chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered/no AE; Initial information received on 15-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 53 years old female patient who received expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Apr-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA expired on 03-Aug-2020 via unknown route in unknown administration site.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was noted.  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 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: F
Vaccine: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received Tenivac instead of Adacel/no AE; Initial information received on 15-Apr-2020 regarding an unsolicited valid non-serious case received from a other health professional   This case involves a 11 years old female patient who experienced received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] Prefilled Syringe for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 04-Dec-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6101AA via intramuscular route in the left deltoid.  It was of actual medication error due to Wrong vaccine administered.  At the time of reporting, no adverse event was noted.  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 Directive and Module VI of the 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.  The patient outcome is reported as Not Applicable for received tenivac instead of adacel/no ae.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inadvertently given Dtap-IVP portion of Pentacel and not the HIB portion/no AE; Initial information received on 16-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who inadvertently given DTAP-IVP portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and not the HIB portion(product preparation issue) On 16-APR-2020 for prophylactic vaccination at the left thigh via intramuscularly [batch number U66AB and expiry date 30-APR-2021]. Batch number and expiry date of DTAP and HIB was reported as U66AB,UJ207ABA and 30-APR-2021, 30-APR-2021 respectively.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Inappropriate reconstitution technique.  At the time of report no adverse event was reported.  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 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: 1.67
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: diluent portion of ActHib that was used for the dose had expired/no AE; Initial information received on 16-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case involves a 20 months old female patient who received expired diluent containing vaccine HIB (PRP/T) VACCINE [ACT-HIB] which was later realized. (PT: Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and HEPATITIS A VACCINE (HEPATITIS A).  On 15-Apr-2020, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE via unknown route in the left thigh for prophylactic vaccination. Powder portion lot, UI990AA expiry 30-Oct-2020 and Diluent portion was U6193AA expiry 01-Apr-2020. The caller stated the carton had the same lot and expiry as the diluent portion.  It was of actual medication error due to Expired product used. The caller stated that it did not seem right to her that the product would be packaged with different expiration dates for different portions. She stated that the product should not be packaged such that the diluent portion expires earlier than the HIB powder portion, as was the case in this instance.  It was unknown whether adverse event was experienced or not.  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 Directive and Module VI of the 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: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 months old received fluzone quadriovalent/no AE; Initial information received on 16-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  It was reported that 4 months old male received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product administered to patient of inappropriate age) on 16-APR-2020 for prophylactic vaccination via intramuscularly[batch number UT6653BA and expiry date 30-JUN-2020].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) ; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) ; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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 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: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip oedema, Lip pruritus, Mouth ulceration, Oral pustule
Clinical narrative: My first dose in 12/2019 I got ulcers in my mouth. I had to go to a urgent care due to Christmas holidays. Valtrex prescribed. It helped. I received the second dose in March 2020. About 1 week later I started with lip pustules. After 2-3 days I had upper lip edema and itching to my lips. No difficulty breathing. I had a virtual visit due to the weekend and Covid. Prescribed Medtol dose pack. It did help .
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase normal, Blood creatinine increased
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Blood immunoglobulin M normal, Blood magnesium normal, Blood potassium decreased, Blood urea normal, Brain natriuretic peptide normal
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: C-reactive protein normal, Chest X-ray normal, Chest pain, Computerised tomogram thorax normal, Cough
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Cytomegalovirus test negative, Dyspnoea, Echocardiogram normal, Ejection fraction normal, Electrocardiogram abnormal
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Fibrin normal, Full blood count, Herpes simplex test negative, Influenza virus test negative, Lipids normal
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Myocarditis, Neutrophil count increased, Painful respiration, Parvovirus B19 test negative, Pleuritic pain
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Polymerase chain reaction, Red blood cell sedimentation rate normal, Respiratory syncytial virus test negative, Right atrial enlargement, Sinus arrhythmia
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Sinus tachycardia, Tachycardia, Troponin I increased, Wheezing, White blood cell count increased
Clinical narrative: The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Loss of consciousness, Nausea
Clinical narrative: with in 1 hour pt  c/o  queasiness, weak, fever, and  chills.  Lack of appetite and at one point passed out and vomited.  Pt now feels well again.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: with in 1 hour pt  c/o  queasiness, weak, fever, and  chills.  Lack of appetite and at one point passed out and vomited.  Pt now feels well again.
Age: 33.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Ear pain, Headache, Hyperacusis, Oropharyngeal pain, Tenderness
Clinical narrative: About 2pm the same day I had sharp, right ear pain as well as sore throat pain. Intermittent ear pain continued that night and also developed pain at the top of head towards the right side. Took Excedrin and Claritin. Ear pain continued intermittently the next day. Headache worsened and mostly in the right side. Jaw tender to touch. Throat pain not severe. No difficulty swallowing. Took Ibuprofen which relieved pain temporarily. Took Claritin in the evening again. Pain subsided on Sunday. Right ear sensitive to loud sounds.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: pain and soreness in upper shoulder area, pt stating she does not have full range of motion in left arm. some weakness. Still ongoing 1 month after receiving vaccine
Age: 0.17
Sex: F
Vaccine: FLU4, PNC
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered the Fluzone Quadrivalent to a 2 months old instead of prevnar/no ae; inadvertently administered the Fluzone Quadrivalent to a 2 months old instead of prevnar/no ae; nurse preparing the product withdrew a Fluzone Quadrivalent dose from a "blue box", where Prevnar is also stored and inadvertently administered the Fluzone Quadrivalent/no AE; nurse preparing the product withdrew a Fluzone Quadrivalent dose from a "blue box", where Prevnar is also stored and inadvertently administered the Fluzone Quadrivalent/no AE; Initial information received on 15-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)  (PREVNAR). (PT: Product administered to patient of inappropriate age, Wrong product administered, Product selection error, Product commingling)  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 15-Apr-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6713LA via intramuscular route in the right thigh.  It was of actual medication error due to Inappropriate age at vaccine administration, Wrong vaccine administered, Wrong product selected, Wrong product and correct product in same container. On 15 APR 2020, a nurse reported a 2 month old female patient was expected to receive a dose of Prevnar. The nurse preparing the product withdrew a Fluzone Quadrivalent dose from a "blue box", where Prevnar is also stored and inadvertently administered the Fluzone Quadrivalent.  It was unknown whether adverse event was noted.  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 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: 45.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, Injection site pain
Clinical narrative: hurt when the injection was given; Patient was administered with the dose of expired vaccine; Initial information was received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 45 years old male patient who experienced hurt when the injection was given (Vaccination site pain), while he received expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included JAPANESE ENCEPHALITIS VACCINE INACT (IXIARO) for immunisation.  On 16-Apr-2020, the patient received a 1 mL booster dose of suspect RABIES (HDC) VACCINE (lot N1L132M and expiry date 14-Nov-2019) via unknown route in the right deltoid for prophylactic vaccination  (pre-exposure prophylaxis).  On 16-Apr-2020, the patient developed a non-serious hurt when the injection was given (vaccination site pain) on same day following the administration of RABIES (HDC) VACCINE.  It was also an actual medication error case due to expired vaccine used. The response was injection of an expired or poorly stored vaccine.  No laboratory data was reported.  Final diagnosis was vaccination site pain.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of  vaccination site pain.  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 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: 20.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting and sore arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: arm soreness and chest tightness x 3 wks.  Both symptoms started the evening after getting the 2nd shingrix that afternoon.  the arm soreness has resolved.  chest tightness has been constant x 3 wks but is getting better.  no treatment needed
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: rash; allergic reaction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 68 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 04-APR-2017, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported). As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 11-APR-2017, patient was caused to suffer an allergic reaction and rash, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, patient was caused to suffer serious and dangerous side effects including an allergic reaction and rash, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, patient requires and/or will require more health care and services and did incur medical, health, she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, patient suffered an allergic reaction and rash and other related health complications. In addition, patient requires and will continue to require healthcare and services. Patient has incurred and will continue to incur medical and related expenses. Patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Patient's direct medical losses and costs include physician care, monitoring, and treatment. Patient has incurred and will continue to incur mental and physical pain and suffering. The outcome of rash and hypersensitivity was reported as not recovered/not resolved. The reporter considered rash and hypersensitivity to be related to Zoster Vaccine Live (ZOSTAVAX).     Allergic reaction and rash were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: Post-Herpetic; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On or about 19-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered from a painful blistering rash. As a result of these symptoms, patient was seen and treated by medical providers and was diagnosed with shingles and post herpetic neuralgia (reported as post-herpetic). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia and herpes zoster was reported as not recovered/not resolved. The reporter considered post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Shingles and post herpetic neuralgia were considered to be disabling.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Injection site erythema, Injection site induration, Injection site pain, Product complaint
Clinical narrative: the medication squirted out the left side from the base of the pre-filled Influenza syringe; Product Complaint; nurse was not exposed to the liquid, but the patient was; Patient had a 0.5-inch hardened mass; 1.5-inch redness on her left deltoid; pain at the injection site; half of the immunization was still in the syringe / did not appear to be administered into her left deltoid; This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number TG729, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 2nd March 2020, the patient received FluLaval Tetra 2019-2020 season. On 2nd March 2020, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site induration, injection site erythema, injection site pain and underdose. On an unknown date, the patient experienced syringe leak, pharmaceutical product complaint and accidental exposure to product. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain, underdose, syringe leak, pharmaceutical product complaint and accidental exposure to product were unknown.   It was unknown if the reporter considered the injection site induration, injection site erythema and injection site pain to be related to FluLaval Tetra 2019-2020 season.  Additional information was provided as follows: The medication squirted out the left side from the base of the pre-filled Influenza syringe and half of the immunization was still in the syringe while administering the vaccine to the patient. The reporter did not believe patient received any of the immunization when it squirted from the base of the syringe, which led to underdose. After a short time, the patient's left deltoid was painful. Patient had a 0.5-inch hardened mass with 1.5-inch redness on her left deltoid. The nurse notified Dr. immediately and he recommended heat application to the left deltoid and to call back if she had any further concerns or worsening symptoms. While administrating the vaccine, the nurse was not exposed to the liquid, but the patient did, which led to  accidental exposure to product. QA result received on 10th April 2020: Conclusions of the QA statement were received as follows GlaxoSmithKline considered complaint of the report as unsubstantiated.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: the medication squirted out the left side from the base of the pre-filled Influenza syringe; Product Complaint; nurse was not exposed to the liquid, but the patient was; Patient had a 0.5-inch hardened mass; 1.5-inch redness on her left deltoid; pain at the injection site; half of the immunization was still in the syringe / did not appear to be administered into her left deltoid; This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number TG729, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 2nd March 2020, the patient received FluLaval Tetra 2019-2020 season. On 2nd March 2020, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site induration, injection site erythema, injection site pain and underdose. On an unknown date, the patient experienced syringe leak, pharmaceutical product complaint and accidental exposure to product. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain, underdose, syringe leak, pharmaceutical product complaint and accidental exposure to product were unknown.   It was unknown if the reporter considered the injection site induration, injection site erythema and injection site pain to be related to FluLaval Tetra 2019-2020 season.  Additional information was provided as follows: The medication squirted out the left side from the base of the pre-filled Influenza syringe and half of the immunization was still in the syringe while administering the vaccine to the patient. The reporter did not believe patient received any of the immunization when it squirted from the base of the syringe, which led to underdose. After a short time, the patient's left deltoid was painful. Patient had a 0.5-inch hardened mass with 1.5-inch redness on her left deltoid. The nurse notified Dr. immediately and he recommended heat application to the left deltoid and to call back if she had any further concerns or worsening symptoms. While administrating the vaccine, the nurse was not exposed to the liquid, but the patient did, which led to  accidental exposure to product. QA result received on 10th April 2020: Conclusions of the QA statement were received as follows GlaxoSmithKline considered complaint of the report as unsubstantiated.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Skin ulcer, Stomatitis
Clinical narrative: sores in mouth and itchy sores to scalp, tingling to right cheek
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of pain in arm that has limited his ability to raise his arm above his head.  As this has been a month since injection it is concerning and patient is going to go see primary care doctor when they are available.  COVID-19 and the restrictions around seeing primary care doctor has delayed his ability to seek medical attention.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Palpitations, Vision blurred
Clinical narrative: LIGHT HEADED, HEART PALPITATIONS, BLURRED VISION, FATIGUE. VITALS WERE TAKEN AND WNL, BP 129/80, TEMP 98.3, PULSE 85. @ 1:55PM ON 04/21/2020
Sex: F
Vaccine: TYP
Symptoms: Product physical issue
Clinical narrative: TOOK A DOSE OF VIVOTIF/ DID NOT COMPLETE VACCINATION PRIOR TO TRAVEL; FOUND A CRACKED OPEN CAPSULE; This spontaneous case report was received from a pharmacist (PVX2019-658, PTC-000047) on 15-Mar-2019. It described a 17-year-old female consumer who "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.   It was reported that the consumer opened the package of Vivotif and she saw that one capsule was cracked open and there was nothing inside the capsule. She took another capsule of Vivotif on 11-Mar-2019 and had 3 capsules left. She had a planned trip on 20-Mar-2019.  The action taken with Vivotif with respect to the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was not applicable.  The clinical outcome of the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was unknown.  Company's Comment: The causality of the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: DID NOT TAKE FIRST TWO DOSES OF VIVOTIF ON AN EMPTY STOMACH; This spontaneous case report was received from a pharmacist (PVX2019-033) on 04-Jan-2019. The report describes a female consumer who "did not take first two doses of Vivotif on an empty stomach". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer did not take the first two doses of Vivotif on an empty stomach. She took the third dose on an empty stomach.  The action taken with Vivotif with respect to the event "did not take first two doses of Vivotif on an empty stomach" was not applicable.  The clinical outcome of the events "did not take first two doses of Vivotif on an empty stomach" was unknown.  Company's Comment: The causality of the event "did not take first two doses of Vivotif on an empty stomach" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event  "did not take first two doses of Vivotif on an empty stomach" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 4; This spontaneous case report was received from a nurse (PVX2019-060) on 08-Jan-2019. The report describes a male consumer who "took third dose on day 4". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took third dose on day 4. The doses were taken on 05-Jan-2019, 07-Jan-2019 and 08-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 4" was not applicable.  The clinical outcome of the event "took third dose on day 4" was unknown.  Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK FIRST DOSE YESTERDAY AND TRAVELLING TOMORROW; This spontaneous case report was received from a pharmacist (PVX2019-118) on 14-Jan-2019. The report describes a 20-year-old male consumer who "took first dose yesterday and travelling tomorrow". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif yesterday and he was leaving tomorrow.  The action taken with Vivotif with respect to the event "took first dose yesterday and travelling tomorrow" was not applicable.  The clinical outcome of the event "took first dose yesterday and travelling tomorrow" was unknown.  Company's Comment: The causality of the event "took first dose yesterday and travelling tomorrow" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose yesterday and travelling tomorrow" was considered as not applicable
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE JELLY BEANS ABOUT 15 MINUTES BEFORE THE LAST DOSE; This spontaneous case report was received from an other healthcare professional (PVX2019-221) on 23-Jan-2019. The report describes a female consumer who "ate jelly beans about 15 minutes before the last dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer ate a few jellybeans about 15 minutes before the last dose.  The action taken with Vivotif with respect to the event "ate jelly beans about 15 minutes before the last dose" was not applicable.  The clinical outcome of the event "ate jelly beans about 15 minutes before the last dose" was unknown.  Company's Comment: The causality of the event "ate jelly beans about 15 minutes before the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate jelly beans about 15 minutes before the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a pharmacist (PVX2019-290) on 31-Jan-2019. The report describes a female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day) (lot number: 3003220 and expiry date: May 2019) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif on Monday (28-Jan-2019). Then it was left unrefrigerated for about 45 hours and then she took the second dose on Wednesday (30-Jan-2019).  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK FIRST TWO DOSES WITH FOOD; This spontaneous case report was received from a pharmacist (PVX2019-375) on 11-Feb-2019. The report describes a male consumer who "took first two doses with food". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first two doses of Vivotif with food on 07-Feb-2019 and 09-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took first two doses with food" was not applicable.  The clinical outcome of the event "took first two doses with food" was unknown.  Company's Comment: The causality of the event "took first two doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first two doses with food" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK THREE UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-427) on 14-Feb-2019. The report describes an adult female consumer who "took three unrefrigerated dose". The consumer was receiving oral Vivotif capsule (one dose every other day; lot number: 3003240) for typhoid prophylaxis.   It was reported that the consumer took the three unrefrigerated doses of Vivotif. The doses were taken on 09-Feb-2019, 11-Feb-2019, and 13-Feb-2019 respectively.  The action taken with Vivotif with respect to the event "took three unrefrigerated dose" was not applicable.  The clinical outcome of the event "took three unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE THE FOURTH DOSE AND TRAVELLED TO AN ENDEMIC AREA; This spontaneous case report was received from a consumer (PVX2019-497) on 25-Feb-2019. The report described a 51-year-old female consumer who "did not take the fourth dose and traveled to an endemic area". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the third dose of Vivotif on 12-Feb-2019 and did not take the fourth dose, instead she traveled to an endemic area from 14-Feb-2019 to 23-Feb-2019.  The action taken with Vivotif with respect to the event "did not take the fourth dose and traveled to an endemic area" was not applicable.  The clinical outcome of the event "did not take the fourth dose and traveled to an endemic area" was unknown.  Company's Comment: The causality of the event "did not take the fourth dose and traveled to an endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the fourth dose and traveled to an endemic area" was considered as not applicable.