chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old female patient who received fourth dose of ACT-HIB lot UI937AA, Exp. Date 05-Nov-2019 via unknown route in the left thigh, on 08-Mar-2019 that was reconstituted with sterile water instead of the ACTHIB diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to wrong solution used in drug reconstitution. It was unknown whether the patient had any adverse reactions. 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. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 69 years old female patient who was vaccinated with once 0.5 ml dose of TENIVAC (lot: U5541AA, expiry date: 12-Jan-2019) via intramuscular route in the left deltoid on 09-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a health care professional. This case involves an 18-months-old male patient who moved away while vaccination and received less than the full dose of 0.5 ml of PENTACEL (lot UJ104AA, expiry date 31-Oct-2020) via unknown route in the right leg on 09-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received Hepatitis A vaccine concomitantly. It was a case of actual medication error due to vaccine under dose. The patient did not experience any adverse event at the time of report (reported as none symptoms). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a four months old male patient who was vaccinated with PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 13-Mar-2019, the patient received only DTap-IPV portion of the suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ082AA, expiry date: 13-Oct-2020) via intramuscular route in the right thigh. It was an actual medication error due to inappropriate reconstitution technique. It was reported that DTap-IPV portion of the PENTACEL was given and not the ACT-HIB portion as they forgot to mix it together. It was unknown if the patient had any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24-years-old female patient who received an incomplete dose while she received 1 ml dose of vaccine IMOVAX RABIES (lot N1K303M, expiry date 28-Oct-2019) via unknown route in unknown administration site on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine on that day. It was a case of actual medication error due to vaccine underdose. It was reported that while the dose was being administered, some of the vaccine leaked out of the syringe near the needle, right around the seal. The syringe tip was pulled off. Vaccine was not available for return, as it had already been discarded. There were no signs of damage or tampering with the any of the items, or with the carton. This was also a case of syringe leak. It was not reported if the patient had any adverse event. Regulatory Authority number was updated as: 100003948. Status: in process. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Follow-up information was received from a nurse on 13-Mar-2019. Regulatory Authority number was updated and changes made in the field and narrative accordingly. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from non-health professional (office staff). This case is linked to cases 2019SA071131, 2019SA071147, 2019SA071148, 2019SA071146, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155, 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE (prefilled syringes) lot UJ043AB (expiry date: 22-May-2019) via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date (during the 2018 - 2019 Flu Season) given during Well Child Check Ups or Vaccine visits. The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided. It was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. No side effects had been 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves an 8 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 8 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Age: 32.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site pruritus, Underdose, Wrong product administered
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 62 years old patient (gender was unknown) who received vaccine FLUZONE QUADRIVALENT instead of TUBERSOL and reported that administered intradermally 0.1 ml of FLUZONE QUAD instead of the TUBERSOL and experienced itching at the injection site. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Mar-2019, the patient received a dose of suspect 0.01 ml INFLUENZA QUADRIVAL A-B VACCINE (lot number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in the left forearm. On an unknown date, following the vaccination the patient experienced injection site itching. It was also a case of actual medication error due to wrong vaccine administered, vaccine underdose 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 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. List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received a dose of ACT-HIB diluted with the MMR diluent. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included DTAP; and PREVNAR. On 08-Mar-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number: UI921AAA and expiry date: 09-Nov-2019) (dose and dose in series was not reported) via intramuscular route in the left thigh. It was a case of actual medication error due to inappropriate reconstitution technique as the patient was administered ACTHIB diluted with the MMR diluent. It was not reported if any adverse event occurred 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 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. List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from other health care professional. This case involves an unknown demographic patient who was vaccinated with a dose of vaccine IPOL (lot number, Exp. Date, dose, route and site of administration not reported) which was stored incorrectly on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was reported that a dose of IPOL was involved in the previously reported excursion. Caller stated she was unsure if the IPOL was opened before the patient was given a dose. It was unknown whether the patient experienced any 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 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. List of documents held by sender: none.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, IPV, PPV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 months (also reported as 1 year) old male patient who inadvertently received 4th dose of vaccine IPOL on 13 mar 2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included HIB VACCINE (HIB); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); and HEPATITIS A VACCINE (HEPATITIS A). On 13-Mar-2019, the patient received a 4th dose of suspect 0.5 ml IPV (VERO) (lot number: N1K921M and expiry date: 14-Nov-2019) (route and site of administration was not reported). The patient had received his first 3 doses of IPOL on schedule. It was a case of actual medication error due to inappropriate schedule of vaccine administered as he was inadvertently administered a 4th dose on 13 Mar 2019, which should not have been administered until after the patient's 4th birthday (in 2022). It was unknown if the patient had any 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 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. List of documents held by sender: none.
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Shoulder dystocia
Clinical narrative: This is a serious spontaneous case initially received from other health professional on 06-Mar-2019, concerning a neonate female patient of body weight 4366 gm. The mother was 30-year-old female with body mass index 44.8. The mother had previous one pregnancy with full term live birth. The mother's current conditions included anaemia, anxiety, hypertensive disorder, depressive disorder and asthma. The mother's concomitant medications included hydrochlorothiazide for hypertension, Proair [salbutamol sulfate] for asthma and Prenatal Vitamins [minerals nos; vitamins nos] for obstetrician (OB) care. The mother's last menstrual period (LMP) date was 26-May-2018. The type of pregnancy was singleton. On 08-Oct-2018, at 19 weeks of gestation, the foetus was exposed to FLUCELVAX QIVc [route of administration: transplacental, batch number: 252226, dose, anatomical location and expiry date: not reported] (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On the same day, the mother underwent a prenatal ultrasound in which no congenital malformation was noted. On 03-Dec-2018, the foetus was exposed to a non-company suspect vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose: 0.5 ml, patient's route of administration: transplacental, parent's route of administration: intramuscular, batch number, anatomical location and expiry date: not reported] for an unknown indication. On 02-Jan-2019, 2 months and 25 days after vaccination, the mother experienced migraine aura without headache and was treated with Zofran [ondansetron, 8 mg, every 8 hours, prn, oral from 02-Jan-2019]. On 27-Feb-2019, at gestation age of 39.6 weeks, the mother delivered a live female infant, vaginally. Pregnancy complication was noted which included chronic hypertension in the mother and shoulder dystocia in the infant. No congenital malformation was noted. The appearance, pulse, grimace, activity, and respiration (APGAR) score was 8 at minute one and 9 at minute 5. The mother's estimated delivery date (EDD) was reported as 02-Mar-2019. This case is linked to 201902538 (mother case).; Reporter's Comments: A female neonate patient experienced shoulder dystocia during vaginal delivery, 4 months 19 days after maternal exposure to FLUCELVAX QIVc (company suspect vaccine) at 19 weeks of gestation (considered as fetal exposure during pregnancy) and more than 2 months after receipt of TDAP vaccine. Time to onset is considered implausible. The event shoulder dystocia is due to the mechanical obstruction during vaginal delivery, hence role of company suspect vaccine is ruled out and assessed the causality as not related. Maternal BMI (44.8) is considered as known risk factor. The event fetal exposure during pregnancy assessed as not related considering the intended use of vaccine. The TDAP vaccine is considered as co-suspect. The company assessed the event shoulder dystocia as serious (medically significant).
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Rash, Rash erythematous, Rash macular
Clinical narrative: 2-12 Dr said to put cold pacs on red, swollen, hot arm. Picture enclosed. 2-13 Dr. prescribed clindamycin 150 mg 3 times a day and BENADRYL 3 times a day. I had a rash on both arms. 2-15 Dr. for spots below right knee. He added ZYRTEC 1 time a day. He felt it may be a reaction to clindamycin and shingles shot. 2-20 Dr. spots on right leg have increased and are red, legs and arms are blotchy. There is a coating on tongue and it feels like I drank hot tea on the end of tongue. He prescribed Triamcinolone 0.1% cream 30 gm to apply on leg and LISTERINE 2 tmes a day for tongue. Picture of leg enclosed. I've received pneumonia and flu shots at pharmacy and never had a problem with any reaction.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Tongue coated
Clinical narrative: 2-12 Dr said to put cold pacs on red, swollen, hot arm. Picture enclosed. 2-13 Dr. prescribed clindamycin 150 mg 3 times a day and BENADRYL 3 times a day. I had a rash on both arms. 2-15 Dr. for spots below right knee. He added ZYRTEC 1 time a day. He felt it may be a reaction to clindamycin and shingles shot. 2-20 Dr. spots on right leg have increased and are red, legs and arms are blotchy. There is a coating on tongue and it feels like I drank hot tea on the end of tongue. He prescribed Triamcinolone 0.1% cream 30 gm to apply on leg and LISTERINE 2 tmes a day for tongue. Picture of leg enclosed. I've received pneumonia and flu shots at pharmacy and never had a problem with any reaction.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Rash macular
Clinical narrative: 2-12 Dr said to put cold pacs on red, swollen, hot arm. Picture enclosed. 2-13 Dr. prescribed clindamycin 150 mg 3 times a day and BENADRYL 3 times a day. I had a rash on both arms. 2-15 Dr. for spots below right knee. He added ZYRTEC 1 time a day. He felt it may be a reaction to clindamycin and shingles shot. 2-20 Dr. spots on right leg have increased and are red, legs and arms are blotchy. There is a coating on tongue and it feels like I drank hot tea on the end of tongue. He prescribed Triamcinolone 0.1% cream 30 gm to apply on leg and LISTERINE 2 tmes a day for tongue. Picture of leg enclosed. I've received pneumonia and flu shots at pharmacy and never had a problem with any reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Ear infection
Clinical narrative: Patient got an ear infection 1 week after receiving second SHINGRIX dose and felt it was due to the shot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Injection site bruising, Loss of consciousness, Muscle spasms, Musculoskeletal chest pain
Clinical narrative: Woke up with a bad cramp up the front of my left leg (ankle to shin). Got up and went to the bathroom. Sat on the commode. Blacked out. Woke up on the floor. Got up went back to bedroom. My legs were like rubber. Fell again in bedroom but didn't black out again. Got up again went to kitchen and drank tonic water for leg cramp and began to feel better. Saw my family doctor on Jan 2. He examined me and recommended that I not get the second SHINGRIX shot. His opinion was that I had a reaction to the first injection. The result of the black out was a small cut under my right eye, large bruise on my left shoulder, bruise on my left side, bruise on my upper left arm, sore ribs on the left side and a skinned left knee. Other than being sore from the fall I continued with my normal activities.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin injury, Skin laceration
Clinical narrative: Woke up with a bad cramp up the front of my left leg (ankle to shin). Got up and went to the bathroom. Sat on the commode. Blacked out. Woke up on the floor. Got up went back to bedroom. My legs were like rubber. Fell again in bedroom but didn't black out again. Got up again went to kitchen and drank tonic water for leg cramp and began to feel better. Saw my family doctor on Jan 2. He examined me and recommended that I not get the second SHINGRIX shot. His opinion was that I had a reaction to the first injection. The result of the black out was a small cut under my right eye, large bruise on my left shoulder, bruise on my left side, bruise on my upper left arm, sore ribs on the left side and a skinned left knee. Other than being sore from the fall I continued with my normal activities.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Skin lesion
Clinical narrative: At time of report, patient has had 4 days of mild rash, which started as 2 small flesh colored papules on left thigh/buttocks. She now has 5 lesions total (1 on her posterior neck, 1 on anterior neck, and 1 on her left lateral abdomen).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dysstasia, Visual impairment
Clinical narrative: Complaining Vision Problem and Balance Issue. Can't stand straight.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Decreased appetite, Fatigue
Clinical narrative: She received vaccine on 2/14. She had same reaction as the first dose on 11/9/19. She had injection site discomfort, body pain that resolved in several days. On 3/4/19, she developed reaggravation of the injection site pain including redness and swelling. She also developed diffuse papular itchy rash, sparing the face and neck. She developed lack of appetite and fatigue. Liver inflammatory markers, CRP and sed rate were elevated. These symptoms dissipated over the next week.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammatory marker test, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She received vaccine on 2/14. She had same reaction as the first dose on 11/9/19. She had injection site discomfort, body pain that resolved in several days. On 3/4/19, she developed reaggravation of the injection site pain including redness and swelling. She also developed diffuse papular itchy rash, sparing the face and neck. She developed lack of appetite and fatigue. Liver inflammatory markers, CRP and sed rate were elevated. These symptoms dissipated over the next week.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash papular, Rash pruritic, Red blood cell sedimentation rate increased
Clinical narrative: She received vaccine on 2/14. She had same reaction as the first dose on 11/9/19. She had injection site discomfort, body pain that resolved in several days. On 3/4/19, she developed reaggravation of the injection site pain including redness and swelling. She also developed diffuse papular itchy rash, sparing the face and neck. She developed lack of appetite and fatigue. Liver inflammatory markers, CRP and sed rate were elevated. These symptoms dissipated over the next week.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site rash, Nausea, Pyrexia
Clinical narrative: Fever, chills, aches and pains in joints, slight nausea, big rash at injection site.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of fever, body aches and pain in arm. Patient was recommended to take ibuprofen as needed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram, Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Onset of numbness of hands and feet, starting 8/7/10. Was hospitalized 8/7/18 to 9/18/18 for Guillain Barre syndrome (GBS)- progressed to respiratory failure and intubation.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging spinal, Respiratory failure
Clinical narrative: Onset of numbness of hands and feet, starting 8/7/10. Was hospitalized 8/7/18 to 9/18/18 for Guillain Barre syndrome (GBS)- progressed to respiratory failure and intubation.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Tired. Muscle ache. Fever. Shivering (chills). Stomach discomfort.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Pain
Clinical narrative: Aches, Chills, Fatigue during the following day. Took TYLENOL and Ibuprofen to ease the discomfort. Felt better 2 days after the shot.
Age: 8.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There is no adverse reaction.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Diarrhoea, Erythema, Hypersensitivity, Injection site hypersensitivity, Injection site swelling
Clinical narrative: Patient gotten his shots at around 9:30 -10 AM. I dropped him off to daycare after that. When I picked him up around 5 PM he was ok, I noticed swelling on his thighs at around 8 PM. He took a bath as normal and after that I noticed he had allergy reaction all over his legs, buddy, some small marks on his back and stomach and arms. The marks looked like blisters, like burn singes, and the small ones looked like big bug bites with white inside and red around it. I have taken pictures. I called my pediatrician and was instructed to give BENADRYL 5ml. When he woke up in the morning he didn't have any more any of the allergy reaction marks. But he did have diarrhea in the morning and was quite warm. He has very runny nose at this point with yellow/green color. He looks and feels sick.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Malaise, Nasal discharge discolouration, Rash vesicular, Rhinorrhoea, Skin warm
Clinical narrative: Patient gotten his shots at around 9:30 -10 AM. I dropped him off to daycare after that. When I picked him up around 5 PM he was ok, I noticed swelling on his thighs at around 8 PM. He took a bath as normal and after that I noticed he had allergy reaction all over his legs, buddy, some small marks on his back and stomach and arms. The marks looked like blisters, like burn singes, and the small ones looked like big bug bites with white inside and red around it. I have taken pictures. I called my pediatrician and was instructed to give BENADRYL 5ml. When he woke up in the morning he didn't have any more any of the allergy reaction marks. But he did have diarrhea in the morning and was quite warm. He has very runny nose at this point with yellow/green color. He looks and feels sick.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Erythema, Nausea, Pain in extremity, Skin warm
Clinical narrative: Patient had some Nausea after vaccine as well as pain in the arm, heaviness and she developed redness below the injection site that is still warm to touch today 3/19/19. Per patient the symptoms started the night the shot was given. The redness, pain and warmness to the area are still present at the time of the visit this morning.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Migraine, Pain, Pain in extremity
Clinical narrative: Client states that the next day after the injection, she had some redness about 2 inches below the injection site. The area was red, painful, and warm. She came to me today to show me (3/19/19) that the area was still painful and hardened. She also had a small penpoint scab  below and to the right of left of the induration. She complaints that her whole arm has been sore since the injection. She also stated that she had a migraine headache one day after the injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin warm
Clinical narrative: Client states that the next day after the injection, she had some redness about 2 inches below the injection site. The area was red, painful, and warm. She came to me today to show me (3/19/19) that the area was still painful and hardened. She also had a small penpoint scab  below and to the right of left of the induration. She complaints that her whole arm has been sore since the injection. She also stated that she had a migraine headache one day after the injection.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pt given adult dose of GlaxoSmithKline Hep B instead of pediatric dose.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt claims she was given injection in her shoulder which caused her arm to hurt for a few days afterward.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Pyrexia
Clinical narrative: Cough and fever s/p VARIVAX.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-MAY-2017, the patient was administered the ZOSTAVAX by a health care provider at a hospital (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider at a hospital for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 48-year-old patient of unknown gender reporting on themselves. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (exact dose, frequency, site of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who experienced patient who received vaccine QUADRACEL (lot number not reported) via unknown route in unknown administration site on an unspecified date. The patient's medical history not reported and no any concomitant medications received at the time of vaccination. It was an actual medication error case due to inappropriate age at vaccine administration. It was reported that the patient was given a QUADRACEL vaccination and she is only 2 months old. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 11 years old female patient who received a expired 0.5ml dose of MENACTRA batch number: U5833AA, expiry date : 25-Feb-2019 via unknown route in unknown administration site on 12-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. The patient was not experiencing any adverse effects so far. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a greater than 50 years old patient (gender unknown) who received a dose of IPOL batch number: N1J451M via intradermal route in the arm on an unknown date instead of TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered and inappropriate route of vaccination. A greater than 50 years old patient received IPOL instead of receiving a TUBERSOL in arm intradermally. No side effects were known at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to cases 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156. This case involves a patient (age 8-17 year old and gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT and reported that given the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT/no AE and administered FLUZONE HD to patients 8-17 years old/no AE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ043AB and expiry date: 22-May-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to wrong product administered, overdose and inappropriate age at vaccine administration. 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a non-health professional (office staff). This case is linked to cases 2019SA071131, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155, 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE (prefilled syringes) lot UJ043AB (expiry date: 22-May-2019) via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date (during the 2018 - 2019 Flu Season) given during Well Child Check Ups or Vaccine visits. The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided. It was an actual medication error case due to wrong vaccine administered, inappropriate age of vaccine administration and overdose. No side effects had been 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) by phone. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071156, 2019SA071154, 2019SA071155, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149 and 2019SA071147 (same reporter). This case involves Child patient (age and gender not reported) who was accidentally vaccinated with FLUZONE HIGH DOSE (formulation: Suspension for injection in pre-filled syringe) instead of FLUZONE QUADRIVALENT (batch number: UJ043AB and expiry date: 22-May-2019, dose, dose in series, route and site of administration were not reported) on an unknown date (during the 2018 - 2019 Flu Season). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. No side effects have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071146, 2019SA071147, 2019SA071155, 2019SA071149 and 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE lot UJ043AB via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to wrong vaccine administered, inappropriate age of vaccine administration and overdose. No side effects had been 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves a 7 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 7 years child patient was given the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.