chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: 6 month-old was supposed to receive Pentacel but the lyopilized ActHIB component was mixed with Quadracel rather than DTap-IPV diluent from the Pentacel package, no AE; 6 month-old received lyopilized ActHIB component mixed with Quadracel rather than DTap-IPV diluent from the Pentacel package, no AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 6 months old female patient who was supposed to receive her DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], immunization. But when it was reconstituted, the lyopilized Act-Hib (lot U6622AA, expiry date: 16-Feb-2021) was mixed with [DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5688AA, expiry date: 26-Nov-2021) rather than the Dtap-IPV diluent from the pentacel package on 29-Apr-2020 via intramuscular route in the left thigh for prophylactic vaccination.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique and inappropriate age vaccine administration.  No adverse event 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.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB lyophilized vaccine reconsituted with "sterile diluent" that they use for other vaccines, such as varicella, rather than the accompanying ActHIB diluent, no AE; Initial information received on 28-Apr-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 months old male patient who was vaccinated with 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ135AB and expiration date 26-Feb-2021) lyophilized vaccine which was reconstituted with sterile diluent that they use for other vaccines, such as varicella, rather than the accompanying acthib diluent (lot U6477AA, expiration date 26-Nov-2020) on 27-Apr-2020 intramuscularly in the left thigh for prophylactic vaccination.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  t was an actual medication error case due to wrong solution used in drug reconstitution.  No adverse event 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.
Age: 1.75
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ActHIB (expired 7 days ago) was given to a 21 month old this morning/No AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 21 months old female patient who received a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ActHIB] (lot UJ055AAA, diluent lot U6205AC, expiry date 22-Apr-2020) on 29-Apr-2020, via intramuscular route in the left thigh for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse effects had been observed.   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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Bradykinesia, Eye movement disorder, Tremor
Clinical narrative: shaking; slowness; eye rolling up; Initial information was received on 01-May-2020 regarding an unsolicited valid non-serious case received from a physician  This case involves a 5 month old female patient who experienced shaking (tremor), slowness (bradykinesia) and eye rolling up (eye movement disorder), 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13); and ROTAVIRUS VACCINE.  On 30-Apr-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ214AAA, expiry date 23-Apr-2021, vial) once via intramuscular route in the left thigh for prophylactic vaccination  On 01-May-2020, the patient visited the physician.  On an unknown date in the morning, the patient was resting with father and it was noted she appeared on the slow side (bradykinesia), her eyes rolled up (eye movement disorder) and she began to shake (tremor) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.. The patient was normal except maybe alittle slower and had no history of seizures.  Final diagnosis was tremor, bradykinesia and eye movement disorder.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.
Age: 20.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered Act-Hib with expired diluent/no AE; Initial information was received on 01-May-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 20 months old female patient who received 0.5 ml HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent (expired product administered) via intramuscularly at the left thigh on 29-Apr-2020 for prophylactic vaccination [batch number and expiry date of diluent U6205AA and 22-APR-2020]. Batch number and expiry date of ACT-HIB and box was reported as UJ064AA , UJ064AAA and 04-OCT-2020, 22-APR-2020 respectively.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case 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: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event, Expired product administered, Exposure during pregnancy
Clinical narrative: Pregnant patient received expired vaccine dose; Pregnant patient received [expired] vaccine dose; This non-serious initial spontaneous case, was received on 22-Sep-2017, concerning a 29-year-old, adult pregnant female patient.  The patient did not use contraceptives. The patient's last menstrual period date was on 22-Jan-2017, foetus status was not reported. The patient had no pregnancy in the past. The infant gestational age was 34.5 weeks and there was no evidence of defect or adverse findings from prenatal test. Concomitant medication included: Prenatal vitamins for unknown indication.  On 21-Sep-2017, the patient was administered with Afluria (TIV) (Influenza Vaccine, dose: 0.5 ml, batch number: WT54607, expiry date: 30-Jun-2017 (expired dose), route of administration and anatomical location: not reported) for Influenza prophylaxis.  It was reported that the pregnant patient received the expired vaccine (explicitly coded to expired vaccine used). The patient experienced adverse event, but no adverse reaction was experienced in the foetus. The estimated date of delivery was on 29-Oct-2017. It was stated that, the mother and the baby was good with no problem. No other information was provided.  The outcome of the event was not reported.  Follow-up report received from the reporter on 17-Apr-2018: The reporter confirmed that the estimated date of delivery was 29-Oct-2017 and the patient was not enrolled in the registry. It was stated that, the mother and the baby was good with no problem. No other information was provided. Amended narrative accordingly.; Reporter's Comments: A 29-year-old, adult pregnant female patient was vaccinated with expired vaccine. The causality is assessed as not related due to nature of the events.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site reaction, Pain in extremity, Rash macular
Clinical narrative: Felt like joints were hurting; Had pain form left armpit to wrist; Blotchy skin began on 01MAR18, in the upper arm area where injection was given; Patient characterized as looks like liver spots; This is a non-serious spontaneous case, initially received from pharmacist on 02-Mar-2018, concerning a 77-year-old, elderly, male patient.  The patient's medical history and concomitant medications were not reported.  On 07-Feb-2018, the patient was administered with Afluria Quadrivalent (influenza vaccine, dose; 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported) for an unknown indication.  On 01-Mar-2018, after 23 days of vaccination, the patient developed blotchy skin in upper arm, where injection was given (skin blotches) which looked like as liver spots. On an unspecified date, the patient had joint pain and pain from left armpit to his wrist (pain in arm).   At the time of this report, the patient had recovered from the events.  Follow-up report received from pharmacist on 28-Mar-2018: The date of birth and the age of the patient was updated. The outcome (recovered) for all the events was updated. Narrative amended accordingly.; Reporter's Comments: A 77-year-old, male patient, developed skin blotches, liver spots after 23 days of vaccination, joint pain and pain in arm on an unspecified date after the vaccination, company assess the events skin blotches, liver spots as not related due to long onset latency and joint pain, pain in arm as unassessable due to unknown onset latency.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Numbness [and tingling] of extremities; Inability to lift the arm past their shoulder; Tingling in extremities; This is a spontaneous case initially received from other health professional (nurse) on 26-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date in Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39107 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day after vaccination, the patient was unable to lift the arm past her shoulder and experienced numbness and tingling in her extremities.  The outcome of the events was recovered (2 weeks or more after administration date).  The reporter assessed the case as non-serious.; Reporter's Comments: A female patient of an unspecified age experienced numbness and tingling in her extremities and was unable to lift her arm past shoulder, on the same day after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and the suspect vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Numbness [and tingling] of extremities; Inability to lift the arm past their shoulder; Tingling in extremities; This is a spontaneous case initially received from other health professional (nurse) on 26-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date in Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39107 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day after vaccination, the patient was unable to lift the arm past her shoulder and experienced numbness and tingling in her extremities.  The outcome of the events was recovered (2 weeks or more after administration date).  This case is linked to 201804876, due to same reporter.  The reporter assessed the case as non-serious.; Reporter's Comments: A female patient of an unspecified age experienced numbness and tingling in her extremities and was unable to lift her arm past shoulder, on the same day after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and the suspect vaccine.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Tenderness
Clinical narrative: Shoulder pain; Tenderness under biceps; This is a spontaneous case, initially received from other health professional on 20-Nov-2018, concerning a 54-year-old, adult, female patient.  The patient had no medical history and did not receive any concomitant medications.  On 30-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252663 and expiry date: 31-May-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in 2018, reported as few days later after vaccination, the patient experienced tenderness under the biceps and pain in the shoulder. The patient had no redness and swelling. The patient went to the doctor and was prescribed with Naproxen twice a day.  At the time of this report, the patient had not recovered from the events.  The reporter assessed the case as non-serious.; Reporter's Comments: A 54-year-old, female patient developed shoulder pain and tenderness on an unspecified date (reported as few days later) after administration of Flucelvax QIVc. The company assessed the causality of the events as unassessable due to lack of information regarding the onset latency. The case will be further assessed upon receipt of follow up information.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Tenderness
Clinical narrative: Shoulder pain; Tenderness under the biceps; This is a spontaneous case, initially received from other health professional on 20-Nov-2018, concerning a 29-year-old, adult, female patient.  The patient had no medical history and concomitant medications.  On 26-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252663 and expiry date: 31-May-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in 2018 (a few days later as reported), the patient experienced tenderness under the biceps and pain in the shoulder. The patient had no redness and swelling. The patient went to doctor and prescribed with Medrol (methylprednisolone) dose pack.  At the time of this report, the patient had not recovered from the events.  The reporter assessed this case as non-serious.  This case is linked to 201805709, due to same reporter.; Reporter's Comments: A 29-year-old, female patient developed shoulder pain and tenderness on an unspecified date after administration of Flucelvax QIVc vaccine. The company assessed the causality of the events as unassessable due to lack of information regarding the event onset date and onset latency between the event and the suspect vaccine. The case will be further assessed upon receipt of follow up information.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Left arm pain; This is a spontaneous case initially received from a pharmacist on 24-Nov-2018, concerning a 25-year-old adult female patient.  The patient did not have any relevant medical history. The patient did not administer any other vaccines or medications.  On 12-Nov-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid left arm, batch number: 252665 and expiration date: Nov-2018) for influenza prophylaxis.  On the same day, after the administration of the vaccine, the patient experienced left arm pain. Pharmacist assessed the site and there was no redness, bruising or swelling, no streaks or numbness or tingling in the arm or fingers. Patient has not tried any over the counter medicines or taken any treatment and was applying ice to site.  The outcome of the events was not recovered.  The reporter assessed this case as non-serious.  Follow-up received from the pharmacist on 28-Dec-2018: The med info number was added in the additional information tab. The reporter advised the patient to follow-up with primary care physician (PCP) and she did not call back with any other complaints. The description as reported for the event (pain in extremity) was changed changed from pain in arm' to painful L arm' in the events tab.; Reporter's Comments: A 25-year-old, female patient experienced left arm pain on the same day after administration of suspect vaccine Flucelvax QIVc. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 15-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 25-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S007770; expirationdate: 24-JUL-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; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 19-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 04-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S007770; expirationdate: 24-JUL-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; Sender's Comments:  US-009507513-1910USA012749:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient received an expired dose of varivax; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (S02469 invalid lot, but expiration date reported as 17-MAR-2022). On 01-MAY-2020, the patient was vaccinated with expired doses of varicella virus vaccine live (oka/merck)(VARIVAX) with a lot # R011809 and expiration date:23-APR-2020 (strength and dose were not reported) via subcutaneous route for prophylaxis (expired product administered). No adverse events were reported. No product quality complaint (PQC) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever of 102 degree F for 3 days. The reporter did not consented to follow up. This case has been linked with US2019197505, for unspecified number of patients.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: rash all over body, red raised bumps
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects reported.; first dose of GARDASIL 9 on an unspecified date in March 2018, second dose of GARDASIL 9 on July 30 2018, third dose of GARDASIL 9 on April 23 2020; This initial spontaneous report has been received from a registered nurse referring to a 17 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date in March 2018, when she was 15 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis. On 30-JUL-2018, 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) (lot #: N021732, expiration date: 01-FEB-2020; route and dose details were unknown). On 23-APR-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: R001262, expiration date: 10-NOV-2020; route and dose details were unknown) (inappropriate schedule of product administration). No additional adverse effects reported. 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: N021732; expirationdate: 01-FEB-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
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: experienced a reaction with Shingrix; This case was reported by a pharmacist via other manufacturer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced adverse reaction to Shingrix. The pharmacist informed that she reached GlaxoSmithKline and not Glen mark pharmaceuticals. The reporter was asked what did the patient experienced with product however she refused to provide it and mentioned that she would call the manufacturer rather. No additional information was obtained.
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: experienced arm pain for about a week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain for about a week after receiving Tdap vaccine of unknown manufacturer. The reporter did not consent to follow up. This case is 1 of the 4 cases, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had received shingrix not placebo.I recently developed shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient participated in Shingrix clinical trial in year 2014. The patient received 2 doses and was later informed that the patient had received Shingrix and not the placebo. Recently, the patient developed shingles and the patient was much improved at the time of reporting. The patient was asking if the patient should receive another Shingrix vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for herpes zoster was not provided.
Age: 70.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Malaise
Clinical narrative: Sore at the injection site; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Twinrix. On an unknown date, less than 2 months after receiving Twinrix, the patient experienced injection site pain and malaise. On an unknown date, the outcome of the injection site pain and malaise were unknown.   It was unknown if the reporter considered the injection site pain and malaise to be related to Twinrix.  Additional details were reported as follows: The pharmacist reported that a patient who does not want to receive the third dose of Twinrix at the recommended period because of the Covid-19 situation and because after the two first doses experienced malaise and sore at the injection site The reporter consented to follow up.  For tolerance after 2nd dose refer case US2020075694. Third dose not coded as suspect because of medical reason event occur after two doses.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Are going to receive the second dose of Shingrix at a longer interval; The case will be considered as invalid as the patient are going to receive the second dose of Shingrix at a longer interval' hence it seems enquiry and potential medication error and reason for this delay not specified if it was due to current pandemic.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Thinks is shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3E7B2, expiry date 4th March 2022) for prophylaxis.   The patient's past medical history included shingles (using medication from the last time he had shingles).   On 13th December 2019, the patient received the 1st dose of Shingrix .5 ml. On 25th April 2020, 134 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The reporter was the pharmacist who called for information on when the 2nd dose should be given since the patient currently has what he thinks was shingles, he has been unable to see his doctor but was using medication from the last time he had shingles.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: Dry cough; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix and an unknown time after starting Ventolin and Flonase, the patient experienced dry cough. The patient was treated with salbutamol sulphate (Ventolin), fluticasone propionate (Flonase), omeprazole (Prilosec), benadryl (nos) (Benadryl), cough cold preparations nos (Cough Syrup) and codeine. On an unknown date, the outcome of the dry cough was not recovered/not resolved.   It was unknown if the reporter considered the dry cough to be related to Shingrix.  Additional information was provided as follows: The reporter reported for her mother. The patient received Shingrix and within a week after vaccination her mother started experiencing dry cough and it continued.  The patient had to clear her throat more often now. Patient had tried prilosec, ventolin, benadryl, Flonase and cough syrup with codeine. Nothing had helped and she was still experiencing the cough. The reporter did not consent to follow up. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain, swelling. redness, and itching at the injection site; pain, swelling. redness, and itching at the injection site; pain, swelling. redness, and itching at the injection site; pain, swelling. redness, and itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2020, 24 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and twenty four hours later developed pain, swelling, redness, and itching at the injection site.  She stated this lasted for twenty four hours and resolved. She stated she treated her symptoms with half a Benadryl. The reporter did not consent to follow up. The consumer declined to provide demographics other than initials, declined health care professional follow up.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: experienced arm pain for about a week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain for about a week after receiving Tdap vaccine of unknown manufacturer. The reporter did not consent to follow up. This case is 1 of the 4 cases, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Malaise, Vaccine positive rechallenge
Clinical narrative: Sore at the injection site; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   Previously administered products included Twinrix with an associated reaction of injection site pain (1st dose received on 29th October 2019, batch number H4A37, expiry date 18 October 2021 refer case,US2020AMR076065).   On 3rd December 2019, the patient received the 2nd dose of Twinrix. On an unknown date, less than 6 months after receiving Twinrix, the patient experienced injection site pain and malaise. Rechallenge with Twinrix was positive. On an unknown date, the outcome of the injection site pain and malaise were unknown.   It was unknown if the reporter considered the injection site pain and malaise to be related to Twinrix.  Additional details were reported as follows: The pharmacist reported that a patient who does not want to receive the third dose of Twinrix at the recommended period because of the Covid-19 situation and because after the two first doses experienced malaise and sore at the injection site The reporter consented to follow up.  Third dose not coded as suspect because of medical reason event occur after two doses.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: doctor mistakenly administered only the diluent portion of pentacel vaccine, no AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 7 months old male patient who was vaccinated only with the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (third dose, 0.5 ml, lot number 6469AA, expiration :03-Nov-2020) mistakenly by a doctor, via intramuscular route in the right leg on 16-Mar-2020 as prophylactic vaccination.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to  active ingredient not added to diluent.  No adverse event 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.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received IPOL that had already expired on 03-May-2020/ No AE; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four years old female patient who was inadvertently vaccinated with 0.5 mL dose of expired vaccine IPV (VERO) [IPOL] (4th dose in series, lot P1A461M and expiry date 03-May-2020) via intramuscular route in the left thigh on 04-May-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  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: 32.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypersensitivity, Incomplete course of vaccination, Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: Pt received Menveo (1st dose) and Bexsero (2nd dose as 1st dose was given at a different location) on 2/10/2020.   Pt stated developed approximately 4cm square like area of red/purple bruising and "hard" swelling to right arm below the injection site.   Reaction lasted about a week and resolved without further issues.   Care Health was unaware of reaction until 2/17/2020 when we called patient to schedule the next Menveo injection.   Per patient scheduler on 2/17/2020: spoke with patient she stated that she had an allergic reaction to the vaccine. Per patient she is waiting to see what her Doctors says and will hold off on making the 2nd appointment.   On 2/28/2020: Program Coordinator/Program: received a call from RN at the MD?s office and she informed me that the MD wishes to not proceed with the Menveo booster due to the patient?s allergic reaction. The patient?s Staff also reached out to me and confirmed this information as well.
Age: 32.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Pt received Menveo (1st dose) and Bexsero (2nd dose as 1st dose was given at a different location) on 2/10/2020.   Pt stated developed approximately 4cm square like area of red/purple bruising and "hard" swelling to right arm below the injection site.   Reaction lasted about a week and resolved without further issues.   Care Health was unaware of reaction until 2/17/2020 when we called patient to schedule the next Menveo injection.   Per patient scheduler on 2/17/2020: spoke with patient she stated that she had an allergic reaction to the vaccine. Per patient she is waiting to see what her Doctors says and will hold off on making the 2nd appointment.   On 2/28/2020: Program Coordinator/Program: received a call from RN at the MD?s office and she informed me that the MD wishes to not proceed with the Menveo booster due to the patient?s allergic reaction. The patient?s Staff also reached out to me and confirmed this information as well.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis
Clinical narrative: Vaccine administered on 5/22/19. On 5/28/19 the pt called the office to report pain in Left arm. Denied redness or warmth. The patient stated that she had a co-worked look at the injection site and it was noted to be two fingerbreadths below the top of the arm. The patient saw her PCP on 5/28/19 and the PCP reports that injection was given directly into Deltoid Bursa. Patient diagnosed with bursitis. Patient instructed to immobilize and ice extremity. Patient started physical therapy on 10/7/2019.  Discharged from physical therapy on 12/27/2019
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Death
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 01-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007770; expirationdate: 24-JUL-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; Sender's Comments:  US-009507513-1910USA012749: