chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the 30 days BUD of December 1, 2022.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the 30 day BUD date of December 1, 2022
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the 30 day BUD date of December 1, 2022
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the 30 day BUD date of December 1, 2022.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
Sex: M
Vaccine: UNK
Symptoms: Death
Clinical narrative: found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. Reporter stated that another friend of his, brother in law, his nephew got the booster shot and found dead Christmas morning. No treatment medicine were reported.  Company comment.  This fatal spontaneous case concerns a male patient (unknown age), with medical history of diabetes mellitus, who received a booster dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the unexpected, serious (medically significant and fatal) event of death. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report mentioned the patient got the booster shot and was found dead. He died on an unknown date. It is unknown if an autopsy was performed. No further information regarding the event and cause of death have been provided. Patient´s mentioned medical history could be considered as a confounding factor for the fatal outcome. The benefit  risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-692839 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This fatal spontaneous case concerns a male patient (unknown age), with medical history of diabetes mellitus, who received a booster dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the unexpected, serious (medically significant and fatal) event of death. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report mentioned the patient got the booster shot and was found dead. He died on an unknown date. It is unknown if an autopsy was performed. No further information regarding the event and cause of death have been provided. Patient´s mentioned medical history could be considered as a confounding factor for the fatal outcome. The benefit  risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-692839:Original Case : MOD-2022-692839; Reported Cause(s) of Death: Unknown cause of death
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac imaging procedure abnormal, Cardiac monitoring abnormal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation
Clinical narrative: Presented to ED on 5/15/21 with chest pain (onset 1 day prior), elevated troponins and diffuse ST elevations concerning for pericarditis vs myocarditis admitted for cardiac monitoring and evaluation. Troponins peaked at 4.91. He had an echo that showed normal cardiac function, an MRI that indicated normal ventricular size and function, with minimal or healing and inflammation or mild myocarditis. Diagnosed with myopericarditis likely secondary to the immuno response from the second COVID vaccine. Hospitalized 5/15/21-5/18/21. Currently follows up with pediatric cardiologist as outpatient.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Myopericarditis, Troponin increased
Clinical narrative: Presented to ED on 5/15/21 with chest pain (onset 1 day prior), elevated troponins and diffuse ST elevations concerning for pericarditis vs myocarditis admitted for cardiac monitoring and evaluation. Troponins peaked at 4.91. He had an echo that showed normal cardiac function, an MRI that indicated normal ventricular size and function, with minimal or healing and inflammation or mild myocarditis. Diagnosed with myopericarditis likely secondary to the immuno response from the second COVID vaccine. Hospitalized 5/15/21-5/18/21. Currently follows up with pediatric cardiologist as outpatient.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Laboratory test
Clinical narrative: Hemorrhagic stroke 4 days after 1st dose.
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Unknown vaccine product administered
Clinical narrative: 3 children were partially vaccinated either on MMR II or PROQUAD; No additional AE reported; This spontaneous report was received from a Company Representative and refers to a child patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was partially vaccinated either with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). No additional adverse events reported.   This is one of 3 reports from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: 1st dose -28Jun2022,2nd dose- 4Aug2022; only experienced sore arm with the previous 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -28Jun2022,2nd dose- 4Aug2022) and MYALGIA (only experienced sore arm with the previous 2 doses) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B, AS1416B and AR9237B) for COVID-19 prophylaxis.     no known conditions such as relevant medical history/conditions, allergy, concomitant diseases and risk factor.    On 28-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -28Jun2022,2nd dose- 4Aug2022) and MYALGIA (only experienced sore arm with the previous 2 doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -28Jun2022,2nd dose- 4Aug2022) and MYALGIA (only experienced sore arm with the previous 2 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. The patient not received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided. Patient did not experienced any symptoms so far.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Aggravated psoriasis, still elevated after 3 month
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Chest pain, Echocardiogram, Fear, Herpes zoster
Clinical narrative: Within a couple weeks I developed shingles on my abnomen and I still have subsequent nerve pain. Most importantly and most concerning is the consistent chest pain since having the vaccine. It has been persistent to the point where I recieved EMS transport from work because the of the chest pain. I still have them to this day. It is incresingly worse if I'm involved with strenuous activities such as fire deparment and ems related tasks, as well as working out trying to stay fit and healthy. This pain is sharp and i can feel it all throughout the day. With research linking multiple deaths and other health concerns I am sincerly afriad that I'm going to suffer a cardiac event or that I'm developing blood clots.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuralgia
Clinical narrative: Within a couple weeks I developed shingles on my abnomen and I still have subsequent nerve pain. Most importantly and most concerning is the consistent chest pain since having the vaccine. It has been persistent to the point where I recieved EMS transport from work because the of the chest pain. I still have them to this day. It is incresingly worse if I'm involved with strenuous activities such as fire deparment and ems related tasks, as well as working out trying to stay fit and healthy. This pain is sharp and i can feel it all throughout the day. With research linking multiple deaths and other health concerns I am sincerly afriad that I'm going to suffer a cardiac event or that I'm developing blood clots.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got my flu shot n still got the flu, 3rd year on a row n bad; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who received INFLUENZA VACCINE. and  still got the flu, 3rd year on a row and bad.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient received INFLUENZA VACCINE. and  still got the flu, 3rd year on a rowand bad (influenza) (unknown latency).  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: fluzone high-dose quadrivalent was administered post excursion with no reported adverse events; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received via pharmacist.  This case involves a 65 years old male patient who was diagnosed with fluzone high-dose quadrivalent was administered post excursion with no reported adverse events after receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza quadrival a-b high dose hv vaccine at a dose of 0.5 ml (strength, frequency, formulation: unknown)(batch number: UJ918AD, Expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization  On 28-Dec-2022 the patient diagnosed with a non-serious event of fluzone high-dose quadrivalent was administered post excursion with no reported adverse events (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Found dead Christmas morning; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Found dead Christmas morning) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes mellitus.    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. Death occurred on 25-Dec-2022 The patient died on 25-Dec-2022. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that a coworker experienced the Same thing. A diabetic, he got the booster shot and was found dead Christmas morning.  Company commnent: This spontaneous case concerns a patient of unknown age and gender with medical history of diabetes mellitus, who experienced the unexpected, serious (fatal and medically significant) event of death. The event occurred an unknown time after a dose of mRNA-1273.222. Cause of death was not reported (unknown). Information regarding clinical evaluation, autopsy report, diagnostic tests, concomitant medications, and treatment provided has not been disclosed. The medical history of diabetes mellitus is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with medical history of diabetes mellitus, who experienced the unexpected, serious (fatal and medically significant) event of death. The event occurred an unknown time after a dose of mRNA-1273.222. Cause of death was not reported (unknown). Information regarding clinical evaluation, autopsy report, diagnostic tests, concomitant medications, and treatment provided has not been disclosed. The medical history of diabetes mellitus is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu badly; Initial information was received on 01-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of  patient who experienced flu badly after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed a non-serious event of flu badly (influenza) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu badly).  At time of reporting, the outcome was Unknown for the event flu badly.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: fluzone high dose quadrivalent being administered post excursion with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient who had vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] high dose quadrivalent being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2022, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ924AC and expiry date: 06-Jun-2023) via intramuscular route in left deltoid for immunisation.  On 28-Dec-2022 the patient developed a non-serious fluzone high dose quadrivalent being administered post excursion with no reported adverse event (poor quality product administered)(latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial had been punctured on Wednesday 2:00 PM on 28DEC2022.Bivalent Dose administered today 30DEC2022), PRODUCT STORAGE ERROR (Stored in the refrigerator between initial vial puncture and dosing administration) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1) in 2021, MODERNA COVID-19 VACCINE (Dose 2) in 2021, MODERNA COVID-19 VACCINE (1st Moderna booster (lot number 032H21A and expiration date 24MAR2022)) on 21-Dec-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.     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 adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vial had been punctured on Wednesday 2:00 PM on 28DEC2022.Bivalent Dose administered today 30DEC2022) and PRODUCT STORAGE ERROR (Stored in the refrigerator between initial vial puncture and dosing administration).    No concomitant medications were reported.    No treatment medications were reported.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia influenzal
Clinical narrative: got the flu with pneumonia; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social media serious case from a consumer/non-health care professional.  This case involves an unknown age and gender patient who got the flu with pneumonia after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient got the flu with pneumonia (pneumonia influenzal) (unknown latency) following the administration of influenza vaccine.   The patient was hospitalized for this event.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.  Seriousness criteria:  medically significant event pneumonia influenzal.; Sender's Comments: Sanofi company comment dated 03-Jan-2023: This case concerns an unknown age and gender patient who got the flu with pneumonia after receiving vaccine Influenza Vaccine. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, other concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based on information provided, the causal role of company suspect cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal, Influenza
Clinical narrative: 1st one in 15 I got flu; feeling funny; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age male patient who experienced flu and feeling funny after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Oseltamivir Phosphate (Tamiflu) for Immunisation.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (with dose, pharmaceutical form, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed non-serious 1st one in 15 i got flu (influenza) and feeling funny (feeling abnormal) (unknown latency) following the administration of Influenza Vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for both the events.   At time of reporting, the outcome was Recovering / Resolving for both the events.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: was administered the separate Hib component of the Pentacel vaccine reconstituted with an unknown diluent, without the DTaP-IPV component with no AE; was administered the separate Hib component of the Pentacel vaccine reconstituted with an unknown diluent, without the DTaP-IPV component with no AE; Initial information received on 29-Dec-2022 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves a patient of unknown age and gender who was administered the separate hib component of the diphtheria/tetanus/5 hybrid AC pertussis /IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was administered an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis /IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (strength - unknown, frequency - once, lot - UJ678AAA and expiry date -09-Sep-2023) via unknown route in unknown administration site for immunization.  On an unknown date the patient was administered the separate hib component of the pentacel vaccine reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event (product preparation error) (single component of a two-component product administered) (unknown latency)   Reportedly, HCP stated that they discovered a box of Pentacel that still had the DTaP-IPV component, but the Hib component had been removed and administered to a patient. HCP stated that they do not know the date this happened, and they do not know which child was administered the separate Hib component of the Pentacel vaccine, without the DTaP-IPV component. They also do not know with what type of diluent the Hib component of the Pentacel vaccine was reconstituted with, prior to administration. HCP stated that they do not know which child received the Hib component of the Pentacel vaccine, but they have narrowed it down to five children, any one of whom may be the one that received the Hib component of the Pentacel vaccine, mixed with an unknown diluent. These five candidates range in age from 6 months old to 4 years old.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: The pt fainted for a few seconds and recovered. Parents were on seen and told me that it happenned to her before. i gave her benadryl just in case. patient apreared to me very stressed from her mom watching her dusring the vaccination process and laughing at her. i gave her benadryl just in case and watched her for 25 min. she said nothing hurts and everything normal
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient states he got dizzy and suddenly blacked out. He fell over from his chair, shaking, and sweating. We helped him up and he being responsive again immediately. Had patient sit at the pharmacy for 30-40 minutes to monitor patient. Had him drink water and cranberry juice and he states that it helped his lightheadedness go away. He became fine after 30-40 mins of observation. I will be calling patient back the next day to check up on him
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient states he got dizzy and suddenly blacked out. He fell over from his chair, shaking, and sweating. We helped him up and he being responsive again immediately. Had patient sit at the pharmacy for 30-40 minutes to monitor patient. Had him drink water and cranberry juice and he states that it helped his lightheadedness go away. He became fine after 30-40 mins of observation. I will be calling patient back the next day to check up on him
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 6:05pm  - BP 92/60 hr 71 patient reports feeling dizzy and flused, alert and oriented X4  6:20pm - BP 95/64 hr 81 - no longer reports feeling dizzy - alert and oriented x4 laughing with father and drinking water, walks out to waiting room and sits with dad  6:30pm BP 99/64  hr 81 - denies dizziness and all symptoms. Alert and oriented x 4
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Fall, Head injury, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium, Additional Details: Patient faited approximately 5 minutes after receiving flu shot. He hit is head on the counter and fell to the floor. He appeared slightly confused initially. He was taken to the immunization room to wait for paramedics. After about 10 minutes, he vomited. Paramedics took over care shortly after.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium, Additional Details: Patient faited approximately 5 minutes after receiving flu shot. He hit is head on the counter and fell to the floor. He appeared slightly confused initially. He was taken to the immunization room to wait for paramedics. After about 10 minutes, he vomited. Paramedics took over care shortly after.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Genital erythema, Pruritus, Pruritus genital, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient reports immense redness and itching on bilaterla sites of hands breasts, and genitals, took 1 week to resolve, wrapped hands and used benadryl
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall, Lip haemorrhage, Lip injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: MOM SAYS HE HAS HISTORY OF FAINTING AFTER VACCINES-Severe, Additional Details: MOM SAYS HE HAS A HISTORY OF FAINTING AFTER VACCINES. SHE DID NOT TELL IMMUNIZING PHARMACIST BEFOREHAND, ONLY AFTER I FOUND PATIENT LYING IN THE AISLE, RESPONSIVE, BIT LIP DURING FALL SO A LITTLE BLOODIED. I ASKED MOM IF HE HAS A HISTORY OF THIS AND SHE SAID YES HE HAS FAINTED AFTER A VACCINE BEFORE. SHE DID NOT TELL ME OF ANY ISSUES BEFOREHAND. EMS CALLED, ARRIVED, PATIENT STABILIZED AND TRANSPORTED TO ER. ATTEMPTED TO FOLLOW UP TODAY BUT NO RESPONSE OR CALL BACK FROM PROFILED NUMBER.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT HAD ALREADY ADMINISTERED THE BIVALENT VACCINE ON 10/06/2022.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Cough, Echocardiogram normal, Hyponatraemia
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/26/2022 Discharge Date: Dec 29, 2022 COVID positive 12/26/2022 PRESENTING PROBLEM: Syncope and collapse [R55] Hypoxemia [R09.02] Hyponatremia [E87.1] COVID [U07.1] Transient loss of consciousness [R55]   HOSPITAL COURSE: Patient is a 85 yo male with PMH of right ureteral obstruction with suprapubic catheter, TIA, SIADH, essential HTN and COPD. He presented to the ED after having 2 separate instance of transient loss of consciousness which had been preceded by 2 days of congested cough and fever.  In the ED patient tested positive for COVID-19 and was noted to be hypoxic with ambulation and was admitted to the medicine service.   # Transient LOC Secondary to Hypoxia Due to COVID-19 CXR was obtained in the ED without acute cardiopulmonary process. He was started on Decadron and Remdesivir and placed on pharmacological VTE prophylaxis. Patient had no further episodes of TLOC or hypoxia. Cardiac echo was obtained to help rule out other causes and was largely unremarkable. CTA thorax was not pursed as PE was felt low on differential given lack of tachycardia and quick resolution of symptoms with steroid therapy. He was discharged on Decadron to complete therapy to prevent rebound of symptoms
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Loss of consciousness, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/26/2022 Discharge Date: Dec 29, 2022 COVID positive 12/26/2022 PRESENTING PROBLEM: Syncope and collapse [R55] Hypoxemia [R09.02] Hyponatremia [E87.1] COVID [U07.1] Transient loss of consciousness [R55]   HOSPITAL COURSE: Patient is a 85 yo male with PMH of right ureteral obstruction with suprapubic catheter, TIA, SIADH, essential HTN and COPD. He presented to the ED after having 2 separate instance of transient loss of consciousness which had been preceded by 2 days of congested cough and fever.  In the ED patient tested positive for COVID-19 and was noted to be hypoxic with ambulation and was admitted to the medicine service.   # Transient LOC Secondary to Hypoxia Due to COVID-19 CXR was obtained in the ED without acute cardiopulmonary process. He was started on Decadron and Remdesivir and placed on pharmacological VTE prophylaxis. Patient had no further episodes of TLOC or hypoxia. Cardiac echo was obtained to help rule out other causes and was largely unremarkable. CTA thorax was not pursed as PE was felt low on differential given lack of tachycardia and quick resolution of symptoms with steroid therapy. He was discharged on Decadron to complete therapy to prevent rebound of symptoms
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/26/2022 Discharge Date: Dec 29, 2022 COVID positive 12/26/2022 PRESENTING PROBLEM: Syncope and collapse [R55] Hypoxemia [R09.02] Hyponatremia [E87.1] COVID [U07.1] Transient loss of consciousness [R55]   HOSPITAL COURSE: Patient is a 85 yo male with PMH of right ureteral obstruction with suprapubic catheter, TIA, SIADH, essential HTN and COPD. He presented to the ED after having 2 separate instance of transient loss of consciousness which had been preceded by 2 days of congested cough and fever.  In the ED patient tested positive for COVID-19 and was noted to be hypoxic with ambulation and was admitted to the medicine service.   # Transient LOC Secondary to Hypoxia Due to COVID-19 CXR was obtained in the ED without acute cardiopulmonary process. He was started on Decadron and Remdesivir and placed on pharmacological VTE prophylaxis. Patient had no further episodes of TLOC or hypoxia. Cardiac echo was obtained to help rule out other causes and was largely unremarkable. CTA thorax was not pursed as PE was felt low on differential given lack of tachycardia and quick resolution of symptoms with steroid therapy. He was discharged on Decadron to complete therapy to prevent rebound of symptoms
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient had administered the vaccine on 10/11/2022. He did not communicate it.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram, Angiogram pulmonary abnormal, Anticoagulant therapy, Asymptomatic COVID-19, Chest pain
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/26/2022 Discharge Date: Dec 28, 2022 COVID positive Date: 12/26/2022  PRESENTING PROBLEM: Bilateral pulmonary embolism [I26.99] Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type [I26.99]   HOSPITAL COURSE: Pt is 89 y/o male with past medical history of diastolic heart failure, CAD, stroke, HLD, HTN, left sided carotid artery disease, permanent afib, prostate cancer w/ recurrence and LN involvement undergoing radiation therapy who presented with shortness of breath and found to have small bilateral PE and found to be positive for COVID 19. In ED, pt VSS on RA. CBC and CMP largely unremarkable. CTA thorax/abd/pelvis showed small bilateral non-occlusive PE w/o right heart strain. He was started on heparin and admitted for further treatment.    Following admission pt was maintained on heparin drip. Echo was obtained showing LVEF 55%, basal to mid inferior wall segment w/ moderate hypokinesis, no note of right heart strain. This was discussed with cardiology who notes this is not a significant change from prior. High sensitivity troponin were negative on admission and chest pain resolved.  BLE US was negative for DVT. Hematology was consulted as pt was on pradaxa when PE occurred. Hematology did not feel true failure given known infection and small clot burden. He was transitioned to lovenox to complete 5 day bridge before resuming pradaxa. He will follow up with hematology otpt. He remained asymptomatic from COVID standpoint. Pt was able to ambulate independently and did not have any desaturations. He was instructed on giving lovenox injections. He was discharged home in stable condition on 12/28.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen, Dyspnoea, Echocardiogram abnormal, Ejection fraction, Full blood count normal
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/26/2022 Discharge Date: Dec 28, 2022 COVID positive Date: 12/26/2022  PRESENTING PROBLEM: Bilateral pulmonary embolism [I26.99] Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type [I26.99]   HOSPITAL COURSE: Pt is 89 y/o male with past medical history of diastolic heart failure, CAD, stroke, HLD, HTN, left sided carotid artery disease, permanent afib, prostate cancer w/ recurrence and LN involvement undergoing radiation therapy who presented with shortness of breath and found to have small bilateral PE and found to be positive for COVID 19. In ED, pt VSS on RA. CBC and CMP largely unremarkable. CTA thorax/abd/pelvis showed small bilateral non-occlusive PE w/o right heart strain. He was started on heparin and admitted for further treatment.    Following admission pt was maintained on heparin drip. Echo was obtained showing LVEF 55%, basal to mid inferior wall segment w/ moderate hypokinesis, no note of right heart strain. This was discussed with cardiology who notes this is not a significant change from prior. High sensitivity troponin were negative on admission and chest pain resolved.  BLE US was negative for DVT. Hematology was consulted as pt was on pradaxa when PE occurred. Hematology did not feel true failure given known infection and small clot burden. He was transitioned to lovenox to complete 5 day bridge before resuming pradaxa. He will follow up with hematology otpt. He remained asymptomatic from COVID standpoint. Pt was able to ambulate independently and did not have any desaturations. He was instructed on giving lovenox injections. He was discharged home in stable condition on 12/28.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypokinesia, Infection, Metabolic function test normal, Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/26/2022 Discharge Date: Dec 28, 2022 COVID positive Date: 12/26/2022  PRESENTING PROBLEM: Bilateral pulmonary embolism [I26.99] Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type [I26.99]   HOSPITAL COURSE: Pt is 89 y/o male with past medical history of diastolic heart failure, CAD, stroke, HLD, HTN, left sided carotid artery disease, permanent afib, prostate cancer w/ recurrence and LN involvement undergoing radiation therapy who presented with shortness of breath and found to have small bilateral PE and found to be positive for COVID 19. In ED, pt VSS on RA. CBC and CMP largely unremarkable. CTA thorax/abd/pelvis showed small bilateral non-occlusive PE w/o right heart strain. He was started on heparin and admitted for further treatment.    Following admission pt was maintained on heparin drip. Echo was obtained showing LVEF 55%, basal to mid inferior wall segment w/ moderate hypokinesis, no note of right heart strain. This was discussed with cardiology who notes this is not a significant change from prior. High sensitivity troponin were negative on admission and chest pain resolved.  BLE US was negative for DVT. Hematology was consulted as pt was on pradaxa when PE occurred. Hematology did not feel true failure given known infection and small clot burden. He was transitioned to lovenox to complete 5 day bridge before resuming pradaxa. He will follow up with hematology otpt. He remained asymptomatic from COVID standpoint. Pt was able to ambulate independently and did not have any desaturations. He was instructed on giving lovenox injections. He was discharged home in stable condition on 12/28.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin normal, Ultrasound Doppler normal
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/26/2022 Discharge Date: Dec 28, 2022 COVID positive Date: 12/26/2022  PRESENTING PROBLEM: Bilateral pulmonary embolism [I26.99] Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type [I26.99]   HOSPITAL COURSE: Pt is 89 y/o male with past medical history of diastolic heart failure, CAD, stroke, HLD, HTN, left sided carotid artery disease, permanent afib, prostate cancer w/ recurrence and LN involvement undergoing radiation therapy who presented with shortness of breath and found to have small bilateral PE and found to be positive for COVID 19. In ED, pt VSS on RA. CBC and CMP largely unremarkable. CTA thorax/abd/pelvis showed small bilateral non-occlusive PE w/o right heart strain. He was started on heparin and admitted for further treatment.    Following admission pt was maintained on heparin drip. Echo was obtained showing LVEF 55%, basal to mid inferior wall segment w/ moderate hypokinesis, no note of right heart strain. This was discussed with cardiology who notes this is not a significant change from prior. High sensitivity troponin were negative on admission and chest pain resolved.  BLE US was negative for DVT. Hematology was consulted as pt was on pradaxa when PE occurred. Hematology did not feel true failure given known infection and small clot burden. He was transitioned to lovenox to complete 5 day bridge before resuming pradaxa. He will follow up with hematology otpt. He remained asymptomatic from COVID standpoint. Pt was able to ambulate independently and did not have any desaturations. He was instructed on giving lovenox injections. He was discharged home in stable condition on 12/28.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 12/23/20, 1/13/21, 12/17/21, 8/3/22. Positive on 1/3/23
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient admitted 11/10-12/19; transferred to Specialty Hospital 12/19-12/27 and came to Medical Center on 12/29 as a direct admit.  She tested positive for COVID 12/22/22 and died 12/30/22.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Patient admitted 11/10-12/19; transferred to Specialty Hospital 12/19-12/27 and came to Medical Center on 12/29 as a direct admit.  She tested positive for COVID 12/22/22 and died 12/30/22.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 11/18/21, Moderna 2/22/21, 3/25/21. Positive on 1/2/23
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/1/21, 3/1/21, 12/2/21. Positive on 12/31/22
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Generalised tonic-clonic seizure, Intensive care, Laboratory test
Clinical narrative: Two  tonic-clonic seizures just hours before receiving second dose of the vaccine, exactly 21 days after the first dose.   development of epilepsy, no previous history of seizures.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case