chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate irregular, Presyncope
Clinical narrative: On the night of 27 July I was awakened by a severe arrythmia, with conflicting beats.  I took an aspirin, and eventually my heart started to beat regularly again. Two nights later the same thing occurred, this time resulting in a near syncope. Inasmuch as the second occurrence was on a Friday night, I couldn't call the doctor the next day, but perhaps I'll call for an appointment on Monday--especially if this re-occurs.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with Covid on June 30th after receiving 2 booster doses.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Intense itching, folllowed by rash on arms, upper body, then large hives
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: about 12 hours after injection patient experienced a sharp, burning pain right around below the right rib towards the back.  The soreness lasted about 36 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Alopecia Areata, Clobetasol solution topically, substantial hair loss in patches
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Fever- day 1 and 2; coughing and runny nose- day 4 and currently (day 6 after shot)
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Daily chills and low grade fever every late evening around 7pm since first night of vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Chills, Condition aggravated, Headache
Clinical narrative: July 7, 2022 developed fever and chills, headache, malaise, sore throat.  Treated with tylenol, Paxlovid, albuterol and Alvesco inhalers.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: July 7, 2022 developed fever and chills, headache, malaise, sore throat.  Treated with tylenol, Paxlovid, albuterol and Alvesco inhalers.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Thrombosis
Clinical narrative: Started having gross hematuria with clots but no other associated symptoms. Never had this symptom before and otherwise no history of UTI, renal disease. No history of chronic disease. This is the first time happened
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red, warm rash at site of injection. About 2-3 inches in diameter. Starting 7 days after vaccination (2nd dose). Child complains of pain and tenderness at the site.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: (Orange) Covid Pfizer 5-11 years old was administered to this 3 y/o child.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: R thigh red & swollen with mild tenderness  no fever
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Vaccination site swelling
Clinical narrative: Post vaccin the injection site swelled up. Asked the patient to stay seated and relax. Checked back in 5 minutes patient said she felt light headed and clamy. Checked patient's blood pressure which was lower than normal
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Feeling abnormal, Pain in extremity, Thyroid function test
Clinical narrative: Within 1 week (about 5 days) after vaccination, hair began to fall out and continued through the second COVID primary dose and for approximately 1 more month.     Second vaccine 10-13/202 Pfizer lot EW0186 left arm.    She lost half of her hair.   She saw an MD and no treatment was offerred.   She then had OVID in May 7 , 2022 without further  hair loss.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, COVID-19
Clinical narrative: Within 1 week (about 5 days) after vaccination, hair began to fall out and continued through the second COVID primary dose and for approximately 1 more month.     Second vaccine 10-13/202 Pfizer lot EW0186 left arm.    She lost half of her hair.   She saw an MD and no treatment was offerred.   She then had OVID in May 7 , 2022 without further  hair loss.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Had J&J in March 2021. Advised to get Pfizer booster 11/21. Next menstrual cycle was exceptionally heavy and longer.  Became so heavy I went to OBGYN because there were days I had to miss work due to flow being so heavy (more than one tampon/pad an hour). This was April 2022. Got labs. Extremely tired too. Ordered ultrasound and repeated. Significant changes seen in uterus consistent with uterine polyp.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Heavy menstrual bleeding, Impaired work ability, Menstrual disorder
Clinical narrative: Had J&J in March 2021. Advised to get Pfizer booster 11/21. Next menstrual cycle was exceptionally heavy and longer.  Became so heavy I went to OBGYN because there were days I had to miss work due to flow being so heavy (more than one tampon/pad an hour). This was April 2022. Got labs. Extremely tired too. Ordered ultrasound and repeated. Significant changes seen in uterus consistent with uterine polyp.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound pelvis abnormal, Ureteral wall thickening, Uterine polyp
Clinical narrative: Had J&J in March 2021. Advised to get Pfizer booster 11/21. Next menstrual cycle was exceptionally heavy and longer.  Became so heavy I went to OBGYN because there were days I had to miss work due to flow being so heavy (more than one tampon/pad an hour). This was April 2022. Got labs. Extremely tired too. Ordered ultrasound and repeated. Significant changes seen in uterus consistent with uterine polyp.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Nausea, Pyrexia
Clinical narrative: 01/08/22 presents to ED for "cough congestion, fevers, nausea/ vomiting and fatigue". PMHx of " breast cancer in remission"
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 01/08/22 presents to ED for "cough congestion, fevers, nausea/ vomiting and fatigue". PMHx of " breast cancer in remission"
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea
Clinical narrative: 01/11/22 presents to ED for "COVID and shortness of breath". PMHx of "COPD, hypertension, CAD, CKD, and seizure".
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Hepatic steatosis, Investigation, Liver injury
Clinical narrative: Two hours after vaccination the patient felt soreness in the right arm, then in the neck, head and all bones.  He had to rest because of dizziness. Vision was blurred. Then he presented swelling of his belly.  He went to see the doctorand he was informed that he has fatty liver. Now he has a mass in the liver .  He also had fever for 12 days after vaccination. Then he developed headache that persisted for 4 months.  Medications did not work for the pain.  His hands, elbows, knees and ankles became swollen. He also has tingling sensation of his feet.  He had to go to 3 different hospitals because of these symptoms. In one of them he was given IM injections. He persists with dizziness and has to stay in bed most of the time. His nipples have also grown.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Two hours after vaccination the patient felt soreness in the right arm, then in the neck, head and all bones.  He had to rest because of dizziness. Vision was blurred. Then he presented swelling of his belly.  He went to see the doctorand he was informed that he has fatty liver. Now he has a mass in the liver .  He also had fever for 12 days after vaccination. Then he developed headache that persisted for 4 months.  Medications did not work for the pain.  His hands, elbows, knees and ankles became swollen. He also has tingling sensation of his feet.  He had to go to 3 different hospitals because of these symptoms. In one of them he was given IM injections. He persists with dizziness and has to stay in bed most of the time. His nipples have also grown.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Bone pain, Dizziness, Headache, Hepatic enzyme abnormal
Clinical narrative: Two hours after vaccination the patient felt soreness in the right arm, then in the neck, head and all bones.  He had to rest because of dizziness. Vision was blurred. Then he presented swelling of his belly.  He went to see the doctorand he was informed that he has fatty liver. Now he has a mass in the liver .  He also had fever for 12 days after vaccination. Then he developed headache that persisted for 4 months.  Medications did not work for the pain.  His hands, elbows, knees and ankles became swollen. He also has tingling sensation of his feet.  He had to go to 3 different hospitals because of these symptoms. In one of them he was given IM injections. He persists with dizziness and has to stay in bed most of the time. His nipples have also grown.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatic mass, Hepatic steatosis, Joint swelling, Neck pain, Nipple enlargement
Clinical narrative: Two hours after vaccination the patient felt soreness in the right arm, then in the neck, head and all bones.  He had to rest because of dizziness. Vision was blurred. Then he presented swelling of his belly.  He went to see the doctorand he was informed that he has fatty liver. Now he has a mass in the liver .  He also had fever for 12 days after vaccination. Then he developed headache that persisted for 4 months.  Medications did not work for the pain.  His hands, elbows, knees and ankles became swollen. He also has tingling sensation of his feet.  He had to go to 3 different hospitals because of these symptoms. In one of them he was given IM injections. He persists with dizziness and has to stay in bed most of the time. His nipples have also grown.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia, Vision blurred
Clinical narrative: Two hours after vaccination the patient felt soreness in the right arm, then in the neck, head and all bones.  He had to rest because of dizziness. Vision was blurred. Then he presented swelling of his belly.  He went to see the doctorand he was informed that he has fatty liver. Now he has a mass in the liver .  He also had fever for 12 days after vaccination. Then he developed headache that persisted for 4 months.  Medications did not work for the pain.  His hands, elbows, knees and ankles became swollen. He also has tingling sensation of his feet.  He had to go to 3 different hospitals because of these symptoms. In one of them he was given IM injections. He persists with dizziness and has to stay in bed most of the time. His nipples have also grown.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: Patient admitted as observation on 7/20 due to syncope and collapse. Patient was tested for COVID-19 and was positive on 7/20.  Patient is a 62 y.o. year old male with complex medical history including ESRD on dialysis, Parkinson's with dementia and activated POA (wife), HTN, CAD, HFpEF, GERD, OSA, chronic pain, urinary obstruction with chronic suprapubic catheter, depression/anxiety, and afib not on AC, who presents with syncope and falls at home after dialysis. A declining course with weakness, fatigue and hypotension/tachycardia complicating dialysis effectiveness.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Fall, Fatigue, General physical health deterioration
Clinical narrative: Patient admitted as observation on 7/20 due to syncope and collapse. Patient was tested for COVID-19 and was positive on 7/20.  Patient is a 62 y.o. year old male with complex medical history including ESRD on dialysis, Parkinson's with dementia and activated POA (wife), HTN, CAD, HFpEF, GERD, OSA, chronic pain, urinary obstruction with chronic suprapubic catheter, depression/anxiety, and afib not on AC, who presents with syncope and falls at home after dialysis. A declining course with weakness, fatigue and hypotension/tachycardia complicating dialysis effectiveness.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, SARS-CoV-2 test positive, Syncope, Tachycardia
Clinical narrative: Patient admitted as observation on 7/20 due to syncope and collapse. Patient was tested for COVID-19 and was positive on 7/20.  Patient is a 62 y.o. year old male with complex medical history including ESRD on dialysis, Parkinson's with dementia and activated POA (wife), HTN, CAD, HFpEF, GERD, OSA, chronic pain, urinary obstruction with chronic suprapubic catheter, depression/anxiety, and afib not on AC, who presents with syncope and falls at home after dialysis. A declining course with weakness, fatigue and hypotension/tachycardia complicating dialysis effectiveness.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure
Clinical narrative: Patient is a 74 y.o. female with PMHx: Diabetes, Heart failure, COPD who is seen for evaluation of AKI. She also tested positive for COVID-19 over 3 weeks ago on June 29th.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient is a 74 y.o. female with PMHx: Diabetes, Heart failure, COPD who is seen for evaluation of AKI. She also tested positive for COVID-19 over 3 weeks ago on June 29th.
Age: 0.75
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was given 3 days after the expiration date.  I reached out to Moderna and they did a lot study, and determined the vaccine to still be effective and no further intervention needed.  Patient's parents have been contacted.
Age: 0.75
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 3 days after the expiration date.  I reached out to Moderna and they did a lot study, and determined the vaccine to still be effective and no further intervention needed.  Patient's parents have been contacted.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was given 3 days after the expiration date.  I reached out to Moderna and they did a lot study and determined the vaccine to still be effective and no further intervention needed.  Patient's parents have been contacted.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 3 days after the expiration date.  I reached out to Moderna and they did a lot study and determined the vaccine to still be effective and no further intervention needed.  Patient's parents have been contacted.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was given 3 days after the expiration date.  I reached out to Moderna and they did a lot study and determined the vaccine to still be effective and no further intervention needed.  Patient's parents have been contacted.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 3 days after the expiration date.  I reached out to Moderna and they did a lot study and determined the vaccine to still be effective and no further intervention needed.  Patient's parents have been contacted.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; administration of VARIVAX via the intramuscular route instead of via the subcutaneous route; This spontaneous report was received from a medical student (pharmacy intern) referring to an unknown age and gender patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 08-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot #U015686, expiration date: 18-MAY-2023) for prophylaxis (strength was not provided) via intramuscular instead of subcutaneous (incorrect route of product administration). No additional adverse event (no adverse event) was reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Vaccination site rash
Clinical narrative: Itchy red rash on the upper half of her daughter's left arm; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious courtesy case received from partner Pfizer via a consumer/non-hcp.  This case involves a 16 years old female patient who had itchy red rash on the upper half of her left arm after receiving vaccine Meningococcal A-C-Y-135 (T Conj) Vaccine [Menquadfi].  The patient's past vaccination(s) included HPV VACCINE on 19-Jul-2021 with Itchy at the site Onset Age: One year ago when her daughter was 15 and Menquadfi on 28-Dec-2016. The patient's past medical history, medical treatment(s) and family history were not provided.   On 19-Jul-2022, the patient received a  dose of suspect Meningococcal A-C-Y-135 (T Conj) Vaccine (lot U7218AA, strength, formulation, dose and expiry date: unknown) via intramuscular route in the left arm indicated for age group and suggested by pediatrician.  On 19-Jul-2022 (at 11:45 am approximately) (latency: same day) the patient had itchy red rash on the upper half of her left arm (vaccination site rash) following the administration of Meningococcal A-C-Y-135 (T Conj) Vaccine.  Action taken: Not applicable.  Corrective treatment: She did talk to nurse about it and they said take Benadryl and watch it but her daughter didn't need to come in.  Outcome: Unknown.; Sender's Comments:  202201006134:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired MENACTRA with no reported adverse event; Initial information received on 20-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who was administered an expired meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero).  On 20-Jul-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine (lot U6878BA, expiry date: 02-Mar-2022; formulation not reported) via intramuscular route in the right deltoid for immunization.  On 20-Jul-2022, the patient was administered an expired meningococcal A-C-Y-W135 (D conj) vaccine with no reported adverse event (expired product administered) (latency: same day).   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Rash
Clinical narrative: the rash was under the arm and not near the injection site; MENQUADFI possibly being administered subcutaneously instead of intramuscularly; Initial information on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced the rash was under the arm and not near the injection site and menquadfi possibly being administered subcutaneously instead of intramuscularly while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Jul-2022, the patient received a  0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE once (strength, formulation, lot number: not reported) via subcutaneous route in the left deltoid for immunization.  On 18-JUL-2022 (latency: same day) the patient developed a non-serious the rash was under the arm and not near the injection site (rash) and menquadfi possibly being administered subcutaneously instead of intramuscularly (incorrect route of product administration) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE..  It was reported the rash was under the arm and not near the injection site. The reporter  states that the person who administered the vaccine stated it was given intramuscularly but the patient stated it was given subcutaneously.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (rash ).  At time of reporting, the outcome was Unknown for the event the rash and incorrect route of product administration.   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 guidelines. 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: they have administered expired pentacel to a patient with no reported adverse event; Initial information received on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from other health professional.   This case involves 2 months old female patient who was administered expired diphtheria/tetanus/5 hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE all for Prophylactic vaccination.  On 15-Jul-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ530AAA, expiry date: 10-Jul-2022, Vial UJ530AA Expiration: 10-Jul-2022 Diluent U6985AA Expiration: 10-Jul-2022) via intramuscular route in the left deltoid for immunization (expired product administered, latency: same day).  No adverse event reported.   Action taken: Not applicable.   Outcome: Unknown for the event they have administered expired pentacel to a patient with no reported adverse event.    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 guidelines. 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: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: have administered expired act-hib to a patient, with no reported adverse event; Initial information received on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old male patient who was administered expired act-hib, with no reported adverse event while receiving vaccine HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jul-2022, the patient received a  dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (lot UJ525AA and expiration date: 11-Jul-2022) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.  On 19-Jul-2022 (latency: same day), the patient was administered expired act-hib with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event .   Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired dose of PENTACEL was administered to a patient, with no reported AE; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient who was administered expired dose of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Pentacel] with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7V (CRM197) (Prevnar); Hepatitis A Vaccine Inact (HEP A in vac); HIB vaccine Conj (TET TOX) (ACT-HIB); and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Prophylactic Vaccination.  On 21-Jul-2022, the patient received a 0.5 ml (once) dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (lot UJ473AA; expiry date; 09-Jul-2022, strength, formulation: unknown) via intramuscular route in the left thigh for immunization.  First time product used : Yes  The patient had last administration of vaccine on 21-Jul-2022.  On 21-Jul-2022 (latency: same day) the patient was administered expired dose of Pentacel with no reported AE (expired product administered).  Action taken: Not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 5.0
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: IPOL was administered after the excursion with no adverse event; IPOL being administered post excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered Ipol post excursion with no reported adverse event, while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 16-Jul-2022, the patient received a  dose of suspect IPV (VERO) lot U1A452M at a dose of 0.5ml once via intramuscular route in the left thigh for immunization.  On an unknown date, the reporter stated that the vaccine Ipol had temperature excursion with no adverse event (product storage error).  On 16-Jul-2022, the patient developed a non-serious event of Ipol being administered post excursion with no reported adverse event (poor quality product administered)same day following the administration of IPV (VERO).  Action taken :not applicable.  Outcome: unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: shortly after the injection in the deltoid bicep began to swell; less than 1 year of child was given Fluzone High-Dose Quadrivalent; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves a less than 1 year old child with unknown gender who was given Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] and shortly after the injection in the deltoid bicep began to swell.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date in November 2020, the patient received a dose of 0.7 mL (millimeter) of suspect Influenza Quadrival A-B High Dose Hv Vaccine once (lot number, strength, formulation and expiry date not reported) via intramuscular route in unknown administration site for immunization.  It was reported that the less than less than 1 year of child was given Fluzone High-Dose Quadrivalent (product administered to patient of inappropriate age) (onset: Nov-2020, latency: same day). Further reported that shortly after the injection in the deltoid bicep began to swell (vaccination site swelling) (onset: 2020, latency: unknown)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for event (vaccination site swelling).  At time of reporting, the outcome was Unknown for both events.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 months infant received QUADRACEL instead of PENTACEL with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 6 months old patient of unknown gender received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] instead of Pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jul-2022, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (Suspension for injection) (lot number; expiry date; strength; frequency) not reported via unknown route in unknown administration site for prophylactic vaccination.  On 22-Jul-2022, 6 months infant received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] instead of Pentacel  with no reported adverse event (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient being given an expired dose of ACTHIB with no reported  adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had being given an expired dose of acthib with no reported  adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (strength, frequency formulation, lot number was unknown and expiry date: 11-Jul-2022) via unknown route in unknown administration site for Immunization. Information regarding batch and expiry date was requested.  On an unknown date the patient developed a non-serious  event of patient being given an expired dose of acthib with no reported  adverse event (expired product administered) (latency: Unknown) following the administration of HIB (PRP/T) VACCINE.  No additional information available at time of call.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 76.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: doctor asked the patient to get second dose of menactra where its not indicated in age above 55 years with no reported adverse event; received a dose of MENACTRA over a year ago with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 76 years old male patient whose doctor asked to get second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] where its not indicated in age above 55 years with no reported adverse event and received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] over a year ago with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asplenia.   In 2021 (over a year ago), the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization (product administered to patient of inappropriate age, Latency: same day). Information regarding batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of doctor asked the patient to get second dose of menactra where it was not indicated in age above 55 years with no reported adverse event (product prescribing issue) (latency: unknown). Reporter stated that she saw on the packing that the MENACTRA was not indicated for patients older than 55 years of age and would like some guidance on dosing.   Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: QUADRACEL as their 2nd dose in the series at their previous Doctors Office, instead of PENTACEL, with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 2 Infant patient under age 4 years who were administered quadracel as their 2nd dose in the series at their previous doctors office, instead of pentacel, with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date,  the patients developed a non-serious event of quadracel as their 2nd dose in the series at their previous doctors office, instead of pentacel, with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: M
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Adacel was administered since the excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA303430(CLUSTER).  This case involves a 13 years old male patient and it reported a medication error (there was range from 31.7 to 52.4 Fahrenheit (F) for 300 hours due to a refrigerator malfunction and Adacel was administered since the excursion with no reported adverse event),  for the  vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA). It was reported that there was a condition from 05-Apr-2022 to 15-Jul-2022 and the range was from 31.7 to 52.4 Fahrenheit (F) for 300 hours due to a refrigerator malfunction (not human error) On 20-Jul-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, ( lot: U6923AA ; expiry date: 21-Jan-2023) via intramuscular route in the right deltoid for immunization.  It was reported that Adacel was administered since the excursion with no reported adverse event (poor quality product administered) (onset date: 20-Jul-2022; latency: same day)  Action taken : not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: a patient was given ACTHIB 8 days after the expiration date with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient with unknown age and demographics who was given HIB (PRP/T) VACCINE [ACT-HIB] 8 days after the expiration date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine (formulation, strength, dosage, route of administration, lot number, expiry date and administration site: unknown) for immunization.  On an unknown date, the patient was given HIB (PRP/T) VACCINE 8 days after the expiration date with no adverse event (expired product administered) (Latency: Same Day).  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 8.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: post excursion menactra administerd to child with no AE; excursion of 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error) with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves 8 years male patient to whom post excursion menactra was administered with no ae and excursion of 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    The condition from 05-Apr-2022 to 15-Jul-2022 was a range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error). The product was not supported by the extended stability data.   On 20-Jul-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 ml (lot V1A121M, expiry date: 15-Feb-2024) via intramuscular route in Left Deltoid for immunisation.   On an unknown date in 2022 there was excursion of 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no adverse event (product storage error) (unknown latency) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  On 20-Jul-2022 the patient was administered post excursion menactra with no ae (poor quality product administered)(latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: Not applicable.   Outcome was Unknown for the event post excursion menactra administerd to 8 years old child with no ae and was Unknown for the event excursion of 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no adverse event.    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 guidelines. 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: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Adacel administered post excursion with no reported adverse event; temperature excursion involving Adacel range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 11 years old female patient to whom adacel administered post excursion with no reported adverse event and temperature excursion involving adacel range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].    The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   The condition from 05-Apr-2022 to 15-Jul-2022 was a range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error).    On 19-Jul-2022, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine at a dose of 0.5 ml (lot U6923AA, expiry date: 31-Jan-2023) via intramuscular route in the left deltoid for immunisation.  On an unknown date in 2022 there was temperature excursion involving adacel range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event (product storage error) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  On 19-Jul-2022 adacel administered post excursion with no reported adverse event (poor quality product administered, latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.   Action taken: Not applicable.   Outcome: Unknown for the event temperature excursion involving adacel range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event and was Unknown for the event adacel administered post excursion with no reported adverse event.    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.