chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: found out last Wednesday that she has HPV; received a dose of GARDASIL on 12/30/2014 and 07/22/2015. The patient then received 1 dose of GARDASIL 9 on 01/03/2017; received a dose of GARDASIL on 12/30/2014 and 07/22/2015. The patient then received 1 dose of GARDASIL 9 on 01/03/2017; This spontaneous report was received from the patient's mother and refers to her 18 year old daughter. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 22-JUL-2015, the patient was vaccinated with her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site, lot# and expiration date were not reported), for prophylaxis. On 22-JUL-2015, the patient was vaccinated with her second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site, lot# and expiration date were not reported), for prophylaxis.   On 03-JAN-2017, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, vaccination site, lot# and expiration date were not reported), for prophylaxis.   On 29-MAY-2019 (reported as "last Wednesday "), the patient found out that she had HPV (papilloma viral infection).  At the time of reporting, the patient had not recovered from papilloma viral infection. The reporter did not provide a causality assessment between human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and papilloma viral infection.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: tested negative for varicella titer; This spontaneous report was received from a female nurse of unknown age regarding herself, via field employee. The patient's past medical history, concurrent conditions and drug reactions/allergies were unknown. The nurse reported that she received unspecified investigational varicella vaccine in the "1960s" and "experienced chickenpox 28 years ago". The nurse reported that she was tested negative for varicella titer and received 2 more doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route of administration, batch/lot # and expiry were unknown) to prevent varicella (PT: prophylaxis) in 2009. The nurse reported that she was again tested negative for varicella titer on an unknown date and received 2 more doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route of administration, batch/lot # and expiry were unknown) in 2011. Outcome and causality of the event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; post herpetic neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 61 year old patient (pt) of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 16-DEC-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) lot number, dosage and route of administration not provided) for long term prevention of shingles and zoster-related conditions.        On an unknown date, the pt was treated for shingles and post herpetic neuralgia as a result of zoster vaccine live (ZOSTAVAX) use. At the time of the report, the pt's outcome was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old patient (pt) of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for long term prevention of shingles and zoster-related conditions.   On an unknown date, the pt was treated for herpes zoster as a result of zoster vaccine live (ZOSTAVAX) use. At the time of the report, the pt's outcome was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old patient (pt) of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 21-OCT-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for long term prevention of shingles and zoster-related conditions.               On an unknown date, the pt was treated for herpes zoster as a result of zoster vaccine live (ZOSTAVAX) use. At the time of the report, the pt's outcome was unknown.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; The patient received one dose of expired PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 07-JUN-2019, the patient received one dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # N024385 with an expiration date on 18-MAY-2019, for prophylaxis (exact dose, route, and anatomical location were not reported). The reporter specified that no temperature excursions were reported and no adverse effects were experienced.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: patient who was administered one dose of VARIVAX on an unknown date "as a child" later experienced a case of shingles.; This spontaneous report was received from the pharmacist, referring to a currently 26-year-old female patient. There was no information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medication.  On an unknown date (also reported as when she was a child), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prevention of varicella (dosage schedule, route of administration, anatomical location, lot number and expiration date were not provided).  On an unspecified date in August 2010, the patient experienced shingles (herpes zoster). Therefore, she sought for medical attention by visiting the physician, then, she received treatment for that event. The laboratory diagnostic studies performed included an unspecified "swab". By the time of the report, the patient was recovered from the event.  There was not required an intervention to prevent a serious criteria. There was no cancer event involved and no overdose.  The causality assessment between the vaccination and the occurred event, were not provided.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects; The patient received PNEUMOVAX 23 twice; This spontaneous report was received from a patient referring to themselves a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant therapies were not reported.  On an unknown day in September 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in their arm (dose, dose number and route of administration was not reported; lot number N011491 and expiration date on 04-NOV-2018) for prophylaxis.  On an unknown day in September 2018, the patient received an extra dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in their arm (dose, dose number and route of administration was not reported; lot number R007722 and expiration date on 10-MAR-2020) for prophylaxis (extra dose administered). No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from a technician (non-health care professional) via company representative refers to a 11 year old female patient. The patient's pertinent medical history, concurrent condition , drug allergies/reactions and concomitant medications were unknown. On an unknown date in early May 2019, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL9) (strength, dose, frequency, route, lot /batch# and expiration date were unknown) for prophylaxis. On an unknown date in May 2019, after receiving the 2nd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL9), the patient experienced syncope. Patient sought no medical attention and did not receive any treatment for the event. The outcome of the event was reported as recovered. The reporter's causality assessment between the event and the suspect therapy was unknown. Product quality complaint (PQC) was not involved.   Up on internal review, the event syncope was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; patient was administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 11-JUN-2019, the patient was vaccinated with expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose and frequency unknown) lot # N026663, expiry: 25-MAY-2019, oral for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Swelling, Vaccination complication
Clinical narrative: bad reaction from Gardasil 9; swelling; Neurology was called; This spontaneous report was received from a medical assistant via company representative refers to an adult female patient who was 23 or 24 year old. Information on patient's pertinent medical history, concurrent conditions, drug allergies/reactions and concomitant therapies were unknown by the reporter.  On an unknown date (also reported as "a few days ago") the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (anatomical location, lot/batch# and expiration date were unknown) at a dose of 0.5 milliliter via injection to prevent HPV(human papillomavirus) as recommended by health care provider.  On an unknown date after leaving the physician's office the patient experienced a bad reaction (adverse reaction following immunization) from HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and went to the emergency room of an unspecified hospital where the patient was "admitted over night for one night". The patient experienced "swelling" and "neurology was called" (adverse event NOS (not otherwise specified)) to treat the patient while in the hospital. The patient received unspecified treatment and sought medical attention. Information on lab diagnostics/studies were unknown. At the time of the report outcome of the events were unknown. The causality of the event adverse reaction following immunization was considered to be related to the suspect therapy, however causality of the other events were unknown. Product quality issue was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: Secondary transmission
Clinical narrative: poster online that claimed "Merck admitted that a person who got ZOSTAVAX transmitted chicken pox to a child.; poster online that claimed "Merck admitted that a person who got ZOSTAVAX transmitted chicken pox to a child.; This spontaneous report as received from a consumer concerning a child patient of unknown age, race and gender.  The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  It was reported that the consumer saw a poster online that claimed "MERCK admitted that a person who got Zoster Vaccine Live (ZOSTAVAX) transmitted chicken pox to a child (secondary transmission).   At the reporting time, the outcome of the events was not reported.  The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the events was reported as related.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; the patient received one dose of MMR-II inadvertently by the intramuscular route; Information has been received from a pharmacist referred to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On approximately 05-JUN-2019 (reported as one week ago),  the patient received one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot number and expiration date was unknown) inadvertently by the intramuscular instead of subcutaneous and no adverse effects was reported(incorrect route of product administration and no adverse event). No product quality complaint(PQC) was found.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Hand-foot-and-mouth disease, Incorrect dose administered, Pyrexia, Rash
Clinical narrative: fever; hand-foot-mouth desease; rash; wrong  vaccine administered; This case was reported by a physician and described the occurrence of fever in a 2-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 24th May 2019, the patient received Havrix adult. On 24th May 2019, unknown after receiving Havrix adult, the patient experienced accidental overdose. On 27th May 2019, 3 days after receiving Havrix adult, the patient experienced fever, hand, foot and mouth disease and rash. On an unknown date, the outcome of the fever, hand, foot and mouth disease, rash and accidental overdose were unknown.   It was unknown if the reporter considered the fever, hand, foot and mouth disease and rash to be related to Havrix adult.  Additional details were provided as follows: The patient had inadvertently received adult dose of Havrix instead of pediatric dose of Havrix, which led to accidental underdose. The patient developed fever and a rash that looked like classic hand foot mouth disease. One of the patient experienced similar adverse event but more mild symptoms.  This case was linked to case US2019AMR104031 (twin's case ), reported by the same reporter
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Hand-foot-and-mouth disease, Incorrect dose administered, Pyrexia, Rash
Clinical narrative: fever; hand-foot-mouth desease; rash; wrong  vaccine administered; This case was reported by a physician and described the occurrence of fever in a 2-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 24th May 2019, the patient received Havrix adult. On 24th May 2019, unknown after receiving Havrix adult, the patient experienced accidental overdose. On 27th May 2019, 3 days after receiving Havrix adult, the patient experienced fever, hand, foot and mouth disease and rash. On an unknown date, the outcome of the fever, hand, foot and mouth disease, rash and accidental overdose were unknown.   It was unknown if the reporter considered the fever, hand, foot and mouth disease and rash to be related to Havrix adult.  Additional details were provided as follows: The patient had inadvertently received adult dose of Havrix instead of pediatric dose of Havrix, which led to accidental underdose. The patient developed fever and a rash that looked like classic hand foot mouth disease. One of the patient experienced similar adverse event but more mild symptoms.  This case was linked to case US2019AMR104029 (twin's case ), reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: chills/ shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, several hours after receiving Shingrix, the patient experienced chills and headache. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the chills was recovering/resolving and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received 2nd dose of Shingrix, on the day before reporting in afternoon. Last night of reporting date, several hours after vaccination, the patient experienced chills/ shivering and less than a week after vaccination, the patient experienced headache. The patient was feeling better for chills/ shivering, but was still having headache. The patient received treatment with couple of Aspirin for headache and enquiring if there was something better than that.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles/ possible Shingles on date of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix. On 4th June 2019, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist inquired that was there any side effects to patient who received Shingrix and had Shingles. The health care professional stated that patient received a dose of Shingrix and the patient thought he had Shingles. The health care professional stated that they did not  know if patient had or not.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Pain, Product preparation issue
Clinical narrative: Hurt like heck; product preparation error; intercepted medication error; This case was reported by a nurse via call center representative and described the occurrence of pain in a 22-year-old female patient who received Rabies NVS (RabAvert) (batch number SWQK49AA ?, expiry date 31st October 2022) for prophylaxis.   On 4th June 2019, the patient received the 3rd dose of RabAvert. On 4th June 2019, immediately after receiving RabAvert, the patient experienced pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain to be related to RabAvert.  Additional details were provided as follows: The patient received only diluent portion of the Rabavert vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that it hurt like heck. The nurse will reconstitute the powder with 1 mL of sterile water for injection and administer to the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: unexpected benefit; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex type ii (developed in 2008). Previously administered products included Shingrix (received on unknown date).   In March 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient had noticed that, the vaccine was helping with her hsv2 (Herpes simplex virus).   The patient heard that there has been some reports of this happening and wanted to know if we have any studies. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Influenza like illness, Pyrexia
Clinical narrative: Redness; Flu-like Symptoms; Low-grade Fever; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 3rd June 2019, less than a day after receiving Shingrix, the patient experienced erythema, influenza-like symptoms, low grade fever and intramuscular formulation administered by other route. On 4th June 2019, the outcome of the influenza-like symptoms and low grade fever were resolved with sequelae. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the erythema, influenza-like symptoms and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously rather than intramuscularly on the right arm, which led to intramuscular formulation administered by other route. Flu-like symptoms and low-grade fever were lasted for approximately 1 day. This case has been linked with US2019103301 and US2019102448, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Influenza like illness, Pyrexia
Clinical narrative: Redness; Flu-like Symptoms; Low-grade Fever; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 4th June 2019, less than a day after receiving Shingrix, the patient experienced erythema, influenza-like symptoms, low grade fever and intramuscular formulation administered by other route. On 5th June 2019, the outcome of the influenza-like symptoms and low grade fever were recovered/resolved. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the erythema, influenza-like symptoms and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously rather than intramuscularly on the right arm, which led to intramuscular formulation administered by other route. Flu-like symptoms and low-grade fever were lasted for approximately 1 day. This case has been linked with US2019103301 and US2019102443, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash on shoulder/neck; This case was reported by a physician via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the right deltoid. The physician reported that the patient developed a rash possibly shingles one week after receiving Shingrix. The rash was on the patient's neck and upper left shoulder. The rash has faded significantly ever since. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: gave a child just the DTap-IPV portion of Pentacel; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case involves a 4 months and 2 days old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), lot number UI969AAB, expiry date 04-Apr-2020.  On 05-Jun-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6327AA, expiry date 19-Sep-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that they gave a child just the DTap-IPV portion of Pentacel and gave ActHIB separately but not the vial that was in the Pentacel box.  It was unknown whether patient experienced 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.
Sex: M
Vaccine: TD
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Tenivac was inadvertently administered to a 4 year old patient; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a four years old male patient who was inadvertently administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U5854AB, Exp date: 25-Jan-2020).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included POLIOMYELITIS VACCINE (INACTIVATED) [IPOL]   It is a actual medication error due to Inappropriate age at vaccine administration.  It was reported that dose of Tenivac was inadvertently administered to a 4 year 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.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired dose of Daptacel, no AE reported; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a non-hcp (office staff).  This case involves 12-month old female patient who was vaccinated with a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number: c5180ba expiration 6-Apr-2019, via intramuscular route and in left thigh on an 10-Jun-2019.  The patient's medical history and family history were not reported.  Concomitant vaccination included a dose of pcv13 and hib vaccine.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB was reconstituted with 0.7ml of sterile water of Merck diluent, no adverse event; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 months old female patient who was vaccinated with a 0.5 ml fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI918AA and Exp. Date 05-Dec-2019) via intramuscular route in unknown administration site on 07-May-2019 which was reconstituted incorrectly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was an actual medication error case due to wrong solution used in drug reconstitution. Act-HIB was reconstituted with 0.7ml of sterile water of Merck diluent and they have them re-administer the ActHIB vaccine with the proper 0.4% Sodium Chloride diluent.  The patient did not experienced 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.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient was inadvertently given the liquid component of the Pentacel vaccine, containing the DTaP-IPV portion of the vaccine, without its being mixed with the lyophilized Hib component first; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Office staff).  This case involves a 17 months old male patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included ROTATEQ vaccine on 10-Jun-2019.   On 10-Jun-2019, the patient received a 0.5ml fourth dose in series of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UI953AAA, expiry date 30-Jun-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that patient was inadvertently given the liquid component of the Pentacel vaccine, containing the DTaP-IPV portion of the vaccine, without its being mixed with the lyophilized Hib component first.  It was unknown whether patient experienced 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.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: involving Tetanus toxoid (Allergy); Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a physician via other manufacturer Pfizer (under reference number: 2015087003).   This case involves a patient of an unknown age and gender who experienced tetanus toxoid allergy, while received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a booster dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number, expiry date, dose not reported) via unknown route in unknown administration site.  On 06-Jun-2019, he patient developed a non-serious involving tetanus toxoid (allergy) (allergy to vaccine) (unknown latency) following the administration of TETANUS TOXOID.  No lab data was reported.  Final diagnosis was involving tetanus toxoid (allergy).  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for involving tetanus toxoid (allergy).  Information on the batch number was requested.  Document held by the sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Headache
Clinical narrative: headache; an extra (third) dose of Menactra administered to patient; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 18 years old male patient who experienced headache, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 30-May-2019, the patient received a third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA via intramuscular route in the right deltoid.  On an unknown date, the patient developed a non-serious headache following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was also the case of medication error due to extra dose administered.  (Other relevant tests included no lab data.)  Final diagnosis was headache.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient was recovered from headache.  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.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV, IPV, MNQ
Symptoms: Product storage error
Clinical narrative: had one vaccine, Pentacel, that was given to a patient, after temperature excursion; temp excursion for the following vaccines: ActHIB, IPOL, Menactra, Pentacel.; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] after there was a temperature excursion of vaccines including MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route.  It was of actual medication error dose due to incorrect product storage and Deteriorated drug administered.  It was unknown whether any adverse event was experienced.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: 6 month old administered Pentacel but MA did not mix the diluent; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a physician via phone.  This case involves a 6 months old patient (gender not reported) who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique because the vaccine was not mix with the diluent.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Incoherent, Nausea, Pyrexia, Vomiting
Clinical narrative: incoherent; really weak.; nauseous; fever; vomiting; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves afemale patient who experienced incoherent, really weak., nauseous, fever and vomiting, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included menactra when she was 11 but did not have any reaction. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a Booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious incoherent, really weak.(asthenia), nauseous (nausea), fever (pyrexia), vomiting following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No lab test reported.  Final diagnosis was vomiting, fever, nauseous, really weak. and incoherent.   Patient was taken to hospital and given IV fluids and a anti-nauseous medication. Patient stated that she thought she was given an antiemetic but she stated that she didn't know that 100%.  The patient outcome is reported as Unknown for the events..  Information on the batch number was requested:
Sex: F
Vaccine: FLU3
Symptoms: Aspiration bursa abnormal, Bursitis, Joint range of motion decreased, Pain in extremity
Clinical narrative: arm very sore with limited range of motion; White blood cells in the bursa; arm  very sore; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient of an unknown age who experienced arm sore with limited range of motion and white blood cells in the bursa, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AB via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arm very sore with limited range of motion  (mobility decreased) and arm  very sore (pain in extremity) 2 weeks following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed non-serious bursa (bursitis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: Aspiration bursa - On 29-April: positive for white blood cells.  Final diagnosis was arm very sore, white blood cells in the bursa and arm very sore with limited range of motion.  It was not reported if the patient received a corrective treatment.  The outcome of the events was Unknown.  Documents held by sender: none.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Angiogram, Angiogram normal, Computerised tomogram head normal, Headache
Clinical narrative: Headache and short-term memory loss associated with sexual activity
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Headache and short-term memory loss associated with sexual activity
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest pain
Clinical narrative: Patient did not reprt adverse reaction to pharmacy until 6/11/2019.  Patient states he left pharmacy and walked to front of store. He experienced chest pain and lower back pain. He met paramedics entering the store and they did an assessment.  He states all vitals were normal and then he felt fine momentarily.
Sex: F
Vaccine: HPV9
Symptoms: Dysplasia
Clinical narrative: dysplasia; Route of GARDASIL 9 administration: oral; This spontaneous report has been received from a company field employee referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was unknown by the reporter.      On an unknown date, the patient was vaccinated with an unspecified number of doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, lot number and expiration date were not reported) orally for Human papillomavirus (HPV) prevention (Incorrect route of product administration).         On an unspecified date, the patient experienced dysplasia after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9); and she was given unspecified treatment. She did not seek medical attention. The vaccine of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was discontinued. The outcome of the event was not reported.  The causality between the even and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The Physician made a general statement regarding Bexsero adverse event of sore arm based on his clinical experience with Bexsero. The reporter did not give consent for follow up.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: rash on arms; bumps that were small and only slightly raised; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Shingrix. In May 2019, 2 days after receiving Shingrix, the patient experienced red rash and raised rash. The patient was treated with benadryl (nos) (Benadryl) and hydrocortisone (Cortisone Cream (Hydrocortisone)). On an unknown date, the outcome of the red rash and raised rash were recovered/resolved.   It was unknown if the reporter considered the red rash and raised rash to be related to Shingrix.  Additional details were reported as follows: The patient about 48 hours after vaccination experienced rash on forearms, the rash was red, with bumps that were small and only slightly raised. The patient after consulting doctor took Benadryl and applied a cortisone cream. Benadryl 6 hours apart and a few applications of the cream about 6 hours apart, the rash had faded and then resolved. The patient asked that is it safe to get the 2nd dose if got the rash after receiving the 1st dose. The patient will would ask to the physician but wanted to know GSK's GlaxoSmithKline view.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Inappropriate schedule of product administration, Musculoskeletal pain, Neck pain
Clinical narrative: achy arm; achy shoulder; headache; neck pain; back pain; Inappropiate schedule of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2018).   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th June 2019, the patient experienced pain in arm, shoulder pain, headache, neck pain and back pain. On an unknown date, the outcome of the pain in arm, shoulder pain, headache, neck pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache, neck pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in arm, shoulder pain, headache, neck pain and back pain after receiving 2nd dose of Shingrix. The patient received 2nd dose of Shingrix 10 months after receiving 1st dose, which led to lengthening of vaccination schedule. This case is linked to case US2019101097, reported by same reporter