chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with unapproved diluent; Reconstituted with unapproved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not reported. Nurse reported that the patient (no data available when asked) received Shingrix vaccination but it was reconstituted with other diluent than the supplied, they used an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No other information were provided. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient filled out webform stated that she developed a rash after receiving the first Shingrix vaccine. No other details regarding rash were available. The reporter did not consent to follow-up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Erythema, Heart rate increased, Heart rate irregular
Clinical narrative: swollen arm; red circle; out of breath when she talks; heart is making weird beating noise; heartbeat is faster; skips a beat; chest felt tight; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise) and HEART RATE INCREASED (heartbeat is faster) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia.    On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise), HEART RATE INCREASED (heartbeat is faster), HEART RATE IRREGULAR (skips a beat), CHEST DISCOMFORT (chest felt tight) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise), HEART RATE INCREASED (heartbeat is faster), HEART RATE IRREGULAR (skips a beat), CHEST DISCOMFORT (chest felt tight) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101.         No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart sounds abnormal, Peripheral swelling, Pyrexia
Clinical narrative: swollen arm; red circle; out of breath when she talks; heart is making weird beating noise; heartbeat is faster; skips a beat; chest felt tight; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise) and HEART RATE INCREASED (heartbeat is faster) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia.    On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise), HEART RATE INCREASED (heartbeat is faster), HEART RATE IRREGULAR (skips a beat), CHEST DISCOMFORT (chest felt tight) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red circle), DYSPNOEA (out of breath when she talks), HEART SOUNDS ABNORMAL (heart is making weird beating noise), HEART RATE INCREASED (heartbeat is faster), HEART RATE IRREGULAR (skips a beat), CHEST DISCOMFORT (chest felt tight) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101.         No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (got COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (got COVID-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient was  treated with monoclonal antibodies. Patient wants to get the second dose of the Moderna vaccine.  Company Comment: Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted/totally fainted; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted/totally fainted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SYNCOPE (Fainted/totally fainted) (seriousness criterion medically significant). On 18-Feb-2021, SYNCOPE (Fainted/totally fainted) had resolved.            Concomitant medications were not reported. Treatment information was not provided.  The patient fainted 20 minutes after receiving the vaccine. A doctor was called to assess her at the vaccination facility. He waved something under her nose and she woke up immediately. The patient's husband would like for her to receive the next dose of the vaccine at a facility that also has a doctor like the first dose.  Company Comment:  Very limited information regarding this event has been provided at this time. The reporter declined further follow-up, so no further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. The reporter declined further follow-up, so no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Thousands of people went blind; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Thousands of people went blind) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Thousands of people went blind) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Thousands of people went blind) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  This is a spontaneous report received through medical information. A male of unknown age reports that ¨thousands of people went blind after Moderna vaccine".  Very limited information regarding the events has been provided at this time. Further information has been requested as per the verbatim of the patient is a generalization.  Neither product administration nor events are clearly stated. Until further information is received, the case is retained as valid.   This case was linked to MOD-2021-307513 (Patient Link).; Sender's Comments: This is a spontaneous report received through medical information. A male of unknown age reports that ¨thousands of people went blind after Moderna vaccine¨ .  Very limited information regarding the events has been provided at this time. Further information has been requested as per the verbatim of the patient is a generalization.  Neither product administration nor events are clearly stated. Until further information is received, the case is retained as valid.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a 58 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had pain in his past medical history and concurrent conditions included: Chronic lymphocytic leukaemia (CLL) also had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Imbruvica (ibrutinib) for Chronic lymphocytic leukaemia (CLL), calcium carbonate, dexamethasone, Dramamine (dimenhydrinate), ibuprofen, loperamide, Prilosec (omeprazole), and Acetaminophen (paracetamol) for unknown indication. On AUG-2021, the patient did the Severe acute respiratory syndrome coronavirus 2 (SARS-cov-2) antibody test which showed negative results, hence confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210856371 and 20210447536. This case is associated with RA: 90000192062.; Sender's Comments: V0.20210904096-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine 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: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY, SPECIAL SITUATIONS
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Intraocular pressure increased, Ocular discomfort
Clinical narrative: Intraocular pressure high; Shoulder pain; This spontaneous report received from a patient via a company representative concerned a 39 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Chron's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 19-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported.  On APR-2021, the patient experienced shoulder pain and on an unspecified date, the patient experienced intraocular pressure high. The patient had eye surgery due to eye pressure being too high. Laboratory data (dates unspecified) included: Sensation of pressure in eye (NR: not provided) too high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from intraocular pressure high, and shoulder pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210904340-Covid-19 vaccine ad26.cov2.s-Intraocular pressure high. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Immunology test, Neutralising antibodies, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; MINIMALLY SYMPTOMATIC SARS COV 2 INFECTION; This spontaneous report was received from literature: This report concerned a patient of unspecified age, sex, 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, batch number: Unknown and expiry: Unknown) dose,1 total administered, 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, Laboratory data included: Enzyme-linked immunosorbent assay and neutralizing antibodies revealed breakthrough SARS-CoV-2 infection. Patient had minimally symptomatic SARS-CoV-2 infection (between days 71 and 239), and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minimally symptomatic SARS-CoV-2 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: 20210905584-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
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000192647.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bradykinesia, Decreased appetite, Feeling abnormal, Nausea
Clinical narrative: WAS ABLE TO DO DAILY ACTIVITIES, BUT THEN SHE FELT BAD ALSO STATED WHEN SHE WOKE UP SHE FELT REALLY BAD; ACHY BODY; POOR APPETITE; FEEL SLOW MOVING EVER SINCE; RESTLESS LEGS; ACHY SHOULDERS; ACHY LEGS; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 137 pounds, and height was 63 inches. The patient's past medical history included: history of lyme's disease, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced was able to do daily activities, but then she felt bad also stated when she woke up she felt really bad. On 02-SEP-2021, the patient experienced poor appetite. On 02-SEP-2021, the patient experienced feel slow moving ever since. On 02-SEP-2021, the patient experienced restless legs. On 02-SEP-2021, the patient experienced achy shoulders. On 02-SEP-2021, the patient experienced achy legs. On 02-SEP-2021, the patient experienced achy body. On 02-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from restless legs, achy body, nausea, poor appetite, was able to do daily activities, but then she felt bad also stated when she woke up she felt really bad, achy shoulders, and achy legs, and the outcome of feel slow moving ever since was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908723.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Restless legs syndrome
Clinical narrative: WAS ABLE TO DO DAILY ACTIVITIES, BUT THEN SHE FELT BAD ALSO STATED WHEN SHE WOKE UP SHE FELT REALLY BAD; ACHY BODY; POOR APPETITE; FEEL SLOW MOVING EVER SINCE; RESTLESS LEGS; ACHY SHOULDERS; ACHY LEGS; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 137 pounds, and height was 63 inches. The patient's past medical history included: history of lyme's disease, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced was able to do daily activities, but then she felt bad also stated when she woke up she felt really bad. On 02-SEP-2021, the patient experienced poor appetite. On 02-SEP-2021, the patient experienced feel slow moving ever since. On 02-SEP-2021, the patient experienced restless legs. On 02-SEP-2021, the patient experienced achy shoulders. On 02-SEP-2021, the patient experienced achy legs. On 02-SEP-2021, the patient experienced achy body. On 02-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from restless legs, achy body, nausea, poor appetite, was able to do daily activities, but then she felt bad also stated when she woke up she felt really bad, achy shoulders, and achy legs, and the outcome of feel slow moving ever since was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908723.
Sex: F
Vaccine: COVID19
Symptoms: Optical coherence tomography, Retinal artery occlusion, Retinopathy
Clinical narrative: REMOTE BRANCH RETINAL ARTERY OCCLUSION IN LEFT EYE; ACUTE MACULAR NEURORETINOPATHY; This spontaneous report was received from literature: This report concerned a female of middle age group. The patient's race and ethnic origin was not reported. The objective of this study was to describe COVID-19, COVID-19 Vaccinations, and Subsequent Abnormalities in the Retina Causation or Coincidence. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, hypertension, and systemic vasculopathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, two weeks after the vaccination, the patient experienced remote branch retinal artery occlusion in left eye, and acute macular neuroretinopathy (AMN). Laboratory data (dates unspecified) included: Optical coherence tomography (NR: not provided) acute macular neuroretinopathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the remote branch retinal artery occlusion in left eye and acute macular neuroretinopathy was not reported. The authors emphasized on the awareness for surveillance for adverse events following the vaccinations which was required in clinical trials and common adverse events were detected. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210910342-COVID-19 VACCINE AD26.COV2.S.- Remote branch retinal artery occlusion in left eye, acute macular neuroretinopathy. This events is considered not related. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative through media concerned a patient of unspecified age, sex, 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 in 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. The patient got vaccine 6 months ago (MAR-2021) and on 03-SEP-2021, the patient was found to have covid (suspected clinical vaccination failure and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000192350.; Sender's Comments: V0: 20210910659-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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Chills, Decreased appetite
Clinical narrative: ACHING ALL OVER/GENERAL PAIN; LOST TIME; PRESSURE IN MIDDLE OF BACK; VOMITING; FEVER; HEADACHE; NAUSEA; DIARRHEA; CHILLS; EXTREMELY WEAK; PAIN IN BACK; NO APPETITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, lost taste, and lost smell, and other pre-existing medical conditions included: Patient was on blood thinner for less than one day and her primary care physician (PCP) discontinued the blood thinner. Patient had family history of blood clot. The patient was previously treated with apixaban for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On APR-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) not reported. On JUL-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) 617, 0.50 (unit not reported). On SEP-2021, the patient experienced pain in back. On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced extremely weak. On 02-SEP-2021, the patient experienced aching all over/general pain. On 02-SEP-2021, the patient experienced lost time. On 02-SEP-2021, the patient experienced pressure in middle of back. On 02-SEP-2021, the patient experienced diarrhea. On 02-SEP-2021, the patient experienced vomiting. On 02-SEP-2021, the patient experienced fever. On 02-SEP-2021, the patient experienced headache. On 02-SEP-2021, the patient experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.1 (average). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost time, and chills on SEP-2021, was recovering from fever, vomiting, and headache, had not recovered from diarrhea, aching all over/general pain, pressure in middle of back, nausea, pain in back, and extremely weak, and the outcome of no appetite was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Disorientation, Fibrin D dimer increased, Headache
Clinical narrative: ACHING ALL OVER/GENERAL PAIN; LOST TIME; PRESSURE IN MIDDLE OF BACK; VOMITING; FEVER; HEADACHE; NAUSEA; DIARRHEA; CHILLS; EXTREMELY WEAK; PAIN IN BACK; NO APPETITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, lost taste, and lost smell, and other pre-existing medical conditions included: Patient was on blood thinner for less than one day and her primary care physician (PCP) discontinued the blood thinner. Patient had family history of blood clot. The patient was previously treated with apixaban for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On APR-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) not reported. On JUL-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) 617, 0.50 (unit not reported). On SEP-2021, the patient experienced pain in back. On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced extremely weak. On 02-SEP-2021, the patient experienced aching all over/general pain. On 02-SEP-2021, the patient experienced lost time. On 02-SEP-2021, the patient experienced pressure in middle of back. On 02-SEP-2021, the patient experienced diarrhea. On 02-SEP-2021, the patient experienced vomiting. On 02-SEP-2021, the patient experienced fever. On 02-SEP-2021, the patient experienced headache. On 02-SEP-2021, the patient experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.1 (average). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost time, and chills on SEP-2021, was recovering from fever, vomiting, and headache, had not recovered from diarrhea, aching all over/general pain, pressure in middle of back, nausea, pain in back, and extremely weak, and the outcome of no appetite was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: ACHING ALL OVER/GENERAL PAIN; LOST TIME; PRESSURE IN MIDDLE OF BACK; VOMITING; FEVER; HEADACHE; NAUSEA; DIARRHEA; CHILLS; EXTREMELY WEAK; PAIN IN BACK; NO APPETITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, lost taste, and lost smell, and other pre-existing medical conditions included: Patient was on blood thinner for less than one day and her primary care physician (PCP) discontinued the blood thinner. Patient had family history of blood clot. The patient was previously treated with apixaban for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On APR-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) not reported. On JUL-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) 617, 0.50 (unit not reported). On SEP-2021, the patient experienced pain in back. On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced extremely weak. On 02-SEP-2021, the patient experienced aching all over/general pain. On 02-SEP-2021, the patient experienced lost time. On 02-SEP-2021, the patient experienced pressure in middle of back. On 02-SEP-2021, the patient experienced diarrhea. On 02-SEP-2021, the patient experienced vomiting. On 02-SEP-2021, the patient experienced fever. On 02-SEP-2021, the patient experienced headache. On 02-SEP-2021, the patient experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.1 (average). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost time, and chills on SEP-2021, was recovering from fever, vomiting, and headache, had not recovered from diarrhea, aching all over/general pain, pressure in middle of back, nausea, pain in back, and extremely weak, and the outcome of no appetite was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown; expiry date UNKNOWN ) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient and his wife, both ended up with Covid and had mild symptoms. The patient was infected on day 3 ,of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210913172. This case was associated with Product Quality Complaint.; Sender's Comments: V0: 20210912838-Covid-19 vaccine ad26.cov2.-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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Pain in extremity
Clinical narrative: STROKE; SORE ARM; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke (transient ischemic attack), and concurrent conditions included: hypertension, tylenol and ibuprofen allergy (one was rash and the other one made him edgy) and he did not know which was which, marijuana drug abuse, patient had used a pot (marijuana) in the past and he still uses but not that frequently and not for pleasure, non alcohol user, and cigarette smoker. Patient used cigarettes as a teen and had used it off and on since then but after his stroke in 2016 he stopped smoking and now sometimes smokes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 13-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate, and lisinopril.  On 13-MAY-2021, the patient experienced sore arm and he mentioned that he could not recall any adverse events except a sore arm. The caller stated that 30 to 37 days later (not sure about the exact date) on 12-JUN-2021, patient had a stroke, patient got up up in the morning and felt crappy, Later he called ambulance and was transferred to the hospital, where they did computerized tomography (CT scan) and Magnetic resonance imaging (MRI) and patient diagnosed with stroke. On 12-JUN-2021 patient was hospitalized and he was there for 2 days and was transferred to the other center and he was there for 19 days. Patient still feels numb and weak, nothing like a sharp pain in the chest but his sensation was odd feeling like his skin was being in somebody else's body. He mentioned it felt like his body went to sleep. His leg had been numb (he used cane at the beginning but not anymore) but not to the degree that cannot walk but it was not easy to walk. Patient reported that he will see a neurologist and a cardiologist in future. It was notable that the patient could not recall the specific dates of hospitalization or other incidences. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0; 20210912862-Covid-19 vaccine ad26.cov2. s- stroke. 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: Medical History
Sex: F
Vaccine: COVID19
Symptoms: Anal fissure, Endometrial thickening, Postmenopausal haemorrhage
Clinical narrative: VAGINAL BLEEDING POST-MENOPAUSAL; ANAL FISSURE TEAR; THICKENED ENDOMETRIUM; This spontaneous report received from a patient concerned a 58 year old female 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 not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 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 thickened endometrium with vaginal bleeding post-menopausal which occurred 3 days after shot and anal fissure tear which occurred 10 days after shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anal fissure tear, vaginal bleeding post-menopausal, and thickened endometrium. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210912883-COVID-19 VACCINE AD26.COV2.S-vaginal bleeding post-menopausal. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: EXTREMELY ITCHY RED PATCHES ON SKIN WHICH SPREADS REALLY FAST; FEVER OVERNIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-MAY-2021, the patient experienced fever overnight. On an unspecified date, the patient experienced extremely itchy red patches on skin which spreads really fast. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever overnight on 31-MAY-2021, and had not recovered from extremely itchy red patches on skin which spreads really fast. This report was non-serious. This case, from the same reporter is linked to 20210708299, 20210738736 and 20210442576.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Pain, SARS-CoV-2 test
Clinical narrative: FLU LIKE SYMPTOMS; ACHES ALL OVER BODY; VACCINE KNOCKED DOWN FOR 3 WEEKS - DID NOT FEEL GOOD; BLACK DOTS IN BOTH EYES ALL OVER LIKE BUGS WERE POPPING UP; SEVERE HEADACHE LIKE HEAD WAS POPPING OFF SHOULDERS; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: coronary artery bypass graft surgery (cabg), and covid-19, and concurrent conditions included: penicillin allergy, anxiety, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAR-2021, the patient experienced severe headache like head was popping off shoulders. On 05-SEP-2021, the patient experienced black dots in both eyes all over like bugs were popping up. On an unspecified date, the patient experienced flu like symptoms, aches all over body, and vaccine knocked down for 3 weeks - did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black dots in both eyes all over like bugs were popping up, and severe headache like head was popping off shoulders, and the outcome of flu like symptoms, vaccine knocked down for 3 weeks - did not feel good and aches all over body was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913090 and 20210913421.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: FLU LIKE SYMPTOMS; ACHES ALL OVER BODY; VACCINE KNOCKED DOWN FOR 3 WEEKS - DID NOT FEEL GOOD; BLACK DOTS IN BOTH EYES ALL OVER LIKE BUGS WERE POPPING UP; SEVERE HEADACHE LIKE HEAD WAS POPPING OFF SHOULDERS; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: coronary artery bypass graft surgery (cabg), and covid-19, and concurrent conditions included: penicillin allergy, anxiety, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAR-2021, the patient experienced severe headache like head was popping off shoulders. On 05-SEP-2021, the patient experienced black dots in both eyes all over like bugs were popping up. On an unspecified date, the patient experienced flu like symptoms, aches all over body, and vaccine knocked down for 3 weeks - did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black dots in both eyes all over like bugs were popping up, and severe headache like head was popping off shoulders, and the outcome of flu like symptoms, vaccine knocked down for 3 weeks - did not feel good and aches all over body was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913090 and 20210913421.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: EXTREME MUSCLE ACHES IN THE BACK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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 patient experienced extreme muscle aches in the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme muscle aches in the back. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine was not applicable. The outcome of medication error was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a 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 covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on an unknown date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, on 28-AUG-2021 the patient was ended up getting corona virus disease (COVID). She seemed to have mild symptoms (suspected covid-19 infection and suspected clinical vaccination failure). She was on day 6 of symptoms. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210912838. This report was associated with product quality complaint: 90000192453.; Sender's Comments: V0. 20210913172-COVID-19 VACCINE Suspected clinical vaccine failure. This event is considered not related. The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Thrombosis
Clinical narrative: CLOTS WERE 4 INCHES LONG/BIG; PROFUSE NOSE BLEED; This spontaneous report received from a patient 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, frequency 1 total administered, 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 patient experienced profuse nose bleed a couple days after receiving the vaccine. The nosebleed lasted for 1 and 1/2 hours and had to go to the emergency department due to the amount of blood and length of time the patient nose was bleeding. At the emergency department cauterize was done in order to stop the bleed. The patient reported that clots were 4 inches long/big. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse nose bleed, and the outcome of clots were 4 inches long/big was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210913219-covid-19 vaccine ad26.cov2.s-clots were 4 inches long/big, profuse nose bleed. 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).