chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 25-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 07-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 08-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Nurse reported that one dose of VARIVAX was inadvertently administered past it's expiry, to the patient on 6/28/2019; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 28-JUN-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # N017699 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 09-JUN-2019 but upon internal validation established as 09-JUN-2019, for prophylaxis (strength, dose and route of administration were not reported).    No adverse effects reported.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Cervical Intraepithelial Neoplasia CIN 1; Abnormal PAP; This spontaneous report was received from a physician, concerning a 19 years old female patient. Information regarding the patient's current conditions, medical history, drug reactions or allergies and concomitant medications was not reported.   On 07-AUG-2013, 05-NOV-2013 and 10-OCT-2014, the patient was vaccinated with the 1st, 2nd and 3rd doses of quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) respectively (strengths, doses, frequencies, routes of administration, anatomical locations, lot numbers and expiration dates were not reported) to prevent human papillomavirus (HPV) disease (prophylaxis).   On 24-JUN-2019, the patient went for office visit, and told the physician that on an unknown date, she had had a papanicolaou (PAP) test which result was abnormal (smear cervix abnormal) at her unspecified gynecologist's office, she also stated that on an unspecified date, she was diagnosed with cervical intraepithelial neoplasia (CN1) (cervical dysplasia). The reporter stated that the patient's gynecologist would follow up with a repeat PAP test in six months.   At the reporting time, the outcome of the aforementioned events was not reported.   The reporter did not provide the causal relationship between quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), and the events occurrence.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: felt feverish; This case was reported by a consumer via call center representative and described the occurrence of feverish in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on an unknown date and experienced experienced flu like symptoms and felt feverish, refer case US2019108612).   On 13th June 2019, the patient received the 2nd dose of Shingrix. On 14th June 2019, 1 days after receiving Shingrix, the patient experienced feverish. On an unknown date, the outcome of the feverish was not recovered/not resolved.   It was unknown if the reporter considered the feverish to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. Yesterday from the date of reporting, the patient stated that she received the Shingrix vaccine and felt feverish at the date of reporting. The call was disconnected and agent was not able to capture additional information.  The reporter was attempted to call back and left voicemail for patient to call back to provide additional details. This case has been linked to the US2019108612, reported for the dose 1 of the same patient.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: exhausted; arm hurts; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced exhaustion, pain in arm and muscle pain. On an unknown date, the outcome of the exhaustion, pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the exhaustion, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for themselves. The patient had the shingles shot in the week of reporting and felt exhausted, their arm hurt and had muscle aches.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient developed a rash at the injection site after her 2nd dose of Shingrix. The patient reported it to medical assistant in physician office.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: body aches; sweats; fever; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 5 hrs after receiving Shingrix, the patient experienced general body pain, sweating and fever. On an unknown date, the outcome of the general body pain, sweating and fever were recovered/resolved.   It was unknown if the reporter considered the general body pain, sweating and fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced body aches, sweats and 105 degree fever 5 hours after receiving her 2nd dose of Shingrix.  The symptoms were resolved the following day. The patient would not had been so concerned by the adverse events because and she would had known they were related to the vaccine.      Lab Comments: On unknown date, body temperature was measured.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: missed dose; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number TP5E5, expiry date 15th November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 28th December 2018, 183 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details was provided as follows: The age at vaccination was not applicable for 2nd dose. The patient has missed the 2nd dose till the date of reporting, which led to incomplete course of vaccination.
Sex: F
Vaccine: PPV, UNK
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Drug Allergies: Cymbalta; Pneumonia Vaccine; This is a spontaneous report from a Pfizer-sponsored Program. A contactable Physician reported that a 40-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at single dose for pneumococcal immunisation and duloxetine hydrochloride (CYMBALTA), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported Drug Allergies: Cymbalta; Pneumonia Vaccine on an unspecified date. The action taken in response to the event for duloxetine hydrochloride and outcome of the event were unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient received her 1st and 2nd dose of IPOL 1 month apart as recommend and that the 3rd dose is due 6 months following the 2nd dose; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demography who received vaccine IPV (VERO) [IPOL] and reported that the patient received her 1st and 2nd dose of Ipol 1 month apart as recommend and that the 3rd dose is due 6 months following the 2nd dose.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 25-Jun-2019, the patient received a 3rd dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site. 2 other doses were administered on unknown dates for suspect IPV (VERO).  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a female patient was administered expired Adacel vaccine; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 65 years old female patient who was inadvertently vaccinated with an expired 0.5 mL dose of suspect DIPHTHERIA -2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (frequency once) lot UI648AA via intramuscular route in the right arm on 24-Jun-2019 after having a cat scratch.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.  It is an actual medication error case due to expired vaccine used.  It was unknown whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: HIBV, PNC13, RVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: child received an extra dose of Hib; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months old female patient who experienced child received an extra dose of hib, while she received vaccines ROTAVIRUS VACCINE, PREVNAR 13 and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jun-2019, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UI954AA via intramuscular route in the left thigh. On an unknown date, the patient received a  dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a  dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported.  It was of actual medication error due to  extra dose administered.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: the Imovax  vaccine was injected in the bicep of a patient as opposed to the deltoid; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that the Imovax vaccine was injected in the bicep of a patient as opposed to the deltoid.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 25-Jun-2019, the patient received a 3rd dose of suspect RABIES (HDC) VACCINE 1 ml lot ARBA221A via unknown route in left biceps muscle, possibly the triceps.  It was a case of actual medication error due to vaccine administered at inappropriate site.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: expired Adacel was administered to a senior citizen, no symptoms reported; expired Adacel was administered to senior citizen, no symptoms reported; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA177590 and 2019SA178356 (same reporter).  This case involves female patient (senior citizen) who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5654AA and Exp. Date 27-Apr-2019, via unknown route in unknown administration site (vaccine was given on 17-May-2019 and 24-May-2019).  The patient past medical history and family history were not provided.  The patient did not receive any concomitant medication.  It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration.  It was reported that the Adacel expired on 4/27/19. Caller stated that the vaccine was given on 5/24 and 5/17.   No symptoms reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered a expired Tenivac vaccine; Initial information received on 28-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient (gender not reported and age at onset not reported) who was administered a expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U5525AA, expiration date: Jan-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Chills, sore arm and achy
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Induration, Injection site pallor
Clinical narrative: Large indurated, erythematous area on arm with itching and 3 small blisters.  Grew over the past week and is still present.  Vaccine site is a pale purple and about 2 cm in circumference.  Distally the erythema and induration extends 5 cm and is 4 cm wide.  The blisters are now dry.  Hot to touch.    Additionally initially for the first 3 days, severe headache and stiff neck, only on the left side (same as vaccine).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pruritus, Vaccination site discolouration
Clinical narrative: Large indurated, erythematous area on arm with itching and 3 small blisters.  Grew over the past week and is still present.  Vaccine site is a pale purple and about 2 cm in circumference.  Distally the erythema and induration extends 5 cm and is 4 cm wide.  The blisters are now dry.  Hot to touch.    Additionally initially for the first 3 days, severe headache and stiff neck, only on the left side (same as vaccine).
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Swelling, itch, large red rash
Sex: U
Vaccine: CHOL
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: TOOK EXPIRED VAXCHORA AT AN AGE OF 70 YEARS; TOOK EXPIRED VAXCHORA AT AN AGE OF 70 YEARS; This spontaneous case (PVX2019-1120) was received from a pharmacist on 06-May-2019. It describes a 70-year-old male consumer who "took expired Vaxchora at an age of 70 years". The consumer was receiving oral Vaxchora (lot no: 7000006 and expiry date: Oct 2018) for cholera prevention.  Case report: A 70-year-old male consumer who administered expired dose of Vaxchora on 06-May-2019.  Action taken with Vaxchora was not applicable.  The clinical outcome of the event "took expired Vaxchora at an age of 70 years" was unknown.; Sender's Comments: Company's Comment: The causality of the event ""took expired Vaxchora at an age of 70 years" was considered as not applicable.
Age: 70.0
Sex: F
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: 70-YEAR-OLD ELDERLY FEMALE CONSUMER WHO TOOK VAXCHORA; RECEIVED VAXCHORA WITHOUT BUFFER; A spontaneous case report was received from a caregiver on 28-May-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201905-000427 (PVX2019-1356; wife) and PVX201905-000428 (PVX2019-1355, husband) were created and cross-linked in the database.  This case describes a "70-year-old elderly female consumer who took Vaxchora" and she "received Vaxchora without buffer". The consumer was receiving oral Vaxchora (lot no: 7000014 and expiry date: Sep 2019) for cholera prophylaxis.  Case report: A 70-year-old female took a dose of Vaxchora on 24-May-2019 and she took it without adding buffer. She mixed the active component of Vaxchora with 100 mL of water. She did not experience any side effects after that.  Action taken with Vaxchora was not applicable.  The clinical outcome of the events was unknown.; Sender's Comments: Company's Comment: The causality of the event "70-year-old elderly female consumer who took Vaxchora" and she "received Vaxchora without buffer"was considered as not applicable.
Age: 69.0
Sex: U
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: 69-YEAR-OLD ELDERLY MALE CONSUMER WHO TOOK VAXCHORA; RECEIVED VAXCHORA WITHOUT BUFFER; A spontaneous case report was received from a consumer on 28-May-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201905-000427 (PVX2019-1356; wife) and PVX201905-000428 (PVX2019-1355, husband) were created and cross-linked in the database.  This case describes a "69-year-old elderly male consumer who took Vaxchora" and he "received Vaxchora without buffer". The consumer was receiving oral Vaxchora (lot no: 7000014 and expiry date: Sep 2019) for cholera prophylaxis.  Case report: A 69-year-old male took a dose of Vaxchora on 24-May-2019 and he took it without adding buffer. He mixed the active component of Vaxchora with 100 mL of water. He did not experience any side effects after that.  Action taken with Vaxchora was not applicable.  The clinical outcome of the events was unknown.; Sender's Comments: Company's Comment: The causality of the event "69-year-old elderly male consumer who took Vaxchora" and he "received Vaxchora without buffer" was considered as not applicable.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 05-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 09-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 13-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 14-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 15-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 16-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: F
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: seizure; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than an hour after receiving Bexsero, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Bexsero.  Additional details were received as follows: This case was received from patient's parent. The age at vaccination was not reported. The patient experienced seizure within 10 minutes of Bexsero vaccination.  The reporter was the only witness.  The physician refused to believe that, it was a seizure.  The reporter reported, it was scary.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: rash behind right ear/ painful rash on neck and temporal area of head; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2019, the patient received Shingrix. On 21st June 2019, 39 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient noticed a rash behind his right ear.  At the time of reporting, the patient had a painful rash over the right side of his neck and the temporal area of his head.  The rash looked like shingles. Emergency visit was required.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Night sweats
Clinical narrative: Night sweats and fatigue x1 month following vaccine administration.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site mass, Pruritus
Clinical narrative: ITCHING HEADACHE JOINT ACHES LARGE LUMP @ INJECTION SITE
Age: 13.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Arthralgia, C-reactive protein increased, Red blood cell sedimentation rate increased
Clinical narrative: Severe pain in the hips, knees and elbows; It could be reaction to gradasil 9; Erythrocyte sedimentation rate elevated; C-Reactive protein increased; This spontaneous report was received from a nurse practitioner intern via a company representative referring to a 13-year-old female patient who is also the daughter of the reporter. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were reported as unknown.   On an unknown date in August 2011, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, frequency, batch/lot # and expiration date were not reported) for adolescent immunization (prophylaxis). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID) (dTAP) (dose, strength,  route, frequency, batch/lot # and expiration date were not reported) for prophylaxis.   On an unknown date in August 2011 (after about 3 weeks from the time of vaccination) the patient experienced severe pain in the hips, knees and elbows (Arthralgia) (hospitalization), erythrocyte sedimentation rate elevated (red blood cell sedimentation rate increased) and c-reactive protein elevated (c-reactive protein increased).  On an unknown date in August 2011, the patient had to be hospitalized due to the events, where she stayed overnight and received acetaminophen (TYLENOL) for pain relief. During hospital stay, the patient underwent laboratory tests of erythrocyte sedimentation rate and C-reactive protein which were elevated but definitive cause for pain was not found. The patient's mother was told that it could be a reaction to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Vaccination complication). On an unknown date in 2011 the patient got discharged from the hospital (shortly after the hospital stay) got completely recovered from the events.   The patient did not complete the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series due to the events. Outcome of the events were reported as recovered. Causality assessment was not reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 11-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 19-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 17-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 20-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 21-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: