chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLUR4, UNK
Symptoms: Bedridden, Cardiac disorder, Complex regional pain syndrome, Computerised tomogram, Condition aggravated
Clinical narrative: I was given the shingles in the office but never given a paper or asked if I had any heart issues. I had also had shingles over 36 at that time. I had asked the cdc before and they said it could help and with crps but no one mentioned not taking with pots. then I went downstairs and took flu. I immediately felt throat closing up and neck starting to break out in hives. A couple days later I went to ER because my heart meds had stopped working all night and we had to add an additional short acting one in the middle. Then twice in October I had stroke like incidents taken by EMS where full body went paralyzed. No one could figure out why these where happening. I also go shingles again multiple times but instead of staying on the lower half they now activate my nerves on face etc. I have had several Crps flares and because my ketamine infusion stopped working early they have now taken them away for good because they said they had never seen this reaction so they wanted to be "safe" but without the infusions I become completely bed bound.
Age: 50.0
Sex: F
Vaccine: FLUR4, UNK
Symptoms: Echocardiogram, Herpes zoster, Immediate post-injection reaction, Loss of therapeutic response, Magnetic resonance imaging
Clinical narrative: I was given the shingles in the office but never given a paper or asked if I had any heart issues. I had also had shingles over 36 at that time. I had asked the cdc before and they said it could help and with crps but no one mentioned not taking with pots. then I went downstairs and took flu. I immediately felt throat closing up and neck starting to break out in hives. A couple days later I went to ER because my heart meds had stopped working all night and we had to add an additional short acting one in the middle. Then twice in October I had stroke like incidents taken by EMS where full body went paralyzed. No one could figure out why these where happening. I also go shingles again multiple times but instead of staying on the lower half they now activate my nerves on face etc. I have had several Crps flares and because my ketamine infusion stopped working early they have now taken them away for good because they said they had never seen this reaction so they wanted to be "safe" but without the infusions I become completely bed bound.
Age: 50.0
Sex: F
Vaccine: FLUR4, UNK
Symptoms: Neurological symptom, Pain, Paralysis, Psychiatric evaluation, Throat tightness
Clinical narrative: I was given the shingles in the office but never given a paper or asked if I had any heart issues. I had also had shingles over 36 at that time. I had asked the cdc before and they said it could help and with crps but no one mentioned not taking with pots. then I went downstairs and took flu. I immediately felt throat closing up and neck starting to break out in hives. A couple days later I went to ER because my heart meds had stopped working all night and we had to add an additional short acting one in the middle. Then twice in October I had stroke like incidents taken by EMS where full body went paralyzed. No one could figure out why these where happening. I also go shingles again multiple times but instead of staying on the lower half they now activate my nerves on face etc. I have had several Crps flares and because my ketamine infusion stopped working early they have now taken them away for good because they said they had never seen this reaction so they wanted to be "safe" but without the infusions I become completely bed bound.
Age: 50.0
Sex: F
Vaccine: FLUR4, UNK
Symptoms: Urticaria, Visual impairment, X-ray
Clinical narrative: I was given the shingles in the office but never given a paper or asked if I had any heart issues. I had also had shingles over 36 at that time. I had asked the cdc before and they said it could help and with crps but no one mentioned not taking with pots. then I went downstairs and took flu. I immediately felt throat closing up and neck starting to break out in hives. A couple days later I went to ER because my heart meds had stopped working all night and we had to add an additional short acting one in the middle. Then twice in October I had stroke like incidents taken by EMS where full body went paralyzed. No one could figure out why these where happening. I also go shingles again multiple times but instead of staying on the lower half they now activate my nerves on face etc. I have had several Crps flares and because my ketamine infusion stopped working early they have now taken them away for good because they said they had never seen this reaction so they wanted to be "safe" but without the infusions I become completely bed bound.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent pfizer was given instead of bivalent pfizer. Will notify patient and offer bivalent in two months PCP has reviewed the chart
Age: 46.0
Sex: U
Vaccine: COVID19-2
Symptoms: Nausea, Pharyngeal swelling, Pruritus
Clinical narrative: Patient reported feeling nausea, itching, and throat swelling, EMS checked vitals and took patient
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Occult blood positive
Clinical narrative: 48 hours after vaccine child developed 15-20 watery stools per day. On third day diarrhea he had bloody diarrhea, which continues today.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22Ab) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 29th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22Ab) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 30th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22Ab) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    Vaccine administered after after 4 temperature excursions  No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 31th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 42nd of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 43rd of 43 adult patients described by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1118314) and via a company representative through social media concerned a 50 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: Addisons disease, and psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on 10-MAR-2021 for an unspecified indication. 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 14-MAR-2021, the patient died from unknown cause of death. An autopsy was performed on an unspecified date and the results were pending. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221252103-death.Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Gait disturbance, Hand fracture, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Within 24 hours his mind deteriorated and could not function very well.  He would just stand in oncoming traffic, hit street signs, walk barefoot and no coat in the cold, walk sideways or backward and could no longer play piano.   His boss asked us to pick him up because she feared he was going to run over by a car and this was the day after his shot.   Things just got worse by the day.  He hit a sign and broke his hand.  He tried to jump out of a moving car.  He was a danger to himself and others.  The first hospital was the Hospital, The second one was the hospital again, the 3rd hospital was hospital, the 4th hospital was hospital again .  The 5th hospital was Mental hospital,  The 6th place was the facility for 3 months!
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment
Clinical narrative: Within 24 hours his mind deteriorated and could not function very well.  He would just stand in oncoming traffic, hit street signs, walk barefoot and no coat in the cold, walk sideways or backward and could no longer play piano.   His boss asked us to pick him up because she feared he was going to run over by a car and this was the day after his shot.   Things just got worse by the day.  He hit a sign and broke his hand.  He tried to jump out of a moving car.  He was a danger to himself and others.  The first hospital was the Hospital, The second one was the hospital again, the 3rd hospital was hospital, the 4th hospital was hospital again .  The 5th hospital was Mental hospital,  The 6th place was the facility for 3 months!
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Patient became very fussy; Patient became very fussy and had erythema and swelling on the left thigh; Patient became very fussy and had erythema and swelling on the left thigh; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2420027-1. The original narrative from the sender is the following:  Approximately 3 hours after vaccines were administered, patient became very fussy and had erythema and swelling on the left thigh at the site of the PCV13 vaccine. Mom was able to soothe infant to sleep. Three hours later, the swelling and redness increased in size to about 3-5 inches in diameter, and infant was inconsolable. Mom gave tylenol and cool compress. Three hours later, the erythema and swelling had resolved.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient became very fussy, and had erythema and swelling on the left thigh".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: Patient became very fussy; Patient became very fussy and had erythema and swelling on the left thigh; Patient became very fussy and had erythema and swelling on the left thigh; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2420027-1. The original narrative from the sender is the following:  Approximately 3 hours after vaccines were administered, patient became very fussy and had erythema and swelling on the left thigh at the site of the PCV13 vaccine. Mom was able to soothe infant to sleep. Three hours later, the swelling and redness increased in size to about 3-5 inches in diameter, and infant was inconsolable. Mom gave tylenol and cool compress. Three hours later, the erythema and swelling had resolved.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient became very fussy, and had erythema and swelling on the left thigh".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC13, DTPPVHBHPB, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: patient was given Vaxelis and Hib on the same day.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2452297-1. The original narrative from the sender is the following:  Patient was given Vaxelis and Hib on the same day. Patient had no adverse reaction or side effects. Dr. did speak with patient's mother regarding the event.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given Vaxelis and Hib on the same day".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC13, DTPPVHBHPB, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given Vaxelis and Hib on the same day.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2452297-1. The original narrative from the sender is the following:  Patient was given Vaxelis and Hib on the same day. Patient had no adverse reaction or side effects. Dr. did speak with patient's mother regarding the event.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given Vaxelis and Hib on the same day".  No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: chest pain; dyspnea; exercise intolerance; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (20Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 at 15:00 as dose 1, single (Lot number: FK9729) at the age of 20 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerance". The events "chest pain", "dyspnea" and "exercise intolerance" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, exercise tolerance decreased.  Additional information: Began expressing chest pain, dyspnea, exercise intolerance, Visit to name, cardiologist all non-diagnostic-told to rest and take NSAIDS. 10 months post vaccine still have some chest pains, less greatest and less intense.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Glomerular filtration rate normal, Inflammation, Laboratory test normal
Clinical narrative: chest pain; dyspnea; exercise intolerance; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (20Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 at 15:00 as dose 1, single (Lot number: FK9729) at the age of 20 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerance". The events "chest pain", "dyspnea" and "exercise intolerance" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, exercise tolerance decreased.  Additional information: Began expressing chest pain, dyspnea, exercise intolerance, Visit to name, cardiologist all non-diagnostic-told to rest and take NSAIDS. 10 months post vaccine still have some chest pains, less greatest and less intense.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin normal, Urine analysis normal
Clinical narrative: chest pain; dyspnea; exercise intolerance; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (20Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 at 15:00 as dose 1, single (Lot number: FK9729) at the age of 20 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerance". The events "chest pain", "dyspnea" and "exercise intolerance" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, exercise tolerance decreased.  Additional information: Began expressing chest pain, dyspnea, exercise intolerance, Visit to name, cardiologist all non-diagnostic-told to rest and take NSAIDS. 10 months post vaccine still have some chest pains, less greatest and less intense.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Chest scan, Dyspnoea, EGFR status assay
Clinical narrative: chest pain; dyspnea; exercise intolerance; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (20Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 at 15:00 as dose 1, single (Lot number: FK9729) at the age of 20 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerance". The events "chest pain", "dyspnea" and "exercise intolerance" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, exercise tolerance decreased.  Additional information: Began expressing chest pain, dyspnea, exercise intolerance, Visit to name, cardiologist all non-diagnostic-told to rest and take NSAIDS. 10 months post vaccine still have some chest pains, less greatest and less intense.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Exercise tolerance decreased, Metabolic function test, SARS-CoV-2 test, Troponin
Clinical narrative: chest pain; dyspnea; exercise intolerance; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (20Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 at 15:00 as dose 1, single (Lot number: FK9729) at the age of 20 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerance". The events "chest pain", "dyspnea" and "exercise intolerance" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, exercise tolerance decreased.  Additional information: Began expressing chest pain, dyspnea, exercise intolerance, Visit to name, cardiologist all non-diagnostic-told to rest and take NSAIDS. 10 months post vaccine still have some chest pains, less greatest and less intense.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered
Clinical narrative: Rotateq vaccine expired 09-04-22; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2464571-1. The original narrative from the sender is the following:  Rotateq vaccine expired 09-04-22.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Rotateq vaccine expired 09-04-22".  No further information is expected.  Notes: Based on the available information, the events were not related to Vaxelis but to Rotateq vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Rotateq vaccine expired 09-04-22; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2464571-1. The original narrative from the sender is the following:  Rotateq vaccine expired 09-04-22.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Rotateq vaccine expired 09-04-22".  No further information is expected.  Notes: Based on the available information, the events were not related to Vaxelis but to Rotateq vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Age: 68.0
Sex: M
Vaccine: COVID19, PPV, COVID19, PPV
Symptoms: Incorrect product formulation administered
Clinical narrative: Ordered Pneumococcal 20 and patient actually given Pneumococcal 23
Age: 68.0
Sex: M
Vaccine: COVID19, PPV, COVID19, PPV
Symptoms: Wrong product administered
Clinical narrative: Ordered Pneumococcal 20 and patient actually given Pneumococcal 23
Age: 52.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Anaemia, Blood test, Computerised tomogram head, Condition aggravated, Essential hypertension
Clinical narrative: Started having weakness in both legs and muscle cramps on 11-8-22. Then tingling in hands and feet which moved up her extremities.  She saw her PCP on 11-11-22, Dr for a regular visit and reported her symptoms. Pt does not have insurance until 1-1-2023.  Since Dr retired, she went to the Community Health and saw, FNP on 12-2-22. Was told if her symptoms worsened then  she should go the the ER.  On 12-7-22, she went to the ER and a CAT scan was done. On 12-11-22, she was admitted to Hospital and was in-patient until the 17th. She saw a neurologist, Dr and ortho, Dr from hospital. She received a week of IV steroids.  She presently is using a walker to walk and still does not have feeling in limbs.  She was told this was a spinal inflammation and she also has partial paralysis in her torso. MRI and labs were done. She stated the MS was ruled out. She is waiting until she has insurance beginning 1-1-2023 to get second opinions and do more follow-up. She stated she has never had any type of reaction to any vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Hypoaesthesia, Inflammation, Magnetic resonance imaging, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Started having weakness in both legs and muscle cramps on 11-8-22. Then tingling in hands and feet which moved up her extremities.  She saw her PCP on 11-11-22, Dr for a regular visit and reported her symptoms. Pt does not have insurance until 1-1-2023.  Since Dr retired, she went to the Community Health and saw, FNP on 12-2-22. Was told if her symptoms worsened then  she should go the the ER.  On 12-7-22, she went to the ER and a CAT scan was done. On 12-11-22, she was admitted to Hospital and was in-patient until the 17th. She saw a neurologist, Dr and ortho, Dr from hospital. She received a week of IV steroids.  She presently is using a walker to walk and still does not have feeling in limbs.  She was told this was a spinal inflammation and she also has partial paralysis in her torso. MRI and labs were done. She stated the MS was ruled out. She is waiting until she has insurance beginning 1-1-2023 to get second opinions and do more follow-up. She stated she has never had any type of reaction to any vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Reflexes abnormal, Spinal cord compression, Vitamin B12 decreased
Clinical narrative: Started having weakness in both legs and muscle cramps on 11-8-22. Then tingling in hands and feet which moved up her extremities.  She saw her PCP on 11-11-22, Dr for a regular visit and reported her symptoms. Pt does not have insurance until 1-1-2023.  Since Dr retired, she went to the Community Health and saw, FNP on 12-2-22. Was told if her symptoms worsened then  she should go the the ER.  On 12-7-22, she went to the ER and a CAT scan was done. On 12-11-22, she was admitted to Hospital and was in-patient until the 17th. She saw a neurologist, Dr and ortho, Dr from hospital. She received a week of IV steroids.  She presently is using a walker to walk and still does not have feeling in limbs.  She was told this was a spinal inflammation and she also has partial paralysis in her torso. MRI and labs were done. She stated the MS was ruled out. She is waiting until she has insurance beginning 1-1-2023 to get second opinions and do more follow-up. She stated she has never had any type of reaction to any vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Computerised tomogram, Inflammation, Laboratory test, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Started having weakness in both legs and muscle cramps on 11-8-22. Then tingling in hands and feet which moved up her extremities.  She saw her PCP on 11-11-22, Dr for a regular visit and reported her symptoms. Pt does not have insurance until 1-1-2023.  Since Dr retired, she went to the Community Health and saw, FNP on 12-2-22. Was told if her symptoms worsened then  she should go the the ER.  On 12-7-22, she went to the ER and a CAT scan was done. On 12-11-22, she was admitted to Hospital and was in-patient until the 17th. She saw a neurologist, Dr and ortho, Dr from hospital. She received a week of IV steroids.  She presently is using a walker to walk and still does not have feeling in limbs.  She was told this was a spinal inflammation and she also has partial paralysis in her torso. MRI and labs were done. She stated the MS was ruled out. She is waiting until she has insurance beginning 1-1-2023 to get second opinions and do more follow-up. She stated she has never had any type of reaction to any vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Muscular weakness, Paraesthesia, Paralysis, Sensory loss, Walking aid user
Clinical narrative: Started having weakness in both legs and muscle cramps on 11-8-22. Then tingling in hands and feet which moved up her extremities.  She saw her PCP on 11-11-22, Dr for a regular visit and reported her symptoms. Pt does not have insurance until 1-1-2023.  Since Dr retired, she went to the Community Health and saw, FNP on 12-2-22. Was told if her symptoms worsened then  she should go the the ER.  On 12-7-22, she went to the ER and a CAT scan was done. On 12-11-22, she was admitted to Hospital and was in-patient until the 17th. She saw a neurologist, Dr and ortho, Dr from hospital. She received a week of IV steroids.  She presently is using a walker to walk and still does not have feeling in limbs.  She was told this was a spinal inflammation and she also has partial paralysis in her torso. MRI and labs were done. She stated the MS was ruled out. She is waiting until she has insurance beginning 1-1-2023 to get second opinions and do more follow-up. She stated she has never had any type of reaction to any vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Hyponatraemia, Influenza virus test positive, Respiratory syncytial virus test positive, SARS-CoV-2 test positive
Clinical narrative: Date of Admission: 11/29/2022 Date of Discharge: 12/6/2022   Active Hospital Problems   Diagnosis o CHF (congestive heart failure), Class I, acute on chronic, combined  o Hematoma of arm, left, initial encounter o Hyponatremia o Hypothyroidism o CKD 3b o CHF o PAF o HLD o CAD- CABG 7/16 o HTN
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Date of Admission: 11/29/2022 Date of Discharge: 12/6/2022   Active Hospital Problems   Diagnosis o CHF (congestive heart failure), Class I, acute on chronic, combined  o Hematoma of arm, left, initial encounter o Hyponatremia o Hypothyroidism o CKD 3b o CHF o PAF o HLD o CAD- CABG 7/16 o HTN
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure acute, Cardiac failure chronic, Cardiac failure congestive, Chronic kidney disease
Clinical narrative: Date of Admission: 11/29/2022 Date of Discharge: 12/6/2022   Active Hospital Problems   Diagnosis o CHF (congestive heart failure), Class I, acute on chronic, combined  o Hematoma of arm, left, initial encounter o Hyponatremia o Hypothyroidism o CKD 3b o CHF o PAF o HLD o CAD- CABG 7/16 o HTN
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Coronary artery bypass, Coronary artery disease, Haematoma, Hyperlipidaemia, Hypertension
Clinical narrative: Date of Admission: 11/29/2022 Date of Discharge: 12/6/2022   Active Hospital Problems   Diagnosis o CHF (congestive heart failure), Class I, acute on chronic, combined  o Hematoma of arm, left, initial encounter o Hyponatremia o Hypothyroidism o CKD 3b o CHF o PAF o HLD o CAD- CABG 7/16 o HTN
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hyponatraemia, Hypothyroidism, SARS-CoV-2 test
Clinical narrative: Date of Admission: 11/29/2022 Date of Discharge: 12/6/2022   Active Hospital Problems   Diagnosis o CHF (congestive heart failure), Class I, acute on chronic, combined  o Hematoma of arm, left, initial encounter o Hyponatremia o Hypothyroidism o CKD 3b o CHF o PAF o HLD o CAD- CABG 7/16 o HTN
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Vaccine coordinator reporting the administration of improperly stored VARIVAX. See Temperature Excursion case 02298756. No PQC reported.   ?    Names of vaccines involved: VARIVAX (W018830 06/14/2024)         ?    Temperature: -5C         ?; This spontaneous report has been received from a vaccine coordinator, concerning 12-month-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On an unknown date, the varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # W018830 experienced a temperature excursion of -5 grades Celsius (C) for a time frame of 12 hours, 0 minutes and 0 seconds. No previous temperature excursion reported, if a digital data logger was involved was not reported (product storage error).   Consequently, on 01-DEC-2022, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, (lot# W018830 confirmed to be valid, expiration date reported and stablished as 14-JUN-2024) administered as prophylaxis (strength, exact dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient age was reported as 69 years 4 months. No concomitant and treatment medication were reported.