chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional via phone. This case involves two patients of an unknown demographics who were vaccinated with an expired dose of ACT-HIB (batch number: UI858AA and expiry date: 09-Jan-2019) (dose, dose in series, route and site of administration were not reported) on 14-Jan-2019 and 18-Jan-2019. 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 expired vaccine used. It was reported that two patients received an ACTHIB injection with an expiration date 09-Jan-2019 that was printed on the label, but when the barcode was scanned on the product, the expiration date showed 31-Aug-2019 on the scanner. The office would have to go by the expiration date printed on the label of 09-Jan-2019 as the true expiration date. It was unknown if any adverse event occurred or not following the 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information was received from other health professional via phone on 30-Jan-2019. Suspect vaccine start date was updated and changes made in the filed and narrative accordingly. Follow-up information was received from other health professional via phone on 04-Feb-2019. No new information was updated. Documents held by the sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient (date of birth and age was not reported) who experienced use of product outside of indication (60 and older), while he/she received vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose in series, route and site of administration was not reported). 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 Inappropriate age at vaccine administration. It was not reported that 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: TDAP
Symptoms: Wrong product administered
Clinical narrative: Initial information and follow up information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four-years-old patient for whom it was reported that the patient was seen in the ER 9 days ago for a laceration and was given tdap BOOSTRIX (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID) instead of DT or DTAP (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE). (dose, dose number, route and site of administration, lot number and date of vaccination not provided). The patient's past medical history included laceration and medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was reported that the patient was seen in the ER 9 days ago for a laceration and was given Tdap BOOSTRIX instead of DT or Dtap. Patient is scheduled to receive the QUADRACEL vaccine today. It was not reported if any adverse event experienced by the patient following wrong 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. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 30-Jan-2019 and additional information also received on same date regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old male patient who received vaccine PENTACEL lot C5517AA via unknown route in unknown administration site on 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the patient received the DTaP-IPV portion and not the ACTHIB portion of the PENTACEL vaccine. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic patient who was vaccinated with both HIB (PRP/T) VACCINE [ACT-HIB] lot UI944AAb via unknown route in unknown administration site and 0.5 ml of PENTACEL (lot C54578A via intramuscular route in the right thigh) on same date of 28-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was an actual medication error due to extra dose administered. It was unknown that any adverse event was 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.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Skin lesion
Clinical narrative: 1.5cm x 3cm erythematous lesion noted at injection site of right lateral thigh. Mild induration. No pustule. Mildly tender to palpation (infant squirms) playful and smiles.
Age: 21.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Fine red rash on trunk, front and back. No fever, uticaria, or any other s/s.
Age: 21.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Eye pain, Grip strength decreased, Hypoaesthesia, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Fine red rash on trunk, front and back. No fever, uticaria, or any other s/s.
Age: 21.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Pain, Vision blurred, Visual impairment
Clinical narrative: Fine red rash on trunk, front and back. No fever, uticaria, or any other s/s.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Drooling, Feeling hot, Immediate post-injection reaction, Loss of consciousness, Posture abnormal
Clinical narrative: Patient sitting upright on exam table. Patient tolerated MENACTRA and TRUMENBA vaccine in left Deltoid with no problems. Immediately after administration of HPV vaccine in right Deltoid, patient leaned forward as if he was passing out. This nurse leaned patient to the side so he would be laying down and not fall. This nurse noticed his entire body was contracting, having tonic clonic like movements, drooling, non-responsive to verbal stimuli or physical touch. I managed to get the patient into a supine position and elevate his legs. Seizure lasted 5 seconds. Patient came back to consciousness and asked what happened. Reported feeling tired and hot. BP 136/80, HR 85, RR 16.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Seizure, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Patient sitting upright on exam table. Patient tolerated MENACTRA and TRUMENBA vaccine in left Deltoid with no problems. Immediately after administration of HPV vaccine in right Deltoid, patient leaned forward as if he was passing out. This nurse leaned patient to the side so he would be laying down and not fall. This nurse noticed his entire body was contracting, having tonic clonic like movements, drooling, non-responsive to verbal stimuli or physical touch. I managed to get the patient into a supine position and elevate his legs. Seizure lasted 5 seconds. Patient came back to consciousness and asked what happened. Reported feeling tired and hot. BP 136/80, HR 85, RR 16.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Injection was administered as part of this organization's mandatory flu vaccination program. Injection was administered by a CMA at this facility. Employee stated pain began immediately, and did not abate. Employee stated he was in the process of changing primary care physicians, and chose not to seek evaluation. He did not rest his arm, but chose to, 'work it out."  Employee described localized pain in the left shoulder that extended from the site of injection to perhaps two inches down his arm. Pain was irregular, and most noticeable when he bent his elbow or moved his arm or  to pick up an object.  He stated the pain was often so sharp and sudden, it made him drop things. Employee was seen by our organization's medical director, Dr. Upon examination, Dr. noted no induration, swelling, or tenderness to palpation. Dr. strongly advised employee to seek evaluation with his new primary care physician.  Dr. suggested an OTC anti-imflammatory (Aleve)  and further advised employee to rest his arm as much as possible. This RN maintained close contact with employee's progress, as he remained reticent to follow through with seeing his PCP. Employee continued to report steadily decreasing pain and eventual discontinuation of Aleve.
Age: 35.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction w/o SOB. EpiPen 0.3mg administered to left thigh, 911 was called, pt transported to ER.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Wrong patient received product
Clinical narrative: Mistakenly given without an order. Confused patient with sister who was also in for a visit. Mother has been notified.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Hypersensitivity, Pruritus generalised
Clinical narrative: Allergic reaction described by the Volunteer: extreme diarrhea, hives in different parts of her body and her face was completely swelled up. "Everything was itchy and feverish and I had a lot of gas and stomach pain". She answered she does not think it is related to food since "I didn't eat anything weird that day". She answered that she treated it with ibuprofen, drank a lot of water and used anti itch cream from the medical kit (Diphenhydramine). She reported she did not have shortness of breath during this episode, neither feel throat tightness or other signs or symptoms that could compromise her breathing. Volunteer did not contact health unit 11/17/2018 to report reaction Sx were resolved at that time.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Swelling face, Throat tightness, Urticaria
Clinical narrative: Allergic reaction described by the Volunteer: extreme diarrhea, hives in different parts of her body and her face was completely swelled up. "Everything was itchy and feverish and I had a lot of gas and stomach pain". She answered she does not think it is related to food since "I didn't eat anything weird that day". She answered that she treated it with ibuprofen, drank a lot of water and used anti itch cream from the medical kit (Diphenhydramine). She reported she did not have shortness of breath during this episode, neither feel throat tightness or other signs or symptoms that could compromise her breathing. Volunteer did not contact health unit 11/17/2018 to report reaction Sx were resolved at that time.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Swelling
Clinical narrative: States had red rash all over left leg and right leg. Lots of swelling and took several weeks to resolve
Age: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Rash, Rubber sensitivity
Clinical narrative: Initial unsolicited report received from a physician on 14-Feb-2018. This case is linked with: 2018SA057952, 2018SA058253. This case involves a 12 years old patient (gender not reported), who was vaccinated with FLUBLOK QIV (expiration date, lot number, route, dose, dose in series and site of administration not reported) on an unknown date. This was a case of actual medication error due to inappropriate age at vaccine administration. On an unknown date, the patient developed a non serious rash diagnosed as a reaction to latex a "few months ago" (rash) following the vaccination with  FLUBLOK QIV. 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 received from a physician on 17-Dec-2018. No new information was provided. Follow up information received on 31-Jan-2019 from other health care professional. Event added and corresponding changes was made in narrative and fields accordingly. Documents held by sender: none
Age: 1.17
Sex: U
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Wrong technique in product usage process
Clinical narrative: Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 14 months old patient who was vaccinated with a diluent of the vaccine PENTACEL lot number C5572AA (Expiry date 13-Oct-2019) via unknown route in the left thigh on 23-Jan-2019. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccination involved Hepatitis A Vaccine, Hepatitis B Vaccine and PREVNAR 13. It is a actual medication case error due wrong injection technique. It was reported that PENTACEL was reconstituted left out for 60-90 minutes but the injection was given. It was unknown if any adverse event occurred. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, HEPA, MMR, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 22 months old patient (gender not reported) who received a 0.5 ml dose of vaccine QUADRACEL (lot C5325BA) via unknown route in unknown administration site instead of ACT-HIB on 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMRV); and PREVNAR 13. It was a case of actual medication error due to wrong vaccine administered. No ill effects 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 31-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 35 years old female patient  who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE instead of QUADRIVALENT INFLUENZA VACCINE expiry date May-2019 (lot number, route and site of administration was not reported) on an unknown date while she was 7 week pregnant. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and overdose. It was also a case of vaccine exposure during pregnancy. It was unknown whether patient experienced any adverse reaction. 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 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: TDAP
Symptoms: Nodule, Swelling
Clinical narrative: Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (office staff). This case involves three unknown demographic patients who experienced abnormal swelling and knots, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, three patients received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, three patients developed a non-serious abnormal swelling and knots (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was abnormal swelling and knots. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for abnormal swelling and knots. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Pain, Ultrasound scan normal
Clinical narrative: Initial information received on 31-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient of an unknown age who experienced pain, while he received vaccine ADACEL. 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 ADACEL lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain six weeks following the administration of ADACEL. Two days ago he went to the ED and received an Ultrasound and it was negative. Final diagnosis was pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for pain. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Upon second medical examination of the case during internal review on 01-Feb-2019, a significant correction was performed on 11-Feb-2019 to correct report type from unsolicited literature to unsolicited non literature. Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a patient (age and gender was not reported) who was administered the diluent for the PENTACEL vaccine which was not mixed with the ACTHIB diluent, lot number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient experienced any adverse events following the vaccination. 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. Documents held by sender: none. Addendum on 11 Feb 2019: a significant correction was performed on 11-Feb-2019 to correct report type from unsolicited literature to unsolicited non literature.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 years old male patient who was vaccinated with a 1.0 ml dose of vaccine FLUZONE PRESERVED (lot number and Exp. Date not reported) via intramuscular route in the left deltoid on 01-Feb-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to overdose. 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: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 11 years old male patient who was vaccinated with a 1.0 ml dose of vaccine FLUZONE (lot number and Exp. Date not reported) via intramuscular route in the left deltoid on 01-Feb-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to overdose. 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: 74.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 74 years old female patient received a 0.5 mL dose of FLUBLOK QIV (Batch number: QFAA1813, expiry date: 30-Jun-2019, for the first time) on 20-Nov-2018 and inadvertently second time on 30-Jan-2019 (batch number, expiry date not reported) via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to extra dose administered. No adverse event was reported at the time of reporting. Reported as not aware of 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 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. Documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight-year-old male patient who was vaccinated with 1.0 ml of FLUZONE lot number not reported via intramuscular route in the left deltoid on 01-Feb-2019. 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 overdose. It was unknown that any adverse event was 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: F
Vaccine: FLU4
Symptoms: Diplopia, Injection site erythema, Injection site pain, Swollen tongue
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient (age not reported) who experienced double vision, swollen tongue and pain, redness, tenderness at the injection site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious double vision (diplopia), swollen tongue and pain, redness, tenderness at the injection site (vaccination site inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was pain, redness, tenderness at the injection site, swollen tongue and double vision. It was not reported if the patient received a corrective treatment. The patient did not report the outcome of all the events. List of documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 63 years old male patient who received 0.5 mL dose vaccine FLUZONE HIGH DOSE lot UJ004AP, exp date: 30-Mar-2019 via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that FLUZONE HD was given to a 63-year-old male and the wrong box was pulled inadvertently. It was unknown if any adverse event was occurred. 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. Follow up information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. No new information received. Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer). This case involves a patient who experienced drug allergies diphth- acell pertussis- tetanus, while he/she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history included Drug Allergies including Codeine; Iodinated Diagnostic Agents. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unspecified date, the patient developed a non-serious allergy to diphth- acell pertussis- tetanus (drug allergy to vaccine) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Lab data not reported. Final diagnosis was allergy to diphth- acell pertussis- tetanus. It was not reported if the patient received a corrective treatment. The event outcome was not reported. List of document held by sender: none.
Age: 18.0
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone. This case involves a 18 years old patient who was vaccinated with 0.5 ml once second dose of MENACTRA (lot number: A12113, expiry date, route and site of administration were not reported) on 27-Jul-2013 at the age of 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL on an unknown date. It was a case of actual medication error due to extra dose administered. It was reported that the patient was given MENACTRA at the age of 12 and again at the age of 13. It was unknown if any adverse event occurred or not following the 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. Documents held by the sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 9 months old patient who received PENTACEL at 9 months of age and again at 15 months of age. 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/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. 1 other doses were administered on unknown dates for suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. 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.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a male patient of unknown age who received an expired dose of vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date (ADACEL was given seven days after it expired), the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5533BA (expiry date: 18-Jan-2019) via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient experienced any post vaccination reaction. 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: 65.0
Sex: F
Vaccine: PPV
Symptoms: Angiogram, Blood pressure increased, Chest X-ray normal, Dyspnoea, Gait inability
Clinical narrative: Patient received a PNEUMOVAX 23 on 7/20/18. She went shopping after the injection and noticed pain in her right shoulder. After a few hours, the pain was so bad that it prevented her from making dinner. By 8pm she was having trouble breathing ? which the patient thinks was due to the pain she was having. She went to the ER. She was worked up for cardiac issues, but that came back negative. She states she was treated for an allergic reaction to the injection. The patient reports that her pain was so severe that she was unable to walk and describes pain as blinding pain. She did not have a fever and the site was not red or swollen. Her blood pressure was elevated in the ER. She said that she was unable to move her arm at all ? had no range of motion.  While in the ER she also had an ultrasound to check for a clot.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Ultrasound Doppler normal
Clinical narrative: Patient received a PNEUMOVAX 23 on 7/20/18. She went shopping after the injection and noticed pain in her right shoulder. After a few hours, the pain was so bad that it prevented her from making dinner. By 8pm she was having trouble breathing ? which the patient thinks was due to the pain she was having. She went to the ER. She was worked up for cardiac issues, but that came back negative. She states she was treated for an allergic reaction to the injection. The patient reports that her pain was so severe that she was unable to walk and describes pain as blinding pain. She did not have a fever and the site was not red or swollen. Her blood pressure was elevated in the ER. She said that she was unable to move her arm at all ? had no range of motion.  While in the ER she also had an ultrasound to check for a clot.
Age: 61.0
Sex: U
Vaccine: FLUR4
Symptoms: Blister, Fatigue, Herpes zoster, Insomnia, Lymph node pain
Clinical narrative: A lot of pain, which affected my walking and sitting, blisters on my left leg and back, could not sleep at night, extreme fatigue, painful lymph nodes. VALACYCLOVIR 1g  every 8 hour, IBUPROFEN 600 mg every 6 hour, over the counter- Capsaicin topical analgesic crème for  blisters multiple times daily.
Age: 61.0
Sex: U
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: A lot of pain, which affected my walking and sitting, blisters on my left leg and back, could not sleep at night, extreme fatigue, painful lymph nodes. VALACYCLOVIR 1g  every 8 hour, IBUPROFEN 600 mg every 6 hour, over the counter- Capsaicin topical analgesic crème for  blisters multiple times daily.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Decreased appetite, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Late on the day of second shot I began to feel warm and tired. Upon waking on 2/18 I was unable to do normal activities. My temperature was 100.8 mid morning. I slept on and off most of the day, had little appetite, aches, stiff neck and a headache on my forehead.  About 2:00 in the afternoon my symptoms declined. By evening I was almost back to my normal. On 2/19 I was able to resume regular activities.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain, Skin warm, Somnolence
Clinical narrative: Late on the day of second shot I began to feel warm and tired. Upon waking on 2/18 I was unable to do normal activities. My temperature was 100.8 mid morning. I slept on and off most of the day, had little appetite, aches, stiff neck and a headache on my forehead.  About 2:00 in the afternoon my symptoms declined. By evening I was almost back to my normal. On 2/19 I was able to resume regular activities.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Terrible headache, recovery in 1 day.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: 36 hours of alternating fever (up to 103) and chills, muscle and body aches, and raging headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Influenza virus test negative, Nausea, Poor quality sleep
Clinical narrative: Had first of the two shingles shot at 2:00 PM on 02/11/19. I had a scratchy throat that day and told the person administering the shot that, and she said that was okay as long as no fever. I did not have a fever so got the shot. By 7:00 PM my chest was tight, I was wheezing a bit, and coughing. Had a rough night and at 5:00 AM the next morning was experiencing strong nausea. Was able to get into the doctor at 8:30 AM on 02/12/19 who administered ZOFRAN for the nausea at 9:00 AM. Took a second dose of ZOFRAN at 10:00 AM at home, and the nausea subsided completely. At the doctor's office they gave me a nebulizer treatment for the wheezing and Albuterol inhaler. Was still coughing on 02/15/19 so went back to doctor and was given the Z-PAC and a cough medicine. Still coughing up phlegm 02/19/19.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Productive cough, Wheezing
Clinical narrative: Had first of the two shingles shot at 2:00 PM on 02/11/19. I had a scratchy throat that day and told the person administering the shot that, and she said that was okay as long as no fever. I did not have a fever so got the shot. By 7:00 PM my chest was tight, I was wheezing a bit, and coughing. Had a rough night and at 5:00 AM the next morning was experiencing strong nausea. Was able to get into the doctor at 8:30 AM on 02/12/19 who administered ZOFRAN for the nausea at 9:00 AM. Took a second dose of ZOFRAN at 10:00 AM at home, and the nausea subsided completely. At the doctor's office they gave me a nebulizer treatment for the wheezing and Albuterol inhaler. Was still coughing on 02/15/19 so went back to doctor and was given the Z-PAC and a cough medicine. Still coughing up phlegm 02/19/19.
Age: 26.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hypersomnia, Impaired work ability, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Thursday night, 2/14/2019, approximately 20 days post vaccine administration, patient noticed pain upon light touch to left deltoid where HPV vaccine had been administered. The site was moderately raised but had no erythema or bruising. The patient began taking 500 mg acetaminophen PO PRN for pain and applied alternating heat/ice pads. The patient reports that the pain became progressively worse over the following 4 days, on Tuesday (2/19/2019, today) reporting that arm movement elicits pain at injection site. Patient reports sleeping throughout Sunday (2/17) afternoon to Tuesday (2/19) morning, noting feeling feverish and calling in sick to work on Monday (2/18). Today (Tuesday 2/19): Light palpation produces pain rated as 4 on a 0-10 scale per patient. The site is moderately raised and palpation feels firm with no warmness. No erythema or bruising is present. The patient reports no complaints or adverse symptoms regarding right deltoid, which received an HAV vaccination at the same time as the HPV vaccination.
Age: 26.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pain, Pyrexia
Clinical narrative: Thursday night, 2/14/2019, approximately 20 days post vaccine administration, patient noticed pain upon light touch to left deltoid where HPV vaccine had been administered. The site was moderately raised but had no erythema or bruising. The patient began taking 500 mg acetaminophen PO PRN for pain and applied alternating heat/ice pads. The patient reports that the pain became progressively worse over the following 4 days, on Tuesday (2/19/2019, today) reporting that arm movement elicits pain at injection site. Patient reports sleeping throughout Sunday (2/17) afternoon to Tuesday (2/19) morning, noting feeling feverish and calling in sick to work on Monday (2/18). Today (Tuesday 2/19): Light palpation produces pain rated as 4 on a 0-10 scale per patient. The site is moderately raised and palpation feels firm with no warmness. No erythema or bruising is present. The patient reports no complaints or adverse symptoms regarding right deltoid, which received an HAV vaccination at the same time as the HPV vaccination.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: The next morning by 7am, 2/15, had severe intense vertigo and fell to her knees. EMS took her to  Medical Center. Work-up for cardiac and neurological clear; everything came was negative including MRI. PCP saw patient at ER and she still had vertigo and couldn't lift head from the pillow. Patient was not admitted to hospital but discharged to assisted living facility. PCP visited patient at facility yesterday. After discharge, patient developed a localized site reaction at injection site--8cm in diameter, warm, swollen to touch. Patient given Meclizine for vertigo and dizziness but it was not helpful at all. In the nursing home received some vestibular physical therapy but still cannot ambulate because of vertigo. Patient still is at facility and will stay there until vertigo resolves. PCP will follow-up with patient after discharge. There were no comments from the patient about adverse events after the first dose of the vaccine.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: The next morning by 7am, 2/15, had severe intense vertigo and fell to her knees. EMS took her to  Medical Center. Work-up for cardiac and neurological clear; everything came was negative including MRI. PCP saw patient at ER and she still had vertigo and couldn't lift head from the pillow. Patient was not admitted to hospital but discharged to assisted living facility. PCP visited patient at facility yesterday. After discharge, patient developed a localized site reaction at injection site--8cm in diameter, warm, swollen to touch. Patient given Meclizine for vertigo and dizziness but it was not helpful at all. In the nursing home received some vestibular physical therapy but still cannot ambulate because of vertigo. Patient still is at facility and will stay there until vertigo resolves. PCP will follow-up with patient after discharge. There were no comments from the patient about adverse events after the first dose of the vaccine.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-FEB-2019, the patient was vaccinated with one dose of PROQUAD for prophylaxis ( lot # R017799, expiration date on 19-DEC-2019; exact dose, route and site of administration were not reported) and one dose of VARIVAX for prophylaxis ( lot # R017947, expiration date on 24-JAN-2019; exact dose, route and site of administration were not reported). No adverse effects were reported.