chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max temperature reached: 8-11°C on 04Oct2023 for 8 hours and 30 minutes with no adverse event; vaccine administered to a patient post-excursion with no adverse event; Initial information was received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2023SA361896 2023SA358554.  This case involves a 5 years old female to whom IPV (VERO) [IPOL] was administered to a patient post-excursion with no adverse event and max temperature reached: 8-11°c on 04-Oct-2023 for 8 hours and 30 minutes with no adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Oct-2023, the patient received a  dose of suspect IPV (VERO) ,Suspension for injection max temperature reached: 8-11°c on 04oct2023 for 8 hours and 30 minutes with no adverse event (product storage error) (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 09-Oct-2023, the IPV (VERO) vaccine was administered to a patient post-excursion with no adverse event (poor quality product administered) (latency same day).  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: 0.42
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: pentacel exposed to 8-11°C upto 8 hours and 30 minutes which was caused by human error with no reported adverse event; vaccine being administered to a patient post-excursion with no reported adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 months old male patient whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] being administered post-excursion  which was exposed to 8-11°c upto 8 hours and 30 minutes which was caused by human error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the Pentacel exposed to 8-11°c upto 8 hours and 30 minutes which was caused by human error with no reported adverse event (product storage error).   On 17-Oct-2023, the patient received unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization post-excursion with no reported adverse event (poor quality product administered) (latency on same day).  Information on the batch number was requested   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: 0.5
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max temperature reached: 8-11°C on 04Oct2023 for 8 hours and 30 minutes with no adverse event; vaccine administered to a patient post-excursion with no adverse event; Initial information was received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2023SA358554 and 2023SA362445.  This case involves a 6 months old female to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered to a patient post-excursion with no adverse event and max temperature reached: 8-11°c on 04-Oct-2023 for 8 hours and 30 minutes with no adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE,Suspension for injection max temperature reached: 8-11°c on 04oct2023 for 8 hours and 30 minutes with no adverse event (product storage error) (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for routine prophylactic vaccination.  On 20-Oct-2023, the pentacle vaccine was administered to a patient post-excursion with no adverse event (poor quality product administered) (latency same day).  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: 1.0
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: received 2 doses of fluzone qiv started having hives; Initial information was received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old and unknown gender patient who  received 2 doses of influenza quadrival A-B vaccine [Fluzone QIV] and started having hives.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknow dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and and received 2 doses of fluzone qiv started having hives (urticaria) (latency: 3 days).  The information on the batch number was requested.  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: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Blood bilirubin increased, Blood lactic acid, COVID-19, Catheter site erythema
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Computerised tomogram abdomen normal, Condition aggravated, Cough, Culture negative
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Culture urine positive, Diagnostic aspiration, Eosinophil count increased, Haemodialysis, Hepatic cirrhosis
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging abdominal abnormal, Medical device change, Nitrite urine absent, Perinephric abscess, Perinephric collection
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Post procedural drainage, Pyrexia, Pyuria, Red blood cells urine positive, Renal cyst
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Renal haematoma, SARS-CoV-2 test positive, Scan with contrast abnormal, Staphylococcus test positive, Streptococcus test positive
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urine analysis abnormal, White blood cell count normal, White blood cells urine positive
Clinical narrative: no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Patient came in around noon today and mentioned that her neck and arm were swollen from the Prevnar Vaccine. She also encountered itchiness, redness, and body aches. She went to Urgent Care and her PCP for this situation. Patient is all better now. This all happened in October and recovered by the end of October. Patient did not indicate any allergies on vaccine form, but was notified today that she is allergic to penicillin and Prevnar (updated in profile).
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 11/22/23 Employee has denied taking FLU shot for the season 2023 at the time of FLU vaccine administration at 0815. Employee was monitored for 15 mins after administration. At the time of documentation, I found an entry for season 2023 in the database. I contacted employee to confirm the FLU shot. Employee admitted having previously taken the FLU shot before on 9/12/2023 with hospital and employee stated she thought this is the updated series. I asked employee if she is feeling ok ? Employee stated she is feeling fine no adverse or serious symptoms stated at the time of call at 1400. Employee educated to seek immediate medical care and call 911 if severe reaction or adverse reaction occurs. Educated employee about FLU shot that should be taken once every season per year. Supervisor notified.
Age: 16.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Deafness, Dizziness, Ear discomfort, Loss of consciousness, Muscle twitching
Clinical narrative: After getting meningococcal ACWY (along with influenza) vaccines, complained of ears feeling plugged, couldn?t hear, dizzy, felt like he was spinning before passing out and twitching. Once came to, then threw up and vision was blurry. Turned pale.
Age: 16.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pallor, Vertigo, Vision blurred, Vomiting
Clinical narrative: After getting meningococcal ACWY (along with influenza) vaccines, complained of ears feeling plugged, couldn?t hear, dizzy, felt like he was spinning before passing out and twitching. Once came to, then threw up and vision was blurry. Turned pale.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase normal, Amylase normal, Aspartate aminotransferase normal, Blood albumin decreased
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood fibrinogen, Blood glucose normal
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium decreased, Blood urea nitrogen/creatinine ratio increased, C-reactive protein increased, COVID-19
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Chest X-ray abnormal, Cough, Full blood count, Haematocrit normal
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin normal, International normalised ratio, Lymphocyte count normal, Lymphocyte percentage decreased, Malaise
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell volume normal, Metabolic function test, Neutrophil count increased, Neutrophil percentage increased, Platelet count increased
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Procalcitonin, Prothrombin time, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Patient presented to the ED on 11/3/2023 with complaints of cough, vomiting, and fever x 2 days.  Father reported 'he got more sick after flu and COVID booster'.  Tested negative for COVID on 10/31/23.
Age: 69.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Patient experienced erythema > 100mm along the left arm which was warm to the touch. Erythema first appeared approximately 16 hours after receiving vaccinations, with pain at injection site still present 2 days later, but improving from previous day
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Insomnia, Nausea
Clinical narrative: Immediately after vaccine began feeling blood pressure problems (low blood pressure, feeling faint, had to lay down,  worsened/didn't feel like it got better with rest; nausea and vomiting; unable to sleep overnight. Symptoms worsened over first 8 hours and felt pretty rough overnight. Began to ebb at 24 hours. This continued for 36-48 hours
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Immediately after vaccine began feeling blood pressure problems (low blood pressure, feeling faint, had to lay down,  worsened/didn't feel like it got better with rest; nausea and vomiting; unable to sleep overnight. Symptoms worsened over first 8 hours and felt pretty rough overnight. Began to ebb at 24 hours. This continued for 36-48 hours
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Cerebrovascular accident
Clinical narrative: Pt had an acute stroke 1 hour after treatment
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event, Product administration error
Clinical narrative: no reaction, pregnant at time of injection when this vaccine should not be given to anyone currently pregnant.
Age: 16.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Confusional state, Fall, Loss of consciousness, Nausea, Vomiting
Clinical narrative: The patient received the 2 vaccines and then walked to the waiting area and sat down.  Within 5 minutes he lost consciousness and slid to the floor.  I did not witness this directly, but the patient's father did. The father told me that the patient slowly lay down on the empty seat next to him and then slid to the floor.  By the time we reached him (about 15 feet) he had started to regain consciousness and push himself into a sitting position.  He was confused for a moment, but it passed.  We kept him on the floor with his father supporting him. A quick look revealed no obvious injury from the fall, and he denied any pain.  After one to two minutes he said that he was nauseous, and then he vomited intermittently over the next three to four minutes.  It was not a large volume overall. He asked for some water and he slowly drank most of a 16 oz bottle over the next 5 minutes. We kept him seated on the floor for about ten minutes, and then back in the chair for about another five. He left with his parents and under their care.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Analgesic drug level therapeutic, Angiogram pulmonary normal, Blood pH normal, Brain natriuretic peptide normal, COVID-19
Clinical narrative: Patient presented to the ED on 10/19/23 complaining of cough and congestion x 3 days.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Full blood count normal, PCO2 normal
Clinical narrative: Patient presented to the ED on 10/19/23 complaining of cough and congestion x 3 days.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Tachypnoea, Troponin normal
Clinical narrative: Patient presented to the ED on 10/19/23 complaining of cough and congestion x 3 days.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Both shots administered in upper L arm around shoulder joint.  Flu shot injected in front - very painful in shoulder - not like usual shot discomfort.  Later that night, left arm totally froze up.  Have gradually been able to increase my range of motion but still experiencing pain when I use my left arm - especially with cross body motion.  Unsure if my loss of range of motion is a short term or permanent issue.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Joint range of motion decreased, Limb injury, Pain
Clinical narrative: Both shots administered in upper L arm around shoulder joint.  Flu shot injected in front - very painful in shoulder - not like usual shot discomfort.  Later that night, left arm totally froze up.  Have gradually been able to increase my range of motion but still experiencing pain when I use my left arm - especially with cross body motion.  Unsure if my loss of range of motion is a short term or permanent issue.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Periarthritis
Clinical narrative: Both shots administered in upper L arm around shoulder joint.  Flu shot injected in front - very painful in shoulder - not like usual shot discomfort.  Later that night, left arm totally froze up.  Have gradually been able to increase my range of motion but still experiencing pain when I use my left arm - especially with cross body motion.  Unsure if my loss of range of motion is a short term or permanent issue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient experienced injection site reaction (red, swollen injection site) and unbearable pain
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash
Clinical narrative: Injection site looked like a wound that had healed, similar to a mole and on 11/20/23 she developed a rash.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Bell's palsy
Clinical narrative: patient was diagnosed with bells palsy with in days of receiving flu and covid shots.  came to pharmacy today to ask if we should report this.  She reports that she has had flu shots for years without out event, whereas this is only her 3rd or 4th covid shot.  She still has some signs of Bell's Palsy, but states it is improving.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient reported to AHOLD claims department, who then contacted the pharmacist that he has had severe pain in his left deltoid pain after his flu vaccine. The claims department informed that he stated he is already receiving treatment from an orthopedist and possibly physical therapy.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: The patient presented to Clinic stating she would like to receive an RSV vaccination as she was currently pregnant. Myself, a nurse practitioner, brought the patient back to the room and verified her name, date of birth, and the intended vaccination requesting to be received. Patient verified all information and stated she needed the RSV vaccination. I accidently mixed up the names of the RSV vaccinations and therefor the patient was accidently given Arexvy vaccination instead of Abrysvo vaccination. I was unaware of the incident until I was recently contacted by my manager on 11/14/23 who discovered the mistake. I have attempted to contact patient via telephone with no answer. HIPAA-safe voicemail was left by myself asking patient to return call to clinic at earliest convenience with a brief reason for call explained. Clinic telephone number provided. At the current time of submitting this form, I have not yet made contact with patient to explain what happened and see if any adverse reactions occurred.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: The patient presented to medical Clinic with mother stating she would like for patient to receive an influenza vaccination as well as a Covid-19 booster vaccination. Myself, a nurse practitioner, brought the mother and patient back to the clinic room and verified name, date of birth, and intended vaccinations requested. Patient and mother verified all information. I accidently mixed up the patient's birthdate due to reading numbers incorrectly and thought patient was 12+ years old. Because of this, the patient accidently received the Covid-19 booster intended for age 12+ instead of the appropriate dose intended for an 11 year old patient. I was unaware of the mistake until I was recently contacted by my manager on 11/14/23 after the mistake was discovered.  I have attempted to contact patient's mother via telephone with no answer. safe voicemail was left by myself asking to return call to clinic at earliest convenience with a brief reason for call explained. Clinic telephone number provided. At the current time of submitting this form, I have not yet made contact with patient's mother to explain what happened and see if any adverse reactions have occurred.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased
Clinical narrative: Loss of ability to lift left arm while maintaining fine motor function in hand
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Tachycardia
Clinical narrative: pt started to have tachycardia the night of into the following morning
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Loud tinnitus developed in right ear day after I received my vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Death, Neoplasm, Perivascular epithelioid cell tumour, Sarcoma
Clinical narrative: Neoplasm. Scarcoma, Picoma rare cancer.  Death.
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Rash, Rash pruritic
Clinical narrative: 3 days after receiving vaccine, patient broke out in an itchy bumpy rash along his chest, stomach, neck, and back. After a few days it seemed to resolve, then came back. He reported it to me today (2 weeks after immunization) and still had visible bumps on his neck. His wife had the same reaction.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Rash pruritic
Clinical narrative: 3 days after receiving the vaccination, patient broke out in an itchy bumpy rash on her chest/back/neck. It lasted a few days then seemed to be resolving, but returned and is still present. Husband had the same reaction to the same vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever of up to 103.7, lasting through today (3.5+ days) Body aches Arm tenderness at injection site
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hypoaesthesia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever up to 102, severe chills, arm pain, muscle aches for 24 hours after vaccine. All resolved, with only acetaminophen for treatment. However, now I have numbness mostly in my fingertips, but also some numbness in hand on the right side. I do have arthritis, so it might be related to arthritis in the wrist and not the vaccine.  I know I got a quadrivalent flu shot, but do not know the manufacturer and just picked the first one. I did not receive any paperwork in hand from store, I registered to receive the shot online.  I have never had a reaction to a flu shot previously. I have received them each year since 1990 and never had more than a little sore arm and maybe felt a little bit bad for a day. This shot kicked me to the curb!
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immediate post-injection reaction, Influenza like illness, Injection site erythema
Clinical narrative: Injection site itchy almost immediately followed by redness  swelling, heat and pain at injection site that hasn't subsided. Followed within hours by flu-like symptoms.. nausea, chills, achy, and the worst headache I've ever had which is saying a lot because I suffer from chronic migraine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Injection site itchy almost immediately followed by redness  swelling, heat and pain at injection site that hasn't subsided. Followed within hours by flu-like symptoms.. nausea, chills, achy, and the worst headache I've ever had which is saying a lot because I suffer from chronic migraine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Injection site itchy almost immediately followed by redness  swelling, heat and pain at injection site that hasn't subsided. Followed within hours by flu-like symptoms.. nausea, chills, achy, and the worst headache I've ever had which is saying a lot because I suffer from chronic migraine.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Error_Patient was given proquad versus given mmr & varicella seperatly based on his age. No reaction to the vaccine
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Sleep disorder, Tenderness
Clinical narrative: On left arm, Red swelling, about 3 inches wide by 1.5 inches high. Warm & very tender to touch.  Wakes me up at night if I roll onto that arm. Taking 800 mg ibuprofen every 8 hours to relieve some tenderness.  I?ve never had a reaction like this to any vaccine nor my previous Covid-19 shots & boosters (all by Pfizer)
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination error
Clinical narrative: On 10/31/23, a 9yo patient received 0.5mL of the COVID Moderna Vaccine for 6mo-11yo as dose #4 (instead of the intended 0.25mL) due to the misunderstanding that the vial had no more than 0.25mL. This is reported as a vaccination dose error.
Age: 70.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Wrong patient received product
Clinical narrative: Nurse administering vaccine gave the patient the vaccine 2 COVID vaccines. 1 was meant for the patient and 1 one set aside for another patient. Pt felt no adverse effects at the time of the vaccination and during the monitoring period.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN ADULT DOSE OF PFIZER COMIRNATY
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN ADULT DOSE OF PFIZER COMIRNATY
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Musculoskeletal stiffness
Clinical narrative: Reported Symptoms:  10003988:BACK PAIN;  10040617:SHOULDER PAIN; 10042043:STIFF NECK;    Narrative: Pt. stated that he received the Spikevax last 10/18/23. Pt. stated that after 6-7 days after the shot, he started having a stiff neck, severe upper back pain, and severe headache. Pt.  stated that he did not go to the ER at that time. Pt. stated that he called his PCP and was given Methocarbamol 750mg last Friday 10/27/23. Pt. stated  that his symptoms started to subside yesterday. Pt. stated that he still has a headache, rates pain a 3 out of ten. Pt. stated that the pain on his back is all gone. Pt. stated that he has no more stiffness in his neck. Pt/ was advised to  go to the nearest ER with a driver today for evaluation. Pt. refused to go to  the ER.  Other Relevant HX: Other: tiff neck, upper back and shoulder pain
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Reported Symptoms:  10028322:MUSCLE PAIN;    Narrative:   Other Relevant HX:   Other:  MUSCLE PAIN
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradycardia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Reported Symptoms: 10006093:BRADYCARDIA; 10038678:RESPIRATORY DEPRESSION; 10043088:TACHYPNEA; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: PFIZER 12/13/2021, 03/04/2021, 02/09/2021 Admitted 9/8/2022, DX: covid pna with hypoxemia, symptomatic bradycardia. Discharged 9/11/2022 with PO ABX azithromycin and cefdinir to complete PNA treatment Other Relevant HX: Recent COVID-19 infection August 19th 2022. Admitted on 9/8/2022 with COVID PNA with hypoxemia and bradycardia Other: covid-19 infection
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Hypoxia, Pyrexia
Clinical narrative: Reported Symptoms: 10006093:BRADYCARDIA; 10038678:RESPIRATORY DEPRESSION; 10043088:TACHYPNEA; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: PFIZER 12/13/2021, 03/04/2021, 02/09/2021 Admitted 9/8/2022, DX: covid pna with hypoxemia, symptomatic bradycardia. Discharged 9/11/2022 with PO ABX azithromycin and cefdinir to complete PNA treatment Other Relevant HX: Recent COVID-19 infection August 19th 2022. Admitted on 9/8/2022 with COVID PNA with hypoxemia and bradycardia Other: covid-19 infection
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory depression, SARS-CoV-2 test, SARS-CoV-2 test positive, Staphylococcus test negative, Tachypnoea
Clinical narrative: Reported Symptoms: 10006093:BRADYCARDIA; 10038678:RESPIRATORY DEPRESSION; 10043088:TACHYPNEA; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: PFIZER 12/13/2021, 03/04/2021, 02/09/2021 Admitted 9/8/2022, DX: covid pna with hypoxemia, symptomatic bradycardia. Discharged 9/11/2022 with PO ABX azithromycin and cefdinir to complete PNA treatment Other Relevant HX: Recent COVID-19 infection August 19th 2022. Admitted on 9/8/2022 with COVID PNA with hypoxemia and bradycardia Other: covid-19 infection
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Reported Symptoms:  100084401:COVID-19 RESPIRATORY INFECTION; Narrative: Patient admitted for alternate reason and found COVID on ED screening. Symptomatic treatment and issue
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Investigation
Clinical narrative: Reported Symptoms:  10084401: COVID-19  RESPIRATORY INFECTION; Narrative:  Patient diagnosed on admission screen.  No specific treatment required.  Other Relevant HX:  Other:
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Reported Symptoms: 10043607:THROMBOSIS; Narrative: Patient refused COVID-19 Pfizer Bivalent COVID-19 Booster 30 mcg/0.3 ml dose reporting "The last one I had nearly killed me. I had a blood clot in my right arm from. I will never get another one again." Last documented COVID-19 Pfizer vaccine was administered in 10/15/2021 Other Relevant HX: