chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEP
Symptoms: Intercepted medication error, Product preparation issue, Therapy non-responder
Clinical narrative: therapy non-respoder; Inappropriate preparation of medication; intercepted medication error; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Engerix B at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Engerix B, the patient experienced therapy non-responder, inappropriate preparation of medication and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the therapy non-responder, inappropriate preparation of medication and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have patient's gender or age.  The patient was previously vaccinated with Hepatitis B series (unknown manufacturer of series). The patient was immunocompromised and was not responding to Hepatitis B series.  The reporter inquired about combining two doses of Engerix-B into one syringe, which led to circumstance or information capable of leading to medication error and would have led to inappropriate preparation of medication if administered. The reporter refused to provide any patient information and address of hospital.
Age: 19.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Incomplete course of vaccination, Mental disorder
Clinical narrative: Psychiatric hospitalization; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of psychiatric disorder nos in a 19-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of RabAvert. On an unknown date, the patient received the 2nd dose of RabAvert. In June 2019, less than a week after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced psychiatric disorder nos (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the psychiatric disorder nos and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the psychiatric disorder nos to be related to RabAvert.  Additional information was provided as follows: The age at vaccination was not applicable for 2nd dose of RabAvert. The patient was recently admitted to the reporter's  inpatient hospitalization facility. The patient did not received 2nd dose of RabAvert, which he should received on day 3 from 1st dose, which led to incomplete cousre of vaccination. When pharmacist inquired for this, the hospital healthcare professional did not provided details surrounding hospitalization and stated that she was calling from psychiatric facility and the patient was hospitalized for those type of reasons. Vaccination facility information was not provided. The healthcare professional declined provide additional details due to patient privacy.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number 27D9A, expiry date 16th June 2020) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional information received were as follows: The 7 month old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Nausea, Pyrexia
Clinical narrative: fever; nausea; headache; fatigue; couldn't sleep; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 24th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th June 2019, less than a day after receiving Shingrix, the patient experienced fever, nausea, headache, fatigue and sleeplessness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the nausea, headache, fatigue and sleeplessness were unknown.   It was unknown if the reporter considered the fever, nausea, headache, fatigue and sleeplessness to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the right arm. The healthcare professional reported that the patient's body temperature was recorded as 100.1 degree F. The patient could not sleep the night she received her second dose of Shingrix. The office instructed patient on 25th June 2019 to call back if symptoms did not resolve in 24 hours and the patient had not called back. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Low titers; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional information received were as follows: The age at vaccination was not reported. The physician on the line reported that about 5 to 6 years ago, the patient received three courses (completed the series three times) of Engerix B and still had zero response, which led the patient to be therapy non-responder. No further information was provided. This case has been linked with US2019AMR117487, reported by the same reporter.       Lab Comments: On an unknown date, the patient had test for Hepatitis B antibody and found to be zero titer.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leg paralysis (Right leg paralysis). Concurrent medical conditions included peripheral neuropathy (right leg peripheral neuropathy).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. 2 months and a couple of weeks ago, the patient received Shingrix on left arm. The patient stated that she experienced injection site soreness that lasted for 2 days. The reporter consented to follow up. The reporter did not had vaccine information for this adverse event. The outcome reported in the structured field of source document was reported as recovered/resolved with sequel and the outcome reported in the narrative was resolved.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Pain
Clinical narrative: soreness; itcheness in left forearm; rash in left forearm; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2019, the patient received the 1st dose of Shingrix. In March 2019, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site rash. On an unknown date, the patient experienced pain. The patient was treated with diphenhydramine hydrochloride + zinc acetate (Benadryl Topical Spray) and benadryl (nos) (Benadryl Oral). Shingrix was discontinued. On an unknown date, the outcome of the injection site itching, injection site rash and pain were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site rash and pain to be related to Shingrix.  Additional details were provided as follows: At the time of reporting, the patient planned not to receive the 2nd dose of the Shingrix. The patient experienced rash and itchiness in the left forearm within 2-3 days after receiving Shingrix. Less than a month after receiving Shingrix, the patient experienced some soreness for a few days. The patient experienced rash and itch for a total of 3 weeks. The patient applied topical Benadryl spray to the area, but the rash and itch did not resolve. Then as per advise from her physician, she received oral Benadryl and the itch and rash resolved.  The reporter consented to follow up. The outcome reported in the structured field (RECOVERED/RESOLVED WITH SEQUEL) and the outcome reported in the source document (RECOVERED).
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: injected Daptacel that expired on 16May2019 to an 18 month old male patient; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient who was vaccinated with expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccine (lot C5202AA, Exp date- 5/16/2019).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to Expired vaccine used.  It was reported that injected Daptacel that expired on 16 May 2019 to an 18 month old patient.  It was not reported if the patient experienced 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 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.  Based on information previously received, the following information [corrections] has/have been amended.  The reporter state has been modified.
Sex: M
Vaccine: MNQ
Symptoms: Crohn's disease
Clinical narrative: Crohn's disease; other things; Initial information received on 28-Jun-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a male patient of unknown age who experienced crohn's disease and other things, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   In 2010, the patient received a first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route and was going to get second vaccination.  On an unknown date, The patient developed a serious crohn's disease and non serious other things (unevaluable event) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event (crohn's disease) was assessed as medically significant.  Nurse asked about any concerns with administering Menactra to a patient receiving Remicade and methotrexate. Nurse stated that she did not have the patient's chart available, so she did not know whether the patient already had been diagnosed with Crohn's in 2010 and already was receiving Remicade and methotrexate, prior to his first Menactra immunization, or whether the patient was diagnosed with Crohn's and began treatment after having received the Menactra vaccine in 2010.  No lab test was reported.   Final diagnosis was other things and crohn's disease.   The patient was treated with INFLIXIMAB (REMICADE) for Crohn's disease and METHOTREXATE (METHOTREXATE) for Crohn's disease.  The event outcome was not reported.  Information on the batch number was requested; Sender's Comments: Patient presented with Crohn's disease after vaccination. Time to onset is unknown. Patient was treated with INFLIXIMAB (REMICADE) for and METHOTREXATE (METHOTREXATE) for Crohn's disease. Further information including patient's medical history, concomitant medications, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: frozen dose of Menactra administered; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an 18 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that frozen dose of Menactra administered.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-Jun-2019, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6455CC and expiry date: 15-Nov-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to product preparation issue.  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: DTAP
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: expired Daptacel was administered/ no symptoms; fourth dose in series of Daptacel was administered to 3 years, 10 month old / no symptoms; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years, 10 month old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not received.   On 13-Jun-2019, the patient received a fourth dose in series 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA, expiry date 24-Apr-2019 via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered.  It was reported that expired Daptacel was administered was administered to patient.  The patient did not experience any adverse reaction after the injection.   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: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: Moderately severe pain  at injection site for 36 hrs Headache, moderately severe body aches, chills starting 12 hours after injection and lasting 24 hours
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: The day after the vaccine my arm was sore and injection site a little red  Starting on July 1 I noticed a rash with warmth and itching it has now increased in area, hot to touch and extremely itchy .
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, tenderness to injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 12-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a certified physician assistant for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; patient inadvertently received an expired dose of VAQTA on 6/24/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug, reactions, allergies, historical drugs or medical history.  On 24-JUN-2019, the patient inadvertently received an expired dose of hepatitis a vaccine, inactivated (VAQTA) (formulation, strength, dose, frequency, route of administration, anatomical location, indication, were not reported). Lot No. R013858 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 12-JUN-2019. No adverse event was reported.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Injection site swelling, Skin lesion
Clinical narrative: Skin lesion; The patient developed two pencil eraser sized lesions on her back; The patient was also experiencing swelling around the injection site although was not severe.; This spontaneous report was received from a patient's mother, referring to a 3-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On 21-JUN-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 injection subcutaneous (lot# R002051, expiration date 22-JAN-2020) and. The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# and expiration date were not reported).   On 23-JUN-2019, the patient developed two pencil eraser sized lesions on her back (skin lesion).  On 24-JUN-2019, the patient experienced two more lesions, one on the upper thigh and one on the sternum. It was reported that the patient was not experiencing any itching or discomfort. The patient was also experiencing swelling around the injection site although was not severe. There were no laboratories or studies performed.   At the time of this report, the patient was not recovered from the events. The causality assessment between the vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events, was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: But "tested positive for HPV 16 and 18 on 21-JUN-2019; This spontaneous report was received from a 29-years-old, female, pregnant (16 weeks) patient reporting on herself. No information regarding the patient's pertinent medical history, previously drug reactions or allergies, and concomitant therapies was provided.   On an unspecied day in June 2006, the patient was vaccinated with at least one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) in the deltoid arm, for prevent human papillomavirus (HPV) (formulation, strength, lot number and expiration date were not provided; the dose and  frequency were unknown by the reporter, and if could not be established how many doses of the suspect vaccine the patient received), however the patient tested positive for human papillomavirus (HPV) (papilloma viral infection) 16 and 18 on 21-JUN-2019. Also, the patient stated that she was "naive to human papillomavirus (HPV)", when she received the vaccionation. The patient did not receive treatment for the event and did not sought medical attention.  At the time of this report, the  outcome of the event papiloma viral infection was reported as not resolved.  The relatedness between the suspect therapy and all the aforementioned event was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse effect; patient received a subcutaneous dose of M-MR II and Varivax on 04-NOV-2008; This spontaneous report was received from a Licensed Practical Nurse referred to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not reported. On 04-NOV-2008 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # 0043X, expiry date 19-DEC-2009, via subcutaneous route for prophylaxis (dose was not reported). On the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # 1216X and expiry date 27-AUG-2010 via subcutaneous route for prophylaxis (dose was not reported) (Inappropriate schedule of product administration). Concomitant therapies included influenza virus 3v reassortant vaccine live intranasal (cold adapted ann arbor master strain)(FLUMIST (INFLUENZA VIRUS 3V REASSORTANT VACCINE LIVE INTRANASAL (COLD ADAPTED ANN ARBOR MASTER STRAIN))) and sterile diluent (STERILE DILUENT). No adverse effects were reported. Product quality complaint was not involved.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse effect; unspecified 10 years old patient inadvertently received an adult dose of VAQTA; unspecified 10 years old patient inadvertently received an adult dose of VAQTA; This spontaneous report was received from the medical assistant, concerning to a 10-years-old patient of unknown gender. The patient's medical history, concomitant therapies, concurrent conditions and past drug allergies or reactions were not reported.   On 14-JUN-2019, the patient was inadvertently vaccinated with and adult dose (incorrect dose administered/product administered to patient of inappropriate age) of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml (lot # S001832 has been verified to be a valid lot number for hepatitis a vaccine, inactivated with expiration date on 12-MAY-2019), one dosage form, via intramuscular route for prophylaxis (anatomical site of injection was not reported).  It was reported by the medical assistant, that it was the first dose of the series. No adverse event reported nor product quality complain involved.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: she is not immune to measles or rubella; had the mumps; This spontaneous report was received from a female patient of unknown age who was referring to herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient received the vaccine twice in her lifetime, however it could not be confirmed when either vaccine was given.  The patient reported that she was not immune to measles or rubella after receiving the vaccine. The patient also stated that she was immune to mumps, because she had the mumps (date unknown). It could not be confirmed if the patient developed mumps after receiving the vaccine or prior to vaccination.  The outcome of the events and the causality assessment were not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000862: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PEDVAXHIB (R027325, 7/10/2021) were administered; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 30-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R027325 has been verified to be a valid lot number, expiration date was reported as 10-JUL-2021 and was confirmed to be valid) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), was stored in the lowest temperature below 2 Celsius degrees (1.4 Celsius degrees) in time frame 42 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002781: US-009507513-1907USA002782:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The patient received two doses of GARDASIL but did not complete the series.; no adverse event; This spontaneous report was received from a nurse concerning a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date in 2005, also reported as about 14 years ago, when the patient was 15 years old she received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) but did not complete the series (inappropriate schedule of product administration). No adverse effects reported.  The outcome of inappropriate schedule of product administration was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient received her first dose of GARDASIL 9 three years ago, received a second dose on 5/29/2019, and was currently in the office to receive the third dose of the series.; no adverse effects; This spontaneous report was received from a nurse concerning a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date in 2016, also reported as about three years ago, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 25-MAY-2019, the patient was administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (inappropriate schedule of product administration). The patient was currently in the office to receive the third dose of the series. No adverse effects reported.  The outcome of inappropriate schedule of product administration was not reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received the first dose of GARDASIL 9 at the age of 12 years old and received the 2nd dose of GARDASIL 9 four months later.; no adverse event; This spontaneous report was received from a female patient of unknown age reporting on herself. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient at the age of 12 years old, received the first dose of she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, also reported as four months later, she was administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (inappropriate schedule of product administration). No adverse effects reported.  The outcome of inappropriate schedule of product administration was not reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; Drug dose administration interval too short; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's past relevant drugs, medical history, concurrent conditions or concomitant medications was not provided.  On 01-FEB-2019, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 microgram per milliliter; on 18-MAR-2019, with the second dose; and on 03-JUN-2019, with an early third dose (inappropriate schedule of product administration). All the doses were administered intramuscularly as prophylaxis (dose, anatomical location, lot number and expiration date were not reported). No adverse events were reported for the patient and no further information was available.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PEDVAXHIB (R027325, 7/10/2021) were administered; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 30-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R027325 has been verified to be a valid lot number, expiration date was reported as 10-JUL-2021 and was confirmed to be valid) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), was stored in the lowest temperature below 2 Celsius degrees (1.4 Celsius degrees) in time frame 42 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001681: US-009507513-1907USA002782:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PEDVAXHIB (R027325, 7/10/2021) were administered; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 30-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R027325 has been verified to be a valid lot number, expiration date was reported as 10-JUL-2021 and was confirmed to be valid) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), was stored in the lowest temperature below 2 Celsius degrees (1.4 Celsius degrees) in time frame 42 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002781: US-009507513-1907USA001681:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Gastric disorder, Vaccine positive rechallenge
Clinical narrative: stomach distress; pain in her stomach; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of gastric disorder (received 1st dose on 18th January 2019, refer case US2019AMR117304).   On 18th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced gastric disorder, stomach pain and upset stomach. The patient was treated with omeprazole. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the gastric disorder, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the gastric disorder, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The customer initially called on behalf of his wife. The patient received Shingrix and she experienced stomach distress. pain in her stomach, upset stomach.  The symptoms have been worse after the 2nd dose of Shingrix.  She was still experiencing these symptoms because they come and go and they come back when she eats something. She has visited her physician and her physician has prescribed omeprazole but that did not help.  She had been taking omeprazole for a month already. She was having an ultrasound on her abdomen after the date of reporting. The patient said that she only weighs 115 pounds. She said that she was a tiny person and maybe the shingrix was too strong for her.  The reporter consented to follow up. The caller put the patient directly on the phone.  The patient said that we could contact her physician.
Sex: U
Vaccine: UNK, UNK, VARZOS
Symptoms: Dysphagia, Oral pain, Pyrexia
Clinical narrative: fever; Mouth sore; Difficulty swallowing; This case was reported by a consumer via other and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. In August 2018, the patient started Xeljanz (oral) 10 mg twice daily (20 mg daily). On an unknown date, the dose was changed to 10 mg twice daily (20 mg daily). In October 2018, less than a year after receiving Shingrix, the patient experienced fever, oral pain and swallowing difficult. The action taken with Xeljanz was unknown (Dechallenge was unknown). Rechallenge with Xeljanz was unknown. On an unknown date, the outcome of the fever, oral pain and swallowing difficult were recovered/resolved.   It was unknown if the reporter considered the fever, oral pain and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced fever, mouth sore and difficulty in swallowing last year in October 2018 ,after 1st dose of Shingrix. In October 2018, the patient missed few doses, The patient was off medication for few days, no symptoms reported during missed doses. Stools formed twice a day prior to start of therapy was feeling sad and resolved.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: shingle outbreak; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and 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 information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and 2 months prior to report, she had shingles outbteak. The patient did not received 2nd dose of Shingrix till the time of report, which led to incomplete course of vaccination.
Sex: M
Vaccine: MENB
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy cervical; This case was reported by a physician via sales rep and described the occurrence of lymphadenopathy cervical in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, 2 days after receiving Bexsero, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was unknown.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and had palpable lymph node around clavicle. The physician did not know whether this was a known a known side effect. The reporter agreed for follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: feeling cold; shivering; fever; achy; tired; headache; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received Shingrix (intramuscular). On 25th June 2019, 1 days after receiving Shingrix, the patient experienced feeling cold, shivering, fever, pain, tiredness and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling cold, shivering, pain, tiredness and headache were not recovered/not resolved and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the feeling cold, shivering, fever, pain, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. After vaccination with Shingrix, on 25th June 2019, about 3 AM, the patient woke up feeling cold and shivering. The patient went back to slept and when woke up in the morning, the patient had fever and headache and felt achy and tired. Tylenol brought the fever down. The reporter consented to follow up. As per source document, the outcome of the events were recovering, but as per case narrative the outcome of the events were not recovered.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: feeling cold; shivering; fever; achy; tired; headache; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received Shingrix (intramuscular). On 25th June 2019, 1 days after receiving Shingrix, the patient experienced feeling cold, shivering, fever, pain, tiredness and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling cold, shivering, pain, tiredness and headache were not recovered/not resolved and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the feeling cold, shivering, fever, pain, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. After vaccination with Shingrix, on 25th June 2019, about 3 AM, the patient woke up feeling cold and shivering. The patient went back to slept and when woke up in the morning, the patient had fever and headache and felt achy and tired. Tylenol brought the fever down. The reporter consented to follow up. As per source document, the outcome of the events were recovering, but as per case narrative the outcome of the events were not recovered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: fever blisters; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   Previously administered products included Valtrex (for fever blister).   On 21st June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The pharmacist reported the patient called on the day of reporting and asked if she could take Valtrex for fever blisters on her mouth.