chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bedridden, Decreased appetite, Dizziness, Illness
Clinical narrative: REALLY SICK; IN BED FOR 7 DAYS; DIZZINESS; NO APPETITE; JOINT PAIN; NAUSEA; This spontaneous report received from a patient via social media  via company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch or lot number.  No concomitant medications were reported. The patient received non-company suspect booster vaccine BNT 162 (form of admin, route of admin, and batch number were not reported), dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2).   On an unspecified date, following BNT 162 (Pfizer) vaccination, the patient got really sick. From the next day the patient was in bed for 7 days with joint pain, nausea, dizziness and no appetite (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and BNT 162 (Pfizer) was not applicable. The outcome of the events in bed for 7 days (captured as recovered), really sick, joint pain, nausea, dizziness, and no appetite was unknown. This report was non-serious. This case, from the same reporter is linked to 20211229714.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: REALLY SICK; IN BED FOR 7 DAYS; DIZZINESS; NO APPETITE; JOINT PAIN; NAUSEA; This spontaneous report received from a patient via social media  via company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch or lot number.  No concomitant medications were reported. The patient received non-company suspect booster vaccine BNT 162 (form of admin, route of admin, and batch number were not reported), dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2).   On an unspecified date, following BNT 162 (Pfizer) vaccination, the patient got really sick. From the next day the patient was in bed for 7 days with joint pain, nausea, dizziness and no appetite (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and BNT 162 (Pfizer) was not applicable. The outcome of the events in bed for 7 days (captured as recovered), really sick, joint pain, nausea, dizziness, and no appetite was unknown. This report was non-serious. This case, from the same reporter is linked to 20211229714.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, CSF protein, Guillain-Barre syndrome, Headache, Magnetic resonance imaging spinal
Clinical narrative: GUILLAIN BARRE SYNDROME; HEADACHE; NAUSEA; VOMITING; This spontaneous report was received from literature: A Novel Case of Bifacial Diplegia Variant of Guillain-Barré Syndrome Following Janssen COVID-19 Vaccination. 2021 Aug 13; Spectrum of Neuroimaging Findings in Post-COVID-19 Vaccination: A Case Series and Review of Literature. 2021 November 19;  The objective of this study was to extensively review published literature regarding post-COVID-19 vaccination neurological complications and characterize neuroimaging findings from three case presentations for early diagnosis and treatment.  This report concerned a 60 year old male of unspecified race and ethnicity. 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 (Dose number in series 01) (suspension for injection, route of administration, batch number and expiry were not reported) dose, start therapy date were not reported for 01 total administered 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 pain in her back and leg, nausea, vomiting, headache and diplopia. Diagnosis (on an unspecified date) was reported to be Guillain-Barre syndrome. Laboratory data (dates unspecified) included: Cerebrospinal fluid (CSF) protein was140 mg/dL, Glucose was normal, Magnetic resonance imaging spinal (Lumbar) demonstrated enhancement of the cauda equina, and Cell count was 9 cells/microL (9 nucleated cells/mm3). Treatment administered was Intravenous Immunoglobulin Therapy (IVIg). Time duration from COVID-19 vaccination to neurological symptom onset (latency) was 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Guillain-Barre, nausea, vomiting and headache syndrome. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210837750.; Sender's Comments: V0: 20211230158-COVID-19 VACCINE AD26.COV2.S-Guillain Barre syndrome. This event is labeled and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Nucleated red cells, Vomiting
Clinical narrative: GUILLAIN BARRE SYNDROME; HEADACHE; NAUSEA; VOMITING; This spontaneous report was received from literature: A Novel Case of Bifacial Diplegia Variant of Guillain-Barré Syndrome Following Janssen COVID-19 Vaccination. 2021 Aug 13; Spectrum of Neuroimaging Findings in Post-COVID-19 Vaccination: A Case Series and Review of Literature. 2021 November 19;  The objective of this study was to extensively review published literature regarding post-COVID-19 vaccination neurological complications and characterize neuroimaging findings from three case presentations for early diagnosis and treatment.  This report concerned a 60 year old male of unspecified race and ethnicity. 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 (Dose number in series 01) (suspension for injection, route of administration, batch number and expiry were not reported) dose, start therapy date were not reported for 01 total administered 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 pain in her back and leg, nausea, vomiting, headache and diplopia. Diagnosis (on an unspecified date) was reported to be Guillain-Barre syndrome. Laboratory data (dates unspecified) included: Cerebrospinal fluid (CSF) protein was140 mg/dL, Glucose was normal, Magnetic resonance imaging spinal (Lumbar) demonstrated enhancement of the cauda equina, and Cell count was 9 cells/microL (9 nucleated cells/mm3). Treatment administered was Intravenous Immunoglobulin Therapy (IVIg). Time duration from COVID-19 vaccination to neurological symptom onset (latency) was 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Guillain-Barre, nausea, vomiting and headache syndrome. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210837750.; Sender's Comments: V0: 20211230158-COVID-19 VACCINE AD26.COV2.S-Guillain Barre syndrome. This event is labeled and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Angiopathy, COVID-19, Cardiac disorder, Vaccination failure
Clinical narrative: COVID 19; SUSPECTED CLINICAL VACCINATION FAILURE; VASCULAR ISSUES; HEART ISSUES; This spontaneous report received from a patient via a company representative via social media concerned multiple patients with unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose, 1 total, 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 reporter stated that, "personally know people who took the jabs, got covid and some have died". The reporter also stated that, "have very recently lost vaxxed friends who died from covid and I have had people I know who have heart and vascular issue since getting the jab".  On an unspecified date, the patient had suspected clinical vaccination failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid 19 and the outcome of vascular issues, heart issues and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000206905. This case, from the same reporter is linked to 20211230784.; Sender's Comments: V0: 20211230489-covid-19 vaccine ad26.cov2.s -Covid 19 . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211230489-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID 19 INFECTION
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: NOT BREATHING WELL FOR 2 DAYS; SECOND SHOTS WORN ME OUT DOWN; This spontaneous report received from a patient via social media post and concerned a male patient of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: Patient was born with bad lungs. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1).It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). 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 was not breathing well for 2 days and second shots worn out down (dose number in series 2).It was reported that the patient did two shots and that was enough. Second shots worn them out down and not breathed well for 2 days. Patient did not wanted to take chance The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not breathing well for 2 days (reported as "unknown" but reported by patient to have lasted for 2 days), and the outcome of second shots worn me out down was unknown. This report was non-serious. This case, involving the same patient is linked to 20211233378.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache
Clinical narrative: FELT COLD ALL OVER HER BODY; FELT TIRED; HEADACHE; This spontaneous report received from a patient concerned a 59-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: cancer (in 2014), and concurrent conditions included: remission of cancer (in Dec-2019). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1), the patient experienced felt cold all over her body, felt tired, and headache (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt cold all over her body, felt tired and headache was unknown. This report was non-serious. The suspected product quality complaint has been confirmed to be voided as this does not meet the definition of a product quality complaint based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20211209858 (booster dose case with both dose numbers in series). This report was associated with product quality complaint number: 90000205465.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART ISSUES AFTER THE BOOSTER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2.s (dose number series 1) (suspension for injection, route of admin, batch number and expiry date not reported) dose was not reported for prophylactic vaccination (dose series 1). Following vaccination, no adverse events associated with previous covid-19 vaccine. The patient received booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 2). 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 heart issues after the booster (dose number series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues after the booster was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Pfizer (BNT 162) form of admin, route of admin, batch number and expiry date not reported) dose was not reported for prophylactic vaccination (dose number series 1). The patient had serious anaphylaxis with previous covid-19 Pfizer (BNT 162) vaccine (dose number series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 2). 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, following vaccination with covid-19 vaccine ad26.cov2.s the patient had fever (dose number series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Poor quality product administered, Product storage error
Clinical narrative: STORAGE OF VACCINE VIAL OUTSIDE OF THE RECOMMENDED  TEMPERATURE RANGE; POOR QUALITY VACCINE ADMINISTERED; MUSCLE ACHE; This spontaneous report received from a pharmacist concerned a female of unspecified age, race and ethnicity. 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 and expiry: UNKNOWN) dose was not reported, 1 total administered on MAY-2021 for prophylactic vaccination (Dose number in series 1). Later, (date not specified) the patient experienced muscle ache (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 10-DEC-2021 for prophylactic vaccination (Dose number in series 2) from a vial that was stored outside of the recommended temperature range (incorrect product storage). 2 doses were drawn from the vial and placed back in the fridge, then the next day another 2 doses were drawn and were given to the patient (poor quality vaccine administered). No concomitant medications were reported.  In DEC-2021, the patient experienced muscle aches (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the storage of vaccine vial outside of the recommended temperature range, muscle ache and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211233061, 20211233514 and 20211233937.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nonspecific reaction, Poor quality product administered, Product storage error
Clinical narrative: MUSCLE ACHES; STORED OUTSIDE OF THE RECOMMENDED TEMPERATURE RANGE; OUT OF SPECIFICATION PRODUCT USE; MINOR REACTIONS; This spontaneous report received from a pharmacist concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received with covid-19 vaccine ad26. cov2. S (dose number in series: 1), (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on 21-MAY-2021 for prophylactic vaccination.  On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patient experienced muscle ache (dose number in series: 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2), (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: unknown) dose was not reported, 1 total, administered on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2021, vial was stored outside of the recommended temperature range which is incorrect product storage (dose number in series 2), 2 doses were drawn from vial and placed back in the fridge then the next day another 2 doses were drawn from that and 1 of the dose was given to the patient which is out of specification product use (dose number in series: 2). In DEC-2021 (unspecified date), following administration of covid-19 vaccine ad26.cov2.s the patient experienced minor reactions and muscle aches (both events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stored outside of the recommended temperature range, muscle aches, minor reactions and out of specification product use was not reported. This report was non-serious. This case, involving the same patient is linked to 20211233937. This case, from the same reporter is linked to 20211233321 and 20211233061.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebral thrombosis, Cerebrovascular accident, Thrombosis, Vaccination failure
Clinical narrative: CLOT IN MY THUMB; CLOT IN THE BRAIN; 4 STROKES; STRICKEN WITH COVID-19 RIGHT AROUND THE TIME I WAS VACCINATED; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 52 year old male of unspecified race and ethnicity. 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, and batch number: 206A21A) dose, start therapy date were not reported, frequency 1 total for prophylactic vaccination. Dose number series was 1. No concomitant medications were reported.  On an unknown date, the patient was stricken with COVID 19 at the time of vaccination (suspected clinical vaccination failure). Less than a week  after receiving the vaccine the patient developed a clot in thumb that broke off and went to the brain. The patient suffered four strokes as a result. Ultimately, the patient was hospitalized for 2.5 months. During this time the patient was on a ventilator and required cardiopulmonary resuscitation (CPR) numerous times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clot in my thumb, clot in the brain, 4 strokes, stricken with covid-19 right around the time I was vaccinated and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with a regulatory authority. The suspected regulatory authority has been confirmed to be voided (patient confirmed during outreach that he got covid either 1 week before or 1 week after he was vaccinated, but doesn't remember. since infection occurred either before vaccination and less than 28 days after vaccination, this complaint does not qualify as an LOE and does meet the definition of a PQC. complaint is being sent for void approval). based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211234782 -Covid-19 vaccine ad26.cov2.s- Clot in my thumb, clot in the brain, 4 strokes, stricken with covid-19 right around the time I was vaccinated. This event(s) is considered unassessable. The event(s) has an 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). V0: 20211234782 -Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 64 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 (dose number in series 1) (suspension for injection, route of admin, and batch number not reported) dose was not reported,1 total, therapy start date was not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported,1 total, administered on 15-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, the patient administered expired vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235341.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure measurement, Blood test, Body temperature, Chest X-ray
Clinical narrative: ELEVATED BLOOD PRESSURE; FELT A HEAVY PRESSURE IN CHEST; NOT FEELING WELL; FELT TIRED; FEVER; ELEVATED D-DIMER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mild covid 19, and concurrent conditions included: alcoholic, non smoker, and inactive thyroid, and other pre-existing medical conditions included: The patient was very healthy and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for drug used for unknown indication, probiotics nos for drug used for unknown indication, and vitamins nos for drug used for unknown indication.  On SEP-2021, Laboratory data included: Antibody test (NR: not provided) COVID Antibodies level was good. On DEC-2021, the patient experienced elevated d-dimer. Laboratory data included: Blood pressure (NR: 60 - 110) 110/60 mmHg, Blood pressure (NR: not provided) High (Elevated), Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (NR: not provided) Not reported, Normal, and Fibrin D dimer (NR: not provided) Elevated. On 13-DEC-2021, the patient experienced felt tired, and fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 14-DEC-2021, the patient experienced elevated blood pressure, felt a heavy pressure in chest, and not feeling well. Laboratory data included: Blood pressure (NR: 92 - 138) 138/92 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired, and fever, had not recovered from elevated blood pressure, and the outcome of felt a heavy pressure in chest, not feeling well and elevated d-dimer was not reported. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram, Electrocardiogram, Fatigue, Fibrin D dimer
Clinical narrative: ELEVATED BLOOD PRESSURE; FELT A HEAVY PRESSURE IN CHEST; NOT FEELING WELL; FELT TIRED; FEVER; ELEVATED D-DIMER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mild covid 19, and concurrent conditions included: alcoholic, non smoker, and inactive thyroid, and other pre-existing medical conditions included: The patient was very healthy and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for drug used for unknown indication, probiotics nos for drug used for unknown indication, and vitamins nos for drug used for unknown indication.  On SEP-2021, Laboratory data included: Antibody test (NR: not provided) COVID Antibodies level was good. On DEC-2021, the patient experienced elevated d-dimer. Laboratory data included: Blood pressure (NR: 60 - 110) 110/60 mmHg, Blood pressure (NR: not provided) High (Elevated), Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (NR: not provided) Not reported, Normal, and Fibrin D dimer (NR: not provided) Elevated. On 13-DEC-2021, the patient experienced felt tired, and fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 14-DEC-2021, the patient experienced elevated blood pressure, felt a heavy pressure in chest, and not feeling well. Laboratory data included: Blood pressure (NR: 92 - 138) 138/92 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired, and fever, had not recovered from elevated blood pressure, and the outcome of felt a heavy pressure in chest, not feeling well and elevated d-dimer was not reported. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Hypertension, Malaise, Pyrexia
Clinical narrative: ELEVATED BLOOD PRESSURE; FELT A HEAVY PRESSURE IN CHEST; NOT FEELING WELL; FELT TIRED; FEVER; ELEVATED D-DIMER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mild covid 19, and concurrent conditions included: alcoholic, non smoker, and inactive thyroid, and other pre-existing medical conditions included: The patient was very healthy and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for drug used for unknown indication, probiotics nos for drug used for unknown indication, and vitamins nos for drug used for unknown indication.  On SEP-2021, Laboratory data included: Antibody test (NR: not provided) COVID Antibodies level was good. On DEC-2021, the patient experienced elevated d-dimer. Laboratory data included: Blood pressure (NR: 60 - 110) 110/60 mmHg, Blood pressure (NR: not provided) High (Elevated), Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (NR: not provided) Not reported, Normal, and Fibrin D dimer (NR: not provided) Elevated. On 13-DEC-2021, the patient experienced felt tired, and fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 14-DEC-2021, the patient experienced elevated blood pressure, felt a heavy pressure in chest, and not feeling well. Laboratory data included: Blood pressure (NR: 92 - 138) 138/92 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired, and fever, had not recovered from elevated blood pressure, and the outcome of felt a heavy pressure in chest, not feeling well and elevated d-dimer was not reported. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Injection site reaction, Muscular weakness, Presyncope
Clinical narrative: feeling of impending doom like I was going to pass out and my chest became heavy.  I felt the vaccine injection all the way down my arm into my fingers and my arm felt as if it'd lost strength
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Raised welts across head, neck, front and back of torso, shoulders and stomach and wrists. Extreme itching. No treatment.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Influenza like illness, Lymphadenopathy, Renal pain
Clinical narrative: On the evening of the shot, urine was a dark orange color, this cleared by the next day.  For the 2 days after the shot my kidneys ached pretty bad.  There was also a large swollen lymph node in the right arm pit, starting on day 2.  Otherwise,  felt flu like for about 48 hours after the shot.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Hives, itchy skin, itchy throat within 5 minutes,  took benadryl
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Pain
Clinical narrative: Left shoulder and left back and left upper arm area hurt really bad after the shot and it is December 2021 now  and it is still hurting really bad when I try to move my left arm up or turn it.  Even removing or wearing clothes lifting my arm extremely hurt.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: Patient is a 10 year-old male vaccinated 12/19/2021 at 1241pm for his 2nd dose of the Child Pfizer 5-11 vaccine (Lot# FK5618). Patient was vaccinated by RN in his Left Deltoid. Per responding post-vaccination observation staff member RN written and verbal report to this documenting Charge RN, the patient complained to his parents shortly after vaccination while he was waiting with them in post-vaccination observation area that he had a ?bad headache and dizziness?. Post-vaccination RNs immediately responded following parent notification to patient complaint, and the two RNs safely escorted patient to private medical cot area with both parents and minor brother present.   One RN stayed with patient while the second RN notified this documenting Charge RN who immediately responded to medical cot area to support patient/family and the two other RNs. Patient laid down supine safely on medical cot with head slightly elevated on pillows for a few minutes. Patient assessed and appeared pale to this documenting Charge RN. Patient reported to RNs that he felt better after lying down for a few minutes and then sat up safely at side of medical cot to drink some apple juice following parent consent. RN took patient sitting vital signs at 1259pm with Blood Pressure: 90/60 Pulse Rate: 96 and Pulse Oximetry reading: 99%. Patient parents stated the blood pressure is baseline to normal for the patient. After drinking juice patient stated that he felt better and had less headache. Patient parents present with minor child throughout the entire medical incident. Patient reported to RNs that he did not eat much that day before receiving 2nd vaccination. Parents confirmed that child did not have much of an appetite before vaccination because he was nervous and anxious about getting his second COVID-19 vaccination. Patient stated he felt less nervous than he did for his first dose, but he still was very anxious. Both of patient?s parents verbally confirmed that he was nervous for both doses.   Patient verbalized again that he felt better, RNs assessed patient skin color return, less pale. Patient parents provided education that if the headache and dizziness return to follow-up with their medical provider as soon as they can and get emergency assistance as needed. Parents verbalized understanding. At military time 1315pm patient safely stood at side of medical cot, denied any further headache or dizziness, patient verbalized he felt better. Patient safely ambulated in care of both parents with his brother present also out of the clinic, stable gait with ambulation noted by RNs.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I received my COVID booster and my regular flu shot at the same time but in different arms. My first two doses of the vaccine were Moderna as was my booster. 8 days after receiving the shot I was out and started getting super itchy mostly on my back, shoulders, head, and neck. I was itching like crazy and getting hives all over. I?ve never had a reaction like this before to anything. The hives and itchiness has persisted for a number of weeks  but gradually become less intense overtime. However at the beginning for the first two weeks I was getting very itchy and hives everyday and always flaring up in the evening. I haven?t found anything else in my apartment or workplace that could?ve caused such a reaction.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Pruritus, Skin lesion
Clinical narrative: Shingles presented by distinct skin lesions on the abdomen, back and groin, itch and burning pain, doctor confirmation of shingles Aug 24th, treated with antiviral oral medication starting Aug 25th and symptoms rapidly subsided, skin scaring from lesions
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have ringing in my right ear
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Urticaria
Clinical narrative: 1. Hives that break out all over my body. Has occurred approximately 2 to 3 times a week since the second round.  Is currently continuing to occur.   2. Feels like I can?t quite catch my breath at times.  3. Brain fog.
Age: 9.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Dyspnoea, Nausea, Pallor, Seizure, Syncope
Clinical narrative: A technician administered the flu and covid vaccines, then walked back to the pharmacy. About a minute later someone in the lobby reported an emergency, I (pharmacist) went to the lobby area to see the matter. Patient was on the floor and appeared to be waking up, his mother stated she thought he had convulsed then fainted. Patient stated he had difficulty breathing and was very pale, I administered 10mL of benadryl 12.5mg/5mL solution. Patient reported nausea and prepared to vomit, but he did not vomit. I stayed with patient to monitor him for changes while his mother called 911, patient stated he did not feel better or worse. EMS arrived shortly after and took over care. Patient's family refused transport to hospital via EMS but did say they would drive to the hospital afterward.  Of note, patient's mother stated he had not had a reaction to a vaccine like this in the past, including the flu vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Anticoagulant therapy, Blood culture, Blood lactic acid, Chills
Clinical narrative: SIRS and NSTEMI: Patient presented to the ER with altered mental status, lethargy rigors, chills, and fever. He developed symptoms near the end of his regular hemodialysis treatment. Prior to dialysis, per patient and son, he was feeling well. Patient noted that he received his COVID booster shot the day before, but did not note any adverse reaction prior to that morning.   Patient became hypotensive and tachycardic in the ER. He was found to have significant tropinemia and lactic acidemia. He was admitted to the hospital.  He was treated with antibiotics, antipyretics, IV fluids, and heparin. During his course he had a cardiac stent placed. No infection source was identified to explain the patient's SIRS Antibiotics were subsequently stopped. Patient recovered and was discharged 3 days later at baseline mental status.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Culture urine, Haemodialysis, Hepatitis B test negative, Hypotension
Clinical narrative: SIRS and NSTEMI: Patient presented to the ER with altered mental status, lethargy rigors, chills, and fever. He developed symptoms near the end of his regular hemodialysis treatment. Prior to dialysis, per patient and son, he was feeling well. Patient noted that he received his COVID booster shot the day before, but did not note any adverse reaction prior to that morning.   Patient became hypotensive and tachycardic in the ER. He was found to have significant tropinemia and lactic acidemia. He was admitted to the hospital.  He was treated with antibiotics, antipyretics, IV fluids, and heparin. During his course he had a cardiac stent placed. No infection source was identified to explain the patient's SIRS Antibiotics were subsequently stopped. Patient recovered and was discharged 3 days later at baseline mental status.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Lactic acidosis, Lethargy, Mental status changes
Clinical narrative: SIRS and NSTEMI: Patient presented to the ER with altered mental status, lethargy rigors, chills, and fever. He developed symptoms near the end of his regular hemodialysis treatment. Prior to dialysis, per patient and son, he was feeling well. Patient noted that he received his COVID booster shot the day before, but did not note any adverse reaction prior to that morning.   Patient became hypotensive and tachycardic in the ER. He was found to have significant tropinemia and lactic acidemia. He was admitted to the hospital.  He was treated with antibiotics, antipyretics, IV fluids, and heparin. During his course he had a cardiac stent placed. No infection source was identified to explain the patient's SIRS Antibiotics were subsequently stopped. Patient recovered and was discharged 3 days later at baseline mental status.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test, Staphylococcus test, Systemic inflammatory response syndrome
Clinical narrative: SIRS and NSTEMI: Patient presented to the ER with altered mental status, lethargy rigors, chills, and fever. He developed symptoms near the end of his regular hemodialysis treatment. Prior to dialysis, per patient and son, he was feeling well. Patient noted that he received his COVID booster shot the day before, but did not note any adverse reaction prior to that morning.   Patient became hypotensive and tachycardic in the ER. He was found to have significant tropinemia and lactic acidemia. He was admitted to the hospital.  He was treated with antibiotics, antipyretics, IV fluids, and heparin. During his course he had a cardiac stent placed. No infection source was identified to explain the patient's SIRS Antibiotics were subsequently stopped. Patient recovered and was discharged 3 days later at baseline mental status.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Troponin increased
Clinical narrative: SIRS and NSTEMI: Patient presented to the ER with altered mental status, lethargy rigors, chills, and fever. He developed symptoms near the end of his regular hemodialysis treatment. Prior to dialysis, per patient and son, he was feeling well. Patient noted that he received his COVID booster shot the day before, but did not note any adverse reaction prior to that morning.   Patient became hypotensive and tachycardic in the ER. He was found to have significant tropinemia and lactic acidemia. He was admitted to the hospital.  He was treated with antibiotics, antipyretics, IV fluids, and heparin. During his course he had a cardiac stent placed. No infection source was identified to explain the patient's SIRS Antibiotics were subsequently stopped. Patient recovered and was discharged 3 days later at baseline mental status.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Near the injection area on upper left arm it swollen to size of my whole hand after one week. It was a big bump and it was warm. It lasted for few days and it disappeared.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain, Pyrexia
Clinical narrative: Rash at injection site, I did not have the rash for the first two doses. Also a slight fever and body aches.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a health care professional concerned a 46 year old white, not hispanic or latino 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 07-MAR-2021 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first covid-19 vaccine ad26. cov2. s. Non-company suspect vaccine included: mrna 1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, following vaccination with non-company booster dose, the patient tested positive for Covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive (Dose number in series 2) . The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Dyspnoea, Myocardial infarction, Pain in extremity
Clinical narrative: Death within 1 hour of event.  My wife called me in the middle of the night - 3:30 am saying "I can't breathe." I rushed to her and asked her whether she could get into the car and when she shook her head no, I called 911.  She kept repeating I can't breathe The paramedics arrived  approx .15 minutes later and took her to Hospital which is nearby.     According to the ER doctor, her heart had stopped beating at the time she reached the hospital.  He asked me whether she had been exposed to COVID and I told him I didn't think so.  She had injured her knee about 3 weeks prior and for a brief period wore a knee brace.  The day prior to her death she said her leg was hurting her but she declined the knee brace when I offered it to her.  She has a family history of blood clots.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Death within 1 hour of event.  My wife called me in the middle of the night - 3:30 am saying "I can't breathe." I rushed to her and asked her whether she could get into the car and when she shook her head no, I called 911.  She kept repeating I can't breathe The paramedics arrived  approx .15 minutes later and took her to Hospital which is nearby.     According to the ER doctor, her heart had stopped beating at the time she reached the hospital.  He asked me whether she had been exposed to COVID and I told him I didn't think so.  She had injured her knee about 3 weeks prior and for a brief period wore a knee brace.  The day prior to her death she said her leg was hurting her but she declined the knee brace when I offered it to her.  She has a family history of blood clots.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: After first shot my daughter had mild fever (101) that lasted one day.  She is a kid who typically runs warm -99-100.   Almost immediately after 2nd shot she was lethargic and mild fever. Gave her motrin.  She woke up the night of shot in the middle of the night with very high fever. Gave her water, cold cloth, motrin etc and fever came down to 101-102 and persisted for 2 days.  She spontaneously vomited around 48 hours after the shot over the course of 1 hour.   Within 4 days she was fine.   I just wanted to report her side effects because her side effects seem atypical compared to most other kids side effects, at least anecdotally and based on what I read to expect online.   Had I known such a high fever was possible I would have kept her fever reducers consistent and not let them lapse the night after shot.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gait inability, Hemiplegic migraine, Immobile
Clinical narrative: The vaccine triggered severe and debilitating hemiplegic migraines that left me immobile and unable to work. I had to receive medication through IV before my symptoms resolved. I was seen at the local Medical Center on 3/26/21 for this medication. I had the exact same reaction to the second vaccination, and I visited an urgent care to receive the same medications through shots.