chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 via a social media 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. It was unknown if the patient had adverse events after 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 was not reported batch number: unknown, expiry: unknown) dose was not reported,1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in mid JAN-2022, the patient experienced mild case of Covid-19 and symptoms mild, sort of like head cold, lost taste for couple of weeks (suspected covid-19 infection) which led to suspected clinical vaccination failure (dose number in series 2). The reporter stated "Had JJ and booster last year. Got mild case of covid mid Jan. this year. Symptoms mild, sort of like head cold, lost taste smell for couple of weeks. Happy for this protection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000216212.; Sender's Comments: V0: 20220213377-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: F
Vaccine: COVID19
Symptoms: COVID-19, Contusion, Fatigue, Pain, Pruritus
Clinical narrative: GENERAL PAIN; ITCHY BODY; BRUISE IN RIGHT LEG; TIREDNESS; FEVER; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and hispanic or latino 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: 1805029, expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date after 10-15 days of vaccination consumer developed tiredness, general pain, itchy body, fever and a bruise in her right leg. Symptoms got better within a month. Then in June 2021 consumer lost taste and smell, had fever and shortness of breath for about 15 days, On an unspecified date in JUN-2021 confirming positive Covid-19 infection by antigen rapid test and PCR (polymerase chain reaction) (confirmed clinical vaccination failure, and confirmed covid-19 infection) done twice during that period of time. Consumer states that Janssen vaccine did not work for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, general pain, itchy body, bruise in right leg, and fever, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216307.; Sender's Comments: V0: 20220215382-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: GENERAL PAIN; ITCHY BODY; BRUISE IN RIGHT LEG; TIREDNESS; FEVER; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and hispanic or latino 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: 1805029, expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date after 10-15 days of vaccination consumer developed tiredness, general pain, itchy body, fever and a bruise in her right leg. Symptoms got better within a month. Then in June 2021 consumer lost taste and smell, had fever and shortness of breath for about 15 days, On an unspecified date in JUN-2021 confirming positive Covid-19 infection by antigen rapid test and PCR (polymerase chain reaction) (confirmed clinical vaccination failure, and confirmed covid-19 infection) done twice during that period of time. Consumer states that Janssen vaccine did not work for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, general pain, itchy body, bruise in right leg, and fever, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216307.; Sender's Comments: V0: 20220215382-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: DIED FROM COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via Social media through a company representative 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 covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient died from covid (coded to suspected covid-19 and suspected clinical vaccination failure). It was reported that "My younger brother died from covid in December. He was vaccinated. I contracted covid in 2020 and the Omicron variant two weeks ago. Each time the symptoms were similar to a mild cold. I have not been vaccinated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from covid in DEC-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000216369.; Sender's Comments: V0: 20220216139 - COVID-19 VACCINE AD26.COV2.S- Died from COVID. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  20220216139- 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; Reported Cause(s) of Death: COVID
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received 2 doses of covid-19 vaccine (Sanofi) (dose number in series 1) (form of admin, route of admin were not reported, batch number: VAT00002 and expiry: unknown) dose was not reported, administered on 26-FEB-2021 and 19-MAR-2021 for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine (Sanofi) (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: 043A21A and expiry: 19-SEP-2021) dose was not reported, 1 total administered on 10-SEP-2021 on left arm for prophylactic vaccination which was off label use (dose number in series 2) and inappropriate schedule of vaccine administered (dose number in series 2). No concomitant medications were reported. On 02-FEB-2022, the patient experienced confirmed covid-19 infection. On 03-FEB-2022, the patient tested positive using a Abbott home kit. On 07-FEB-2022, the patient went to clinic and got a PCR (Polymerase Chain Reaction) test done and it came back positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 61.0
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 patient concerned a 62 year old African American, Not Hispanic-Latino female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (previous to receiving the first Covid 19 dose), and concurrent conditions included: asthmatic, so problematic when had Covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A31A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, patient got Covid (omicron variant), real bad (suspected covid-19 infection and suspected clinical vaccination failure). Patient was scheduled for monoclonal antibodies, but could not find. Hence steroids were given. 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: 90000216498.; Sender's Comments: V0. 20220217797-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: M
Vaccine: COVID19
Symptoms: Ammonia, Blood iron, Cerebrovascular accident, Communication disorder, Confusional state
Clinical narrative: POSSIBLE BLEEDING ULCER; SUSPECTED LIVER DAMAGE; STROKE; UNABLE TO COMMUNICATE; SEVERE CONFUSION; This spontaneous report received from a consumer concerned a 34 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior history of any of the events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's parent reported that the last week, he was hospitalized because the patient was unable to communicate and had severe confusion. The blood work showed very high ammonia levels, low hemoglobin and iron. There might have been other results that she did not know about. A brain MRI (magnetic resonance imaging) showed two small infarctions which was mentioned as strokes that was unusual for someone his age. It was believed that the patient had liver damage, a possible bleeding ulcer where he required a blood transfusion. The patient had no prior history of any of these and seems unusual that three unrelated events happened at the same time. The patient had been discharged from the hospital and were awaiting for follow-up visits from the neurologist and GI (gastrointestinal). The number of days of hospitalization was not reported. Laboratory data (dates unspecified) included: Ammonia (NR: not provided) Very high, Hemoglobin (NR: not provided) Low, Iron (NR: not provided) Low, Lab test (NR: not provided) Not reported, and MRI brain (NR: not provided) 2 small infarctions (strokes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to communicate, severe confusion, suspected liver damage, stroke and possible bleeding ulcer was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220217887-COVID-19 VACCINE AD26.COV2.S-Possible bleeding ulcer,Suspected liver damage,Stroke,Unable to communicate,Severe confusion. 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: M
Vaccine: COVID19
Symptoms: Haemoglobin, Laboratory test, Liver injury, Magnetic resonance imaging head, Ulcer haemorrhage
Clinical narrative: POSSIBLE BLEEDING ULCER; SUSPECTED LIVER DAMAGE; STROKE; UNABLE TO COMMUNICATE; SEVERE CONFUSION; This spontaneous report received from a consumer concerned a 34 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior history of any of the events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's parent reported that the last week, he was hospitalized because the patient was unable to communicate and had severe confusion. The blood work showed very high ammonia levels, low hemoglobin and iron. There might have been other results that she did not know about. A brain MRI (magnetic resonance imaging) showed two small infarctions which was mentioned as strokes that was unusual for someone his age. It was believed that the patient had liver damage, a possible bleeding ulcer where he required a blood transfusion. The patient had no prior history of any of these and seems unusual that three unrelated events happened at the same time. The patient had been discharged from the hospital and were awaiting for follow-up visits from the neurologist and GI (gastrointestinal). The number of days of hospitalization was not reported. Laboratory data (dates unspecified) included: Ammonia (NR: not provided) Very high, Hemoglobin (NR: not provided) Low, Iron (NR: not provided) Low, Lab test (NR: not provided) Not reported, and MRI brain (NR: not provided) 2 small infarctions (strokes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to communicate, severe confusion, suspected liver damage, stroke and possible bleeding ulcer was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220217887-COVID-19 VACCINE AD26.COV2.S-Possible bleeding ulcer,Suspected liver damage,Stroke,Unable to communicate,Severe confusion. 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: M
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: COULD NOT WALK; LEGS HURT SO BAD FOR 3 DAYS; This spontaneous report received from social media a patient via a company representative concerned a male of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal arteriovenous malformation (AVM). 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced legs hurt so bad for 3 days, and could not walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs hurt so bad for 3 days, and the outcome of could not walk was not reported. This report was non-serious. This case, involving the same patient is linked to 20220222825 and 20220222831.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH AFTER A MONTH OF RECEIVING VACCINE; This spontaneous report received from a consumer via social media via a company representative concerned two male patients of unspecified age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, two patients died after a month of receiving vaccine due to unknown cause. The reporter stated that, "Our church has, had two young men. Die after a month of receiving the VAX. Mandatory to attend local college". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220220610-covid-19 vaccine ad26.cov2.s- Died after a month of receiving vaccine. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NEVER BEEN THE SAME; This spontaneous report received from a patient via a company representative from social media 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced never been the same. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of never been the same was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: blood clots. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient was very healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 blood clot. The reporter stated that, "I know a lady got J&J did within a week from blood clot and was very healthy before she got it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220220791-Covid-19 vaccine ad26.cov2.s-blood clot . 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).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 35 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, smoker (marijuana) and other pre-existing medical conditions included: The patient had nothing worth mentioning history, The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in OCT-2021, about 4 months after vaccination, the patient was diagnosed with clinically confirmed COVID-19 test (Confirmed Clinical Vaccination Failure) at doctor's office and the patient stated that it was not rapid test as he had to wait for a few hours but he did not remember exactly what kind of test it was. Patient stated that he chose Janssen vaccine because it is only one shot and he has bad response to needles (crying and shaking even hours after the shot) and also he mentioned that it is really embarrassing. He was little annoyed that he still got really sick with COVID-19 even after vaccination and spread it so easily to other family members. His other family members were vaccinated with different vaccine and his 3-year-old daughter was not vaccinated. Patient stated that he wears his mask religiously. He also stated he was sick for 2 weeks and needed 3 extra days from the 5 day's quarantine guidelines. Patient did not really remember when he got sick but he stated he was in quarantine on Halloween day. He also mentioned that he did not get sick as bad as his other family members. He and his unvaccinated 3-year-old daughter got it the least. Patient stated he is not and anti-vaxxer but he believes that COVID-19 vaccine is as effective as flu shot which is not really effective. Laboratory data included: COVID-19 virus test (NR: not provided) Positive COVID-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of Confirmed Clinical Vaccination Failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216622.; Sender's Comments: V0:20220220795- Covid-19 vaccine ad26.cov2.s- Confirmed 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
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: WORSENED NEUROPATHY; This spontaneous report received from a patient concerned a 73 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: on 21-FEB-2021 patient had neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration: unknown, batch number and expiry: unknown) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had worsened neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worsened neuropathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220221145-JANSSEN COVID-19 VACCINE Ad26.COV2.S- worsened neuropathy. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN ON  THE LEFT ARM WHERE HE GOT THE INJECTION; This spontaneous report received from a patient concerned a 73-year-old male. The patient's height, and weight were not reported. The patient did not have known drug allergies. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 for prophylactic vaccination at left arm. On 18-MAR-2021, the patient experienced pain on the left arm at site of injection for 2 to 3 hours (dose number in series 1). The patient recovered from pain on the left arm at site of injection. The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-NOV-2021 for prophylactic vaccination at left arm. No concomitant medications were reported.  On 11-NOV-2021, the patient experienced pain on the left arm where he got the injection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the left arm where he got the injection on 14-NOV-2021. This report was non-serious. This case, involving the same patient is linked to 20220222828.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN ON THE LEFT ARM AT SITE OF INJECTION FOR ONLY 2-3 HOURS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain on the left arm at site of injection for only 2-3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the left arm at site of injection for only 2-3 hours. This report was non-serious. This case, involving the same patient is linked to 20220221177.
Sex: M
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: ALMOST DIED; This spontaneous report received from a patient via social media  via company representative concerned a male of an 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, and expiry date: unknown) dose, start therapy date were not reported, 01 total was administered 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 (reporter's neighbour) experienced almost died, On an unspecified date, the patient got vaccine and he ended up in Intensive care unit (ICU) for almost 2 weeks. The patient stated that he will not get the booster and going to take his chances. It was reported by reporter that "My neighbour got the JJ vaccine. He ended up in ICU for almost 2 weeks. Almost died...he said he will not get the booster and going to take his chances". On an unspecified date he was hospitalized. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20220224229-COVID-19 VACCINE AD26.COV2.S-Almost died. 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: Adverse drug reaction
Clinical narrative: ADVERSE EFFECTS AND WERE SUFFERING; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced adverse effects and were suffering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effects and were suffering was not reported. This report was non-serious.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter reported that the vaccines were stored in freezer and they take out one to two vials and placed in fridge each day as needed.  No treatment medications were provided.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccines were stored in freezer and took out one to two vials and place in fridge each day as needed. No concomitant medications were reported. No treatment given.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vaccines were stored in freezer and one to two vials were taken out and placed in fridge each day as needed.  No treatment information was provided.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported. No treatment medications were provided. The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vaccine was stored in freezer, took out one to two vials and place in fridge each day as needed. Patient took booster shot.  No treatment medications were reported.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were stored in freezer and required vials were taken out to place in fridge as needed. No concomitant medications were provided by the reporter. No treatment given to patients.