chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Vomiting
Clinical narrative: EXCESSIVE URINATION; VOMITING; INCREASED HEART RATE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 134 pounds, and height was 176.78 centimeters. The patient's concurrent conditions included supraventricular tachycardia, high cholesterol, thinning bones, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no no allergies/no history of drug abuse/no past history of similar event/no adverse event after any previous vaccinations/ no history of allergy to vaccine, drug or food/ no history of hospitalization in last 30 days, with cause/no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at the time of event. the patient was not currently breastfeeding.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 to the left deltoid, on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included fish oil for heart health, pravastatin for high cholesterol, metoprolol succinate for supraventricular tachycardia, and calcium carbonate/colecalciferol for thinning bones. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive urination, vomiting, increased heart rate, nausea, and fatigue on 08-MAR-2021, and chills on 07-MAR-2021. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as the case is non serious
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye contusion, Pyrexia, Syncope
Clinical narrative: CHILLS; FEVER; PATIENT FAINTED IN BATHROOM; FAINTING RESULTED IN BLACK EYE; This spontaneous report received from a patient via a company representative concerned a patient of unknown sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On the night of vaccination, 05-MAR-2021, the patient had chills and fever. The following day, the patient fainted in the bathroom which resulted in a black eye. At the time of this report, there were no reports of the previously mentioned adverse events. The patient would get a head x-ray to make sure everything was okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from patient fainted in bathroom, chills, and fever on MAR-2021, and the outcome of fainting resulted in black eye was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and chills, fever, patient fainted in bathroom was related. The reporter causality between covid-19 vaccine ad26.cov2.s and fainting resulted in black eye was possible. Company causality between covid-19 vaccine ad26.cov2.s and chills, fever, patient fainted in bathroom, fainting resulted in black eye was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210318094-covid-19 vaccine ad26.cov2-fainting. This event is considered unassessable. The event 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: CHILLS; HEADACHE; INJECTION SITE SORENESS; CHEST PAIN; SORE ARM; FATIGUE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight was 190 pounds, and height was 158.49 centimeters. The patient's concurrent conditions included smoking, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting and has no history of illicit drug abuse and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 16:30 to left arm for prophylactic vaccination. Non-company suspect drugs included: amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate ( form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication; and drospirenone/ethinylestradiol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced slight fever. On an unspecified date, the subject experienced chills, headache, and injection site soreness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, slight fever, and chest pain, and the outcome of sore arm, headache, chills and injection site soreness was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: CHILLS; HEADACHE; INJECTION SITE SORENESS; CHEST PAIN; SORE ARM; FATIGUE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight was 190 pounds, and height was 158.49 centimeters. The patient's concurrent conditions included smoking, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting and has no history of illicit drug abuse and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 16:30 to left arm for prophylactic vaccination. Non-company suspect drugs included: amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate ( form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication; and drospirenone/ethinylestradiol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced slight fever. On an unspecified date, the subject experienced chills, headache, and injection site soreness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, slight fever, and chest pain, and the outcome of sore arm, headache, chills and injection site soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for an unspecified indication. No concomitant medications were reported. On MAR-2021, the subject experienced exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure via breast milk was not reported. This report was non-serious.  Version created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Event of Maternal exposure during breast feeding was changed to Exposure via breast milk.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Presyncope
Clinical narrative: ATRIAL FIBRILLATION; VASOVAGAL EPISODE; 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, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a very adverse reaction. According to the physicians at the site, it was a vasovagal episode. Ultimately, the patient had to go to the ER because of atrial fibrillation. If interested, the patient would be happy to speak about it, and share the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vasovagal episode and atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).  Version (1) created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Reporter causality statement was removed from narrative, vaccine type and vaccination site were removed.; Sender's Comments: V1: Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, vasovagal episode. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION; VASOVAGAL EPISODE; 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, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a very adverse reaction. According to the physicians at the site, it was a vasovagal episode. Ultimately, the patient had to go to the ER because of atrial fibrillation. If interested, the patient would be happy to speak about it, and share the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vasovagal episode and atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).  Version (1) created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Reporter causality statement was removed from narrative, vaccine type and vaccination site were removed.; Sender's Comments: V1: Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, vasovagal episode. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Incorrect route of product administration
Clinical narrative: INAPPROPRIATE ROUTE OF DRUG ADMINISTRATION; FEELS BEAT; SEVER HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 70 kilograms, and height was 177.8 centimeters. The patient's past medical history included non smoker, and concurrent conditions included 4 drinks per week. The patient had no known drug or non-drug allergy. The patient had no history of drug abuse or illicit drug use. The patient was non-smoker. The patient had no pre-existing acute illness or illness at the time of vaccination or 30 days prior to vaccination. The patient did not have significant past history of similar events and not had any adverse events after any previous vaccinations. The patient did not have significant history of hospitalizations. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feels beat. On MAR-2021, the subject experienced sever headache. On MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced inappropriate route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inappropriate route of drug administration  on 13-MAR-2021, and the outcome of sever headache, feels beat and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASHES AND BUMPS ON FACE, NECK, ARM, BACK AND CHEST; 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced rashes and bumps on face, neck, arm, back and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes and bumps on face, neck, arm, back and chest. This report was non-serious. This case is a duplicate of 20210330522.  Additional information was received from [patient] on [29/Mar/2021].  It was determined that Manufacturer Report Number [20210330522] was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Report Number [20210331685], upon review following corrections were amended, reported reaction term updated.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PATIENT RECEIVED 0.25ML DOSE; This spontaneous report received from a pharmacist . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 0.25 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced subject received 0.25ml dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received 0.25ml dose was not reported. This report was non-serious.  Additional information was received from the patient on 31-Mar-2021. The following information was updated and incorporated into case narrative: This report was associated with product quality complaint: 90000174361. The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria, based on the PQC evaluation/investigation performed.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: QUIETER THAN NORMAL; FEVER; This spontaneous report received from a consumer via a company representative concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease, and cerebral palsy, non-verbal. 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 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ustekinumab for Crohn's disease. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced quieter than normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and quieter than normal was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; HEADACHE; 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 was not reported, once a total administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, fatigue, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: FELT ALITTLE NAUSEOUS; TIRED; SHORT HURT; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once total 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 felt a little nauseous, tired, short hurt, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little nauseous, tired, short hurt, and slight headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; FELT TIRED; FEVER; This spontaneous report received from a patient via a company representative . 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 company was unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, felt tired, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, felt tired, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse event
Clinical narrative: "HIGH RISK" FOR BEING ON TREMFYA  AND RECEIVING THE COVID VACCINE; 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 combination product guselkumab (solution for injection in pre-filled syringe, route of admin not reported, batch number: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. Product constituent parts included .The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the subject experienced "high risk" for being on tremfya and receiving the covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of "high risk" for being on tremfya and receiving the covid vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: NAUSEA; LOW GRADE FEVER; BODY ACHE (AROUND THE NECK); CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 49 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 31-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021 23:00, the subject experienced body ache (around the neck). On 31-MAR-2021 23:00, the subject experienced chills. On 31-MAR-2021 23:00, the subject experienced headache. On an unspecified date, the subject experienced nausea, and low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache (around the neck), chills, low grade fever and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Thirst
Clinical narrative: BODY ACHE; INSATIABLE THIRST; FEVER; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On 28-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced body ache. On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced insatiable thirst. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, body ache, bad headache, and insatiable thirst on 30-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: PRETTY SEVERE WHOLE-BODY MUSCLE SORENESS; 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 unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pretty severe whole-body muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pretty severe whole-body muscle soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral pain, Pyrexia
Clinical narrative: SORE MOUTH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 54 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: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced sore mouth. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, and had not recovered from fever, and sore mouth. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAINFUL ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced painful arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 (LOSS OF TASTE, LOSS OF SMELL, BODY ACHES, CHILLS AND 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 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced suspected covid-19 (loss of taste, loss of smell, body aches, chills and fever). Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 (loss of taste, loss of smell, body aches, chills and fever) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as case assessed as non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: FEELING UNWELL; SICK; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sick. On 01-APR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and feeling unwell. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: BOWEL ISSUE; SORE ARM; LOW GRADE FEVER; This spontaneous report received from a consumer 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: 1805022, expiry: unknown) dose was not reported, administered on 13-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced bowel issue. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bowel issue, sore arm, and low grade fever on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Feeling hot, Gait disturbance, Headache
Clinical narrative: LOSS OF TASTE; UNABLE TO WALK STRAIGHT; FLU-LIKE SYMPTOMS; HOT AND COLD CHILLS; HEADACHE; NAUSEA; FEELING HOT INTERMITTENTLY; 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 before 08:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feeling hot intermittently. Treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced unable to walk straight. On 12-MAR-2021, the subject experienced flu-like symptoms. On 12-MAR-2021, the subject experienced hot and cold chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced loss of taste. On 01-APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk straight, flu-like symptoms, and headache on 13-MAR-2021, had not recovered from nausea, and loss of taste, and the outcome of feeling hot intermittently and hot and cold chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, SARS-CoV-2 test
Clinical narrative: LOSS OF TASTE; UNABLE TO WALK STRAIGHT; FLU-LIKE SYMPTOMS; HOT AND COLD CHILLS; HEADACHE; NAUSEA; FEELING HOT INTERMITTENTLY; 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 before 08:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feeling hot intermittently. Treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced unable to walk straight. On 12-MAR-2021, the subject experienced flu-like symptoms. On 12-MAR-2021, the subject experienced hot and cold chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced loss of taste. On 01-APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk straight, flu-like symptoms, and headache on 13-MAR-2021, had not recovered from nausea, and loss of taste, and the outcome of feeling hot intermittently and hot and cold chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Feeling hot, Migraine
Clinical narrative: MIGRAINE; DIARRHEA; BODY WAS SO HOT; FELT LIKE HAD COVID AGAIN; CHILLS; COULD NOT GET UP AT ALL; NAUSEA; 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 30-MAR-2021 20:00, the subject experienced migraine. On 30-MAR-2021 20:00, the subject experienced diarrhea. On 30-MAR-2021 20:00, the subject experienced body was so hot. On 30-MAR-2021 20:00, the subject experienced felt like had covid again. On 30-MAR-2021 20:00, the subject experienced chills. On 30-MAR-2021 20:00, the subject experienced could not get up at all. On 30-MAR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, migraine, nausea, diarrhea, body was so hot, could not get up at all and felt like had covid again was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Suspected COVID-19
Clinical narrative: MIGRAINE; DIARRHEA; BODY WAS SO HOT; FELT LIKE HAD COVID AGAIN; CHILLS; COULD NOT GET UP AT ALL; NAUSEA; 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 30-MAR-2021 20:00, the subject experienced migraine. On 30-MAR-2021 20:00, the subject experienced diarrhea. On 30-MAR-2021 20:00, the subject experienced body was so hot. On 30-MAR-2021 20:00, the subject experienced felt like had covid again. On 30-MAR-2021 20:00, the subject experienced chills. On 30-MAR-2021 20:00, the subject experienced could not get up at all. On 30-MAR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, migraine, nausea, diarrhea, body was so hot, could not get up at all and felt like had covid again was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to penicillin. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210347232.
Age: 66.0
Sex: F
Vaccine: COVID19
Clinical narrative: SORENES AT INJECTION SITE.; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, pre-diabetic, abstains from alcohol, and non-smoker, 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, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 31-MAR-2021 at 12:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: LITTLE COLD; 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 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced little cold. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, headache and little cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hypersomnia, Pyrexia
Clinical narrative: SLEPT THE MAJORITY OF THE DAY; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced slept the majority of the day. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and slept the majority of the day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210403741.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: ITCHING; BURNING; RASH; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 165 kilograms, and height was not reported. The patient's concurrent conditions included hypertension, thyroid, remission from multiple myeloma, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 25-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced burning. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching, and burning. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS THAWED THEN  REFROZEN AND THAWED AGAIN  BEFORE IT WAS ADMINISTERED TO PATIENT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose was not reported, administered on left deltoid on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine was thawed then refrozen and thawed again before it was administered to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was thawed then refrozen and thawed again before it was administered to patient was not reported. This report was non-serious. This case is associated with Product Quality Complaint, PQC number: 90000175087.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Renal pain
Clinical narrative: HOT FLUSHES IN THE FACE; A LITTLE DIZZINESS; A LITTLE KIDNEY PAIN ON HIS RIGHT  SIDE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back fusion, rheumatoid arthritis, and mild high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis. On 06-MAR-2021, the subject experienced hot flushes in the face. On 06-MAR-2021, the subject experienced a little dizziness. On 06-MAR-2021, the subject experienced a little kidney pain on his right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes in the face, and a little dizziness on 06-MAR-2021, and a little kidney pain on his right side on 12-MAR-2021. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chills, Pyrexia, Rash
Clinical narrative: CHILLS; FEVER; BURNING SENSATION  RIGHT THIGH; RASH RIGHT THIG; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, night sweats, and chills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180525, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 in left arm for prophylactic vaccination. Concomitant medications included ibandronate sodium for osteoporosis. On 12-MAR-2021, the subject experienced burning sensation right thigh. On 12-MAR-2021, the subject experienced rash right thig. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation right thigh, and rash right thig on 12-MAR-2021, and chills, and fever on 30-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear pain, Electrocardiogram, Fatigue, Palpitations
Clinical narrative: LEFT EAR ACHE; HEART PALPITATIONS; DRY COUGH; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included heart stent, and other pre-existing medical conditions included the patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left ear ache. On 24-MAR-2021, the subject experienced heart palpitations. On 24-MAR-2021, the subject experienced dry cough. On 24-MAR-2021, the subject experienced fatigue. On 01-APR-2021, Laboratory data included: EKG (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 26-MAR-2021, and had not recovered from left ear ache, heart palpitations, and dry cough. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hair disorder, Injection site pain, Mucosal disorder, Multiple allergies
Clinical narrative: PAIN IN INGROWN ARMPIT HAIR; THROAT MUCUS; ALLERGIES; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-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 31-MAR-2021, the subject experienced pain in ingrown armpit hair. On 31-MAR-2021, the subject experienced throat mucus. On 31-MAR-2021, the subject experienced allergies. On 31-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in ingrown armpit hair, pain at injection site, throat mucus and allergies was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; SORE THROAT; EXTREME FATIGUE; FEVER; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not have any known allergies. 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 31-MAR-2021 10:00 on right deltoid 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 31-MAR-2021, the subject experienced body aches. On 31-MAR-2021, the subject experienced sore throat. On 31-MAR-2021, the subject experienced extreme fatigue. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme fatigue, body aches, fever, and sore throat. This report was non-serious.