chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: pain /achiness; shivering; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 30 years ago).   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain, shivering and tiredness. On an unknown date, the outcome of the pain, shivering and tiredness were unknown.   It was unknown if the reporter considered the pain, shivering and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in the left arm. The patient administered vaccine in early September 2019. The patient had pain, shivering, tiredness and achiness. The reporter consented to follow up. For tolerance of 2nd dose refer case US2019204840.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient asked if they had shingles and year later had 1st dose of Shingrix vain nine and experienced all the worst side effect of it. The patient asked if they should go ahead and get second dose of Vaccine. It was unknown if the reporter consented to followup.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain in extremity, Vision blurred
Clinical narrative: Blurry vision; headache; malaise; Tired; arm pain; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th November 2019, 6 hrs after receiving Shingrix, the patient experienced blurred vision, headache, malaise, tiredness and pain in arm. On 6th November 2019, the outcome of the blurred vision was recovered/resolved. On an unknown date, the outcome of the headache, malaise, tiredness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the blurred vision, headache, malaise, tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient applied ice on her arm because it was very sore. The event headache, malaise and tiredness resolved after about 2-3 days. The arm pain resolved after 4-5 days. The reporter Consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Toothache
Clinical narrative: Nerve Pain in sinuses; Toothache; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2019, 1 hr after receiving Shingrix, the patient experienced nerve pain and toothache. On an unknown date, the outcome of the nerve pain and toothache were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and toothache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm, intramuscularly and experienced severe nerve pain in sinuses developed along with referred toothache pain. At the time of reporting the patient still had severe pain. The reporter did not consent to Health care professional follow-up during call.
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Febrile reaction; This case was reported by a physician via call center representative and described the occurrence of febrile reaction in a 60-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2018-2019 season) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2018-2019 season at an unknown dose. On an unknown date, less than 2 years after receiving FluLaval Tetra 2018-2019 season, the patient experienced febrile reaction. On an unknown date, the outcome of the febrile reaction was unknown.   It was unknown if the reporter considered the febrile reaction to be related to FluLaval Tetra 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced 103 degree F after receiving what he believed to be a GlaxoSmithKline Trivalent Flu vaccine. The patients febrile reaction resolved within 12 hours. The patient had received the vaccine at work and the event was reported by his consulting PCP. No additional details were provided at the time of report. The Vaers details were provided. The reporter Consented to follow up.      Lab Comments: On an unspecified date, Lab test performed.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue
Clinical narrative: Bone pain; Fatigue; This case was reported by a other health professional via call center representative and described the occurrence of bone pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced bone pain and fatigue. On an unknown date, the outcome of the bone pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the bone pain and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient complained of bone pain and fatigue for a month after receiving the second dose of Shingrix. It was reported that vaccine not administered at the physicians office. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Wrong product administered
Clinical narrative: Interchange of Vaccines; Wrong vaccine administered; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 45-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in November 2018) and Havrix (received on 30th April 2019).   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, unknown after receiving Twinrix, the patient experienced drug dose administration interval too long, wrong vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long, wrong vaccine administered and incomplete course of vaccination were unknown.  Additional information was reported as follows: The age at vaccination was not reported. The patient received a dose Havrix after 1st dose of Twinrix, which led to wrong vaccine administered and lengthening of the vaccination schedule for the Hepatitis A. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Cardiac failure, Pharyngeal swelling
Clinical narrative: Heart failure; Swelling of the soft palate of the throat; This is a spontaneous report from a Contactable Physician via Pfizer sales representative. A 50-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine (FLU), via an unspecified route of administration on the same date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient developed a swelling of the soft palate of the throat. He had heart failure and was taking Lisinopril. He was sent to the Emergency Room where he was given benadryl and the symptoms resolved. The outcome of the event heart failure was resolving and the other event was unknown.; Sender's Comments: The association between the event heart failure with pneumococcal 13-valent conjugate vaccine use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: delayed transit of Fluzone HD was administered, no AE; delayed transit of Fluzone HD was administered, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 76 years old male patient who was vaccinated with dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ283AB, expiry date: 29-May-2020), via intramuscular route in the right arm accidentally, on 14-Oct-2019  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was a case of incorrect product storage and product shipment delay due product was to be delivered on 10Oct2019 and was not received until 14Oct2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: shipment was to be delivered on 10Oct2019 and was not received until 14Oct2019,no AE; shipment was to be delivered on 10Oct2019 and was not received until 14Oct2019,no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from Nurse.  This case is linked with 2019SA287366 and 2019SA287333 (same reporter)  This case involves a 75 years old female patient who was vaccinated with 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ283AB, expiry date: 29-May-2020), via intramuscular route in the left arm on 14-Oct-2019  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an case of incorrect product storage and Product shipment delay due to product was to be delivered on 10Oct2019 and was not received until 14Oct2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 52.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Fluzone QD instead the Flublok, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 52 year old patient (gender not reported) who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Flublok).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of Wrong vaccine administered.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 20 yo patient inadvertently received Fluzone High-Dose on 22Oct2019/ No AE; 20 yo patient inadvertently received Fluzone High-Dose on 22Oct2019/ no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 20 years old patient who inadvertently received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date not reported) via unknown route and site of administration on 22oct2019.  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 the product administered to patient of inappropriate age and overdose. It was reported that patient inadvertently received Fluzone High-Dose on 22Oct2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  Batch number was requested.
Age: 10.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 year old daughter received Flublok Quadrivalent vaccine, no adverse event; Upon second medical examination of the case during internal review, a significant correction was performed on 20-Nov-2019 to correct classification from non-case to valid case.  Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 10 years old female patient who was vaccinated with a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in the right deltoid on 21-Oct-2019.  The patient's medical history not reported and no other vaccines received.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse symptoms reported at the time of reporting.  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.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Rubber sensitivity
Clinical narrative: reaction was related to latex in the product packaging; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who experienced reaction was related to latex in the product packaging, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious reaction was related to latex in the product packaging (unevaluable event) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that latex-related reaction after receiving a Fluzone HD at a hospital 10 years ago.Patient reported the reaction was related to latex in the product packaging.  Other relevant tests were not reported.  Final diagnosis was reaction was related to latex in the product packaging.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB, MMR
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6-year-old male received an inadvertent dose of Pentacel and Quadracel 0.5 mL intramuscular in the left deltoid on 11Nov2019 instead of MMRV; 6-year-old male received an inadvertent dose of Pentacel and Quadracel 0.5 mL intramuscular in the left deltoid on 11Nov2019 instead of MMRV; 6-year-old male received an inadvertent dose of Pentacel and Quadracel 0.5 mL intramuscular in the left deltoid on 11Nov2019 instead of MMRV; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old male patient who received an inadvertent 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] Lot number- C5656AA, expiry date 13-Aug-2021 instead MMR VACCIN (lot: UJ110AAA, expiry date: 14-Oct-2020, intramuscular in the left deltoid) on 11-Nov-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 wrong vaccine administered, Inappropriate age at vaccine administration and Extra dose administered.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to patient instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316262, 2019SA316286, 2019SA316289, 2019SA316290, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261 and 2019SA316288. (Same reporter).  This case involves a 77 years old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to patient instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261, 2019SA316262, 2019SA316263, 2019SA316288, 2019SA316289, 2019SA316290 (same reporter).  This case involves a 85 years old male patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the right deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms reported at the time of reporting.  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: U
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Fluzone HD was inadvertently administered to 5 patients shipped on 06Nov2019 and not received until 11Nov2019, no AE; Lab tech reports delayed shipment of Fluzone HD, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (lab technician).  This case is linked to case 2019SA316735 (same reporter).  This case involves 5 patients who inadvertently received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number, expiry date, route and site of administration were not reported) after shipment delay 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 incorrect product storage and product shipment delay.  Lab technician reported delayed shipment of Fluzone HD which was shipped on 06-Nov-2019 and not received until 11-Nov-2019 at 1308. Caller reported that Fluzone HD was inadvertently administered to 5 patients.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a 2 years old patient ,no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 24 months old male patient who received 0.5 ml of expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE  [DAPTACEL] , lot C5307AA and expiry date 23-OCT-2019 via intramuscular route in the left thigh on 12-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error due to expired vaccine used.  AE symptoms: None 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.
Age: 66.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 66 years old patient administered regular flu vaccine in error, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 year old female patient who was vaccinated with a dose of INFLUENZA VACCINE lot number not reported via unknown route in unknown administration site instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on an unspecified date.  The patient's past vaccination(s) included Fluzone HD (reported that patient was taking Fluzone for two years). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Hypogammaglobulinaemia.   It is an actual medication error case due to wrong vaccine administered.  At the time of reporting the patient did not 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.  Information on the batch number was requested.
Age: 25.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy
Clinical narrative: female patient received Flublok vaccine while she was pregnent/no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 25 years old female patient who was received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] while she was pregnant.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date is 05-Jun-2020. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Dose reported for vaccines = 0.25-2 mL) lot number not reported via unknown route in the right deltoid.  It was case of vaccine exposure during pregnancy.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: delayed shipment of Fluzone HD and Fluzone Quad shipped on 06Nov2019 and not received until 11Nov2019 at 13:08, Fluzone Quad was inadvertently administered to 19 patients/No AE; delayed shipment of Fluzone HD and Fluzone Quad shipped on 06Nov2019 and not received until 11Nov2019 at 13:08, Fluzone Quad was inadvertently administered to 19 patients/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (lab technician).  This case is linked to case 2019SA320779 (same reporter).  This case involves 19 patients who inadvertently received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after shipment delay.  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 incorrect product storage and product shipment delay.  Lab technician reported delayed shipment of Fluzone Quad which was shipped on 06-Nov-2019 and not received until 11-Nov-2019 at 1308. Caller reported that Fluzone Quad was inadvertently administered to 19 patients.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 1.08
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 month old received Patient received a dose of Flublok Quadrivalent vaccine/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-HCP.  This case involves a 13-month-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Nov-2019, the patient received first 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1952, expiry date- 30-06-2020) once via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients received expired doses of Flublok Quadrivalent/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from other health care professional.  This case is linked to cases 2019SA316777, 2019SA316760 and 2019SA316778 (same reporter).  This case involves a 57-year-old male patient who received expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1824, expiry date- 30-06-2019) via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 35 years old female patient received an expired dose of Flublok Quadrivalent/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to case 2019SA316754, 2019SA316777 and 2019SA316778 (same reporter).  This case involves a 35 years old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml an expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1824, expiry date: 30-Jun-2019) via intramuscular route in the left deltoid.  It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 63 years old female patient received an expired dose of Flublok Quadrivalent, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA316754, 2019SA316760 and 2019SA316778 (same reporter).  This case involves a 63 years old female patient who received an expired dose (0.5 ml ) of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1824 and expiry date 30-JUN-2019) via intramuscular route in the left deltoid on 02-Nov-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.  At the time of reporting no adverse events was 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.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone Quad had given to a patient which was delay in shipping time, no AE; Fluzone Quad had given to a patient which was delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case is linked to cases 2019SA320728, 2019SA320727, 2019SA320730, 2019SA320730 and 2019SA320731 (same reporter).  This case involves a 19 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ3058A, Exp. Date 20-Jun-2020 via unknown route in unknown administration site on 12-Nov-2019, that was delay in shipping time.  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 incorrect product storage and product shipment delay.  It was reported that shipment had been in transit for over 2 days. Customer agent advised the vaccines was not good any longer.  At the time of reporting, no adverse reactions were 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: F
Vaccine: FLU4
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: cramps; tingling on head, face, arms and legs; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a female patient who experienced cramps (muscle spasms) and tingling on head, face, arms and legs (Paraesthesia), while she received vaccine INFLUENZA QUADRIVAL A-B 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 of Sep-2018, the patient developed a serious cramps (muscle spasms) and tingling on head, face, arms and legs (paraesthesia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized one weeks after receiving the vaccine.  Other relevant tests were not reported.  Final diagnosis was tingling on head, face, arms and legs and cramps.  Patient has been treated by a neurologist.  The patient outcome is reported as Unknown for both the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who presented with muscle cramps and tingling on head, face, arms and legs after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac arrest, Chest X-ray, Echocardiogram, Electrocardiogram, Eye movement disorder
Clinical narrative: Pt received flu shot in office. Just after walking out of the exam room she had syncope with collapse, eyes rolled back. Head/face struck metal scale on the floor as she fell, resulting in through and through laceration to lower lip. Pt unresponsive for a few seconds and then regained consciousness and was able to answer questions. Ambulance called and pt transported to nearest ER where she had 7 seconds of asystole and compressions initiated. Air transport to hospital where pt was monitored overnight in ICU and then on floor, no further episodes noted. Presuming vasovagal episodes but asystole remains unexplained. No prior episodes of syncope for pt. Will be following outpatient with cardiology.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Face injury, Fall, Full blood count, Head injury, Intensive care
Clinical narrative: Pt received flu shot in office. Just after walking out of the exam room she had syncope with collapse, eyes rolled back. Head/face struck metal scale on the floor as she fell, resulting in through and through laceration to lower lip. Pt unresponsive for a few seconds and then regained consciousness and was able to answer questions. Ambulance called and pt transported to nearest ER where she had 7 seconds of asystole and compressions initiated. Air transport to hospital where pt was monitored overnight in ICU and then on floor, no further episodes noted. Presuming vasovagal episodes but asystole remains unexplained. No prior episodes of syncope for pt. Will be following outpatient with cardiology.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Lip injury, Loss of consciousness, Presyncope, Resuscitation, Syncope
Clinical narrative: Pt received flu shot in office. Just after walking out of the exam room she had syncope with collapse, eyes rolled back. Head/face struck metal scale on the floor as she fell, resulting in through and through laceration to lower lip. Pt unresponsive for a few seconds and then regained consciousness and was able to answer questions. Ambulance called and pt transported to nearest ER where she had 7 seconds of asystole and compressions initiated. Air transport to hospital where pt was monitored overnight in ICU and then on floor, no further episodes noted. Presuming vasovagal episodes but asystole remains unexplained. No prior episodes of syncope for pt. Will be following outpatient with cardiology.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt received flu shot in office. Just after walking out of the exam room she had syncope with collapse, eyes rolled back. Head/face struck metal scale on the floor as she fell, resulting in through and through laceration to lower lip. Pt unresponsive for a few seconds and then regained consciousness and was able to answer questions. Ambulance called and pt transported to nearest ER where she had 7 seconds of asystole and compressions initiated. Air transport to hospital where pt was monitored overnight in ICU and then on floor, no further episodes noted. Presuming vasovagal episodes but asystole remains unexplained. No prior episodes of syncope for pt. Will be following outpatient with cardiology.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's left arm was broken and patient did not want a vaccine in left arm, so pharmacist did both shots in right arm, 1-2 inches apart. 2 days later her right arm got very swollen and red all the way down her arm and hurt very bad. She had to go to immediate care. They thought it might be cellulitis. They told her that they would have just given her 1 injection and asked her to come back in a few weeks. However, you can give these 2 vaccines in the same arm. She was treated as if she had cellulitis.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Skin warm
Clinical narrative: later in day notice arm was red and hot, redness was down to her elbow, iced it and took motrin, unable to move arm mo0nday night and Tuesday.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Chills, Flushing, Middle insomnia, Nasal congestion
Clinical narrative: 10/22/2019 2330 - awoke from deep sleep, face flushed; T 103.4 oral 2333 - acetaminophen 12.5 mL   10/23/2019 0100 - sleeping, easily aroused; complained of chills; T 101.1 oral 0215 - sleeping, easily aroused; T 99.8 oral 0530 - sleeping, easily aroused; T 98.3 oral 0720 - awake, complained of general body aches; T 99.4 0800 - acetaminophen 12.5 mL 1012 - T 98.6 oral 1330 - T 98.8 oral 1610 - complained of general body aches, stuffy nose; T 98.5 oral 1930 - T 97.9 oral
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: 10/22/2019 2330 - awoke from deep sleep, face flushed; T 103.4 oral 2333 - acetaminophen 12.5 mL   10/23/2019 0100 - sleeping, easily aroused; complained of chills; T 101.1 oral 0215 - sleeping, easily aroused; T 99.8 oral 0530 - sleeping, easily aroused; T 98.3 oral 0720 - awake, complained of general body aches; T 99.4 0800 - acetaminophen 12.5 mL 1012 - T 98.6 oral 1330 - T 98.8 oral 1610 - complained of general body aches, stuffy nose; T 98.5 oral 1930 - T 97.9 oral
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Upper arm sore after shot.  Soreness subsided, now no pain at rest. Now, when lifting arm certain ways fell stiffness in arm at spot of injection. Patient has not seen a doctor regarding the issue.  Patient has not taken OTC medication for the stiffness
Age: 47.0
Sex: M
Vaccine: FLU4, MMR, PPV
Symptoms: Catheterisation cardiac, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt developed a fever of 103,  he did have a heart cath done the morning of 11/14/19. Arm of the injection site where the PPSV 23 and flu vaccine was given is red, swollen and tender.  He was seen at Hospital ER the evening of 11/14/19, was diagnosed with fever and injection site reaction, possible cellulitis. Placed on Keflex 500mg .  Pt seen in the office 11/18/19 still had some redness and swelling, advised to finish course of Keflex and return if symptoms failed to improve or worsened.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Intussusception, Surgery
Clinical narrative: Client's mother called in and left a voicemail stating the client had been hospitalized for intussusception and subsequently undergone surgery following the vaccination.  Multiple voicemail were left attempting to contact mom to inquire re: patient and gain further details but client's mother has not called back.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster oticus
Clinical narrative: zoster-like rash on right external ear
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Pain, Swelling
Clinical narrative: Local reaction to flu shot. symptomatic control ice to area, tylenol, and benadryl for pain and swelling. RTC or ER if redness or swelling increases, pain increases, dyspnea or fever.
Age: 16.0
Sex: F
Vaccine: FLUN4, MENB
Symptoms: Fall, Joint injury, Pallor, Seizure, Syncope
Clinical narrative: She fainted and has a seizure. Dr. was present and she had other Drs. support with all the office staff (Nurses). They help her to recover and provide Pedialyte and gummy bears. Sha was pale and took some time to recover. Due to the fall she hurt her right wrist.