chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Rash, Vomiting
Clinical narrative: vision loss in both eyes; severe outbreak of a rash and shingles on her left leg, back and the side of her abdomen/multiple shingles outbreaks; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 04-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   Shortly after receiving the Zoster Vaccine Live (ZOSTAVAX), on or about 24-AUG-2015, the patient experienced a severe outbreak of a rash and shingles on her left leg, back and the side of her abdomen, tremendous pain in her ankle as well as a sickness that included headaches, vomiting, and diarrhea. The shingles and associated injuries eventually resulted in vision loss In both eyes resulting in a surgery on her right eye in May 2016. She suffered multiple shingles outbreaks as a result of the Zoster Vaccine Live (ZOSTAVAX). As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).    Outbreak of shingles and vision loss were considered to be disabling.  Upon internal review vision loss was considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: The patient has had soreness since the injection; This spontaneous report was received from a pharmacist referring to a 63 year old male patient. The patient's concurrent conditions included type 2 diabetes mellitus and hypertension. Information regarding medical history or concomitant medication was not provided. The patient did not have drug reactions or allergies.  On an unknown date in 2019 (also reported as 28-AUG-2019, conflicting information), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R016638, expiration date 28-JAN-2020) intramuscularly  in his dominant arm, for prophylaxis.  On approximately 07-AUG-2019 (reported as about 3 weeks ago), the patient had soreness since the injection and he spoke with the pharmacist to see how much longer the soreness would last. The patient had not complained of any other symptoms. It was also reported that laboratory diagnostics or studies were not performed.  At the reporting time, the outcome of pain was reported as not recovered. The causality assessment was not provided.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored PROQUAD; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a 4 years old female. On 26-NOV-2018, she was vaccinated with improperly stored varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012374: US-009507513-1908USA012377:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a one year old male. On 26-NOV-2018, he was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012365: US-009507513-1908USA012374: US-009507513-1908USA012377:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect reported; 22 year old patient received one dose of PROQUAD; This spontaneous report was received from a healthcare professional (Medical assistant) refers to a 22-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On 22-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), via subcutaneous route for prophylaxis (Therapy type: rHA, Lot # S006830, expiry date: 02-SEP-2020). Other suspect therapies included sterile diluent (STERILE DILUENT) (Lot # S013899, expiry date: 07-MAR-2022). On 22-AUG-2019, the 22-year-old patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age). No adverse effect reported. No PQC involved. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.  This is one of the two report received from the same reporter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a one year old female. On 26-NOV-2018, she was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N025933, expiration date 19-SEP-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012374: US-009507513-1908USA012377:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored PROQUAD; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown) (product storage error), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a 4 years old female. On 27-NOV-2018, she was vaccinated with improperly stored varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012377:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a one year old male. On 27-NOV-2018, he was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012374:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 23-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. Data logger was not involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received unspecified dose of PEDVAXHIB that was improperly stored/experienced excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-MAY-2018, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose and route of administration were not reported, lot # N003536, expiration date 02-NOV-2019) for prophylaxis. On 10-MAY-2018, the administered dose of vaccine experienced the temperature excursion of 8.72 degrees Celsius for 1 hour and 35 minutes. Data logger was involved. There was more than 1 previous excursion reported. There was no adverse effects reported.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine on 19-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknow age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-APR-2019, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot number R021078 with expiration date 12-JUN-2021. There was no previous temperature excursion reported, the vaccine was exposed to temperature of 52.5 Fahrenheit degrees during 4 hours and 40 minutes. Digital data logger was filled.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experiencing pain, erythema and swelling at injection site; Patient is experiencing pain, erythema and swelling at injection site of PNEUMOVAX; Patient is experiencing pain, erythema and swelling at injection site of PNEUMOVAX; Vaccine was also administered the subdermal route; This spontaneous report was received from a registered nurse concerning a 46 year old male patient. The patient's concurrent conditions included intravenous drug abuse and hepatitis C. The patient's allergies included Mountain Cedar Tree. The patient's concomitant therapies included piperacillin sodium, tazobactam sodium(ZOSYN) and vancomycin(VANCOMYCIN).   On 27-AUG-2019 the patient was vaccinated with a dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S012822 with expiration date of 21-FEB-2021, subdermal for prophylaxis (dose and frequency were not provided).       On 29-AUG-2019, the patient was experiencing pain, erythema and swelling at injection site. The patient sought unspecified medical attention and no laboratory diagnostics or studies were performed. The outcome of injection site swelling, injection site pain and injection site erythema was reported as not resolved. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: A patient experienced vomiting; Information has been received from a nurse prescriber who reported to another nurse prescriber via company representative, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the 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) injection for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were unknown by the reporter).   On an unknown date experienced vomiting after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of vomiting was unknown.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and vomiting was not provided.
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported.; a male patient received properly stored M-M-R II and properly stored VARlVAX intramuscularly in the right deltoid instead of subcutaneously; VARIVAX was given concomitantly with MMR II; This spontaneous report was received from a nurse concerning a currently 17 years old male patient. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 29-AUG-2019, the patient was vaccinated with properly store Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) lot number R029513 with expiration date on 14-OCT-2020 and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R024024 with expiration date on 22-AUG-2020 (inappropriate schedule of vaccine administered) booth vaccines were administered intramuscularly in the right deltoid instead of subcutaneously (inappropriate route of vaccination) for prophylaxis (exact doses, and frequencies were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot number S000978 with expiration date on 22-JUL-2021). No adverse effect reported.
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Began vomiting while in the office; This spontaneous report was received from a respiratory therapist and refers to a 2 year old male patient. The patient had no pertinent medical history, drug reactions and allergies. The patient's concomitant therapies included cetirizine hydrochloride (ZYRTEC).     On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, dose 1, intramuscular (strength, anatomical location, lot # and expiration date were not provided) for hepatitis A prevention. On 27-AUG-2019, the patient was in the physician office to receive a second dose of hepatitis a vaccine, inactivated (VAQTA), and began vomiting while in the office. It was reported that the patient did not receive the dose of hepatitis a vaccine, inactivated (VAQTA). No treatment was given for the event. No laboratory diagnostic studied were performed.  The outcome of vomiting, as well as, the causality between the event and the suspect therapy were unknown.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No Adverse effects were reported; improperly stored doses of ROTATEQ, GARDASIL 9, and RECOMBIVAX were administered; This spontaneous report was received from a nurse referring to an 11-year-old female patient. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided.  On 07-MAY-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose, lot numbers R017251 (expiration date 04-MAY-2021) or N022718 with expiration date reported as 31-MAY-2020 which has been verified to be non-valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route and anatomical location were not reported), for prophylaxis. Then on 22-AUG-2019, she was vaccinated with a second dose of the vaccine.   Administered doses of vaccines experienced the temperature excursion above 47 degrees Fahrenheit (F) 9 degrees / Celsius (C) (highest temperature: 50.31 F) for 40 minutes and below 36 F / 2 C (lowest temperature: 0.13 C) for 152 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same source.
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: significant pain; redness in arm; swelling in arm; felt burning; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female 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 at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm, erythema of extremities, swelling arm and burning sensation. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and burning sensation were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and burning sensation to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her late 60s or early 70s. The medical assistant reported to a field representative that she received Shingrix and felt burning right after the injection. The patient experienced burning right after the injection, significant pain, redness and swelling in her arm. This case has been linked with US2019139615, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 17th December 2018, the dose was an unknown dose. On 17th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 6th July 2019, 355 days after receiving Shingrix and 201 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain in arm. The patient was treated with acyclovir (Zovirax) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced sore arm that lasted for about 3 days after Shingrix dose 1 and dose 2.  On 6th July 2019, the patient broke out with Shingles rash on middle of stomach to the chest and to the right side of the body to the middle of her back. The patient went to see her doctor on 9th July 2019, and she was diagnosed with a case of Shingles. The patient was prescribed Zovirax 500 mg five times a day for 7 days and that did not work, so she was then given Valtrex 800 mg four times a day for a week. The patient condition has improved but not resolved completely. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up. No further details were provided. For 1st occurance of soreness event refer case US2018192677 (same patient)
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: MA administered expired Menactra dose; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old male patient who was administered with 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U5917AA, expiry date: 30-Jun-2019) via intramuscular route in the left deltoid, on 20-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: RAB
Symptoms: Wrong technique in product usage process
Clinical narrative: the 4 month old female was given Imovax in a divided  dose of 0.5 ml in the same leg so she received the 1 ml dose but in 2 injections on the same day. No AE; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who was given RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number, expiry date not reported), in a divided dose of 0.5 ml in the same leg so she received the 1 ml dose but in 2 injections on 19-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong technique in product usage process.  At the time of the report, adverse event 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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Quadracel vaccine that was expired by one day was given to a consumer, no adverse event; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old patient (gender not reported) who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5248AA and Exp. Date 21-Aug-2019 )via intramuscular route in the left deltoid on 21-Aug-2019.  The patient's medical history not reported and concomitant medications included MMRVAXPRO vaccine for imunisation.  It was an actual medication error case due to expired vaccine used. It was reported that Quadracel vaccine was expired by one day was given to patient.  It was not reported whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Quadracel was given to a 5 year old accidentally, no AE; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a five years old male patient who accidentally received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5248AA, Exp. Date 21-Aug-2019) via intramuscular route in the left deltoid, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was reported that 5 year old was given a dose of Quadracel that expired yesterday. The patient was not administered any other vaccines.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adacel was given outside of age recommendation to a 4 month old; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6321AA, expiry date- 07-JUN-2021 via unknown route in the left thigh on 20-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration. Adacel was administered to a 4 month old in error as the first dose of a DTaP series.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: enlarged and tender lymph nodes; body aches; enlarged and tender lymph nodes; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 11 years old female patient who experienced enlarged and tender lymph nodes and body aches and, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Aug-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient had enlarged and tender lymph nodes (lymph node pain), body aches (pain) and enlarged and tender lymph nodes (lymphadenopathy) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Lab data was not reported.  Final diagnosis was enlarged and tender lymph nodes, body aches and enlarged and tender lymph nodes.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown all the events.  Information on the batch number was requested.  List of document held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: nurse inadvertantly gave an expired dose of Menactra; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old male patient who inadvertently received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 23-Aug-2019, the patient received a single 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841AA (expiry: 08-MAR-2019) via intramuscular route in the right deltoid.  It was a case of actual medication error case due to expired vaccine used.    It was unknown whether any adverse event was experienced by patient or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ, UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: got her 1st dose at 11 yr of age and 2nd dose at 16 yr and now she was possible given another Menactra at 18 yrs/no side effects; received Menactra instead of Meningococcal B/no side effects; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp and additional information recieved on 29-Aug-2019.  This case involves an 18 years old female patient who got her 1st dose at 11 yr of age and 2nd dose at 16 yr and now she was possible given another menactra at 18 yrs. no specific symptoms reported (extra dose administered) and received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MENINGOCOCCAL VACCINE B (wrong vaccine administered) lot number not reported, via unknown route in left deltoid on 24-Aug-2019.  The patient's past vaccination(s) included first dose of MENACTRA at 11 year. The patient's past medical history, medical treatment(s) and family history were not provided.  No other vaccines were given on that day.  It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was reported that Caller stated that pharmacy stated that is what they gave her daughter but caller is not convinced. Caller stated her daughter did not need another meningococcal vaccine, just the B portion and she thinks her daughter was given the full meningococcal vaccine. The patient received a Menactra instead of a Meningococcal B.  The patient did not experience any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Batch number was requested.  List of document held: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient was by mistake given a Quadracel that expired; Initial information received on 23-Aug-2019 regarding an unsolicited non-valid non-serious case received from a non-health Care Professional.  This case involves a 4 years old male patient (also reported as 4 years and 1 month) who was mistakenly vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication at the time of vaccination.    On 22-Aug-2019, the patient received a single 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA (expiry date: 21-Aug-2019) via intramuscular route in the left deltoid.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a FluBlok to a 15 yr old patient/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old male patient who received a dose 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1901, exp date: 17-May-2020 via intramuscular route in the right arm on 21-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that a 15 year old patient received Flublok.  It was not reported if the patient experienced any adverse event.  Outcome: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of document held: none
Age: 7.0
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: medical assistant gave 7 year old patient Pentacel, no AE; medical assistant gave 7 year old patient IPOL and Pentacel, no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a seven years old female patient who received vaccines IPV (VERO) [IPOL] (lot number and Exp. Date not reported) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6208AG, Exp. Date 11-Nov-2020), on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to  inappropriate age at vaccine administration and extra dose administered.  It was reported that the medical assistant gave 7 year old patient IPOL and Pentacel .   At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  Information on the batch number was requested for Ipol.   List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Impaired driving ability, Injection site bruising, Mobility decreased, Musculoskeletal pain
Clinical narrative: left shoulder pain with limited mobility, having difficulty driving or lifting anything; left shoulder pain with limited mobility; bruising at the injection site; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 31 years old female patient who experienced left shoulder pain with limited mobility, having difficulty driving or lifting anything, left shoulder pain with limited mobility and bruising at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious left shoulder pain with limited mobility, having difficulty driving or lifting anything (mobility decreased), left shoulder pain with limited mobility (musculoskeletal pain) and bruising at the injection site (vaccination site bruising) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was bruising at the injection site, left shoulder pain with limited mobility and left shoulder pain with limited mobility, having difficulty driving or lifting anything.  It was not reported if the patient received a corrective treatment.  The patient was Not Recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The side effects started within twelve hours. They included muscle pain in the left arm where the shot was given and redness and swelling at the injection site and it was  extremely warm to the touch. I was having bad chills and I could not get warm starting twelve   hours after the shot and lasting for 24 hours. I had a fever a few times within that time period and I was very tired. Most of my symptoms were gone within 48 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: The side effects started within twelve hours. They included muscle pain in the left arm where the shot was given and redness and swelling at the injection site and it was  extremely warm to the touch. I was having bad chills and I could not get warm starting twelve   hours after the shot and lasting for 24 hours. I had a fever a few times within that time period and I was very tired. Most of my symptoms were gone within 48 hours.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Menveo given, accidently, before minimum interval was met.