboratory data included: Heart rate (NR: not provided) 102 {beats}/min. On an unspecified date, the patient experienced stomach ache that felt like cramp in stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The patient had not recovered from increased heart rate, and the outcome of stomach ache that felt like cramp in stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Muscular weakness
Clinical narrative: BACK PAIN GOTTEN WORSE; WEAKNESS IN RIGHT ARM; NUMBNESS IN RIGHT ARM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 180 pounds, and height was 63 inches. The patient's concurrent conditions included: back pain, non smoker, and non alcoholic, and other pre-existing medical conditions included: The patient does not have any known allergies. The patient does not have any history of 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: 212A21A, expiry: 21/DEC/2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-OCT-2021, the patient experienced back pain gotten worse. On 12-OCT-2021, the patient experienced weakness in right arm. On 12-OCT-2021, the patient experienced numbness in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in right arm, weakness in right arm, and back pain gotten worse. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: IMMUNE THROMBOCYTOPENIC PURPURA; This spontaneous report received from a pharmacist concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 JUL-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 after the vaccination, the patient was diagnosed with immune thrombocytopenic purpura (ITP) and patient received the courses of Intravenous immune globulin (IVIG) and steroids. The patient recently started on Eltrombopag. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from immune thrombocytopenic purpura. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20211028342-COVID-19 VACCINE AD26.COV2.S-. This event(s) immune thrombocytopenic purpura 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: Dysphagia, Headache, Nausea, Pain, Vomiting
Clinical narrative: CAN'T EAT ANYTHING; BODY IS SORE; NAUSEA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-OCT-2021, the patient experienced can't eat anything. On 14-OCT-2021, the patient experienced body is sore. On 14-OCT-2021, the patient experienced nausea. On 14-OCT-2021, the patient experienced vomiting. On 14-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, can't eat anything, body is sore and headache was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 and expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028561 and 20211029005.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028555.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vertigo
Clinical narrative: VERTIGO; GETTING SHORT OF BREATH; 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: fibromyalgia, bad breathing, peanut allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient had an allergy to whatever is in like medication to lower cholesterol and allergy to NSAIDs. The patient stated that she was very healthy, motivated, hands-on, very energetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate for bad breathing, meloxicam for fibromyalgia, tramadol for fibromyalgia, ascorbic acid, cyanocobalamin, magnesium, and paracetamol. On 21-SEP-2021, the patient experienced vertigo. On 21-SEP-2021, the patient experienced getting short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting short of breath, and vertigo. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028555 and 20211028561.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Pain, Palpitations, Tremor
Clinical narrative: RACING HEART (HEART STUFF WAS AWFUL); HIGH BLOOD PRESSURE; PAIN; UNCONTROLLABLE SHAKING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced racing heart (heart stuff was awful), high blood pressure, pain, and uncontrollable shaking. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart (heart stuff was awful), and high blood pressure, and the outcome of pain and uncontrollable shaking was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous, non-serious report received from a patient. A male, of unspecified age (height, and weight not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown) dose, start therapy date not reported, for immunization. No past medical history or concurrent conditions reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications reported. On an unspecified date, patient experienced a little injection site pain. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of a little injection site pain: not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dyspnoea, Headache
Clinical narrative: STIFFNESS IN THE NECK; DIZZINESS; SHORTNESS OF BREATH; PAIN IN THE NECK; UNABLE TO ROTATE NECK TO THE RIGHT; SEVERE PAIN IN THE RIGHT SHOULDER AND SHOULDER BLADE; SEVERE HEADACHE; OVERALL WEAKNESS; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has had no change in lifestyle to account for effects. 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 16-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-OCT-2021, the patient experienced stiffness in the neck. On 17-OCT-2021, the patient experienced dizziness. On 17-OCT-2021, the patient experienced shortness of breath. On 17-OCT-2021, the patient experienced pain in the neck. On 17-OCT-2021, the patient experienced unable to rotate neck to the right. On 17-OCT-2021, the patient experienced severe pain in the right shoulder and shoulder blade. On 17-OCT-2021, the patient experienced severe headache. On 17-OCT-2021, the patient experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in the right shoulder and shoulder blade, stiffness in the neck, severe headache, dizziness, shortness of breath, overall weakness, pain in the neck, and unable to rotate neck to the right. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Musculoskeletal stiffness, Neck pain
Clinical narrative: STIFFNESS IN THE NECK; DIZZINESS; SHORTNESS OF BREATH; PAIN IN THE NECK; UNABLE TO ROTATE NECK TO THE RIGHT; SEVERE PAIN IN THE RIGHT SHOULDER AND SHOULDER BLADE; SEVERE HEADACHE; OVERALL WEAKNESS; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has had no change in lifestyle to account for effects. 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 16-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-OCT-2021, the patient experienced stiffness in the neck. On 17-OCT-2021, the patient experienced dizziness. On 17-OCT-2021, the patient experienced shortness of breath. On 17-OCT-2021, the patient experienced pain in the neck. On 17-OCT-2021, the patient experienced unable to rotate neck to the right. On 17-OCT-2021, the patient experienced severe pain in the right shoulder and shoulder blade. On 17-OCT-2021, the patient experienced severe headache. On 17-OCT-2021, the patient experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in the right shoulder and shoulder blade, stiffness in the neck, severe headache, dizziness, shortness of breath, overall weakness, pain in the neck, and unable to rotate neck to the right. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Colour vision tests, Stress, Visual impairment
Clinical narrative: VISION IMPAIRED; ANXIETY; STRESS (NORMAL); This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: epstein barr, and other pre-existing medical conditions included: The patient never had COVID but was exposed to COVID twice in the past before received the vaccine. The patient had glasses before. The patient have had underwent through DNA (deoxyribonucleic acid) immunity test and had immunity after the vaccine was reported. The patient was previously treated with guaifenesin for allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced vision impaired, anxiety, and stress (normal). Laboratory data (dates unspecified) included: Color vision tests (NR: not provided) 20/20. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vision impaired, and anxiety, and the outcome of stress (normal) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia
Clinical narrative: INSOMNIA; MINOR MUSCLE SORENESS FROM THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: The patient was mostly in bed by midnight. The patient had 2 monsters drink at 8-9 PM so that might had a little to do with insomnia. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced insomnia, and minor muscle soreness from the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of the insomnia and minor muscle soreness from the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: FATIGUE; NAUSEA; HEADACHE; FEVER; RACING HEART; WEIRD DREAMS; FEEL UNUSUAL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 05-OCT-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 OCT-2021, the patient experienced feel unusual. On 06-OCT-2021, the patient experienced racing heart. On 06-OCT-2021, the patient experienced weird dreams. On 06-OCT-2021, the patient experienced fatigue. On 06-OCT-2021, the patient experienced nausea. On 06-OCT-2021, the patient experienced headache. On 06-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, weird dreams, fatigue, headache, and fever on 13-OCT-2021, and had not recovered from nausea, and feel unusual. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: FATIGUE; NAUSEA; HEADACHE; FEVER; RACING HEART; WEIRD DREAMS; FEEL UNUSUAL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 05-OCT-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 OCT-2021, the patient experienced feel unusual. On 06-OCT-2021, the patient experienced racing heart. On 06-OCT-2021, the patient experienced weird dreams. On 06-OCT-2021, the patient experienced fatigue. On 06-OCT-2021, the patient experienced nausea. On 06-OCT-2021, the patient experienced headache. On 06-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, weird dreams, fatigue, headache, and fever on 13-OCT-2021, and had not recovered from nausea, and feel unusual. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report received from a patient via a company representative concerned an 80 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 patient 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pyrexia, SARS-CoV-2 test
Clinical narrative: SLIGHT FEVER; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: generalized neuropathy, and fatigue syndrome, and other pre-existing medical conditions included: patient had no known allergies and no drug abuse or illicit drug user. The patient was in hospital prior to receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 06-APR-2021, the patient experienced slight fever. Treatment medications included: paracetamol. On 05-AUG-2021, Laboratory data included: Antibody test (NR: not provided) positive for spike. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) natural antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever on 06-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 patient experienced very sick for 12 hours straight, and fever for few hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for 12 hours straight, and fever few hours. This report was non-serious. This case, from the same reporter is linked to 20211032411.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Depression, Influenza like illness
Clinical narrative: DEPRESSION; ANXIETY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 AUG-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 AUG-2021, the patient experienced flu like symptoms. On an unspecified date, the patient experienced depression, and anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from depression, and anxiety, and the outcome of flu like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced leg pain. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clot was ruled out. The action taken with covid-19 vaccine was not applicable. The outcome of leg pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea
Clinical narrative: This is a spontaneous, non-serious report received from a consumer. A female, of unspecified age (height, weight and concomitant medications not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown), dose not reported, administered on Mar 7, 2021, for immunization. The patient's concurrent conditions included: type 1 diabetic. The batch/lot number requested. On Mar 8, 2021, patient felt nauseous (like flu coming on) and tired. Laboratory data included: Body temperature (NR: not provided/not over 100). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from felt nauseous (like flu coming on) and tired on Mar 10, 2021. This case, from the same reporter linked to 20211031878.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea
Clinical narrative: This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced 12 hours after injection felt nauseous like flu coming on but more intense, quite intense. On 08-MAR-2021, the patient experienced basically wiped out. Laboratory data included: Body temperature (NR: not provided) Not over 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 12 hours after injection felt nauseous like flu coming on but more intense, quite intense, and basically wiped out on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211031835.
Sex: U
Vaccine: COVID19
Symptoms: Freezing phenomenon, Headache, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous, non-serious report received from a patient. A patient, of unspecified age and sex (height and weight not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown/not reported) dose, start therapy date not reported, for immunization. No medical history or concurrent conditions reported. The company was unable to perform follow-up to request batch number. No concomitant medications reported.  On an unspecified date, patient experienced freezing, sore arm, headache and nausea. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from freezing, sore arm, headache and nausea.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, General physical condition abnormal, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: LOW OXYGEN SATURATION; HEALTH ISSUES; HIGH FEVER; SEVERE FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 patient experienced low oxygen saturation, health issues, high fever, and severe fatigue. Laboratory data (dates unspecified) included Body temperature (NR not provided) High, and Oxygen saturation (NR not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, severe fatigue, health issues and low oxygen saturation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOW OXYGEN SATURATION; HEALTH ISSUES; HIGH FEVER; SEVERE FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 patient experienced low oxygen saturation, health issues, high fever, and severe fatigue. Laboratory data (dates unspecified) included Body temperature (NR not provided) High, and Oxygen saturation (NR not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, severe fatigue, health issues and low oxygen saturation was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had family history of Multiple sclerosis and had a higher risk of Guillain Barre. 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 patient experienced sick from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick from vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211032083.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: POTENTIAL MEDICATION ERROR (JASSEN VACCINE RECEIVED AFTER PFIZER VACCINE); 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 concurrent conditions included: diabetic, and other pre-existing medical conditions included: Patient had other underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On JUL-2021, the patient experienced potential medication error (jassen vaccine received after pfizer vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential medication error (jassen vaccine received after pfizer vaccine) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. The action taken with covid-19 vaccine was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: THE DRUGS HE WAS GIVEN, THEY POISON HIM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced the drugs he was given, they poison him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drugs he was given, they poison him was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: RAPID HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-OCT-2021, the patient experienced rapid heart rate. On 16-OCT-2021, the patient experienced dizziness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rapid heart rate, and dizziness. This report was non-serious.