chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Postural orthostatic tachycardia syndrome
Clinical narrative: a dose of GARDASIL-9 may hace exacerbated her preexisting POTS condition; This spontaneous report was received from a physician referring to a 15 year old female patient with postural orthostatic tachycardia syndrome (POTS). The patient's pertinent medical history was not provided and her drug reactions/allergies and concomitant medications were unknown by reporter.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, by intramuscular route, as vaccination.         On an unknown date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose might have exacerbated the patient's pre-existing POTS condition (postural orthostatic tachycardia syndrome). She did not sought medical attention and did not receive treatment for the adverse experience.  At reporting time, the outcome of postural orthostatic tachycardia syndrome was unknown and it was considered probably related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects.; An administered dose of GARDASIL 9 underwent a temperature excursion prior to being administered to 1 patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 15-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number R027946 and expiration date 27-APR-2021). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 52.6 degrees Fahrenheit for a time frame of 7 days on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported; a patient received an expired dose of VAQTA; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 20-JUL-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA) 25/0.5 (units not reported) 0.5 milliliter, lot # S021092, expiration date 18-MAY-2020 as prophylaxis (route of administration not reported). No other adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021092; expirationdate: 18-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: a half centimeter induration, a subcutaneous mass that was tender at the injection site; bump at the injection site; slight tenderness at injection site; This spontaneous report was received from the medical assistant referring to a 23-year-old female patient.  The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were unknown.  On 24-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular route in the left deltoid as prophylaxis (strength, dose, frequency, lot number, and expiration date were not reported).      On the same date, the patient experienced slight tenderness at injection site. On 11-JUL-2020, the patient experienced an increased in tenderness and a bump at the injection site. On 17-JUL-2020, the patient sought medical attention and the medical assistant noted that the patient had a half centimeter induration, a subcutaneous mass that was tender at the injection site. No treatment was given.  At the reporting time, the patient did not recover from the events.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; patient was administered an improperly stored VARIVAX; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 20-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S028925 exp date 16-SEP-2021) (dose and route not reported) that was reconstituted with a properly stored diluent. There was no data digital issue involved. The temperatures of excursion were 6 °F to 14°F (9.0 F) for a time frame of 1 hour on 17-JUL-2020, 15°F to 46 °F (45.9) for 10 hours and 30 minutes on 17-JUL-2020; - 47 °F to 77 °F (77 F) for 15 hours starting at 10:07 pm on 17-JUL-2020 and 78 °F/26 °C or warmer (79.5 F) for 32 hours starting at 2:52 pm on 18-JUL-2020. There was no previous temperature of excursion. No adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first dose at an unspecified time then patient received second dose 6 days prior to 6 months recommended schedule.; No symptoms or additional adverse effects reported.; This spontaneous report was received from a physician via company representative referring to a pediatric patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.     On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength 25/0.5 (unit not provided); dose detail, lot#, route and expiration date were not provided) for prophylaxis. Then the patient received the second dose 6 days prior to 6 months recommended schedule (inappropriate schedule of product administration). No symptoms or additional adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Her daughter passed out on her way out of the doctor's office; this was immediately after her second dose of the HPV vaccine; This spontaneous report was received from the patient's mother via a company representative referring to her daughter, a 12 years old female patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.     On an unknown date, the patient was vaccinated with the second dose of human papillomavirus (HPV) vaccine (manufacturer unknown) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis (product origin unknown). Immediately after the second dose of HPV vaccine (manufacturer unknown), the patient passed out on her way out of the doctor's office. The outcome of pass out was not provided.  The causality between passed out and the HPV vaccine (manufacturer unknown) was not provided.  Upon internal review, passed out was determined to be medically significant.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Improperly stored dose of Pneumovax23 was administered to a patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 22-JUN-2020, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (strength, route of administration, and anatomical location were not reported; lot number S029265, with an expiration date not reported but validated as 31-MAR-2021) for prophylaxis.   It was reported that the improperly stored vaccine experienced a temperature of 12.1 degrees Celsius for a time frame of 2 hours and 20 minutes. There was not previous temperature excursion and a data logger was involved. No additional adverse effects reported, nor product quality complaints involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Adverse Reaction or Side effect: none; hepatitis Avaccine was administered on 29-DEC-2010, 28-JAN-2011 and 01-JUL-2011; This spontaneous report was received from a other health professional and a consumer referring to a 59-year-old female patient.   The patient's medical history included tobacco use. The patient's concurrent conditions included gastrooesophageal reflux disease. The patient's historical vaccine included hepatitis B vaccine (manufacturer unknown) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient's concomitant medications included omeprazole (PRILOSEC) and hepatitis B vaccine (manufacturer unknown).  On 29-DEC-2010, the patient was vaccinated with the first dose of hepatitis A vaccine vaccine (manufacturer unknown) for prophylaxis; and on 28-JAN-2011, with the second dose (inappropriate schedule of product administration). It was reported that the patient did not experience any adverse reaction or side effect with the vaccine.  On 08-DEC-2014, the patient experienced Vaccination failure and Herpes zoster (captured in # 1806USA007435).; Sender's Comments:  US-009507513-1806USA007435:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: suspected vaccination failure; had the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not repoted. In only one unknown year the patient experienced flu after vaccination. This is suspected vaccination failure case.
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: fatigue; Fever; Generalized aching; Injection site pain; This case was reported by a consumer and described the occurrence of fatigue in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for crohn's disease.   Concurrent medical conditions included crohn's disease.   On an unknown date, the patient received Shingrix. On 24th April 2020, the patient started Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, fever, generalized aching and injection site pain. Humira was continued with no change. On an unknown date, the outcome of the fatigue, fever, generalized aching and injection site pain were unknown.   It was unknown if the reporter considered the fatigue, fever, generalized aching and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received shingrix on unknown date. In 2020, the patient experienced fatigue, fever, generalized aching and injection site pain. The patient received humira for moderate to severe crohns disease. Less than 3 months, after receiving humira, patient experienced all events. No information related to conmed medications and medical history was reported. It was unknown if the reporter considered the fatigue, fever, generalized aching and injection site pain to be related to Humira.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The age at vaccination was not reported. In 2019, the patient received flu shot last fall and she came home, ate cereal then got sick and after that she felt better. The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a double dose of Ipol on the same day inadvertently, no AE; Initial information was received on 15-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional   This case involves a 4 year old female patient who received a double dose of IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] inadvertently on the same day (Extra dose administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE for prophylactic vaccination.  On 18-Jun-2020, the patient received a dose of suspect IPV (VERO) (lot R1D9749, Expiry 17-Jul-2021) via subcutaneous route in the left leg and a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6540AE, expiry date 25-Apr-2021) once via intramuscular route in the right deltoid for prophylactic vaccination  It was a case of an actual medication error due to extra dose administered  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: 34.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received ADACEL vaccine which was exposed to 52.6 degree Fahrenheit for seven days, no AE; A pregnant female received a dose of Adacel, no AE; Initial information was received on 20-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA189059, 2020SA189085, 2020SA189112 and 2020SA189132 (same reporter).  This case involves a 34 year old female patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA, expiry date 04-Dec-2022) via an intramuscular route at the left arm for prophylactic vaccination on 15-Jul-2020, while she was pregnant and which was exposed to 52.6 degree Fahrenheit for seven days from 08-Jul-2020 to 15-Jul-2020.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period and estimated due date was not reported.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to incorrect product storage and vaccine exposure during pregnancy.  A medical assistant reporting having Adacel exposed to 52.6 degrees F from 08Ju2020to 15 Jul2020 that was administered to pregnant patient.  at time of reporting, the outcome of the pregnancy is unknown.  At the time of reporting, 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: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Menactra vaccine was administered to the patient/ No AE; Initial information was received on 21-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 year old male patient who received 0.5 mL once dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6208AD and expiry date 08-Jul-2020) (Pharmaceutical form- Injectable) via intramuscular route in the left deltoid for prophylactic vaccination on 21-Jul-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was an actual medication error case due to expired vaccine used. It was reported that on 21-Jul-2020 the patient received vaccine which was expired 08-Jul-2020.  No adverse event symptoms 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
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: 22 month old female patient administered only diluent component of Pentacel, no AE; Initial information was received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 22 month old female patient (also reported as 23 month old female) who received only diluent component of Pentacel (product preparation issue), while she received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 07-Jul-2020, the patient received a 0.5ml dose (Interval dosage : once) only diluent component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ104AA and expiry date: 13-Oct-2020) (Injection) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent.  It was reported that nurse reported only diluent component of Pentacel was administered to 23 month old female.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Vaccination site haemorrhage, Venous injury
Clinical narrative: two month old female patient received Pentacel vaccine in the inner thigh; bleeding during administration, hit a femoral vein because blood came out; Initial information received on 22-Jul-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a two month old female patient who experienced bleeding during administration, hit a femoral vein because blood came out (vaccination site haemorrhage), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE via an oral route for prophylactic vaccination.  On 15-Jul-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ018AAA and expiry date: 10-Dec-2020) via an intramuscular route in the right inner thigh for prophylactic vaccination.  On 15-Jul-2020, the patient developed a non-serious hit a vein because blood came out, bleeding during administration (vaccination site haemorrhage) on the same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was a case of actual medication error due to vaccine administered at inappropriate site. A two month old female patient received Pentacel vaccine in the inner thigh.  Details of laboratory data not reported.   Final diagnosis was vaccination site haemorrhage.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was not 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: vaccine was given incorrectly (Pentacel) Nurse only gave DTPA-IPV, but didn't mix the ActHIb powder/No AE; Initial information was received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4-month-old female patient who was given only DTPA-IPV from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing ActHIb powder (Product preparation issue).  Medical history, medical treatment(s), vaccination(s), family history were not provided.  No other vaccines were given.  On 22-Jul-2020, the patient received a second 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ344AA, expiry date- 04-Apr-2021) via intramuscular route in the right vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique. It was reported that nurse was supposed to give pentacel and only grabbed liquid and did not mix with the powder part and wanted to know if ActHIb can be given alone.  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 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: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Pentacel was administered to a patient/ No AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old male patient who on 14-Jul-2020 received 0.5 mL expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UI952AB and expiry date 30-Jun-2020) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A), Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) and Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used. It was reported that Pentacel which was expired on 30-Jun-2020 was given to the patient on 14-Jul-2020, and the packaging has been discarded.  At a time of reporting no adverse event 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: 17.0
Sex: F
Vaccine: UNK
Symptoms: Eye pain, Fatigue, Insomnia, Joint range of motion decreased, Limb discomfort
Clinical narrative: The time of injection was a stinging sensation. Nurse stated that this was the second time someone said it stung this week. The left arm was sore. Could not sleep because of pain. Saturday,  07/25/2020pain still present with heaviness to arm. Limited range of motion. To move arm above head there was pain. To have left hand touch left should there was pain.  Sunday 07/26/2020, fatigue, weakness pain BOTH arms (right and left). There was pain when she tried to extend either arm. Stiffness in neck. Pain in eyes when looking to the left side. Fever of 100.5 was first documented at 21:57. Took equate acetaminophen 500 mg at 22:18.  On Monday 07/27/2020 at 04:11 temperature was retaken and it read 98.2. However, at 6:51am the temperature was 100.2
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
Clinical narrative: The time of injection was a stinging sensation. Nurse stated that this was the second time someone said it stung this week. The left arm was sore. Could not sleep because of pain. Saturday,  07/25/2020pain still present with heaviness to arm. Limited range of motion. To move arm above head there was pain. To have left hand touch left should there was pain.  Sunday 07/26/2020, fatigue, weakness pain BOTH arms (right and left). There was pain when she tried to extend either arm. Stiffness in neck. Pain in eyes when looking to the left side. Fever of 100.5 was first documented at 21:57. Took equate acetaminophen 500 mg at 22:18.  On Monday 07/27/2020 at 04:11 temperature was retaken and it read 98.2. However, at 6:51am the temperature was 100.2
Age: 49.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Patient began having edema, erythema, and pain at injection site 24 hours after injection. Area continued to swell over next 24 hours.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Dehydration, Febrile convulsion
Clinical narrative: Per mother's report patient had a febrile seizure the following day after her vaccine. She was brought to the ER and treated for dehydration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abdominal discomfort, Blood test, Fatigue, Malaise, Seizure
Clinical narrative: Per mother's report patient had a febrile seizure the following day after her vaccine. She was brought to the ER and treated for dehydration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Skin warm, Urine analysis, Vomiting
Clinical narrative: Per mother's report patient had a febrile seizure the following day after her vaccine. She was brought to the ER and treated for dehydration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Dehydration, Febrile convulsion
Clinical narrative: Patient started feeling unwell with an upset belly in the afternoon on 7/21/20. At the time of picking her up from preschool, she had been outside playing so she was very warm due to the hot weather. We were unaware of her fever at the time and just thought she was hot from playing outside. She then began acting extremely fatigued to the point of not being able to answer simple "yes/no" questions. She started nodding her head left/right and up/down to answer. That turned into no response. At this time, my husband was driving in a vehicle with her and saw all this from the rearview mirror. He then pulled over and she immediately threw up. At this point we think she was having a seizure because she was non-responsive. My husband then drove her to the ER for care. She seized for several more minutes before coming out of it and being treated. All of this happened within an hour of noticing she wasn't feeling well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abdominal discomfort, Blood test, Fatigue, Malaise, Seizure
Clinical narrative: Patient started feeling unwell with an upset belly in the afternoon on 7/21/20. At the time of picking her up from preschool, she had been outside playing so she was very warm due to the hot weather. We were unaware of her fever at the time and just thought she was hot from playing outside. She then began acting extremely fatigued to the point of not being able to answer simple "yes/no" questions. She started nodding her head left/right and up/down to answer. That turned into no response. At this time, my husband was driving in a vehicle with her and saw all this from the rearview mirror. He then pulled over and she immediately threw up. At this point we think she was having a seizure because she was non-responsive. My husband then drove her to the ER for care. She seized for several more minutes before coming out of it and being treated. All of this happened within an hour of noticing she wasn't feeling well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Skin warm, Urine analysis, Vomiting
Clinical narrative: Patient started feeling unwell with an upset belly in the afternoon on 7/21/20. At the time of picking her up from preschool, she had been outside playing so she was very warm due to the hot weather. We were unaware of her fever at the time and just thought she was hot from playing outside. She then began acting extremely fatigued to the point of not being able to answer simple "yes/no" questions. She started nodding her head left/right and up/down to answer. That turned into no response. At this time, my husband was driving in a vehicle with her and saw all this from the rearview mirror. He then pulled over and she immediately threw up. At this point we think she was having a seizure because she was non-responsive. My husband then drove her to the ER for care. She seized for several more minutes before coming out of it and being treated. All of this happened within an hour of noticing she wasn't feeling well.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VARIVAX, on 7/20/2020, that had been improperly stored.; Information has been received from a nurse, referring to a 12 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-JUL-2020, the patient was inadvertently vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail and route of administration were not provided; lot # T002844 with expiration date 23-JAN-2022) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were not reported).  The vaccine experienced a temperature excursion of 70 degrees Fahrenheit (F) for 48 hours. There were no previous excursions reported. The digital data logger was involved. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding current condition, historical condition or concomitant medication was provided. On or about 15-OCT-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose details, strength, route, batch/lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions by a healthcare provider (HCP). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The lawyer considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to an elderly female patient (pt) of unknown age. No information regarding current condition, historical condition or concomitant medication was provided. On or about 27-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose details, strength, route, batch/lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of herpes zoster and post herpetic neuralgia was unknown. The lawyer considered herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S036635, expiration date 14-NOV-2021 for prophylaxis (exact doses, dose # and route of administration were not reported) which was reconstituted with properly stored sterile diluent (STERILE DILUENT). The following temperature excursions were reported: from -14 degrees Celsius (C) to -10 degrees C (-11.1 C) for 2 hours, from - 9 degrees C to 8 degrees C (2.2 C) for 9 hours and 30 minutes, from -14 degrees C to -10 degrees C (-9.8 C) for 2 hours and 30 minutes and from -9 degrees C to 8 degrees C (0.4 C) for 3 hours. There was following previous temperature excursion reported: from - 9 degrees C to 8 degrees C (- 6.1 C) for 8 hours. The digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: flu like symptoms/side effects; side effects; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on unknown date. Please refer the case US2020092721).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and adverse drug reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms and adverse drug reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient had not elaborated beyond the flu like symptoms. the caller did not wish to participate in a safety report and would not elaborated on flu like symptoms, or other side effects. The reporter did not consent to follow up.   Follow up information received from consumer on 25th June 2020: The patient's flu-like symptoms lasted approximately 48 hours.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092721:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shingles; still suffer nerve damage; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had shingle vaccine and still got the shingles.  The patient was still suffering nerve damage.  The patient stated that commercial was misleading because you can still get the shingles even if you get the vaccine. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Per patient, "Friday night I began having a fever, headache and nausea. Fever has come and gone, but currently do not have a fever."
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dyspepsia, Fatigue, Feeling of body temperature change
Clinical narrative: The following morning I was extremely tired and had a headache, chills and a fever.  I felt hot and cold and sweaty.  Zero energy.  When I tried to eat lunch it sort of came up in an acid liquid - indigestion?  I pretty much slept for 32 hours which is completely weird for me because I have a lot of energy and am really active!!!  I was awake only to try to force myself to eat and to text a little.  I got up last night to eat dinner at 9pm then slept all night again!!  crazy.  almost back to normal today
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Pyrexia
Clinical narrative: The following morning I was extremely tired and had a headache, chills and a fever.  I felt hot and cold and sweaty.  Zero energy.  When I tried to eat lunch it sort of came up in an acid liquid - indigestion?  I pretty much slept for 32 hours which is completely weird for me because I have a lot of energy and am really active!!!  I was awake only to try to force myself to eat and to text a little.  I got up last night to eat dinner at 9pm then slept all night again!!  crazy.  almost back to normal today
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Crying, Detoxification, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: The day after she received the shot she was at her softball game and told her coach she couldn?t run, her ankles hurt. This happened again during the following week at dance. I remembering her texting me from dance (I was at her open house) that she couldn?t do the jumps because of he ankles. Then Fri. morning she woke up and could not move her neck at all. I heard a scream come from upstairs, went up and she was standing there crying. We took her to the doc., who prescribed 800 mg of Ibuprofen every 4 hours. It did not make a dent in her pain. The next day she was still in pain and she asked me if I could take for acupuncture, which I did. The practitioner told us her glands were so swollen! The NP never mentioned this to us. She improved over the next few days after  acupuncture treatments, but now every month when she gets her period, she gets swollen lymph glands. We are seeing another doctor and working on detoxing her body.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Mobility decreased, Screaming
Clinical narrative: The day after she received the shot she was at her softball game and told her coach she couldn?t run, her ankles hurt. This happened again during the following week at dance. I remembering her texting me from dance (I was at her open house) that she couldn?t do the jumps because of he ankles. Then Fri. morning she woke up and could not move her neck at all. I heard a scream come from upstairs, went up and she was standing there crying. We took her to the doc., who prescribed 800 mg of Ibuprofen every 4 hours. It did not make a dent in her pain. The next day she was still in pain and she asked me if I could take for acupuncture, which I did. The practitioner told us her glands were so swollen! The NP never mentioned this to us. She improved over the next few days after  acupuncture treatments, but now every month when she gets her period, she gets swollen lymph glands. We are seeing another doctor and working on detoxing her body.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Vaccinated on 07/23/2020 with Trumenba. Patient woke up on morning of 07/26/2020 (3 days post-immunization) and was unable to lift his right arm (not the same arm as injection site). Mother was able to lift patient's arm to assess mobility range and patient did not complain of any pain. Mother gave ibuprofen throughout the day on 07/26 with no improvement. Mother states that patient is not able to lift arm to lift a fork or to drive as some examples. Mother is going to try Benadryl and if no improvement, will return to clinic for further evaluation.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: vomiting, diarrhea lasting approximately 12 hours; aches/pains lasting  for about 10 days
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Abdominal discomfort, Hypotension, Lethargy, Loss of consciousness, Pallor
Clinical narrative: Client lost consciousness and had seizures x2 after vaccinations. Mother states this has happened before.  Mother requested EMS be called. Client had very low bp (60/20), was lethargic, very pale and complained of an upset stomach.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Seizure
Clinical narrative: Client lost consciousness and had seizures x2 after vaccinations. Mother states this has happened before.  Mother requested EMS be called. Client had very low bp (60/20), was lethargic, very pale and complained of an upset stomach.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Neck pain, Pain, Pain in jaw, Pyrexia
Clinical narrative: NAUSEA, VOMITING, FEVER, JAW AND NECK PAIN, SHAKING, BODY ACHES
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Tremor, Vomiting
Clinical narrative: NAUSEA, VOMITING, FEVER, JAW AND NECK PAIN, SHAKING, BODY ACHES
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine administrated afte a temperature excursion; This spontaneous report was received from a nurse referred to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant therapies and drug reactions or allergies was provided.  On 01-JUL-2020, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# S005878 with expiration date :25-NOV-2020.   The dose of vaccine was stored above 9 Celsius degree: 8.9 Celsius degree for 15 minutes. Previous temperature was above 9 Celsius degree: 14.2 Celsius degree for2 hours. Digital data logger was involved. No adverse effects were reported.